Risk-based Monitoring for Clinical Research Leaders

from any of you are these are already late hours believe me at the time you will invest today is worth of investing if particularly you're interested in the next generation of the monitoring or the next generation of clinical trial management and if you are interested in understanding what it will would bring for me and for our company so I will try to be as concise as possible today and bring only the highlights and the most important points of such concepts as risk-based monitoring as risk management and quality by design I hope you can see everybody can see the slide yes great so first of all I want to begin our presentation with like basic topic what we are going to cover today so we are starting with with the some discussion about centralized monitoring challenges first of all why why we do centralized monitoring and centralized monitor is one part of the RPM so it's not the full erbium but it's like on the sub part we can speak about triggers and targeted monitoring on the later stages then we come to a question what what is our BM a general so what there are lots of risk and misunderstandings and different interpretations we will try to dot the i's and cross the t's and really bring one concise and precise definition of that and the third question what I'm going to answer today is what what are the results for everybody of you why it is reasonable to think about or why it is not reasonable to think about it or just what is what is inside of this methodology and how each clinical trial can benefit from that please don't forget to use the chat for asking as many questions as you like and please also really use this opportunity to to build up a dialogue and these two to have kind of clarifying your questions maybe that you have that you had before or that will appear during our my presentations today we are doing for yes we are going to spend one hour and this is very complicated to cover all these questions within the time probably it's important to to understand that today you will hear only the highlights only the main general topics so for every detail we will have to maybe to make a build up a separate discussion so I'm going to start with one question who we are and what why we are doing what we do and why we speak about our BMI in generally my team and I have been working in risk management and risk based monitoring for at least six years we had previously we were a data quality group of arte research technology so we were dealing with hundreds of clinical trials for all big pharma and during this time period we have established a methodology how to identify certain defects and discrepancies daya days nobody have thought have thought about has thought about our BM at all that's why we just captured every mechanism for identification of certain discrepancies and misconducts and suddenly realized that there is a connection between risks and the data and that's how integrity appeared its integrity is clinical integrity which is nothing more than finding so-called the butterfly effect maybe you've heard about it before butterfly effect in in a clinical trial so that means slight hints of certain discrepancy that may result of a storm later on that's why you can recognize a part of life Ono and logo as well actually speaking more simple terms we are going we're helping to recognize from from this we are helping to we are helping to recognize something this let me speak about centralized monitoring your monitoring in general there are certain challenges that every pharma company faces and these challenges are connected with the amount of data which we are capturing now connected with a human with the human effects that that so many participants are involved they are so different there are so many cultural differences between so in this huge projects and that's actually result in in certain in certain [Music] effects that that occur in clinical trials and let us review some of the challenges that we have first what I want to start with is our clinical sites are not equal among each other so if we will speak about certain percentages of clinical sites that bring us difficulties we come to so-called Pareto rule rule which tells twenty percent of sites of clinical sites will result in eighty percent of difficulties that we will have in in a clinical trial that the challenge is to identify who is twenty percent of sites and to know that more in the beginning to help them to improve if it's possible or to get rid of them if it's not possible during the trial or in the next trial next challenge that we all face today a real huge amount of third-party data data recording systems and third-party data in general that that we are facing today in clinical trials we have EDC in the center but a part of is EC we have central labs medical coding pharmacokinetics safety information which is usually stored in situ databases all of them have difficult different dynamics and different processes dealing with the data for example a safety database they always so safety they are dealing with the with with with such processes as when certain issue begins it has continuation so adverse events happens they are following the patient through a certain procedure and helping was kind of different side effects appear again and again whereas EDC is more snapshot of data capturing from from various recording systems from various recording devices and from various sites our central labs are more detailed information about certain measurements that I've done and might be they can can be imported in EDC or might it could be that they are separately it could be that they come later in ADC so there is a huge variety of recording systems by on average there are five to seven recording systems so in clinical trials but of course the diversity of the data and the processes behind of this capturing are quite different that's all result in discrepancies in these recorded systems and the complexity to manage that I see some questions in between yes the session is recorded so please apply after the session so that you will get a link to these recordings when we speak about capturing the data it's always not to forget that there are some motivations that are not so genuine and these motivations are influenced or many of the stakeholders are influenced by this motivation for example a patient can participate in several clinical trials simultaneously just to get some gains from the all of these trials site can manipulate the data if for example they have troubles with the recruitments or if the if the site we wishes to show a better recruitment ratio of course there is someone monetary gain behind recruitment as well for site zero can hide certain errors particularly if these errors are connected with with the air activities so based on the internal trial of bring the Ingelheim we can speak that at least at least 10 percent of clinical trial data is affected by misconduct and fraud at sites add to that professional patients add to that zero zero manipulations and export difficulties data export difficulties and he will land to 20 30 percent of of data which is affected so it's a huge amount where do the data so to say can influence dramatically the results of clinical trials each each of these [Music] component influence statistical significance that we get influence confidence confidence intervals of clinical trials so our confidence intervals goes wider and wider and wider so we have less chances to get statistical significance at the end so [Music] that's and don't forget about recruitment ratios and recruitment dynamics just based on various studies the 30% of sites never recruit a single patient on average many seasonal breaks like we all know do July almost no recruitment happened or in August and in the near of December right now the recruitment rates goes go down so how to manage your trial with taking in consideration of these challenges so again we were speaking about dirty data we were speaking about recruitment challenges diversity of recording systems so all these difficulties are create some burdens on the way of of a clinical trial manager so when we near the end of the clinical trial many of us know that that actually we lost the last push so to say the last 5% of getting the data is true just probably the hardest if I will show you the diagram how the stress levels just go through the clinical trial they usually start with the like with the highly stressed level so clinical trial starts we are trying to plan everything we're trying to create a solid protocol to fix all the issues that are possible compliance issues and if they are like if they exist and we are aiming to first patient first visit deadline and when we have done the reason huge relief happens so there's really many F team members really relaxed so this is this is a typical typical study development and when we database closure suddenly a certain difficulties appear so and the stress level goes up again just because there are so many missing data including our databases and there are some discrepancies that we identified already and we need ought to clean this up altogether just all together in order to close the database in the timely manner so the whole principle of Quality by Design risk management and risk based monitoring are dedicated to reduce the second level of stress and use the time during the trial to to be more prepared more proactive for trial management it starts even before a trial is before first patient first in so and the questions the risk assessments begin even even before protocol is finalized so why it is important to begin earlier because on the one hand side we can mitigate a lot and these mitigation actions are quite easy for us and of course on the other hand side we we have still enough resources time money and and our team to meet to take these actions and to focus these actions actually on on certain areas so when we speak about risk based monitoring what we are what we understand behind what it is actually let us clarify the terms and let us agree on these terms because without understanding the terms we cannot we cannot discuss this topic at all when we ask these questions among our teams we see that everybody of us understands these this topic differently for example if you speak about with with a query team they always think oh we probably need to start again we will need to just start our education just Cierre think that we all be fired probably its end of our career some data management says say finally they have understood the power of data that's that's good thing so it's our time now yes again project management says again something new stuff some new stuff maybe we can just ignore that so CEO says you know what guys please concentrate on the goal it's it's still and it needed to be done risk management it's nice stuff but like keep an eye on the goal and many say you know what is new here we always done this way it's yeah it's actually quite quite a common sense and why everybody is so excited about it we always under divide those sides which who are like high-risk sides and we always configure it our monitoring somehow there so there is a as you see there are a lot of different opinions water is based monitoring really is and why they meet it means I mean it means for them so please if you have any questions use the chat on the right side and use this opportunity actually to ask the questions [Music] recently reverse there was a very interesting questionnaire asked by quintiles about their sponsor about their customers what implement are being implemented drivers actually do you have interestedly that the most the biggest motivation behind our BM was reducing of monitoring costs reduced seer a travel costs which is actually somehow connected with the first point and on the third was mitigated risk I must say looking at this graph I definitely see that there is some kind of misunderstanding just imagine an example you would you would wish to fly for example from America to Europe to spend your vacation and you buy a ticket for flight and then you come to - I don't know some airlines and ask for a ticket and there they provide to you two tickets one costs for example [Music] $1000 and another costs 500 and when you want to buy the second one which is cheaper they say you know what actually these flights are crash every second time what would you choose my question yeah so how can we combine the costs and the risks so we assume in this and bind if tickets for flights we always always assume that the flights are absolutely secure and maybe why the airlines different in their pricing maybe that because they just the service additional service is is is quite different some of them are cheaper optimize their cost others are more luxury so they provide more services for their patient passengers but none of the airlines actually can say that they provide less safer flights as others that's why the whole risk management methodology is is not dedicated to save costs saving costs happens automatically on a long run when you run risk management methodology and risk management actions and that happens with Airlines by the way as well so we see that the tickets historically where so the price for the tickets go down down down down and actually recently a Ryan Eric is one the European airlines even announced that they will provide tickets for free so just imagine that we will reach some point then clinical trials will be completely free just could be done for free so that's that's the level of so to say which we can aim to and learn and the the motivations and implementation drivers we need to to pick up with the understanding of the of those aims and goals that could be achieved so again thinking in terms of the risk management or in terms of the risk based monitoring please do not take the cost savings as the ultimate goal or implementation driver so if you take it the whole implementation will be flawed already yeah I see already the first question which tells which asks are there any statical ducted that RBM saves certain amount of costs 10 20 I must say many trials which are known for me were tried to prove the saving costs the world it was some trial from price water Cooper's or there was some claim and the publication from price water Cooper's but after analysis they came to a saving of 18% but none of the trial that I know till now couldn't prove that in the real genuine scientific way so even more meaning of implementation of RBM will result in more costs in the beginning so you should count with at least 5% of more cost in the first one tooth trials you will see reduction in the third in the fourth trial but again speaking about the cost implementation as a cost reduction as a as an implementation driver for rpm to my mind absolutely flawed and and that that's actually the sign that that the implementation probably will be disasters and we see that every day really different sponsors and companies come to us and they speak about so called IBM real ouchie that's already a topic that's already a term inside of at least I love our company but I'm afraid even within the industry and that happens because actually many companies started implementation with the driver reduce the cost monitoring costs that's that's not how it should be approached and that's why the land with this huge number of critical findings that's why they they have they have to relaunch rpm and they have to start thinking about risks first about mitigating actions first and about method really scientifically sound methodology how monitoring can be reduced so I see in the next question if we assume a good mix of good and not-so-good sides the cost can be assumed to be a neutral we will come to in a later slides we will come to advanced adventures or the benefits of risk based monitoring and you will see where where where there is the potential why why it is reasonable to to start thinking about it apart that are BMP has become required by regulatory so we will see that another types of performance indicators that could show to you that you have achieved success implemented are BM or risk management methodology I continue with with my slides and well I will address the questions by step so I just wanted to notify or to say recently couple of weeks ago at the GCP addendum was finalized by ice age and this GP addendum says quite clearly that the sole sponsor should develop a systematic realized risk management approach to monitoring clinical trials risk based risk based approach to monitoring clinical trials so feel free to go to IC h website and take a look there so the GCP starts affecting us from the June 2017 so that's where we're all auditors will take a look if your monitoring strategy are aligned with risk with your risk assessments if we go if we will summarize very very very briefly and very high-level what actually RBM really is we can say that previously traditionally we had to visit different sites on a regular basis every fourth week with our series has done have done resource data verification and some other activities we to identifies different if issues and now we got a new knowledge layer so to say knowledge layer of risk profiles of every site and by the way when when I speak about risk profile of every site I also mean that there is a risk profile of certain region and there is a risk profile of my study and there is even a risk profile of my portfolio so please be not not misguided by this by this slide when I speak about this dish additional risk profiles off site I really understand and mean that we have risk profile for a site for a trial for a geographical region and for a whole portfolio of my trials and using this additional information we can do reduced trigger it targeted and centralized monitoring actually that's what rel BM is is that we get the this additional information and by means of that we apply certain tools that we have and these tools are reduced monitoring trigger time monitoring targeted monitoring and actually as an overall term centralized monitoring that means certain consequences for everybody of us first of all we need to identify these risk profiles we need to identify this esque risks in our trial overall we need to define new roles like central monitor or risk monitor or risk manager and we need to to assign certain certainly there are certain people we need we need to go through a change management process just to 14 to accept this methodology we need to build up certain technology to be able to to implement centralized monitoring to be able to grab certain risk relevant information from all recording systems that we have here so there is a lot of things to do and if you remember regulatory June 2017 it's time to start if you didn't start before it's a lot of things to take care about new roles needed to be defined u.s. apiece needed to be defined new methods implemented in the clinical trials so lots of things to do and please be aware that all these new methodologies new concepts new technologies they all bring risks with them with themselves so if you misunderstand and if you implemented in the wrong way you will bring more risks in your trial as you had before so the question is how to implement it in a such way that you will only get the benefits not the additional risks when we speak about the whole risks that appear on our landscape we usually identify external risks that happen outside the company and internal risks so the internal risks are connected with the with internal processes internal procedures internal compliance with a staff turnover with the overload and external risks are more political geography or graphical complexity risks of a trial and I must say if you are a small company then probably you will be more affected by the internal risks if you're a bigger giant company then probably you need to be aware about external risks more because you're more vulnerable to external risks when we build up with different strategies so to say for for our for our trial we to be sure that we captured all the aspects of those issues that can go wrong so just imagine you planning a trip and we started this with example with Airlines just imagine you are going to spend your vacation somewhere in Africa so there are many risks which with compo combined with this trip so how would you address your personally this trip so first of all to my mind if I would do that I would probably think what can go wrong first just in general I could be all run out of money I could be run out of some connections maybe some difficulties with waters and digestion or problems so I will summarize everything that can happen maybe I'm doing it even subconsciously without like structural mechanism but that that are implemented for example in other industries but when I do that I start thinking about some mitigating actions okay if I will have some difficulties with connection with the mobile phone for example maybe I need to think about some satellite satellite connection if I will have some digestion or problems maybe I need to take some pills - with me which will which will help me to over go to go through some poison poison in food poisoning if I will have some troubles just just going having lack of cash maybe I need to take my credit cards with me or I will I need medicine to take some some goat in order to be able at least to to sell it if it if it's something if everything goes wrong so you start thinking okay what should be done right now before I even trip begins in order to mitigate this risk that can happen in the future so and similarly you approach clinical trials you start thinking what can go wrong and how do we just help how do we approach that in integrity we start looking at primary of outcome measures we start we start thinking about sponsor specific risks so what has what what was in the past that has gone already wrong before when you've done your three clinical trials did you had some fraud issues didi had some some non-compliance did you had some issues with with the recruitment and intent then we can deal with the status specific risks for example if it's like an ecology trial you might be looking on certain risks like suicidality in the trial or if it's for example a trial for just dedicated into cardiology maybe you may take might take a look on the QT prolongation parameter are there to forecast certain risks with the cart attack so of course we will take a look on the safety so all the issues can be connected with adverse events with the serious adverse events with the Sue's ours these are this is very important to take care then some called project management risks like recruitment milestones even budgeting could take it could be in this port in this in this group and we we ground everything on protocol compliance and we ground everything on misconduct sloppiness and fraud detection so that's how how we approach these ands integrity and build up a real defense strategy for for a clinical trial so maybe let's let's address couple of questions to before it's switch to the next trial so we had what is triggered monitoring first tribute monitoring means that you have you set up certain trigger for example risk indicator when this risk indicator goes beyond certain thresholds it's it's triggers that certain monitoring activity must happen for example you can communicate with a site just making a call or you may might be a certain special visit to side so this is a triggered monitoring targeted monitoring may be to make it clear is when you're select certain subset of sites which have which which have certain commonality and then you do certain actions to these to this subset of sites so going to Parata analysis it's 20% data that requires more attention which is already been covered under normal routine monitoring visits so we are just looking at cross seven-point only with RBM it's true I I will have a couple of slides in the very end of the presentation which might help answer in you these questions about cost savings overall let's keep it for for later RBM is all about the focused approach normal routine focused usual focus usually lost absolutely agree rpm is about being focused on what is matters the question is how to identify what to focus at and what matters for you I must say rpm is more answer as it actually contains risk inside of it it's more about being proactive also that means managing your monitoring in such a way that you will proactively identify the issues that didn't happen yet so or that you identify the issues in a very beginning and I will have assumed I have one of the slides about it maybe this one yes if you had a certain issue that a problem can not disappear the problem will only go exponentially and that's where the the action is needed so there are two paths one that the problem can go really wrong for example we had recently one trial we monetary data quality and the site which acquired most of the data actually actually produced a lot of dirty data so there were rounding defects there were missing information there were discrepancies so when if we would identify this later in later stages of a trial probably it would be already too late just because this site accumulated the most portion of the data but being able to identify this in the middle or in the beginning of a trial we were able to do some corrective actions and preventive actions and to clarify that the site really started produce more genuine and more high-quality data so what are the technologists industry going to use to analyze the data part of Spotfire generic system I will have a slide offering the RBM vendors and it Spotfire to my mind is not really our an RBM vendor but you will see the Spotfire on the on this slide as well so we won't dress it right now how can I be me 15 C be measured or other than outside monetary cost water yeah a very good question and equality as compared to non RBM studies we will have this slide for that as well I see that there are many questions are just you're so excited that that actually you're following by so our our path actually and you will see the answers just in a couple of minutes I wanted to say that that when we speak about risks we just grouped them to external internal but if we take a deeper look into the into their types you will recognize that there are some study level risks for exact connected with with the for example Texas City of the draw connected with the complexity of a trial and these risks are not really dynamic so they stay the whole trial more or less the same so we call them so called fixed risks so they they don't change too much and but there are some risks that are more connected with the site level activities like visits unscheduled visits certain acquisition of data the timeliness of how fast the data arrived to spawn so database and there are some really operational risks and these risks are very dynamic for example one of example is a fraud so it's really can escalate very fast and could be mitigated really fast so these risks really you need to take care about during the trial and that's why you need different approaches to tackle each of the type so for more fixed risks it's reasonable to assess them before the beginning and maybe students during the trial regularly for example every half a year we apply a transcelerator risk assessment data categorization to for that so there are some other tools and if you have interest I can provide you more information on other alternatives but for more dynamic risks you need to grab the risk relevant information during the trial and you need to put certain data-driven TPI's key arise so key P key risk indicators key performance indicators and do the assessment real on a regular basis so that you will get notified when you should trigger your activities maybe let's skip a couple of slides in order to speed up because we have we are nearing actually the the end of the presentation I mentioned transgender rights approach and transcelerator many of you have have heard about it it's a big nonprofit organization which unites 20 pharma companies and they really deal about with standardization of certain procedures and risk management is one of their initiatives and that's why they created so called risk assessment and position tool abbreviation is Ray and they provided for free so you can download it from transcelerator site and make a risk assessments before even trial begins and we do the risk assessment route during the trial even more subtlety for example provides a free cloud solution which is available for everybody and it we guarantee it will be free and feel free to use it and by using the cloud solution you have some advantages for example you can use this cold solution in your teams and you have certain additional criteria how to choose what risk what risk property so you go through the questionnaire fracked and USS impact probability and detectability of each of the after the question that might have in your trial the important thing is that it's reasonable to be clear what risk you're really assessing and this is one so by the way so if you're going to utilize this free tool its wracked are being proud feel free to register and there are no charges be kind of it the disadvantages of wracked just advantage first of all advantages is very structured very Big Pharma driven if we see this is an advantage but still and pretty complete a way of assessing the risks the disadvantage of rack is that is it still very subjective so you and your staff assess the risk and it the assessment could be really can depend on their mood even if they're in good mood maybe the certain risk will be assessed as a light weight and certain risks other way around and the next day when they are in bad mood for example still [Music] so that's why it's important to involve many stakeholders to review several times and to comments up to certain consensus me personally I'm not very great fan of racked just because it's not not very quantity and [Music] the methodology connected with the probabilities of the risks and the probabilities means that we go into historical data and take and calculate probability of each other individual risk that might happen and based on these probabilities we decide what risk we should not litigate so again rack is more categorical tool that you can use and utilize immediately there are free and there are lots of solutions for that probabilities are more complicated and by bores and typically sound way to deal with that and again we are happy to make discussion if somebody's get interested in that somebody has asked why how to measure IBM success in general if we if not speaking about risks you will definitely be able to measure the success of our BM using certain KPIs in your trial for example I will guarantee if you will implement rpm in a standardized holistic way and holistic means involving stakeholders involving different risk categories analyzing and doing it rigorously repeatedly and so on and so forth you will definitely recognize certain data quality improvements why because being able to control certain certain certain defects in the beginning you will reduce the systematic issues and that's what actually rpm is also about is to be able to eliminate the systematic errors being just not focused on on random errors the random errors will happen anyway but systematic issues is that what you are you can deal and you can improve so be sure by by implementing in a holistic way the risk based monitoring you will see data quality improvements you will see improvements in frequency on side of on-site visits and you will ask me it would ask me okay but would have certain cost improvements here definitely yes but you would need another investments for example in in methodology in implementation of a surpise in a change management these all procedures that need and new investments and they were unfortunately they will treat any of cost savings so they will reduce any cost savings which you will get by reducing the frequency of on-site visits you will see a deep protocol deviation improvements you will see more more natural and more so let's see better reporting of adverse events and serious adverse events what does it mean it's another topic it's probably worth of another webinar but under reporting and over of reporting of adverse events and data what you will be able to control after implementing of rpm you will have less site audit findings and you will have a reduction in loss to follow-up just because sites will be more engaged just because the engagement will be more you will see this engagement that the patient will be more engaged and that's that's all reduces the loss to follow-up ratios somebody somebody was asking about Spotfire and other vendors I've tried to plot different vendors on D on two graphs so you will see you RBM vendors based on the dependence and independence and those who are focused on rpm and or who are focused on general business intelligence Spotfire for example is one of the example of one of the tools that is typical bi solution it could be applied for rpm it could be applied for other issues but it will not provide you the holistic approach of rpm for example it has no risk assessment mechanisms inside it has no issue management inside it has no copper inside it has no kinetic immune occation about risk inside and so on so forth so it is a nice dashboard presentation which you can utilize but it's only part of the whole procedure the dependent providers why they are called dependent they are more connected with the certain activities in clinical trials for example with the data acquisition or with the project management like quintiles Nabeel clinical icon they are all zeros that are connected with with the the project management and midi data or ERT they are more connected with the data acquisition so they all claim that provide they provide RBM now just be sure that if you will take the dependent solution you even face conflict of interests so that means that those companies who are assessing their activities will be not easily communicate the sloppiness and the problems that they what they were resulting and please be sure that a conflict of interest is definitely something you need to be aware about in risk management so when do you in with with the risks with the controlling of risks be sure that the pirates who are involved that are free of conflict of interests and independent solutions are are providing the RVM solutions in independent way which are free of this conflict of interests just let let us a couple of slides I wanted to see couple of words about fraud detection but we are free where we are let us just summarize what it would bring you if you would start implementing the RBM or if you started already what it will bring you for your operations result number one which you will which will definitely see is that you will get categorized your sights high risk sites medium risk site low res designs sites this is already a huge advantage which will help here in in in optimizing your monitoring activities you will see differently and in improvement in data quality because again you will mitigate systemic issues that provide dirty data and that's what you will you will recognize in the lower number of queries you recognize in the better statistical in better chances to reach statistical significance and in a smaller confident intervals confidence intervals so this is what you definitely will observe you will see that you start the next trial not from zero but from from already knowledge base that you bring from the previous trial and that's so-called continuous improvement methodology guide then maybe you've heard about this from Japan and that's why we all like Japanese cars because they are so reliable because of the skies and methodology continuous improvement each of the car each of this type of the car cumulated the whole knowledge of the whole mistakes of the previous cars and the same in clinical trials you will accumulate the knowledge in certain knowledge bases and start at the new trial with the information about risks and about performance of your previous trials of your of your sites and and actions which worked the best previously and you will face an environment that knowledge sharing it will be quite common thing we know that many zeros and many pharma companies work in silos you have certain therapy areas silo or they have certain isolated groups that work really without without benefiting of knowledge of the other groups and that's what where risk management and centralized monitoring can be also helping helping mechanism so it brings everybody again to a certain intellectual network when everybody is connected with each other you see the dynamics of the trials and you can forecast the same dynamics in another trials or you see certain difficulties and solutions in one trial and you can transport the solutions to another trial and bring these solutions to a less experienced employees when when we speak about number of STV rates you will differently as TV error rate STV versus a error rates you will see certain improvements you will see certain improvements in error rates overall and definitely some cost reduction are connected with that but as I said maybe on later stages here's another graph which shows how your monitoring activities could be could be designed so here's the classical monitoring that's that's starts and ends at the end and here's more adaptive and more reflective proactive monitoring scheduling so you have a bigger portion in the beginning but then it reduces reduces and really on the tree gets triggers when you should do certain monitoring activities so that's what why you definitely see certain improvements and of course there are some very proposition for pharma companies value proposition from zero companies and for vendors but that's what we unfortunately don't have too much time for them for I will be able to provide this lights for everybody who is in the call but you need to actively ask ask for for and provide your email for that otherwise I will not be able to send it to you so if I will summarize the value proposition for current pharma companies that the trial in general gets more weight goes in a more predictable way the trial itself so to say has more predictable start and end series get the advantages that they can work from home they can work in this from a centralized place and jump on a train only when it's needed you have improvements in data quality you have certain performance improvements in monitoring activities so one monitor can capture more and can cover more clinical trials it doesn't mean that it's a Geo party or a danger for them as a job it means that their job will be more interesting so we will have risk profiles for sites these risk profiles are available for the sites themselves and they could even utilize this information to argue that they are high level site that's why probably they need a charge more than others for example just yes I want to summarize everything what I said we started with why rbms actually appeared on the our landscape which we decided to dig down inside and see you what what we understand under this term we saw that there are different approaches how to tackle that we saw there are a lot of vendors who are suggest that some of them are like dependents some of them are less dependent we saw that there are some certain advantages but these advantages are not directly connected with or shouldn't be triggered by a cost saving motives behind more by a motivation to reduce the uncertainty and to reduce the risk in your trial and I want to say last final quote which I liked very much from even Fisher he says he said risk varies inversely with knowledge the more we understand the more we know about how we drive how we fly in a trial the more predictable we'll trial be and the less risk we will have we will face so by saying that I really appreciate your time today I will address the rest of the questions right now so if you will be not available I absolutely understand for those who are leaving now thank you for participating today and if you have any further questions please feel free to contact me and all my contacts are available in the group where we are or on our website as integrity comm so seeing some words asking the questions yes is it possible to share the slides yes I am I can share the slides please if you use the slides later don't forget to put a reference that would be very I would be very thankful for that so what are the tip no oh to do this just I cannot read the question when some messages appear so regarding the reduction of on-site monitoring visits and greater other side visits interval with RBM this cannot be considered an absolute measure of efficiency since it doesn't necessarily mean a reduction of monitoring activities what are your thoughts I my thoughts are in this regard that monitoring activities so every monitor has a certain tool set that they apply so and a visit to a site as one of these tools so to say and when we speak about connecting these tools with the risks that's why we speak about certain optimizations and that's absolutely not my absolute measure of efficiency important is to be clear what your target our targets are when you start our BM initiative in your trial so just put certain kpi's what you are going to achieve measure these KPIs from their previous trials and then set up certain expectations measure them during their trial for example you could say we wish to reduce number of queries it's absolutely reasonable approach and attempt to attract this KPI and see how your risk mitigation activities and more optimize monitoring helped to reduce your number of queries or you can say we wish to measure for example your number of on-site visits again you will you just remember those slides which I showed you you can do more optimized on-site visits again important to understand what you're willing to achieve to put a KPI for that to measure that and to communicate successes or failures with open it with within your team just to react accordingly when I was saying that our BM Prince or risk manager brings their own risks I really mean that and I really saw this in many companies that's why I do advise to invite certain experts who have done already several projects connected with rpm and they will definitely help you avoid certain pitfalls ok do you help have experience with risk based monitoring across trusts very good question actually one of the projects but that we fulfilled was particularly across the trials first of all measuring the risks and measuring the advantages that it means particularly and also we involved with the risk indicators connected with the cultural differences where the we will see certain their cultural dynamics for example reporting of adverse events in Japan is quite different to reporting of adverse events in for example in America it's connected with the culture it's connected with a legal background and make making these measurements across trials will help you to be prepared to these cultural differences in the future so and be prepared to design your trial in such a way that you will mitigate these risks as well so I hope I answered this question today today so very much would appreciate these slides ok the audio connections was quite poor sorry for that the recording as well yeah we will provide recording yes so I see that rather there are certain follow-up questions how easy it's in your experience to establish data sharing agreements with sponsors to implement RBM oh good question actually not easy absolutely not easy every sponsor is considered they are data as a kind of the property and that's absolutely it's absolutely key and what sponsor is not it doesn't understand usually is that you know we are not in a competition of risks every just again if we will make a parallel example of with the arrow airwaves certain crashes will be communicated immediately among industry and this will be immediately provided so Airbus or Boeing they will get the full report why certain crash happened I would I would wish if that would happen in farm as well for example if a certain fraud and misconduct happen done by Novartis everybody gets sue kind of information and the method how to be protected from that why mask us a love artists just recently 2013 they had certain issues with the fraud with the medication diovan maybe you've heard about it so so ask answering your question it's not easy but it moves to a right direction so many of the sponsors get understanding get understand understanding that share in certain risk relevant information will benefit the whole industry so thank you for sharing thank you for a good presentation how to possible to identify fraud oh that's a very good question and it's a big big big question we we've done several days educational sessions of the about fraud detection I I would like to start this discussion right now if you wish to talk about fraud detection maybe let us connect separately and plan maybe a separate separate event about it it's very important and very large topic how to deal with the fraud how to identify fraud before it becomes a problem and there are lots of methods for that they are well established they are very scientifically grounded we care we have these methods from different industries and we adapted and implemented them from for clinical trials so if you have interest maybe it let's let's plan another another session for that I hope I ask answered many questions I really enjoyed that everybody stayed active I really enjoyed that it hopefully I hope that it was beneficial for all of us and if you have further questions please visit our site our newsletter tagged speaks about our events we usually do webinars for different topics it could be very beneficial for for everybody of us then you soft available yes there are a lot of software packages available on the market some software packages provide with integrity many other vendors specialize each of the software package has their strengths and weaknesses and maybe you need to be aware about that and if you wish I could share some information about their strengths and weaknesses in the private sessions again I have a couple of articles I could I could provide you the rest of free software packages as well that's that's that's what we can definitely discuss I wish everybody happy Kris Merry Christmas and Happy New Year and I hope to see you in in in the future year and I wish that we all get protected from the risks in the year thank you very much thank you you

Channel: MyRBQM Academy - CyntegrityEDU

Views: 3,515

Rating: 4.8823528 out of 5

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Id: dox2K7dKkEA

Length: 69min 46sec (4186 seconds)

Published: Wed Dec 21 2016