Clinical Research

Clinical research is a systematic approach to finding out what clinical approaches do and do not work and then using this gained knowledge in to advance and improve clinical decision making. There are many kinds of research, but in the US, about 59% of research focuses on drug research. At any one point in time the FDA has approximately 9-11 thousand clinical trials registered and these trials are seeking 2.8- 3 million subjects. Clinical trial investigative work is conducted in every disease state. Currently, a great deal of research is ongoing in cancer, cardiovascular, Neurology, and anti-infectives.

Bringing a drug to market in the US is a long (10-15 years) and expensive endeavor as about 90% of drug trials do not make it past the first phase of clinical trials. High quality results, timeliness and actionable evidence remain key indicators for a clinical trial. There are four phases of drug trials. Phase I involves safety testing in small numbers of patients. Phase II tests the drug in larger patient populations who have conditions or diseases the drug is meant to treat. Phase III is a pre-approval round where large populations of subjects with affiliated health issues test the new drug as compared to standard treatment. Roughly, 2/3 of Phase III clinical trials are approved by the FDA. Phase IV trials are post- FDA approval trials to explore additional adverse events, performance vs. competitive drugs and additional possible uses.

Patients often enroll in clinical trials with the belief that their experience may be of benefit to future patients. Clinical trial management is highly regulated with involvement and monitoring from many agencies. Informed consent is required. Most consumers and clinicians think of clinical trial research as being performed in large academic medical centers. However, there are many community level models that are available to extend participation and the quality of the research across populations as we are finding that drug response may vary more than previously expected due to each person’s unique pharmacogenomics.

Tune in to this segment to learn about clinical trial research in general and for more information about unique and highly successful community based models of research occurring in GA and the Southeast. Dr. Jeff Kingsley, a clinical research veteran at the national level and his associates will lend their expertise in the field of drug clinical trial research. Listeners can also obtain more information on www.serrg.com and the FDA’s research site at www.clinicaltrials.gov.

Dr. Jeff Kingsley