It is easy for biopharma industry leaders to talk about the impact that clinical trials have on the lives of patients who are in desperate need of better treatment options. But sometimes the most compelling stories come from the patients and their advocates.

In honor of International Clinical Trials Day, May 20, I recently spoke with representatives from the Crohn's & Colitis Foundation of America (CCFA) and Lupus Foundation of America (LFA) - North Carolina, to talk about how clinical trials impact their members’ lives, and what the industry can do to make these trials easier to access and participate in. They offered powerful insights and stories about their experiences with the clinical trial community and what patients fear the most about being in a trial. This kind of patient-centric feedback has the potential to change the way the industry approaches recruiting and retaining patients in their clinical research efforts.

I’d like to thank Ashley Deplitch (CCFA), Christine John-Fuller (LFA-NC), Ally Hunter (LFA-NC), and Rebecca Kaplan (CCFA) for their time and willingness to share their thoughts on this important topic.

How do you talk with your members about clinical trials?

Deplitch (CCFA): Our patients are in need of additional treatment options, specifically in the inflammatory bowel diseases space, so we’ve really tried to educate them and their providers about clinical trial opportunities. We host webcasts and live education programs to teach them about the clinical trial process, and we have a registry where our partners can post information about specific trials for which they are recruiting patients.

We are also really excited about our new IBD Clinical Trials Community, launching this year, which will bring together patients, providers, clinical coordinators, and a host of other stakeholders to form a community where they can have more open and honest dialogue about participation in clinical trials.        

John-Fuller (LFA): Our journey with clinical research in the lupus research community has been evolutionary in the last decade. The first FDA-approved drug for lupus was only approved in 2011, so until recently, participation in clinical trials among our members was very minimal. That’s beginning to change, but our biggest challenge now is that we have a patient base who have little experience in clinical trial participation. Our focus now is on infusing clinical trials into every conversation that we have, because we know we’re not going to be able to move the needle unless we see more participation. 

What would make it easier for your patients and their physicians to participate in clinical trials?

Deplitch (CCFA): One of the biggest gaps we face is helping our primary physicians communicate more effectively with the doctors running the clinical trials.  If a provider has a patient who is an ideal candidate for a trial, there should be a mechanism by which that provider can refer that patient without worrying about losing them. This way, physicians would be more open to referring patients and those investigators would have another pool of patients to recruit from.

John-Fuller (LFA): The gaps that we hear from both ends are that sites don’t always understand the differences between patient types. An arthritis patient follows a very different journey through the clinical trial process than a lupus patient, and it’s important for investigators to acknowledge that journey.

The sites also need to do a better job connecting with organizations like ours to enhance their enrollment.  A lot of times they don’t fully understand what we do, who manages patient services, and how involvement in that can really drive progress towards their open enrollment.

What kinds of programs or resources do you have to help patients better understand what it means to participate in clinical research? 

Hunter (LFA): We have a website that aggregates all clinical trials that are lupus-specific from  They can see the type of lupus being studied, who the primary investigator is, what the contact information is, and reach out to the individual study leader specifically to express their interest. It also has patient registry component, so individuals can register to be notified of trials they might qualify for in their area.  

And last October, we partnered with Quintiles to host and film a clinical trials educational panel at our annual summit to dispel some of the myths about trials. It was moderated by a research coordinator and included three clinical trial participants who shared their stories and answered questions. We have found that educational opportunities like this one are very helpful because they provide that patient perspective about the experience, whether it was positive, how they got involved, and what worries they had going into it. We have since turned that video into a recruitment tool that we will provide to patients and constituents, and to physicians in the clinical trial space so they can provide it to their patients who are thinking of taking part in a trial and want more information.  

Education is just so incredibly important when it comes to clinical trials.  Patients don’t know what questions to ask unless you educate them.

Ashley and Rebecca, do you have similar programs or resources in place for patients?

Deplitch (CCFA): Absolutely. Patients can go on CCFA’s website to search for clinical trials, and we are building tools to push trial information out to our patients. We also offer several recorded and live programs that dive into specifics of clinical trials, and what different terminology means so when somebody says something is “double-blind” or “placebo-controlled” these terms don’t scare them away. Trials can seem scarier than they actually are when physicians start speaking in very technical terms, so we are trying to demystify what a clinical trial is, and to alleviate patient concerns.

And we have a very cool peer-to-peer mentoring program called the Power of Two, where we can match someone looking to participate in a clinical trial with somebody who has gone through that process. We find that our patients always feel more comfortable if they’re able to talk to somebody who has had a similar experience. 

Kaplan (CCFA): And we offer live education through our social media network. On International Clinical Trials Day we’re going to do a Twitter chat with a doctor from our Clinical Research Alliance and a patient who is a former clinical trial participant, to talk about the basics of clinical trials. We offer similar opportunities through Facebook for patients to ask doctors live questions about a variety of topics, which I’m sure, at some point, we will be doing one on clinical trials.

Do you have any programs for physicians?

Kaplan (CCFA): CCFA is hosting a physician’s workshop in 2017 for providers interested in clinical research. Our focus groups show that both patients and providers feel out of touch once the trial starts, so we want to teach them how to be more communicative with trial patients, and how to develop programs that allow physicians to maintain contact with patients throughout the clinical trial process. 

What are the biggest concerns your patients share about participating in clinical research?

Deplitch (CCFA): The things we hear most often from groups is that they don’t want to be part of an experiment, that doctors don’t bring it up, or that clinical trials are considered ‘a last resort.’  So, if there’s currently a product in the market with an IBD indication that patients haven’t yet tried, they tend to try that first before looking at a clinical trial.

When we talk one-on-one with patients, the concerns are more specific. I had a conversation recently with a patient who went through a lengthy clinical trial process that went really well. He ended up on the drug for which he was part of the clinical trial, and he’s been doing well for 10 years. When I asked him what his biggest worry was when he was being screened for the trial he had two concerns: the first was that he wasn’t going to get into the trial, and the second was that they were making him call a number in Europe to get screened. This was something I had never considered, but it wasn’t familiar to him, and it made him wonder if it the trial was legitimate, and whether it was approved in the US. It was one of those things no-one would think of in terms of a patient fear, but it could have caused him not to participate.

How interesting. Christine and Ally, what concerns do your patient have about participating in a trial?

Hunter (LFA): We hear that location and transportation are often issues for people who want to take part in clinical trials. A lot of our constituents don’t drive or are on fixed incomes, so getting to the trial site is a challenge. They also have a lot of worries about their care and safety. They are concerned that they won’t get proper oversight of their disease treatment, and that the only thing that will be monitored is what’s being tested in the clinical trial. There is also a misconception about the risks of being in a clinical trial. A lot of people don’t understand that the risks of the trial are most times the same as the medication that they are taking currently.

John-Fuller (LFA): Family influence is another important piece, where you can have somebody who is completely on-board with being in a trial, then they drop out because their family isn’t comfortable. That tells us that we not only have to educate the patients about the clinical trial process, but their caregivers and loved ones as well.

When patients actually do participate in a clinical trial, what do you think surprises them the most?

Hunter (LFA): One of the things we’ve heard from patients is their surprise in the thoroughness of care they’re receiving.  Going in, a lot of people are afraid that their care is going to be neglected, and in actuality, it’s quite the opposite.

How are you helping your members to influence the design of clinical trials?

Deplitch (CCFA): One thing we’ve done through the focus groups is provide feedback to our partners. It is a way for them to hear right from the patients what their barriers are. I think the more that we get the patient’s voice out there, the more you’ll start seeing that voice incorporated into the design of their clinical trials. We’ve already seen some of that with our partners changing the way they structure trials to address some of the concerns that our patients have shared.

John-Fuller (LFA): The Lupus Foundation is part of PARTNERS (Patients, Advocates and Rheumatology Teams Network for Research and Service) a patient-powered research network funded by the Patient Centered Outcomes Research Institute (PCORI).  The LFA is also developing the LFA-REAL™ system, a first-of-its-kind set of tools to monitor lupus disease activity, which takes into account both the physician and the patient perspective using patient-reported outcomes. Everyone’s experience with a flare is different, and this is a great example of how we are starting to take into account greater patient perspective.

Why is International Clinical Trials Day important for your organization, for your patients, and for industry alike? 

Deplitch (CCFA): It raises awareness of clinical trials and highlights their importance in the development of new treatment options. Any time our patients see new treatments on the horizon, it gives them hope that there will be something to alleviate the challenges of living with chronic diseases. We want our patients to be aware that new research is being conducted, and that they can play a role in the development of new treatment options.