invivodata urges the FDA to address patient reported outcomes data in its Critical Path Initiative

The FDA's Critical Path initiative aims to streamline the new-drug and medical-device development and approval process, allowing effective new products to get to market faster while keeping costs

By Editor on Oct 12, 2004

The FDA's Critical Path initiative aims to streamline the new-drug and medical-device development and approval process, allowing effective new products to get to market faster while keeping costs to a minimum.

"Many clinical trials rely on Patient Reported Outcomes (PRO) data to support primary or secondary endpoints. However, the collection of PRO data too often relies on outdated paper diary methods whose validity and scientific properties have been seriously challenged," invivodata said in comments posted on the FDA's Web site. Evidence showing that the majority of paper diary cards are back-filled by subjects (Stone et al., 2002, British Medical Journal) and that using electronic diaries can enhance the sensitivity of clinical trials (McKenzie et al., 2004, Applied Clinical Trials) is also included in the comment. By increasing their study sensitivity, sponsors are able to run fewer and smaller trials, while also being more certain of their clinical results.

Unlike many critical-path initiatives that require a substantial investment in new technology, electronic diaries are already in use and have played a growing role in clinical research for more than 18 years. Therefore, their widespread adoption could be implemented quickly as a near-term objective of the Critical Path initiative. In its comment, invivodata also noted that existing FDA standards for data quality and integrity are fully satisfied by electronic diary systems, and should be applied uniformly to both paper and electronic diary trials.

"We applaud the FDA's initiative to get safe, effective new products into patients' hands in the most timely, cost-effective manner. Moreover, we feel that electronic patient diaries have a fundamental role to play in helping the FDA meet those goals," said Michael Tansey, M.D., current president of Competitive Drug Development LLC, chief medical officer at NovaCardia Inc., executive director of Clinical Research Services at Medifacts International, and a member of invivodata's board of directors.