A Model for the Role of TIRS in Helping to Develop and Validate Best Practices Across Clinical Trial Management.

Abstract

The complex and competitive nature of medical product development requires protection of intellectual property. At the same time, the need for cross-company/regulatory collaboration in what has been described as ‘‘pre-competitive space’’ has become increasingly apparent. All those involved with product discovery, development, and regulation struggle with many of the same issues. Not infrequently, companies end up ‘‘reinventing the wheel,’’ repeating the same errors, using the same flawed methodologies over and over. The recognition that there is opportunity for multiple sponsors and regulators to work together to develop validated, agreed upon tools that all can use to maximize the efficiency and credibility of the drug development process has, in turn, led to a number of collaborative consortia. For example, the NIH Foundation, working together with multiple companies and FDA, helped fund and organize initiatives including drug safety signal ascertainment known as the Observational Medical Outcomes Partnership (OMOP), and validation of biomarkers that can be used to assess oncologic drug treatment outcomes (the Biomarker Consortium). In this issue ofTIRS,we have two papers from TransCelerate, a consortium of companies that set forth a new initiative to validate novel approaches to centralized monitoring of clinical trials and a comprehensive approach to risk-based monitoring. Their manuscripts, entitled ‘‘Defining a Central Monitoring Capability: Sharing the Experience of TransCelerate BioPharma’s Approach, Part I’’ and ‘‘Technology Considerations to Enable the Risk-Based Monitoring Methodology’’ are not designed as stand-alone documents, but rather represent the beginning of what hopefully willbea seriesofcommunications describingthe challenges and opportunities of new types of monitoring of clinical trials, validation of approaches to more efficient and effective approaches, and suggested horizons for optimizing how people, processes, and technology can increase our comfort in the quality and integrity of data developed in clinical trials. At TIRS, we view this as a partnership in communication— papers published in the journal, podcasts, potentially blogs and ongoing dialogue, DIA website and Global Forum ,f ormal sessions at DIA meetings. For all those trying to improve clinical trial methodologies, and particularly where multiple companies and regulators are working together, TIRS/DIA can help assure wide dissemination of new ideas, and perhaps even more importantly, can serve as a forum for follow-up information and validation of those ideas. As opposed to a warehouse of isolated scientific papers, perhaps our major contribution can be as an ongoing source of updated new knowledge, and validation of the utility of new approaches to product discovery, development, regulation, and use.