Registration Has Closed
Letter of Intent due June 29, 2022
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.
The ALS Association has established a goal to significantly increase the number of high-quality clinical trials in the ALS ecosystem as part of its strategic priority to find new treatments and cures. There is an urgent need to increase the number and capacity of trial sites to complement this increase in the number of trials. Increases in clinical trial capacity will allow for potential new therapies to be tested faster and will improve trial accessibility for people with ALS in currently underserved areas. The Clinical Trial Capacity Awards will support efforts to increase the number and diversity of people living with ALS who have the opportunity to participate in clinical trials, and efforts to improve the speed and efficiency of clinical trial conduct at both established and emerging clinical trial sites across the US.
Many people living with ALS want to participate in clinical trials but are currently either unaware of opportunities or unable to engage in them due to lack of accessibility to clinical trial sites within their local areas. These awards should help eliminate barriers, especially those impacting currently underserved populations, to trial participation. Similarly, many ALS clinics and drug development companies wish to pursue clinical development in ALS and these awards should help establish infrastructure allowing them to conduct faster and more efficient clinical trials in ALS. Applications that focus primarily on specific barriers / bottlenecks rather than spreading funding across all trial-related expenses are preferred.
To view the full funding announcement, click here.
Topics of Interest (Scope)
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: lab equipment and space, biosample handling and storage (e.g., freezers, centrifuge) equipment for outcome measures (spirometry, hand held dynamometry, etc.), etc.
- Efforts to increase trial recruitment and retention in 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 costs or travel costs for attendance to 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.
- 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., coordination with other neurodegenerative diseases, leveraging with other trial sites in the local area to share trial participants or travel funds to support experienced study personnel from established trial sites providing 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, including those listed as in scope examples above, that are already covered by a clinical trial sponsor
Funding and Eligibility
- The maximum period of performance is four years
- The maximum total budget is $400,000 (inclusive of both direct and indirect costs)
- Indirect costs are limited to 10 percent of the total direct costs
- All funds must be expended within the approved period of performance
- Letter of Intent Due Date: June 29, 2022, 5 p.m. US ET
- Full Proposal Due Date (by invite only): August 31, 2022, 5 p.m. US ET
- Anticipated Award Decision: October 2022
- Anticipated Earliest Start Date: November 2022
To Register for a proposalCENTRAL account, create a new Letter of Intent or to access an existing saved Letter of Intent, please visit: https://proposalcentral.com/
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We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Submit general questions and other related correspondence to [email protected].