Frequently Asked Questions About the ITP
What is the purpose of the NIA Interventions Testing Program (ITP)?
Answer: The ITP was designed to identify agents that extend lifespan and healthspan in mice. Testing in the ITP is carried out in two stages. Stage I tests a single dose of an agent to determine its effect on lifespan. Stage II tests additional doses or alters treatment start times to determine the effects of the agent on lifespan, age-sensitive health measures, and pathology.
Can I suggest an intervention for inclusion in this test program?
Answer: Yes, anyone can suggest an intervention for inclusion in the ITP. Please see the Application Instructions for details on how to submit an application.
Is there a deadline for submission of a proposed intervention?
Answer: The deadline for submission is the last weekday in February of each year. Please see the ITP Homepage for the next specific date.
What classes of interventions are suitable for this program?
Answer: Proposed interventions can be pharmaceuticals, nutraceuticals, dietary supplements, plant extracts, hormones, peptides, amino acids, chelators, redox agents, or other agents, or mixtures of compounds. Priority consideration will be given to interventions that are easily obtainable, reasonably priced, and can be delivered in the diet.
Where are these experiments conducted?
Answer: The experiments are conducted in three research laboratories: one at the Jackson Laboratory, one at the University of Michigan, and one at the University of Texas Health Science Center at San Antonio.
How are the experiments conducted?
Answer: Agents are administered in the food to groups of specific pathogen-free male and female mice of the UM-HET3 stock. UM-HET3 mice are the progeny of CByB6F1 females and C3D2F1 males and are genetically heterogeneous, the equivalent of a large sibship. Each mouse is observed until its natural death or until it becomes so severely ill that survival for more than an additional week seems very unlikely. The study design includes sufficient numbers of mice to provide 80% power to detect a 10% increase in average lifespan in either sex.
How do I propose a specific intervention?
Answer: Please see the Application Instructions for details. In their application, applicants must provide a rationale as to why they believe the intervention will extend lifespan, propose the dose and source of the test agent, and describe any information about possible toxic side effects and safety issues.
Can I propose more than one intervention?
Answer: Yes. There is no limit to the number of interventions any individual or group can propose. Each intervention proposal must be submitted separately and will be considered on its own merits.
Can I propose that an agent be tried at two or more doses, or do I have to select a single dose to test?
Answer: Because the ITP can usually only accept up to six new interventions for study each year, a decision to test two or more doses of a given agent would diminish the number of other interventions that can be evaluated. Therefore, most agents will be tested at only a single dose. If there are good reasons for considering two or more doses, or in starting the treatment at more than a single age, these reasons should be described carefully in the application.
Who selects which interventions to be tested each year?
Answer: The ITP Access Panel evaluates all applications and scores them for discussion by the ITP Steering Committee. The ITP Steering Committee makes the final selection of the interventions to be tested each year. Please see About the ITP for more information.
How does this process differ from the usual NIH peer review?
Answer: The ITP selection process does not resemble the usual NIH peer review process. Prior to deciding whether a proposed intervention will be accepted into the program, Access Panel and/or Steering Committee members typically correspond with applicants to request additional information or suggest modifications to the protocol.
How long will it take to hear whether my proposed intervention is accepted for testing in the ITP?
Answer: Please allow for up to five months after the application deadline to be notified of the outcome of the reviews.
If my application is not accepted the first time, can I resubmit it?
Answer: Yes. Applicants who are able to fully address the reviewers’ questions and concerns are welcome to resubmit their application for consideration another year.
What do I get out of this?
Answer: Sponsors of interventions accepted into the ITP will collaborate with the ITP investigators to develop the test protocol for their compound. All data will be available for sponsors’ use in their own grant applications, research talks, etc. Sponsors will be asked to serve as coauthors on any papers that result from research using their proposed intervention and will help to interpret and report the data. Sponsors will also be given priority for CIP plasma and tissue.
How long will it take to get data?
Answer: Mid-point data (when 50% of the control mice at each site have died) are usually obtained approximately 3.5 years after the intervention is accepted into the ITP. End-point data (when 90% of the control mice at each site have died) are usually obtained approximately 5.5 years after.
If the agent shortens the lifespan or has negative effects, what will happen to the data?
Answer: The ITP plans to publish all data, including data on agents that fail to increase lifespan or delay late-life illnesses, or interventions that have deleterious side effects.
Do I get paid for my efforts in this collaboration?
Answer: No. Sponsors are not paid for their efforts as collaborators in the ITP, neither as consultants nor by means of research grant awards.
If I propose that an agent be tested in the ITP, does this prevent me from using this agent in a grant application or other sponsored project of my own?
Answer: No. Sponsors of interventions may inquire about other sources of funding, including NIH grant funds for studies of the same intervention. Agents accepted by the ITP are evaluated for effects on longevity, but the ITP resources do not allow for the investigation, for example, of the biochemical or physiological impact of the intervention in much detail.
Are tissues from the ITP-treated mice available for analysis in my laboratory?
Answer: Yes. Plasma and certain fixed and frozen tissues from some ITP-treated mice are available to investigators, free of charge. Please contact Dr. Jennifer Fox (jennifer.fox@nih.gov). for more information.
Where can I receive more information about the ITP?
Answer: Please see the ITP Homepage for contact information.
