Physicians – Valley Institute of Research

Physician

Physician.

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why physicians need to consider clinical research as a viable option for their patients as well as for their private practices.

It is usually a given fact that physicians who have busy private practices, work in hospitals, or are employed by urgent care centers have access to a variety of patients that may be perfect candidates for clinical studies. However, there is a bit of an issue: these physicians that see a plethora of qualified study candidates do not have enough time to participate in the clinical research studies, and do not understand the clinical research industry well enough to consider referring their patients to another physician for a clinical trial.

Because the majority of clinical trials experience some sort of delay in meeting study enrollment target dates, clinical studies end up costing the drug companies more, which in turn, causes the prices of pharmaceuticals to increase. Furthermore, if the physicians realized the opportunity cost that they are paying by not getting involved in clinical research they would most likely change their participatory behavior.

Awareness .

Clinical Research has a branding problem. Most people, physicians included, perceive clinical studies to either be weird experiments conducted in obscure laboratories, or in ivory tower academic institutions and secret government buildings.

This couldn’t be further from the truth. Many single practice physicians conduct research studies from their own private practice in a typical outpatient setting. These physicians apply for studies with various pharmaceutical companies and contract research organizations, are given a protocol, training, and guidance to follow, enroll and supervise their own patients as they participate in the study, and submit the data collected back to the pharmaceutical companies in exchange for an often lucrative reimbursement from these same pharma companies. Most of the time these physicians hire specialized staff members called clinical study coordinators to handle the majority of the paperwork and data collection at their office. Without leaving their private practice, or even doing a significant amount of additional work, these physicians are able to create new revenue streams for themselves, be on the cutting edge of latest treatments, earn some prestige within the research community, and establish their own brand over time as key opinion leaders. If more physicians were aware of the clinical research opportunities available to them, they would most likely be willing to participate as Investigators and in turn, refer their own patients to these important trials.

Fear.

What prevents most physicians from participating in studies after awareness is no longer an issue? Fear. Countless myths abound in regards to this highly regulated industry. The FDA will fine you and or take away your license. Patients will get injured and sue you.

Pharmaceutical companies will sue you. You will drown yourself in massive amounts of paperwork. Many of these fears are either highly unlikely or have strong contingencies in place by the industry to protect the physician from worst case doomsday scenarios. Yes you have to maintain adequate oversight and supervision of any study that you are a Principal Investigator for. Yes you may get audited by the FDA. However, as long as you are following the study protocol and Good Clinical Practices, you will be indemnified from any litigation sprung up against you by a patient or any other groups.

Pharmaceutical companies are highly dependent upon physicians for clinical research participation, patient referrals, and ultimately, for writing prescriptions for these drugs. The last thing a pharmaceutical company would ever want to be known for is throwing their Principal Investigators under the bus should a patient or regulatory agency raise issues with the physician. Furthermore, the extensive documentation and paperwork that goes into the data collection and reporting for any clinical trial is handled by specialized staff members called clinical research coordinators. Additionally, the source documentation and data is regularly reviewed by internal quality assurance professionals referred to as clinical research associates, all on the pharma company’s dime. As you can see, there is actually a system that has been put in place for physicians to successfully be able to come in and conduct clinical research trials with a minimal amount of inconvenience to them in most cases.