Patient Engagement at Every Step
Finding the right balance between scientific rigor and convenience for participants will enable successful and efficient clinical trials.
Danielle Barron interviews Andreas Koester, VP Clinical Trial Innovation & External Alliances at Janssen ahead of his presentation at Patient-Centric Clinical Trials Europe on transforming the clinical trial experience for patients, with convenience for the patient front-of-mind.
Danielle Barron: Do you think improving patient engagement is crucial - has this been less of a priority in the traditional clinical trials process?
Andreas Koester: I think it's important that we broaden the patient focus we naturally have as scientists and physicians who want to bring novel medicines to patients in need also to those - comparatively few - patients in our trials.
To find out how burdensome studies we are designing really are for patients, we need to talk to patients and incorporate their voice in the study design process".
What I'm saying is, we're used to thinking about the disease, the disease burden and the expectations of the patient for a new drug, but we are less familiar with putting ourselves in the shoes of the patient that has to reconcile a demanding clinical trial schedule with an already busy life. To find out how burdensome studies we are designing really are for patients, we need to talk to patients and incorporate their voice in the study design process. We can't afford any longer to put a study out there and only realize when the trial doesn't enrol that we have not found the right balance between scientific rigor and a realistic level of convenience for future trial participants.
In other words, the challenge for our industry is that we need to get better at designing trials that are patient-friendly, trials that don't collide with the life every patient lives outside of the study. If we fail to do this successfully, we won't be able to gather the data necessary to bring new medicines to market. So yes, patient engagement at every step of the clinical research continuum– pre-trial, during trial, post-trial – will become ever more important.
DB: How difficult is recruitment and retention – what rates do you think those who run clinical trials should be aiming for?
AK: A common figure that is cited is that 80% of trials missed their milestones, because recruitment is exceedingly difficult and once a patient has agreed to participate in a trial, attrition and the resulting bias is a constant threat to the validity of the study results. While there is probably no magic number, a common target for study teams is to keep attrition under 10%.
This figure can only be achieved if the study procedures are not too frequent or too burdensome and if the patient receives support from the site or from the sponsor that help him or her to stay the study course.
DB: Speeding up the process is key in this faster-moving market - how can patient engagement enable this?
Better informed patients will be more engaged and clinical trials will become much more mainstream than they are today where only a small fraction of the population are aware and an even smaller fraction are actually participating".
AK: Patient engagement has the potential to enhance every step of the drug development process. Looking at what could happen before a clinical trial starts, I can think of patient education, general awareness of clinical trials as a treatment option, advice on how to cope with the disease. The expectation is that better informed patients will be more engaged and clinical trials will become much more mainstream than they are today where only a small fraction of the population are aware and an even smaller fraction are actually participating. As we know from many polls, the vast majority of patients would be willing to participate in clinical trials if they were easier to access. Factors such as driving distance, time commitment for procedures – these all affect participation.
DB: In terms of reducing costs, clinical trials are notoriously expensive - what areas can be looked at to make the process more cost-effective?
What comes to mind is a spectrum of possible solutions in the use of technology, technology that is pervasive in any other area of our lives but hasn't made the transition into the clinical trial process. Think about patient visits to the investigator site - both time-consuming and costly. If we can measure outcome parameters remotely, we could space out these visits and get better data for less cost. But more importantly, less frequent visits would make it easier for patients to participate in trials, so more patients can participate and reconcile a trial with a busy life but also help us to bring new medicines to patients who need them.
Andreas Koester, VP Clinical Trial Innovation and External Alliances at Janssen, is presenting at Patient-Centric Clinical Trials Europe, June 8th-9th, 2015 on “Improve patient engagement and incorporate the patient voice to boost recruitment and retention; speed up the process and reduce costs”.
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