Empowering Patients to Be Active Participants in Clinical Trials

One of the topics of discussion at the recent Rare Patient Advocacy Summit hosted by Global Genes was the role of patients in healthcare.  A statement that clearly resonated with the audience, from Roni Zeiger of Smart Patients, was that patients are not passive recipients of care and in clinical trials, but rather are co-collaborators. 

The good news is that biopharmaceutical companies are seeking patient input at increasingly earlier stages of drug development.  In the Q&A on Clinical Trials with PACE USA which we received permission to repost below, Tom Krohn, Business Lead for Lilly Clinical Open Innovation, explains his company’s commitment to seek patient input in the design of clinical trials to minimize obstacles to participation and to improve the quality of information available to patients, physicians and caregivers.

Over the last several weeks, Tom has attended a number of conferences focusing on the present and future state of health care - specifically, clinical trials. Below, he answers a few questions about what he's heard, seen, and learned.

When it comes to clinical trials, what does "patient-centered" really mean?

Ultimately, being patient-centered means keeping the things that patients value most--both tangible and intangible--firmly in mind when designing and running clinical trials. That means asking people considering and participating in clinical trials what they think, what they need, and what they want.

What are some of the biggest barriers to patient participation in trials?

One of the largest hurdles facing patients who want to enroll in a clinical trial is a lack of awareness and understanding of what clinical trial options are available, as well as what a clinical trial entails. Actually finding a trial that you're eligible for can also pose a struggle, and if a trial is far away, the time and resources necessary to participate can be substantial. And of course, there's the "fear factor"--most people don't know what to expect from a trial.

As an industry, pharma has not done a great job of providing patients with the information and resources they need in order overcome these barriers. That's why I, and the team at Lilly COI, am focused on collaborating more across the industry in pre-competitive spaces, and in opening up the lines of communication among patients, caregivers, and researchers. Before we design a clinical trial and commit to a given protocol, we should be making a concerted effort to gather patient input. While the required scientific design may not be ideal from a patient perspective, we have an opportunity - and in my mind, an obligation - to better understand the preferences and implications of a study design from a patient point-of-view.

How can patients be empowered to be active participants in clinical trial?

First of all, I think we have to listen to what patients are telling us about their experiences and how we can make them better. In order to do that, we have to provide real opportunities for them to provide us with feedback and ideas. Sometimes it's a struggle for us to find ways to do this in the highly-regulated environment in which we operate, but we have had some success through social media, and through hosting and attending conferences that are inclusive of patients. We have also developed user-centered simulation approaches so that we can model and run-through a study with our site colleagues and patients. This allows us to hear their ideas and insights before we commit to a given protocol.

Also, I think it's important to receive patient input with an eye toward innovation. If we truly want to make things better, we need to think more in terms of possibilities. What if we gave potential participants the information they need in an easy, accessible way? What if, before they even enrolled, we answered their questions about their doctor's role, the site of the study, what will happen to them? And of course, patients aren't the only ones looking for trial information--their families and caregivers also want and need to know what a trial entails. These are practical, important questions, and answering them can go a long way toward empowering patients to play a more active role in research, and in encouraging more outside-of-the-box thinking among industry professionals.

What can be done to increase patient enrollment in clinical trials?

• Better information. Patients need better, more relevant information about clinical trials. While many online sources offer lists of potential trials, the information is often scientific and may not be accessible to the average person. At Lilly COI, we've committed to making open information about trials more available and valuable to patients, the public, scientists, and anyone else interested. We also believe strongly in making the information consistent across studies. Patients need to be able to look for options and compare them. Some basic consistency in areas such as eligibility criteria will help patients quickly understand what options may be - and just importantly may not be - possible for them. I'm excited about our leadership in this area and our collaboration with Pfizer and Novartis. We look forward to scaling this effort in the months and years ahead.
• Better education. People often look to their doctor as their first source about clinical trials, but not all doctors are familiar with trial opportunities. A recent study showed that while more than half of patients preferred to receive clinical trial information from their primary physician, only 20% actually did. Educating more physicians about clinical trials in their area could increase patient awareness and enrollment.
• Better communication. As I saw at every conference I attended, social media is a huge venue for conversation about clinical trials--and the online patient communities that have developed are inspiring, well-versed in their disease, and looking for answers. Online social networks offer a huge opportunity to connect patients with trials and vice-versa.

The last several weeks have been busy, but above all, inspiring. I'm more committed than ever to listening to patients and their families, to engaging in an open discussion about what can be done to improve clinical trials, and acting upon these ideas to make patient-centered clinical trials a reality. And as always, I want to keep the conversation going--so if you have any questions of your own, feel free to reach out to me at @takmad. 

This Q&A originally appeared at https://pacenetworkusa.com/entry.php?id=118.