Derms weigh many factors in considering clinical trials

May 01, 2007, 4:00am

Clinical trials are necessary before products can be approved by the Food and Drug Administration (FDA), and often afterward, as product safety and efficacy are further investigated.

Dermatologists are always looking for better ways to treat patients suffering from skin conditions such as psoriasis or melanoma; in addition, they're always looking for improved cosmeceuticals.

On Call wondered whether dermatologists take part in clinical studies or refer patients out to studies. We also talked about characteristics that make a patient a good candidate to take part in a study.

She says she just wouldn't feel comfortable doing clinical trials.

"I sense that might be a little conflict of interest. It would depend what the project was and whether or not, if I were the patient, I would want to be involved.

"If I thought the product was something that would be a marked improvement over current therapy, I could be very interested, as long as it had minimal side effects. I wouldn't want to be in that salesman-type of position, however. I want to look at what is best from the patient perspective and wouldn't want the patient to think my decisions were influenced by some study I was trying to complete."

"Talking biologics, specifically, I think we may be over-hammering the immune system and putting us at risk for infections, as well as cancers. Coming down with lymphoma is just not a risk I'm willing to take."

She prefers to see more data first.

Practical restrictions

Other dermatologists say practical reasons restrict their involvement in trials.

Susan W. Cox, M.D., a dermatologist in Newport Beach, Calif., took part in a trial one time, because her patient worked for the manufacturing company and asked for her help. She learned that personnel, and even space, can be factors in making studies work.

"We didn't have anyone devoted to drug study. It was pretty much me doing the paperwork, me doing photographs, me doing pretty much everything. It was time-consuming.

"Also, our office is crunched for space and it takes a good amount of space for studies - space for information binders, a desk for the study monitor when they come in, space for patient information, not to mention the space just to see the patients," she says.

Dr. Cox, in practice 17 years, says there are benefits to doing the studies, but it isn't always easy to attract participants.

"I enjoyed doing it in terms of being involved in something new and exciting. If it's a good product, it is fun," she says.