Letter of Intent Due June 8, 2023
The ALS Association’s Trial Capacity Awards support efforts to increase participation in ALS clinical trials and efforts to improve the speed and efficiency of clinical trial conduct at both established and emerging ALS clinical trial sites.
Clinical trials are the most reliable – and ultimately the fastest – way to translate promising laboratory science into new and better ways to treat and care for people living with ALS. Therefore, the Association is working to significantly increase the number of high-quality ALS clinical trials as part of its strategic priority of finding new treatments and cures.
As the number of ALS trials increases, the number of people with ALS participating in research will need to increase as well. Many people living with the disease want to participate in clinical trials but are unaware of opportunities or lack access to local trial sites. In addition, many trial sites do not have the infrastructure or capacity to accommodate significantly more participants and/or additional trial protocols.
The ALS Association’s Trial Capacity Awards support efforts to improve the speed and efficiency of clinical trial conduct at both established and emerging clinical trial sites across the U.S., as well as initiatives to help improve trial accessibility for people with ALS. These awards help eliminate barriers to trial participation, especially those impacting currently underserved populations, to increase the number and diversity of people living with ALS who have the opportunity to participate. Applications that focus primarily on specific barriers or bottlenecks rather than spreading funding across all trial-related expenses are preferred.
To view the full funding announcement, click here.
Examples of items that this funding opportunity will support include:
- Salary support for study personnel, including but not limited to support for clinical trial coordinators, research project or program managers, research assistants, regulatory specialists, physicians and allied health providers, budget/contracting and other administrative support, etc.
- Physical infrastructure, including but not limited to laboratory equipment and space, biosample handling and storage equipment (e.g., freezers, centrifuges) for outcome measures, such as spirometry, handheld dynamometry, etc.
- Efforts to increase recruitment and retention of individuals from underserved populations, including but not limited to funding of patient travel costs, language translation services, telehealth utilization, local community partnerships for targeted outreach, etc.
- Training and associated costs specific to the conduct of ALS trials, such as registration or travel costs to attend NEALS trainings, licensing, professional memberships, and certifications.
- Services specific to the conduct of ALS trials, such as genetic testing and counseling, required hospital services, specialized contract support staff, pharmacy contracting for drug supply, start-up support, etc. Please note that grant support should not be used for services for a specific clinical trial but rather for building capacity that is applicable for multiple trials.
- Cross-site or cross-disease coordination efforts to improve availability of trials and services to patients (e.g., coordinating across other neurodegenerative diseases, partnering with other sites in the local area to share participants, or having experienced study personnel from established trial sites provide mentorship/training at emerging trial sites).
- Other efforts to improve efficiency and effectiveness of clinical trial recruitment and retention.
The following are not appropriate for this funding opportunity:
- Support for individual research projects or clinical trials.
- Support for clinical care.
- Any costs that are already covered by a clinical trial sponsor, including those listed above.
Funding and Eligibility
Budgets for total costs up to $400,000 (inclusive of both direct and indirect costs) may be requested for a period of 4 years. Indirect costs are limited to 10% of total direct costs. All funds must be expended within the approved period of performance.
Individuals with the skills, knowledge, and resources necessary to carry out the proposed research may apply as a principal investigator (PI). PIs could be clinical directors (medical directors), clinical research coordinators, or other clinically trained personnel. Both established and emerging clinical trial sites are encouraged to apply.
- Letter of Intent Due Date: June 8, 2023, 5 p.m. U.S. EDT
- Full Proposal Due Date (by invitation only): August 10, 2023, 5 p.m. U.S. EDT
- Anticipated Award Decision: October 2023
- Anticipated Earliest Start Date: November 2023
Our expectation is that contracting will be completed within 60 days of the award offer. If not, we reserve the right to rescind the award offer and redirect the funds to other projects.
All application materials must be submitted electronically. To register for a Proposal Central account, create a new Letter of Intent or access an existing saved Letter of Intent, please visit proposalcentral.com.
Instructions for Proposal Central:
We encourage inquiries concerning this funding opportunity. Please submit your questions and other related correspondence to [email protected].