The National Institute of Diabetes & Digestive & Kidney Diseases

Answer : Individual applicants should not submit more than one application, and institutions should not submit more than one application.

Question 5: The RFA states that, "Applications should include a Principal Investigator with demonstrable experience in the conduct of T1D clinical research as well as a Co-Investigator with significant expertise in the area of T1D immunology . If the Principal Investigator is a T1D immunologist rather than an endocrinologist, the Co-Investigator should be a pediatric or adult endocrinologist with expertise in the area of T1D clinical research. The experience of both of these individuals should be described in detail in the application." What is meant by "expertise in T1D immunology"?

Answer: The Principal Investigator (whether an endocrinologist or immunologist) must have significant experience in the operation of T1D clinical trials. If the Co-Investigator is an immunologist, he/she must have experience that is pertinent to the study of immunologic approaches to T1D prevention/intervention.

Question 6: Where in the application should the documentation addressing required federal citations (human subjects protection, data and safety monitoring plan, sharing of research data, inclusion of women/minorities/children, ethics training, etc.) be included?

Answer: This documentation should be included in the body of the application. There are designated areas on Form PHS 398 for these items. Therefore, these items are included on pages that are subject to the 45 page application limit.

Question 7: Can the individual site recruitment reports provided by the TrialNet Coordinating Center (to existing TrialNet Centers and Affiliates only) be included in the application Appendix, or does this report need to be included in the body of the application?

Answer: These recruitment reports may be included in the Appendix of the application and need not be counted toward the 25 page research proposal limit or the maximum 45 page limit. Appendices should be submitted on a Compact Disk (CD). These reports can be included in the body of the application but will then be counted toward page limitations.

Question 8: Can two institutions submit a joint TrialNet application to be a single TrialNet Center?

Answer: It is possible for two institutions to submit a joint TrialNet application as a single Center. However, there can only be one Principal Investigator. The lead Investigator from the second institution would need to be a Co-Investigator. Further, the application would need to include a T1D clinical research endocrinologist and an immunologist with research experience pertinent to T1D (as is outlined in the RFA).

Question 9: The screening/recruitment reports only show numbers and do not reflect the nature and intensity of the individual studies. How will reviewers know the nature and intensity of these studies?

Answer: The applicant may include descriptions of the nature and intensity of each of these studies in the Appendix of the application.

Question 10: What information should be included in the Target/Planned Enrollment Table(s) of the PHS 398 form?

Answer: Current TrialNet Centers should include projected enrollment for all phases of the Natural History Study as well as projected enrollment for new-onset type 1 diabetes studies (in general). The projected/targeted enrollment for all studies should reflect what the Center feels it can enroll based on past performance. If the Center feels that it can enroll in excess of what has been enrolled in the past, the proposal must state why the Center feels this is the case as well as how it plans to accomplish this. For institutions that have not participated in TrialNet in the past, realistic estimates should be included in these tables with justification (based on institutional data) to support these estimates.

• A research proposal that is no more than 25 pages in length as detailed in the RFA and FAQs. The research proposal should include a comprehensive background and rationale for the study, the study design, the number of subjects required, the projected time for study completion, a power analysis, and proposed mechanistic studies to be done in conjunction with the trial. The proposal should be sufficiently detailed to understand what the study entails for the Centers, the patients, and the Coordinating Center but need not include a detailed accounting of exactly what will be done at each individual study visit.
• A recruitment/retention plan. Pertinent portions of this plan can go into the Human Subjects Section (Section E) of the PHS 398. The Human Subjects Section does not have a page limitation. Additional portions of the recruitment/retention plan should utilize no more than 10 pages. Overall, the recruitment/retention plan should include a detailed description of the Center’s prior experience in the performance of T1D clinical research studies as well as data supporting the Center’s past and present ability to recruit T1D patients for treatment studies. The Center must demonstrate access to a population of T1D patients and family members at high risk for developing T1D.

  • The application should provide a detailed accounting of the Center’s recruitment and retention goals, and its plans to accomplish these, for each type of study that TrialNet conducts: new onset T1D, prevention, and natural history.
  • Three Targeted/Planned Enrollment Tables should be included in the recruitment/retention plan. These are being included to enable reviewers to evaluate the site’s projected ability to enroll subjects into TrialNet studies. The first table should detail projected screening for Phase 1 of the Natural History Study, the second should detail projected enrollment into Phases 2 and 3 of the Natural History, and the third should detail projected enrollment for new-onset type 1 diabetes studies (in general). For current TrialNet Centers, the projected/targeted enrollment tables should reflect what the Center feels it can enroll based on past performance. If the Center feels that it can enroll in excess of what has been enrolled in the past, the proposal must state why the Center feels this is the case as well as how it plans to accomplish this. For institutions that have not participated in TrialNet to date, realistic estimates should be included in these three tables with justification (based on institutional data) to support these estimates as well as a report detailing the Center’s experience in the conduct of T1D clinical research studies.
  • In addition to the three Targeted/Planned Enrollment Tables, the application should include data addressing gender, minority, human subjects, inclusion of children, etc. issues as required by the PHS 398.
  • Centers that have not participated in TrialNet should include a recruitment plan specific to TrialNet’s ongoing and planned studies (http://www.diabetestrialnet.org/patientinfo/studies.htm). This plan should contain details of past accomplishments and available resources that will enable the site to become an effective and productive TrialNet Clinical Center. This section should also include a description of available facilities at the Center for the conduct of TrialNet studies. This should include details regarding the availability of extended and weekend hours to accommodate patients and available support services, such as research centers, to assist TrialNet in the conduct of study-related drug administration (including infusions) and testing (such as Oral and IV Glucose Tolerance Testing and Mixed Meal Tolerance Testing). A description of experience (if any) that the Center has had in managing one or more affiliate sites as well as a plan for recruiting and maintaining a productive network of TrialNet Affiliate Centers should also be included in this section.
• The remaining 10 pages of the application should include any required items that have not been covered in other parts of the application as well as any information that the applicant feels is pertinent to the application.