Breakthrough T1D – Accelerating Clinical Trials Evaluating Disease-Modifying Therapies for T1D
Event details
| Date | 10.10.2024 |
| Category | Conferences - Seminars |
Aim: Breakthrough T1D is soliciting proposals aimed at the clinical assessment of novel or untested disease-modifying therapies, or combinations of molecules that have shown preliminary clinical efficacy as single agents, with the potential to delay, halt, or reverse the progression of disease in individuals in Stage 3 of disease. Expanding the repertoire of therapeutic approaches showing efficacy following diagnosis will increase the probability of success in meeting an unmet need for patients, provide critical data for the establishment of endpoints to increase trial efficiencies, and develop a path for testing these therapies in populations earlier in disease (or in those with established T1D in combination with beta cell replacement therapy).
Breakthrough T1D is requesting applications that propose Proof of Concept human subject research trials to provide the data necessary to enable further clinical development, and Phase 1 or 2 trials to determine safety and efficacy. Trials should be powered for the stage of clinical development proposed and include the appropriate and justified endpoints (Phase 3 trials may be considered with approval from Breakthrough T1D).
Examples of research proposals appropriate for this RFA include, but are not limited to:
Funding: $1.5M per year
Duration: max. 4 years
Eligibility: Applications may be submitted by domestic (US) and foreign non-profit organizations and public and private entities, such as universities, colleges, hospitals, laboratories, units of state and local governments and, where relevant, eligible agencies of the federal government.
Applicants must hold an MD, DMD, DVM, PhD, or equivalent degree, and hold a faculty position or equivalent at a college, university, medical school or other research facility. There are no citizenship requirements
How to Apply: Prospective applicants should submit a LOI online through RMS360 to be considered for a full proposal request. The LOI template provided on the RMS360 website must be used to complete the applications.
Deadline:
Further information:
Breakthrough T1D is requesting applications that propose Proof of Concept human subject research trials to provide the data necessary to enable further clinical development, and Phase 1 or 2 trials to determine safety and efficacy. Trials should be powered for the stage of clinical development proposed and include the appropriate and justified endpoints (Phase 3 trials may be considered with approval from Breakthrough T1D).
Examples of research proposals appropriate for this RFA include, but are not limited to:
- Trials evaluating novel small molecule drugs or biologics in people with T1D.
- Clinical trials evaluating the repurposing of small molecule drugs or biologics with demonstrated efficacy in non-T1D populations that have clear rationale or preclinical data for assessment in T1D.
- Inclusion of people with T1D in existing or planned clinical trials evaluating small molecule drugs or biologics in a non-T1D population.
- The inclusion of an additional arm to an ongoing T1D trial to test an additional intervention or new patient population.
- T1D-focused real world studies collecting efficacy and safety data on drugs or biologics with expected benefits for people with T1D.
Funding: $1.5M per year
Duration: max. 4 years
Eligibility: Applications may be submitted by domestic (US) and foreign non-profit organizations and public and private entities, such as universities, colleges, hospitals, laboratories, units of state and local governments and, where relevant, eligible agencies of the federal government.
Applicants must hold an MD, DMD, DVM, PhD, or equivalent degree, and hold a faculty position or equivalent at a college, university, medical school or other research facility. There are no citizenship requirements
How to Apply: Prospective applicants should submit a LOI online through RMS360 to be considered for a full proposal request. The LOI template provided on the RMS360 website must be used to complete the applications.
Deadline:
- Letter of Intent: 10 October 2024 (outcome notification: 31 October)
- Full proposal: 13 January 2025
Further information:
- More information about the call is available here.
- The proposal should be submitted on the online portal RMS360.
- For any other questions, please contact the Research Office.
Practical information
- Informed public
- Free