Diabetes and Research Trials: Who and Why?

Dr. Fran Cogen Health Pro
  • "While we have not been successful finding a cure, we have been highly successful in driving the industry to consider better tools for better diabetes management and much of that has been from the research that did not bring us a cure!" Ann Bartlett, June 30, 2011.

     

    Situation:

    I met with a 13-year old and his family two weeks after his diagnosis of type 1 diabetes. They came into my office with reams of downloaded material from the Internet about every aspect of diabetes: management, complications, and research directions. They were interested in the possibility of participation in a research trial being conducted at "_____" University and wanted my opinion as to whether or not participation is advisable.

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    A lengthy discussion ensues...

     

    Ann Bartlett's recent blog, "Diabetes and Failed Research, What does that mean for us?" discusses significant issues about relationship of research participation and the significance of the results. Per Ann's blog, the following heated comment from a participant in the Yale audience was directed to Dr. Kevan Herold, an MD, PHD researcher in the field known for anti-CD3 monoclonal antibody research.

     

    "For all the money spent, I would assume you would have known this wasn't going to work!"

     

    My question would be "Why would Dr. Herold, a person with type 1 diabetes, waste his efforts for a research approach of which he had NO faith? I am sure Dr. Herold is devastated by the lack of efficacy of his Macrogenics Anti-CDC trial. However, not to be deterred by failure, he will continue to work on anti-CD3 and find out what is missing in the immunologic puzzle.

     

    It is important to understand that all findings in research are useful and should not be considered "failed research." If the findings do not support one's hypothesis, the researcher should then try to determine why? It is often by trial and error in association with a brilliant idea that discoveries are made! There are many examples of this in history: the discovery of Penicillin, Smallpox vaccine, even DNA! However, what I believe provoked this audience member was the frustration tied to the fact that we are not getting answers now, which forces families and diabetes healthcare teams to use the management tools that are available and not "cure" diabetes. Yes, it is frustrating...we keep hearing that the "cure" will be available in 5 years... which then passes and we are promised another 5 years. This pattern gets old quickly for families with a person with diabetes. However, do we stop making attempts and discontinue funding to our promising and devoted researchers? This practicing diabetes clinician thinks not.

     

    So, let's go back to my new family. What did I tell them?

     

    To advise people in regard to research trials, clinicians need to be educated in scientific research and ethics. To even consider conducting research trials, the IRB (Investigational Review Board) requires all investigators to take an extensive online course delineating the ethical behavior associated with research. We are required to learn the different laws that have been passed worldwide and in the United States that protect "human subjects." One of the most important aspects of these rules is the status of "informed consent." The participant in the study must know the risks and benefits of the study before he or she agrees to enroll. Thus, the investigator must (legally) discuss these concerns in depth.

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    My role in the process is to be informed about the different research protocols that are available locally and around the country. I do not readily know some of these studies; however, my patient families bring me the literature, and at times, I contact the Principal Investigator (PI). It is important to me that the older child (in a position to understand and help make decisions) be comfortable with all the choices available. Therefore, it is my belief that a 13-year old is capable of making an informed decision and thus is able to provide informed consent with agreement of the family. It is important for the child and family to realize that they may NOT get the study drug (and be placed on a placebo); however, they will be providing much needed data to determine the efficacy of the study drug. This must be explained. If they do get the study drug (after the study is unblinded) they must realize that they may not necessarily be able to continue using the study drug after study completion.

     

    Why do people choose to participate? Is it self-serving, altruistic, or a bit of both?

     

    If my patient families chose to participate in a trial, after having discussed pros and cons, I reinforce their contribution to the field of diabetes research and emphasize the altruistic component that they may not only be helping themselves in the present, but might be able to help someone in the future. It is important to understand the research is not always linear. Steps are made both in the positive direction and then perhaps go back several paces.

     

    However, as human minds continue to move forward, we must applaud those that would pursue truth despite previous failures to discover the coveted diabetes cure.

     

     

Published On: July 07, 2011