Patients Becoming Partners in Research

When it comes to clinical trials, everyone knows the drill: experts create and patients participate. Right?

Well, yes and no.

Historically this has been the common practice but times are changing and the current accepted methods used to design clinical trials may be going the way of advice like “take two aspirin and call me in the morning.”

Clinical trials have been around in one form or another for centuries but it’s only been since the end of World War II that they’ve evolved into the carefully researched double-blind controlled studies we know today¹. During this time, researchers seemed to settle into a comfortable status quo where they designed the trials² while the only role of patients was providing necessary data.

While there have been a few exceptions to these clearly defined roles over the years, particularly in the fields of breast cancer and AIDS research where individuals and patient groups played a more active role³, it has only been since the 1990s that the true value of the patient/researcher partnership has been recognized.

The first major government-supported initiative to engage patients and the public in health-related research was the United Kingdom’s National Health Service INVOLVE program, launched in 1996.⁸ Today, INVOLVE trains and encourages patients and the public to participate in all levels of research from design to review to dissemination.

Another important milestone came in 2008 with the European Commission funding Patient Partner, a three-year, one million euro project “to identify the patients’ needs for partnership in the clinical trials context.” In time it evolved into a means for ongoing communication as well as guidelines to encourage patient and researcher interactions.^5a

In the U.S., the creation of the Patient-Centered Outcomes Research Institute (PCORI), a U.S. non-profit non-governmental organization, was established in 2010 and focuses on creating and promoting research that includes patients and caregivers.⁴

As a result of these initiatives (and others), researchers have been encouraged to look at clinical trials differently—though as with any type of big change there can be challenges when it comes to implementation. The addition of a patient perspective can bring unique insight and new ideas to the process. However, it can also bring issues to overcome - like how to specifically measure certain elements and incorporate them into the results.

While there are other concerns too, such as whether including patients will make the clinical design process take longer, overall this approach offers significant benefits to patients, researchers, and trials.

• Patients can help determine what is studied by offering specifics. Researchers can only guess when it comes to what questions to ask and what their real concerns are.
• Patients can provide important input on logistics like suggesting good times for working parents’ schedules to encourage more participation and discussing issues like whether both parents and children should answer questionnaires in trials involving minors.⁶
• Patient involvement has been shown to help with a persistent problem facing many studies – enrollment. Various groups have found that by encouraging and allowing individuals to demonstrate leadership and ownership in the clinical trial process they may have more of a stake in it and be more likely to spread the word to recruit others.⁶
• Patient involvement can lead to better satisfaction with the study results. Not only could findings themselves be more useful but answers could be more easily understood by laypeople thanks to patient participants looking over them first and adding more or simpler explanations as needed.

While being able to measure its success from a scientific discovery perspective is likely still years away, the patient-centered clinical trials movement is already changing the way both researchers and regular people think about what they want to learn, how they want to go about it and the ways they can do it together.