Quality physician investigators key to successful clinical trials
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There is significant art to medical practice, but today’s clinician is from day 1 in medical school trained to apply evidence-based medicine in the care of every individual patient.
There are three levels of evidence-based medicine (EBM), and the interested reader can find a nice summary of EBM in Wikipedia. Every level requires the thoughtful analysis of clinical outcomes.
Level 1 evidence requires a well-designed prospective, randomized, masked clinical trial properly powered in size to deliver statistically significant outcomes. The evidence provided by a single well-designed and well-powered level 1 clinical trial is powerful in supporting EBM decisions, but even more convincing is two or ideally three level 1 clinical trials performed by independent investigators that deliver the same outcomes.
Level 1 evidence is required to achieve regulatory approval for any medical device, drug or biologic in the advanced countries before it can be launched and marketed for general application in patients. Billions of dollars and millions of hours are spent each year by governments, industry and research institutions creating and analyzing the data generated in patient-based level 1 prospective clinical trials.
While those who design the studies, monitor them and analyze the data are critical, I believe the most important participants in this massive effort to improve quality of care are the practicing clinician/surgeon investigator along with their patients. An experienced quality physician/surgeon clinical investigator and their team are at the core of every successful clinical trial.
I am often asked by younger ophthalmologists: “How can I become involved with industry and find my way onto the podium lecturing at meetings?” The pathway for most, if not all, so-called clinician key opinion leaders (KOLs) is through successful participation in clinical trials.
Step one in being invited to participate in a level 1 clinical trial is to build a meaningful practice and select one or more areas of special interest. Recruitment and timely enrollment of patients are critical to any entity funding a clinical trial. Once you have the patients, it is necessary to design your practice to accommodate the demands of a clinical trial in your area of interest. This requires interested and trained support staff, in some cases specially designed examination lanes and often specialized testing equipment. There will be a study sponsor site visit to evaluate a practice’s ability to perform a clinical trial successfully, including in-depth interviews with the clinician and their support staff and evaluation of the facility and patient volumes.
Once ready, the motivated physician must make those that fund and support clinical trials aware of their capabilities and interest. This can be facilitated through local industry representatives, the support of mentors who are active in the field and attendance at meetings focused on one’s area of interest. Every entity that funds and manages level 1 clinical trials is always looking for new investigators.
One good opportunity is to design and propose an investigator-initiated clinical trial (IICT). A well-designed and well-performed IICT can give the younger clinician and their practice the opportunity to confirm their ability to be a good investigator. It will also give them the opportunity to present their results in writing and verbally at one or more meetings. It is important to spend the time necessary to write a quality paper for publication and present well from the podium when given the opportunity. Professional writers, mentors as coaches or editors, and diligent practice before any presentation are critically important. I repeatedly tell my fellows and those I mentor that I can open doors for them and provide opportunity, but only they can deliver a superior performance that will get them a return invitation.
In summary, clinical trials are the backbone of EBM. Clinicians are the backbone of clinical trials. Quality execution, publication and presentation of the results of a clinical trial are a proven pathway to becoming a KOL in one’s chosen field.
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