The new SBIR/STTR (Clinical Trial Optional) funding opportunities have been announced! Find links to the full announcements on the NIH website using this link.
For biotech and medical device business planning to include a clinical trial in your application, here are two important things to keep in mind.
1) These NIH institutes are NOT funding clinical trials under this announcement:
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- National Institute of Dental and Craniofacial Research (NIDCR)
- National Center for Advancing Translational Sciences (NCATS)
- Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)
- All participating components of the Food and Drug Administration (FDA)
- Center for Biologics Evaluation and Research (CBER/FDA)
- Center for Drug Evaluation and Research (CDER/FDA)
- Human Foods Program (HFP/FDA)
- Center for Devices and Radiological Health (CDRH/FDA)
- Center for Veterinary Medicine (CVM/FDA)
2) Your proposed clinical study must address review criteria assessing if it’s compliant with regulations, and operationally realistic.
As part of the review criteria Approach, here are just a few questions reviewers are assessing:
How sound is the proposed Regulatory Plan to meet Federal regulatory requirements?
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested?
Are potential ethical issues adequately addressed?
Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate?
You can find the full list on the NOFO pages.
As you can see, SBIR/STTR reviewers are assessing your proposal from an FDA reviewer’s perspective as well. It’s therefore worth your while to ensure your regulatory strategy is ready before submitting your application.
If you’re thinking “Hmm I need a person who understands grant writing and clinical trials to help me here…” … hello! That’s me. I’m a freelance writer with experience in both SBIR/STTR grant writing and regulatory medical writing.
I use my understanding of clinical trials and regulation to help companies draft a well-written proposal that is convincing and compliant, so you have the best chance of winning. If you’re aiming to meet the September 5th deadline, contact me here.
