Q&A: Patient Participation in Research

June 2, 2016

Q&A: Patient Participation in Research


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Celiac disease expert Dr. Daniel Leffler and Beyond Celiac Director of Healthcare Initiatives Kristin Voorhees, MA, talk celiac disease research and the patient’s role.

Patient participation in research is vital, and patients that are reluctant or unable to participate in clinical trials can help advance celiac disease research in several other ways. Less intensive participation, including surveys, focus groups and Beyond Celiac social media discussions, all provide essential information to researchers. This month, we sit down with two experts to talk about patient involvement in celiac disease research.

Daniel Leffler, MD, MS
Daniel Leffler, MD, MS, is Director of Clinical Research at The Celiac Center at BIDMC and Director of Quality Assurance, Division of Gastroenterology at Beth Israel Deaconess Medical Center and Beth Israel Scientific/Medical Advisory Council Member.

Kristin Voorhees, Beyond Celiac Director of Healthcare Initiatives

Kristin Voorhees, MA in Health Communications, is the Director of Healthcare Initiatives at Beyond Celiac. She has been working with Beyond Celiac since 2010 and is diagnosed with celiac disease.

In what area is most celiac disease research currently being done?

Leffler: Research is being done across nearly all areas of celiac disease, from basic science into the immune reaction to coping and adaptation of family members. It would be hard to pick which area has the “most” research at any one time.

What topics in celiac disease need more research and exploration?

Leffler: I believe that, while we have learned a great deal in the past few decades, we still have much to learn across all of celiac disease, from the genetics to the psychological. In my opinion, one of the most important areas that urgently needs evaluation is the costs and benefits of celiac disease screening programs.

I don’t want to participate in clinical trials that involve testing drug therapies. Are there other ways I can contribute to research outside of this? If so, how do I find out about them?

Voorhees: Yes, there are many other types of research outside of drug trials. These can include surveys taken online or at your doctor’s office, focus groups, one-on-one interviews with researchers or studies that take place in the doctor’s office (also known as clinical research). Letting your doctor or dietitian know that you’re interested in research is a great place to start. You can also stay informed by connecting with the patient advocacy organizations, like Beyond Celiac, on their websites and social media. Beyond Celiac began the Research Opt-In as part of our commitment to advancing research. The Research Opt-In updates patients and family members about ways to participate in research. We keep up-to-date on the latest in celiac disease research so you can have opportunities delivered automatically to your inbox. It is just one of the many ways Beyond Celiac works to advance celiac disease research. You can sign up for the Opt-In here.

What makes someone a good candidate for participation in research? What are the potential benefits and risks of participating?

Voorhees: Each research study and clinical trial has its own inclusion criteria, which are the characteristics that a person must have in order to participate in a study. These are specific to each study, but often include things like a person’s age, length of time on the gluten-free diet and whether the person has ongoing symptoms or their celiac disease is well-controlled. The benefits and risks will vary by study or trial, but overall, I think it’s important that patients remember that one of the biggest benefits is playing a direct role in helping doctors and scientists better understand celiac disease and advance its research.

I see requests to answer online surveys several times a year. Does taking a survey actually help with scientific research? What happens with the information gathered in surveys?

Voorhees: Yes, it does! Researchers will often use surveys to help guide their research strategies and to learn more about patients and the challenges or needs they might have. Surveys can also help doctors or dietitians better understand how well a patient is handling their celiac disease diagnosis or maintaining their gluten-free diet. This can help to improve the ways clinicians are managing and treating their patients’ diagnoses and also determine new topics that require further research.

Why do I have to keep sharing some of the same information in surveys, focus groups and conversations with researchers? Do researchers share data they gather with each other?

Leffler: Hopefully you are not getting the exact same questions over and over again. We certainly share our results with other groups, but regulations usually prevent us from sharing individual, patient-level data. You may see different groups doing similar research. This is all part of the scientific process. To make sure findings are real and robust, we like to see similar studies with similar results in different populations.

If I participate in a study, will I be provided with the results of the study and of my contribution? If not, how can I find out the results?

Leffler: This depends a little on the type of study. You should always be able to find out the results of the overall study from either the investigators directly or by looking on www.clinicaltrials.gov. We are always happy when people reach out to us after a study to hear about the results. At the same time, it can often take months or longer to interpret the data, and in some trials of therapies, we may never know who got active treatment and who got placebo, so individual data may not be available.

What are examples of research that have focused on things other than developing new treatments and already had an impact on the celiac disease community?

Leffler: One area that has been very helpful is the study of non-responsive celiac disease. These studies have given doctors a much better sense of what is going on when patients with celiac disease don’t feel better and have guided diagnostic and treatment algorithms. (You can access Dr. Leffler’s research on non-responsive celiac disease here.)

How do I stay up-to-date on the most recent developments in celiac disease research?

Voorhees: There is a great deal of research currently being conducted on celiac disease, but it can be difficult locating all of this exciting news. Beyond Celiac gathers the most important news from the world of celiac disease research and provides regular updates through our Research Opt-In. You can stay up-to-date with new celiac disease research by signing up here.