By Lamb McErlane attorneys Vasilios J. Kalogredis, Esq. and Sonal Parekh, Esq.

Clinical trials are the primary means to assess the efficacy and safety of new drugs and medical devices, and often take place at hospitals, universities, clinics, and doctors’ offices. Companies funding the clinical trials often seek out scientists, physicians, and other healthcare practitioners (collectively, “Practitioners”) to design, conduct, analyze, and report clinical trials in exchange for compensation. Accordingly, conducting a clinical trial can prove to be a highly profitable business strategy, whether as a business model separate from a Practitioner’s Practice, or as a supplemental form of income. Participating in clinical trials can provide a number of benefits to Practitioners.

Financial Incentives

Clinical trials can bring in welcome extra revenue. Practitioners can add to their income by participating in clinical trials. Specifically, they can contract with the National institutes of Health (“NIH”), pharmaceutical or medical device companies, or even clinical research organizations (“CROs”) on behalf of such companies, to conduct the clinical trials as a principal investigator (“PI”) or participate in the conduct of a trial. Certain testing organizations have been reimbursed $2,000 per patient for multiple visits, and as much as $10,000 per participant if the clinical trial was in phase 1 due to higher testing costs.[1] Whether or not acting as a PI, Practitioners tend to appreciate contracting with companies to participate in a clinical trial because it serves as a guaranteed supplemental income without the necessity of dealing with insurance companies in order to be compensated.

Other Benefits

In addition to financial benefits, participation in clinical trials can benefit Practitioners in several ways. Through the involvement of innovative research, participation can enhance a Practitioner’s reputation in the community and among healthcare leaders. It can also provide more comprehensive care solutions to patients through offering access to clinical trials, provide patients in underserved and rural communities with access to potential treatment plans that can lead to better health outcomes, and nurture the Practitioner’s academic side by staying involved and helping to advance science.

Practitioners are often hesitant to participate in clinical trials for several reasons including (1) a lack of opportunity, time, personnel support, and resources; (2) the anxiety associated with the increase in work associated with participation, while handling logistics of devoting time to current patients; and (3) dealing with the potential administrative and regulatory “red tape” surrounding clinical trials. It is true that clinical trials bring an increase in work and require careful adherence to compliance, protocol, and reporting requirements. However, with the right legal, business, and administrative guidance, Practitioners interested in participating in clinical trials can plan in advance and get set up to overcome such obstacles and participate in a clinical trial in a smooth manner.

Currently, there are approximately 166,537 clinical trial studies within the United States listed on the U.S. government registry. To find clinical trials to participate in, Practitioners can visit www.clinicaltrials.gov.

If you are interested in supplementing your income and helping to foster medical advances through participation in a clinical trial, feel free to contact Vasilios J. Kalogredis, Esq. at bkalogredis@lambmcerlane.com or 610-701-4402, or Sonal Parekh, Esq. at sparekh@lambmcerlane.com or 610-701-4416.

[1] Daly, Pete, Clinical trials generate cash flow, Crain’s Grand Rapids Business, September 9, 2012, https://www.crainsgrandrapids.com/news/clinical-trials-generate-cash-flow/

______________________________________________

Vasilios J. (Bill) Kalogredis, Esq. has been advising physicians, dentists, and other healthcare professionals and their businesses as to contractual, regulatory and transactional matters for over 45 years. He is Chairman of Lamb McErlane PC’s Health Law Department. Bill can be reached by email at bkalogredis@lambmcerlane.com or by phone at 610-701-4402.

Sonal Parekh, Esq. is an associate at Lamb McErlane PC who focuses on healthcare transactional matters and a broad range of healthcare regulatory-related issues on behalf of healthcare systems, physicians, dentists, and other healthcare providers. As a pharmacist by education and training and a practicing attorney, Sonal has unique experience in dealing with the pharmaceutical and clinical trial fields. Sonal can be reached by email at sparekh@lambmcerlane.com or by phone at 610-701-4416.

*This alert is for educational purposes only and is not intended to be legal advice. Should you require legal advice on this topic or have any questions or concerns, please contact Vasilios J. (Bill) Kalogredis, Esq. or Sonal Parekh, Esq.