From Subject to Partner: Patient Participation in Research

The transition of patients from subjects to partners in research has a distinct impact on all who benefit from truly patient-centered research.
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Patients have always been critical to the research process. Without their participation as research subjects — answering surveys, providing tissue samples, taking investigational drugs — studies can’t be conducted. Traditionally, there were few opportunities for patients to participate beyond the role of study subject, and historically, many of those subjects were not treated well. However, a paradigm shift is underway which increasingly incorporates patients as partners in research. This shift means that patients are protected, and that studies are designed to ensure that participating is a good experience as well.

From Abusive Practices to Patient Protections
High-profile abuses of the clinical research system have led to changes that are designed to protect patients. Henrietta Lacks’ cells were harvested without her knowledge or consent when she was treated for cervical cancer, and researchers multiplied them in the lab, shipping them out across the country and the world. Her cells changed medical science in some pretty powerful ways, but when her family found out that her cells had been immortalized and researchers had profited from sales of the cells, they felt betrayed. (If you haven’t read the book or seen the movie, do it!)  

Another gross overreach of medical research is the Tuskegee Syphilis Trial. African- American men were recruited to the study, and while they participated freely, they were not properly informed about the goals of the trial or what participation would mean to themselves or their families. The study was conducted over the course of 40 years, and during that time penicillin was shown to be an effective treatment for syphilis, But the drug was withheld from study participants who suffered immensely and even died as a result of the untreated disease. In addition, because treatment was withheld, many of the participants’ wives and unborn children contracted syphilis because the disease spread from husband to wife and mother to child.

These two events, along with other patient abuses in the name of science, spawned the National Research Act of 1974 and the issuing of the Belmont Report in 1976. Now, there are very strict guidelines that protect research participants, and Institutional Review Boards must approve every detail of any research involving human subjects to ensure patients are protected.

However, even though medical research studies are now designed to place a high priority on patient protections, there are still few studies designed with the patient experience in mind.

Partnership Provides Perspective for Researchers
Traditionally, clinical research studies were primarily designed to give the researcher adequate data to answer a scientific question, and then the researcher would ensure the design was ethical and proper patient protections were put in place. Patient experience was largely ignored not because the researchers were thoughtless, but because it was something they had not been trained to consider. Incorporating patients as part of the research team trains the researcher to consider something new, and many scientists will listen to the comments of the patient with wide eyes, eager to incorporate the new ideas to improve their research.

I will never forget the look on the face of an established researcher — who had been touting the benefits of the drug tamoxifen for years — when he listened to a room full of women share their experiences with it. He had never considered how life-altering the side effects could be, nor how devastated a patient might feel, knowing he or she needed to take the drug for 10 years. The researcher left that meeting with a more realistic view of tamoxifen’s impact, and I’m sure he has a better understanding of the urgency to find better solutions for breast cancer patients.

Patient Partnership Impacts the Future of Medicine
While I don’t necessarily agree with what I’ve heard about new tricks and old dogs, I’ve found that working with young researchers — early career investigators or even students — is a great way to help them consider the patient perspective from the beginning, before they have established their routines. I’ve had the pleasure of working with several early career investigators who have sought out the patient perspective, and through that partnership, they have gained an increased sense of urgency for their work and developed more thoughtful protocols, even altering procedure schedules to be more accommodating to a patient’s lifestyle. It’s so exciting to remember the conversations where I’ve introduced the idea of partnering with patients to fascinated investigators who had never even considered the concept, and I have had the privilege of watching as they realize how interactions can have such a tremendous, positive impact on their research. When these transformative relationships start early, they impact not only a single career, but future generations who will be trained by those investigators, and the many patients who will benefit from better research.

Making the Move from Patient to Partner
Patients partner with their treating physician all the time, as they work through the process of shared decision making to decide on a final treatment plan. But partnering with researchers to impact the care of the patient community is a much bigger step. If you’re interested, there are resources to help you get started. The FDA does great work reaching out to patients, and they’re a good place to start for anyone. Another great way to get involved is to check with the big advocacy groups in your patient community and with the relevant professional societies.

Moving from patient to partner takes work — lots of learning about science, the research process, and the regulatory process, but the rewards, both to the individual and to the community, are immeasurable.

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