Advancing Our Clinical Care

It was about 10 years ago when The Jackson Clinic began a new clinical research endeavor. The desire was to offer physicians the opportunity to collect data which would help establish new treatments for medical problems. This differs from regular clinical practice in that standard practice uses treatment already established. This also offers patients the opportunity to receive cost-free, cutting-edge treatments, hope for relief of their conditions which have not responded to established treatments, help with the development of new therapies, and receive additional care and attention from the clinical trial staff. Research may involve development of new drugs; new uses and indications for established drugs, devices, surgical procedures, and testing. There is an established process through which new therapies undergo in order to become approved therapies. For drug therapies, this may start in the laboratory, in progress to studies involving very small numbers of people to test for safety, then to studies involving slightly larger numbers of patients at a therapeutic dose to test for efficacy, then on to large numbers of patients to determine therapeutic effect and to get FDA approval. Occasionally there will be further studies involving post marketing surveillance to watch for long-term effects. The stages of drug development are referred to as phases, Phase I, Phase II, Phase III, and Phase IV. Phase II is frequently broken down to Phase IIa and Phase IIb, where IIa assesses dosing requirements and IIb randomizes patients to either placebo or standard treatment. The Jackson Clinic participates predominantly in large multicenter trials involving large numbers of patients determining therapeutic effect that is Phase III. Physician participation from the Clinic has been primarily from OB/GYN, Internal Medicine, Pediatrics, and Family Practice. Trials we have participated in have resulted in new therapies and vaccines which are now on the market and part of standard clinical practice.

An essential for successful clinical research trials is patient recruitment. This is accomplished in several ways including general clinical practice patients, advertising, and word-of-mouth. Some patients have concerns about participation, feeling that they may be involving themselves in experimentation. Really nothing could be further from the truth as patient safety, including their complete informed consent, is paramount in clinical research. There were times in the distant past where this was not the case, and occasionally grave injustices were done. Now there are guidelines for patient safety which are established both nationally and internationally. Researchers are required to have training in procedures maximizing patient safety, generally referred to as GCP, or good clinical practice. Use of GCP will be part of the contract with the sponsoring company in order to conduct a trial. Patients can therefore be reassured that their safety is the prime consideration, and they can completely voluntarily choose to participate, or withdraw if they desire, once they have been completely informed of what they will be involved in doing and given their consent. Informed consent is another essential part of clinical research. Once a patient is enrolled in a trial, their evaluation and treatment will be free of charge and their time and effort are usually compensated with a patient stipend.

When The Jackson Clinic first entered into clinical research, we contracted with an organization to help us manage our site. These organizations help with all aspects of clinical research such as finding studies, contract negotiations, providing clinical research coordinators, invoicing, and archiving records. Recently we have separated from this type of system and taken on all aspects of research within The Jackson Clinic. This has been like starting over from scratch, and this process is still evolving. Of utmost importance are having the right clinical research coordinators, or CRC’s. Having two excellent coordinators in place allows us to proceed to include other medical specialties in the research endeavor. Our Cardiology Department is expressing a serious interest in research, and after Cardiology becomes involved hopefully we can expand further from there. Research has been a rewarding addition to Jackson Clinic services, as we are excited to be a part of advances in clinical care.

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