Inouye SK and Fiellin DA (2005) An evidence-based guide to writing grant proposals for clinical research. Ann Intern Med 142: 274–282

Inouye and Fiellin, from Yale University School of Medicine, have recently provided an evidence-based guide to grant writing for the new clinical researcher. They state that application of the systematic approach described should help researchers to manage this important task.

Published in Annals of Internal Medicine, the guide begins by providing background information on funding sources, the types of grants available, and the NIH review process. Examples of timelines are presented, detailing the steps involved in the grant-writing process, from the conceptualization of the project and initiation of pilot work to submission of the final grant.

Having analyzed review sheets from 66 NIH clinical research grant applications, Inouye and Fiellin defined the areas most often commented on by reviewers. The specific aims and hypotheses, although judged to be the most important part of the grant, are often 'poorly focused, underdeveloped, or overly ambitious'. Preliminary work is often lacking or is not well described, and applicants frequently fail to describe the significance with regard to the proposed study. The Methods section of the application receives much of the criticism from reviewers, usually because the methods are underdeveloped and fail to include sufficient details on design and setting, inclusion and exclusion criteria, availability of participants, data collection procedures, the intervention strategy itself, and data analysis. Inouye and Fiellin provide guidance on all these aspects, as well as a checklist covering each section of the grant.

Although geared towards clinical research and to NIH funding in particular, this paper should also be useful to those seeking funding elsewhere and to scientists in general.