Ancillary Studies to Large Clinical Projects
Purpose of the Session
Clinical studies ranging from epidemiological observational studies to clinical trials play a valuable role in carrying out the mission of the NIAMS and those of many other NIH Institutes. Large clinical projects offer unique opportunities to conduct additional investigations that go beyond the core activities of the original study and generate new information related to the original study. The purpose of this retreat session was to discuss the needs and opportunities for NIAMS to facilitate the development of meritorious ancillary studies.
Background/Relevance to NIAMS Mission
In general, ancillary studies use resources developed by another, fully funded "parent" study to address research questions that are independent of the parent study's aims. An ancillary study may begin at any time during the course of the parent study, but ideally should begin in the early stages of the parent study (at least before the recruitment is completed). Once a clinical protocol is finalized, the investigators of the parent study are often ready to begin as soon as the Institutional Review Board (IRB) approval is obtained. This time-sensitive feature demands a robust administrative system within NIAMS that is compatible with the timeline of the parent study to avoid any missed opportunities.
Ancillary studies or substudies have been successfully utilized by several NIH Institutes, such as NHLBI, NIDDK and NIAID, as a strategy to fully tap the research potential of the established cohorts, to enhance the scientific contents and value of the parent studies, and thereby to maximize the return on the Institute's investment.
The NIAMS supports a large number of clinical studies. Currently, very few of the ongoing clinical trials have ancillary studies. However, a large observational study of osteoporosis in men, Mr. OS, has developed many ancillary studies and has an active policy in place to approve them. Between 1998 and 2006, the NIAMS participated in the NIAID Hyperaccelerated Award program (RFA-AI-05-028), an initiative to enhance ongoing projects by encouraging ancillary studies that would address mechanisms of immunomodulation.
- How should NIAMS define an ancillary study? Why are ancillary studies useful for enhancing the scientific content and value of existing clinical studies?
- What can NIAMS do to facilitate the process of supporting ancillary studies?
- Does it need to do more? Does it need to do anything?
- What NIAMS policies currently exist? Does the Institute need to encourage the establishment of ancillary study policies at the onset of large clinical research projects?
- Would oversight be provided by the parent study DSMB/OSMB?
- Is an expedited review and award process needed?
- What types of parent studies would qualify for NIAMS ancillary study programs?
- NIAMS-sponsored only? NIAMS- and other NIH-sponsored? Public and private sponsored?
- Phase-I, II, III clinical trials? Epidemiological and observational studies? Registries?
- Recruitment ongoing or completed?