Pilot Studies in 10 minutes

References:
• Lancaster, G.A. Design and Analysis of Pilot Studies: recommendations for Good Practice. Journal of Evaluation in Clinical Practice.
• Moore, C.G. Recommendations for Planning Pilot Studies in Clinical and Translational Research.
• Leon. The Role and Interpretation of Pilot Studies in Clinical Research.
• Parker. Sample Size: More than Calculations.
• Gurka, M. Statistical Considerations in Pilot Studies. University of Florida CTSI.

While the CCTS Pilot award period is one year, application through end of award is more like 18 months. Check out an example timeline of program activities below.

Consider drafting a human subjects protocol (i.e. IRB application) early. Even if you do not intend to submit a protocol, they can help frame critical study components, such as defining study populations, barriers to recruitment, retention and other components of study feasibility, recognizing costs and more. Beyond helping frame study design, information in human subject protocols often overlap with the information that the NIH requests before your study can begin – see “Initiating a Pilot Study” below for details on what may be requested.

Discuss your project with your IRB. Some IRBs hold standing office hours.

• UAB: https://www.uab.edu/research/home/irb-about
• Auburn: https://cws.auburn.edu/OVPR/pm/compliance/irb/home
• UA: http://ovpred.ua.edu/research-compliance/institutional-review-board-irb/
• USA: https://www.southalabama.edu/departments/research/compliance/humansubjects/
• UM: https://www.research.olemiss.edu/irb/contact
• LSUHSC: https://www.lsuhsc.edu/administration/academic/ors/
• PBRC: https://www.pbrc.edu/hrpp/contact.aspx

Learn how to submit a human subjects protocol at UAB
Practice drafting and submitting a human subjects protocol at UAB
IRAP Development Site – You must be logged into UAB’s VPN to access this site.
IRAP Development Instructions

A field guide for recruitment and retention (15:09)

– “A human subject study may be a clinical study which may be a clinical trial. However, not all human subject studies are clinical studies and not all clinical studies are clinical trials. Check out these links for clarification and planning.”
– “What is considered an NIH clinical trial?”
– Consider drafting a clinical trial protocol based on NIH clinical trial protocol templates or using the OSP e-Clinical Portal. While these resources are intended to support Phase II/III trials or Behavioral and Social Sciences Research Involving Humans Clinical Trials, they include sections that are highly relevant to the information NIH-fended Centers are often requested to provide if selected for funding. See PHS Human Subject and Clinical Information form under “LAUNCHING A PILOT STUDY.”

Consider drafting an IACUC protocol. Even if you do not intend to submit a protocol, they can help frame critical study components, such as why a particular animal species is appropriate, the animal resources needed to execute the study and more. Beyond helping frame study design, information in an IACUC application can overlap with the information that the NIH requests before your study can begin – see “Initiating a Pilot Study” below for details.