The true heroes of clinical research

One of my patients mentioned to me that he was taking an investigational drug as part of a clinical research study.

“Thank you for your participation,” I said.

He seemed a little puzzled.

I clarified: “Thank you for volunteering to be a participant in that research study.”

After a moment, the patient replied, “Oh thank you and … uh … you’re welcome.”

He still seemed unsure as to why I would thank him for being in a research study through another clinic.

My colleagues and I are very active in clinical research. I have been a principal and/or sub- investigator for a number of clinical research trials. The study in which this patient was participating, however, was not one of our trials but was a study through another research site.

Why would I thank him for volunteering as a research subject in a study through another clinic? Because I believe the true heroes of clinical research are the research participants themselves.

In clinical research, the lead investigators get the credit when a study is completed; they get authorship when the study is published; and they are invited to report study results at professional society meetings. Sometimes, if a study is of particular importance, the investigators are even interviewed by the press.

Credit must be given where credit is due; much effort goes into designing, performing and completing a clinical research study. Nonetheless, the true heroes of clinical research are the research subjects themselves. Without the voluntary participation of research subjects, new treatments could not be developed and cures for disease would never be discovered. No clinical research study was ever completed without the people who volunteered to be in the study.

Sometimes, there are benefits to participation in research. Research subjects may get access to new or cutting-edge treatments. Participants are monitored closely; they often get more frequent follow-up and personal attention than they would as a patient in traditional medical practice. Even research participants in the placebo arm are usually still offered standard-of-care therapy so that it may be compared with a new investigational approach.

Often, however, there is no direct benefit to being a clinical research subject. Indeed there can be drawbacks to study participation. These include time required to come to study visits, undergoing study-related procedures, repeated blood draws as well as other expectations. Most investigational therapies have been extensively studied before being allowed to be evaluated in humans. The possible adverse effects are well-understood; however, there is always the potential for the unknown. Research is research, after all.

If there is no guarantee of direct benefit — and potentially the risk of harm — why would someone even volunteer to be in a clinical research study?

Over the years, I have heard many versions of the following from study participants with whom I have worked: “I know there might not be any benefit to me from being in the study — I might even get placebo. But if me being in the study will help you learn something that someday could help my children and others, then it is something I would like to be a part of.”

This is no greater reason to be a participant in clinical research than a desire to help others. This is why I feel that the true heroes of clinical research are the clinical research subjects themselves.