Clinical research for clinical endocrinologists

Most endocrinologists are exposed to research in one form or another during their fellowship training. However, few continue to be engaged in research after their training, except those of us who choose a career in academic medicine. Being a clinical investigator is not for everyone. There is a growing shortage of qualified clinical researchers, however, which means there are opportunities for those who are interested.

Before engaging in clinical research, it is essential to ask yourself: Why would you like to be a clinical researcher?

There are a number of reasons. I enjoy contributing to the science of medicine. Without the efforts of clinical researchers, the development of new medications and therapies would be delayed. Many studies require frequent follow up and close monitoring of subjects. We enjoy getting to know our research subjects and working closely with them. Patients and colleagues are often impressed by a center that not only has a reputation for providing excellent patient care, but which also offers investigational therapies as part of clinical research studies.

Occasionally I am asked, “Is clinical research lucrative?” If this is the most important concern, then clinical research is probably not for you. Although sponsored clinical research may be another means for a practice to generate revenue, it requires a great deal of effort and time. There are other, easier ways of making money, if that is what is most important to you.

The protection of research subjects is paramount. It is essential for clinical investigators to take the ethics of research seriously. No research study can be initiated until approved by your independent review board (IRB). Some research centers use a local IRB; others a central IRB. There are advantages and disadvantages to each.

Informed consent must obviously be obtained before any subject participates in a study. Subjects most understand that this is research and there could be risks, known and unknown. It needs to be made clear that subjects are under no obligation to proceed if they do not want to and they may withdraw at any time. Although sponsors would like adequate numbers of subjects enrolled into their studies, no one wants a subject recruited who does not understand what the risks are or someone who will not be able to follow through with requirements of the study protocol. Recruitment is important, but so too is retention.

So how does one go about becoming involved in clinical research? Good clinical research practice requires not only an interested clinical investigator but also dedicated research coordinators and other support staff. If there are others in your practice already doing research who could mentor you and whose research staff you could make use of, that is would be the easiest route.

On the other hand, if you are in a practice not yet involved in clinical research, then you will need to build your center from scratch. The best way to begin in that situation is to try one or more simple phase 4 studies. Whereas phase 2 and 3 studies require one or more dedicated full time research staff, some of the more straightforward phase 4 studies might not require the efforts of full time coordinators. The study procedures, documentation and other requirements could be done by you and your current staff. That way you can find out if clinical research is truly for you before making a greater commitment.

There are several courses available to learn about good clinical research practice. I found the American Association of Clinical Endocrinologists’ Basic Good Clinical Practice Training Workshop for Clinical Research as well as the AACE Advanced Good Clinical Research Practice Workshop to both be extremely useful. If you are contemplating becoming a clinical investigator and are unsure of where to begin, I highly recommend attending these workshops the next time they are offered.