Berlin – 30 August 2016 – No clinical trial can be successful without a proper patient recruitment process. It’s at the heart of the full trial and most crucial ingredient for a successful outcome. The Heads of RCOS at KCR, Tetyana Byelyayeva and Katarzyna Lepecka-Czajkowska, discuss the most critical issues when it comes to patient recruitment & retention during a clinical trial.
Both of you are involved in clinical operations in Europe. What are in your opinion the main factors to ensure successful patient recruitment?
Tetyana Byelyayeva (TB): When being asked this type of question, my first inclination is to speak about the importance of feasibility modeling and analysis, countries and sites selection, CRAs communication with the investigators, etc. But then I am challenging myself: is it really possible to define the main factors? What is more important: to have a proper study start-up with appropriate countries and sites selection or to ensure a proper logistic of study materials and a close collaboration with the sites during the recruitment? What will be more valuable: to train the investigators or to work on marketing communication? I am not sure, if it is actually possible at all to give an unequivocal answer... It may vary depending on the study design and the Investigational Medicinal Product (IMP), the selected countries and expected patient population, the investigators’ experience and many more factors. So the only way to ensure successful patient recruitment in my opinion is to have a toolbox with different tools which can be used based on the peculiarities of each particular trial and each particular country.
Katarzyna Lepecka-Czajkowska (KLP): I fully agree with Tetyana. At KCR we have extensive experience in recruitment and retention in various therapeutic areas. We have developed an advanced toolbox based on real life experience. In my opinion, there are many factors to ensure successful recruitment, however it all starts with proper planning at the very early stage - during the design of the study. Recruitment research begins with knowing the target audience. The most important thing is to remain patient when executing your strategy to let it work, but at the same time remain flexible and ready to apply adjustments to your approach. Finding that balance is a real challenge for the leadership and teams, as we all know how big the pressure might be related to timely patient recruitment.
Which aspects of patient recruitment can be and which cannot be controlled by a contract research organization (CRO)?
TB: At KCR we use a cross-functional model for ensuring successful patients’ recruitment. It helps us to control a lot of components that influence the recruitment process such as countries and sites selection, the proper organization of the study logistic, a proactive collaboration with the investigators and site management. However, it would not be true to say that we can control absolutely everything. In our everyday life, we are used to hear that this or that CRO has a proven solution to ensure timely recruitment. At the same time, according to the National Institutes of Health (NIH), more than 80 percent of clinical trials in the US fail to meet their patient recruitment timelines. Would this happen, if absolutely everything could be controlled by the CRO or sponsor? And does this always mean, it’s the CRO’s or sponsor’s fault?
KLC: From our data, we also know that 20 percent of the sites never recruit. This is a topic that nobody likes to comment, because in the idealistic world with perfect feasibility nobody wants to hear this. But it’s a fact that between feasibility and First Patient In (FPI) lies a period of 4-6 months. During this time a lot can happen with the sites. The investigator might leave, new policies might be adapted or simply more attractive studies could be presented to the site. A CRO can control the majority of recruitment and retention factors, but we do not live in an ideal world; therefore, some unpredictable situations may happen. We need to have a “plan B” ready to be implemented when needed. That’s why we are focused on recruitment strategies at the beginning of the study with a vast majority of situations covered by a patient recruitment and retention study specific plan.
Is there a certain step in the recruitment process which you consider the most critical?
KLC: In my opinion there is one single and most critical step in the recruitment process: this is understanding. Starting from understanding the sponsor’s needs as well as protocol peculiarities, country possibilities, etc. we will always be able to deliver patients and apply the most detailed and optimized strategy for recruitment.
TB: I find it difficult to point out the most critical step, because in my opinion everything is important. But what I would definitely like to underline is the fact that KCR understands the value of quick recruitment and proper patient retention. That is why we develop a study-specific recruitment policy prior to each study start-up and agree on our strategy on patient retention prior to the recruitment start. At the same time we understand the importance of data quality. We would never accept the approach of recruiting at any cost. Our concept is to see human behind every number.
We remember that each recruited subject is a patient with his/her needs and a hope for a positive outcome. We remember that each investigator is a person with a deep scientific and practical background who puts his/her reputation at stake while proposing a patient to participate in a clinical trial. We remember that we as a CRO always represent Pharma, which will then present the medical product to the market and will collaborate with former investigators as well as with medical doctors who will prescribe this medical product to patients. That is why after the study start-up and during the recruitment process our main efforts are focused on the communication with the investigators.
KLC: This is very important for us to identify the investigators’ needs, to see what motivates them, to provide them with the updated knowledge on Investigational Medicinal Product (IMP), on its scientific and medical value. We believe that well motivated investigators will ensure successful recruitment and will be happy to promote the IMP in future.
Why do you think retention starts before the recruitment?
TB: In order to get proper data on the safety and effectiveness profile of the IMP, it is necessary not only to recruit the patients, but also to ensure their retention. That is why prior to the recruitment start we continually analyze study-specific nuances that may influence the retention of the patient, and prepare a list of actions which may eliminate or at least decrease the probability of patients preliminary withdrawn.
KLC: For me, retention is even more important than recruitment, especially for long lasting studies. Having a toolbox for patients’ retention, starting from a turned payment pyramid, through supplement tools, study awareness, etc. is key for successful CROs these days. Even small tools like the “KCR Data Forecaster”, a mobile application for iOS and Android, which is a smart tool to navigate doctor appointments and medical examinations in a timely manner, can make a difference.
Which new trends are you experiencing in patient recruitment?
TB: Today we live in a time in which new technologies are emerging. KCR uses many of them, like digital patient communities, study-specific web-portals, e-announcements about clinical trials, etc. At the same time we are sure that one technology solution will not be a panacea for all situations. We see a huge difference between a population depending on the study indication and selected countries. Even within one study and one country the population may vary depending on the age groups. That is why a differentiated approach on recruitment processes and tools in different situations is necessary. At the same time we see that our investigators are becoming busier each day. One of the most common reasons of recruitment failure is the lack of investigators’ time and attention. I therefore personally consider the implementation of the role of study coordinators and correspondingly proactive site management as the most current trend today.
KLC: Digitalization is the new trend which will lead patient recruitment processes in the future, if you ask me. We can already observe this in a wider perspective, when looking at young people, who communicate via chats, media, phone, apps, snapchat, FB. Communication has moved from traditional face to face meetings to the virtual space. I see a lot of possibilities to use the digital space for patients’ recruitment and retention. On the other hand, we cannot disregard the diversity of countries. For some countries digitalization is still a giant step to take. In these countries we apply “old-school” recruitment methods that will be applicable for at least for another 10 years. So to sum up, an extensive and complex knowledge of all aspects of today’s patient world is crucial to successfully achieve our clients’ recruitment targets. Unfortunately, this conclusion is quite obvious.
KCR is a Contract Research Organization (CRO) providing strategic clinical development solutions for the pharmaceutical, biotechnology and medical device industries in Europe, Israel and the U.S. More than 300 professionals support clients with full-service capabilities across our three main service areas: Trial Execution (TE), Functional Service Provision (FS) and Late Phase (LP). Focusing on knowledge, quality and innovation, KCR delivers high value solutions customized to clients' needs. Headquartered in Berlin, Germany, KCR operates across 19 countries in Europe as well as the U.S. For more information, visit www.kcrcro.com.
KCR: We see human behind every number.
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