Proposal Review

The CTN Study Review Committee includes the core CTN members, clinical research experts, and academic and community clinicians. The Study Review Committee has at least 5 members who serve on an annual basis.

CTN Tick-borne Disease Pilot Treatment Study Award

The Clinical Trial Network (CTN) Coordinating Center provides funding support for a small number of pilot studies that address treatment of Lyme and the Tick-borne diseases and have a reasonable potential to help patients. The CTN will solicit proposals for pilot studies annually. The CTN welcomes physicians, scientists, and other investigators to submit a formal proposal for pilot treatment studies to the CTN. The best pilot study proposals may lead to funding by the CTN Coordinating Center, and the pilot study will then be further developed to be conducted by investigators at one of the CTN nodes.

Pilot studies are small-scale human treatment studies conducted in preparation for a larger investigation. Pilot studies are exploratory in nature and do not necessarily answer the same questions as larger RCT (randomized control trials).

What pilot studies CAN do:

  • Assess aspects of feasibility like recruitment, retention and treatment adherence, eligibility criteria, etc.
  • Assess the safety of treatment or interventions
  • Assess resources needed for a larger study
  • Assess sample size needed for a larger study
  • Assess the dose levels and response to the treatment

What pilot studies CANNOT do:

  • Definitively test a hypothesis. Small sample sizes limit conclusions that can be drawn from a pilot study, even if there is a control group.

Pilot study proposals will be reviewed by the Clinical Trial Network Study Review Committee. One or two pilot studies will be conducted each year at one of the CTN nodes. The CTN researchers are committed to conducting these studies using the highest methodological standards. Results of the CTN pilot studies – if favorable – will lead to consideration for larger Randomized Controlled Trials.

All applications will be critically reviewed by our Study Review Committee for possible development into a more formal pilot study proposal.