A support staff and the proper infrastructure are key. There has to be a principal investigator, a study coordinator, and possibly a subinvestigator, a regulatory specialist, a patient recruiter, and an RN or pharmacist for studies involving intravenous drugs, Dr. Troum said.
Acquiring a study. To begin acquiring studies, new investigators can ask their medical science liaisons from pharmaceutical companies, attend industry meetings, go to seminars, ask colleagues for referrals, be introduced to company scientists, and subscribe to periodicals that publish research opportunities.
Negotiating a contract. Routinely, the sponsor of the trial will propose a lower budget than is needed to cover costs, so negotiation is important, Dr. Troum said. Never begin a study without a signed contract, he warned.
Clinical trials should be considered a separate business entity. There are overhead and costs, he said, as well as hidden costs such as purchasing dry ice and having to store documents for many years. A payment schedule should be agreed upon prior to the study. If a sponsor refuses to negotiate fair value, the study should be refused, he said.
Performing a stellar study. The best method to obtain further studies is to conduct stellar studies, Dr. Troum said. Accrue the promised number of patients, accurately and efficiently collect data, and demonstrate excellent execution of the study. All assessments and procedures should be documented.
"Successful completion of a clinical trial should be a rewarding experience for the subject and investigators," he said. Enroll patients who are willing to participate through advertising, doctor-to-doctor letters, and community outreach.
"If done properly, clinical investigation may be both intellectually and financially rewarding," he concluded.
BIOTECHNOLOGY
"Careers in biomedical industry are increasingly attractive career options," said Dr. Louie, who was the medical director for Amgen for 5 years. They are also rewarding, he said, because you have a hand in creating the most effective therapies for patients, while keeping up with the latest advances in medicine.
It is a very exciting time in rheumatology because the therapeutic landscape is changing and there are powerful new research technologies, he said. "We are progressing toward personalized medicine."
To prepare for a career in the biotechnology industry as a student or fellow, participate in the recruitment, data collection, and interpretation of clinical trials and translational research, advised Dr. Louie, professor emeritus in rheumatology at the University of California, Los Angeles. Also, investigative experience and an advanced degree should be considered (MBA, MPH, PhD).
Before accepting a position in the pharmaceutical industry, ask yourself three questions:
• How will you negotiate for your contract?
• What do you want to learn from the experience?
• What will be your exit strategy as you move to other areas of interest?
There are fundamental financial considerations in pharmaceutical/biotechnology companies, so negotiate carefully with advice from your colleagues and lawyers.
There is money in industry, so negotiate carefully, he said. And if this is the route that a fellow chooses to take, he or she should continue to attend at a teaching institute to stay current in patient treatment.
The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.