Taming clinical research's paper tigers.

Several years ago, a prominent NIH intramural physicianscientist wanted to translate basic science observations to clinical medicine, but the paperwork involved in taking a protocol from concept to conduct was overwhelming. ‘‘It was easier to get a paper published in Nature, Science , or The New England Journal of Medicine than to get a protocol written and approved,’’ said the frustrated scientist. So began the journey by a group of intramural scientists, a quest dedicated to designing tools that could cut through the complex and often confusing paperwork associated with the development and implementation of clinical research projects. By taming the literal paper tiger of bureaucratic paperwork (or red tape), these tools can help create a clinical research enterprise that is safer, more efficient, and better managed. The ultimate goal is a tool, ProtoType, which we are building from scratch. The vision is that ProtoType will facilitate protocol writing and review, filing of investigational new drug forms, patient recruitment, resource projections, and the informed consent process. It also will track protocol activity, generate early toxicity alerts, initiate adverse event reports, and automate milestone letters to referring physicians. Some portions of the tool are complete; others are under development or will be developed elsewhere. The major completed component is protocol authoring. This component has a standard format that comprises a précis, an introduction, background, study design, patient enrollment, study analysis, adverse event/data safety monitoring plan, human subjects protection, pharmacologic and device information, references, and structured informed consent forms. Throughout the tool are learning portals for access to details on how to use the resource and links to historical and current references. Cassettes with the most up-to-date language recommended by institutional review boards can be dragged into the protocol and placed in appropriate sections, a feature particularly helpful when writing consent forms. It’s even possible to tailor a protocol to specific institutional review board requirements (there are 14 institutional review boards at the NIH). Protocol authors can