Becoming a Clinical Trial Investigator: Making Clinical Research Successful for All Parties
Dan Sfera, CEO of The Clinical Trials Guru, shares how to start your research clinic and how clinical research can be successful for all parties involved.
11 April 2016
This is part two of a three part series on how to get your research clinic off the ground.
In our last post, we talked about how to get started as a new clinical research site owner and set up your first research clinic for success. Today’s blog is about how the pharmaceutical industry (sponsors) can encourage more new sites and physicians to participate in clinical research and become Principal Investigators (PIs).
Finding sufficient candidates who meet a study’s eligibility criteria is increasingly problematic for the industry and the primary definition of success or failure for an investigator site is determined by this metric (namely the number of patients, if any, they enroll).
Physicians who treat a high volume of patients within their private practices would be able to help rectify this dilemma by enrolling qualified patients into clinical studies, however, they need to be motivated to do. The clinical research industry has long been plagued with the fact that physicians typically conducting studies do not see enough patients in the “real world” that can be considered for enrollment, while physicians not involved with clinical research have access to the patients but they sadly never get enrolled in (or even made aware of) a clinical trial.
One strategy that pharmaceutical companies can employ is to use their existing infrastructure of sales reps to help educate physicians about upcoming research opportunities while sharing information about their pipeline and clinical development progress, then if interest exists, connect them with medical liaisons. Medical liaisons are literally at the intersection of sales and research. They can help potential new sites explore clinical research opportunities — and their background is usually that of a pharmacist or another physician.
Many physicians have the misconception that clinical research is solely conducted by academic institutions or non-profit organizations. They are often unaware of how to conduct clinical research right out of their private practice offices — generating additional revenue streams and offering their patients access the investigational drugs, whether desired out of hope or financial necessity. Furthermore many may be intimidated by the amount of time and paperwork that they assume they will have to commit to when starting their research business. This is another misconception. While there undoubtedly is a burden of paperwork encompassing clinical study visits, SOPs, regulatory documents, logs and the like, most of this work can be delegated to a qualified and competent study coordinator.
Today, site documents can also be managed more efficiently AND securely with the help of an enterprise collaboration tool, such as Intralinks VIA®, which can provide easy filing in the cloud and sharing — securely, compliantly and fast — with whoever needs to access.
If physicians knew that the barriers-to-entry for starting a research site is contextually low and that the biggest expense is the annual salary for an experienced study coordinator, I believe that many more would be participating in clinical research opportunities. It’s important to also remember that pharmaceutical companies stand to gain quite a bit from attracting new physicians participating in research. Not only are they likely to complete their studies on time, there is an added bonus: physicians who participate in a clinical trial for a medication are more likely to prescribe that medication as opposed to the physicians who don’t. It’s a win-win situation for everyone as long as the pharmaceutical industry is able to capitalize on the opportunity.
While the clinical research workload for a potential PI may not be as high as some would fear, operating a research site is certainly not free of its own challenges. In part three of this series, I will explore clinical research site operations. Stay tuned!
Dan Sfera is the CEO and President of The Clinical Trials Guru, LLC and DSCS Sweat Equity & Investments, LLC. Through these two companies Dan assists Sponsors and CRO's with Site Selection, Research Staff Training, Recruitment, Contract and Budget Negotiations and Business Development. Dan is also owner, partner and advisor for dozens of clinical research sites across the United States as well as Internationally. With a focus on marketing, finance and operations, he and his team have helped successfully launch many research organizations in the past 10 years.