Rapporteur Summary: Role Of Technology In Clinical Trials-validation Of Information

Abstract

Policy should be directed toward increased scientific rigor in clinical trails, not rigor mortis of the review process. New technologies such as biomedical imaging can increase rigor by providing objective, quantitative measures of device efficacy. Furthermore, a variety of digital technologies for management of clinical trails data and for computerization of the regulatory submission and review process should also be encouraged. In sum, policy should encourage technologies that facilitate the clinical trails and regulatory review process, while increasing scientific rigor. Specific recommendations: 1) Encourage more early information exchange between sponsor companies and FDA regarding the optimal conduct of clinical trials and submission of data. this would help to avoid insufficient submissions, lengthy reviews and extended development timelines. 3) Encourage appropriate applications of biomedical imaging technology to generate more objective and quantitative data. Such technology can reduce subjectivity that often hampers validation of clinical information. 4) Encourage digital submission technology that enhances data review. The same benefits anticipated in the computerization of patient medical records would apply to the digitilization of the clinical trails and regulatory review process.