The AUPN Online Engagement Committee, led by Dr. Barbara Vickrey, continues to innovate and is now developing yet another new AUPN initiative: AUPN’s Leadership Minute. The Leadership Minute will be a 1 to 2 minute, highly focused summary of analysis and practical advice for Chairs, Program Directors and other leaders in academic neurology, delivered as mini-podcasts or in short form videos. The goal of this new program will be to provide relevant and useful information in a modicum of time, designed to fit seamlessly into our very busy schedules. More to come on this exciting initiative in the future.
Human clinical research is a critical part of the translational pathway to developing new therapies for neurological disease. Some departments have a robust clinical trial portfolio as a major focus, while others are more basic science oriented, and some have a balance of basic and clinical research. For those departments with little clinical research activity, trying to develop a program from scratch can prove challenging. Initiating a clinical research program begins with interested academic clinicians who have established reputations in their subspecialty areas, and who have developed significant subspecialty clinics with sizable patient populations. For clinical research to succeed, an institution and chair supportive of this mission is very important. Ideally, core resources are available, most especially a clinical research office, to assist with processing and negotiation grants, IRB approvals, research space needs and other matters best handled centrally within the institution. Starting investigators will also need, at a minimum, a research coordinator and/or research nurse; if they are beginning with only one trial, it may be necessary to share personnel with other research units, or to assign clinical and research duties to these individuals until enough grants have been obtained to fully pay their salaries. Of course, the investigator and their research team need to thoroughly review the inclusion and exclusion criteria prior to contract negotiations, to determine whether they have the resources for the study and can realistically meet their allotted patient targets within the timeframe allotted (feasibility assessment). Once these conditions are met, successful negotiations of contracts with the sponsor at fair market value or better for startup and other costs associated with the trial are absolutely critical, and require close collaboration between the site investigator and their team with the clinical research office. Outside of direct negotiations with the sponsor, internal negotiations with the medical school and university regarding return of an appropriate and fair share of the indirect cost piece (which is typically far lower than the indirect costs provided on federal grants) is also essential. After agreement is reached on the contract, rapid turnaround of IRB approvals and start up, along with expedited enrollment will both enhance the relationship and reputation of the research unit with the sponsor, and will also facilitate funds flow, as most clinical trials pay per patient visit and/or when predetermined milestones have been reached. Close tracking of patient enrollment and clinical trial revenues vs. expenses by the department and/or institutional fiscal teams, with regular feedback to the unit can help facilitate patient enrollment and also enable early termination of unsuccessful trials before excessive deficits have developed.
Unfortunately, there are far fewer resources for guidance in starting a clinical research program than are available for NIH and other federal programs. However, the University of Pennsylvania Perelman School of Medicine, and also the UCSF Offices of Clinical Research have instructive websites providing useful resources on the details and steps for starting industry sponsored clinical trials (linked below).
If you have not already done so, don’t forget to register for the AUPN and ANA virtual fall meetings at the below links. We look forward to seeing you there! (Early Bird registration ends Sept. 8th).
Clifton L. Gooch, MD
Today’s Resource Links
Clinical Research Startup Guides
The University of Pennsylvania Perelman School of Medicine, and also the UCSF Offices of Clinical Research have instructive websites providing useful resources on the details and steps for starting industry sponsored clinical trials:
University of Pennsylvania OCR: https://www.med.upenn.edu/ocr/ocr-sponsored-study-guide.html
UCSF OCR: https://hub.ucsf.edu/clinical-research/setup-study
Registration: AUPN & ANA Fall Meetings & Career Fair
Register for the AUPN Meeting at AUPN Meeting Registration, and for the ANA meeting at 2020.myana.org. Due to our shared virtual platform, you must register for the ANA meeting to be able to register for the AUPN meeting. AUPN registration is a member benefit at no extra charge and ANA Meeting registration is free for ANA members this year (join the ANA at ANA Membership). ANA-AUPN Career Fair registration (fee) is at https://2020.myana.org/program/sessions/ana-aupn-career-fair
AUPN’s Leading Edge Podcast (Free)
AUPN’s Leading Edge will focus on issues of interest and practical use to Neurology Department Chairs, and will be freely available on Apple’s iTunes, Spotify and Google. AUPN’s Leading Edge first episode preview segment is here:
Apple & iTunes