Special to Orlando Medical News

With pharmaceutical and biotech research companies spending over $58.8 billion yearly for research and development of medicines and vaccines, many private practice and hospital-based physicians are considering clinical research as a way to boost their shrinking bottom line. Yet despite the billions spent on clinical research, the percentage of physicians serving as clinical trial investigators is estimated at between 4 and 10 percent.  

The advantages of being a clinical trial investigator include:
    Professional development.  Clinical trials enable physicians to work on medications and therapies not yet approved by the FDA.  These trials allow physicians to be on the cutting edge of future treatments and possible cures, and enable them to increase their knowledge base.
    Recognition within the community.  Being an investigator enables physicians to enhance their reputation and gives them a unique edge when speaking or writing articles.  
    Personal satisfaction.  New treatment options only available through clinical trials can be offered patients and those within the community.  Investigators work to combat diseases, treat chronic conditions, and improve the health of those worldwide.  
    Innovative care for patients.  As a clinical researcher you can provide patients with no-cost treatment options that are administered under the highest standards of care.  With certain conditions, such as Alzheimer’s Disease, clinical researchers can provide treatment options that would otherwise be unavailable.
    Compensation.  Physicians receive compensation for their work on clinical trials.

“Some physicians join clinical research for the wrong reasons which contributes to their lack of success in the field,” explained Mildred V. Farmer, MD, of Meridien Research in St. Petersburg, Fla. “At first glance, clinical research may seem like an easy way to make money with some studies paying $10,000 and more per patient enrolled.  But when you factor in all that is involved in successful clinical research – regulatory compliance, patient recruitment, drug storage, equipment and office space, monitoring and record keeping – it quickly becomes apparent that there truly is a science to clinical research that can be daunting to those first starting out.”

Crucial to success in clinical research is Good Clinical Practices (GCP) and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).  Those conducting clinical trials must adhere to GCP, including adequate human subject protection (HSP), which have been regulated by the FDA since the 1970s.  ICH gathers regulatory authorities and pharmaceutical industry experts from the United States, Europe and Japan to achieve greater “harmonization” in regards to technical guidelines and requirements for research and development testing and product registration.  ICH guidelines are law in many countries, but only serve as guidelines for the FDA.

The regulatory climate has changed dramatically since Farmer and co-founder Cathy Collins first began their research company in 1990, which now consists of four sites in the Tampa Bay area.  According to an Association of Clinical Research Organizations survey, the number of physicians participating in clinical trials in the United States has continued to decrease over the last 10 years.  Seventy percent of all respondents cite current regulations that make clinical trials difficult to manage as the reason for the decline in U.S. participation.

 Conversely, Asia, Latin American, and Central and Eastern Europe have seen double-digit increases in clinical research participation.  Increasing competition and a more stringent regulatory climate has caused research trials to move overseas. Many of the investigational medications currently under study in the U.S. are already available to the public overseas.

Despite these issues, 73 percent of physician non-investigators expressed an openness to clinical research and an interest in becoming an investigator, according to the Oncology Times. Survey respondents cited lack of ways to identify clinical trials, regulatory structure for conducting them, liability issues and compensation as barriers to participating in clinical research.
Instead of hanging out their own shingle, many physicians are signing on with established clinical research companies as sub-investigators. “Sub-investigators are able to receive supplemental compensation from the clinical research company while maintaining their current practice,” said Meridien’s Farmer.  “We take the time to educate the physician on how to properly perform clinical trials and make sure they have an in-depth knowledge of GCP and ICH.”

Often sub-investigators are retired physicians who want to work a few afternoons a week or those in private practice who have decided to participate in clinical research but do not want the burden of responsibility associated with actually running the trials.  “It’s a win-win situation for the physicians and the clinical research companies to have a qualified pool of sub-investigators because they can get studies in a variety of therapeutic areas and we can receive compensation with a time-only investment,” explained Gigi C. Lefebvre, MD, a physician in private practice who also conducts clinical trials for Meridien Research.

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