Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative.

BACKGROUND: Traditional clinical trials are often expensive, inefficient, include selected populations, and can create significant participant burden via travel and other logistical demands. Using new technologies and methodologies to promote a decentralized approach has the potential to improve the efficiency of clinical trials. The Clinical Trials Transformation Initiative (CTTI)-a public-private partnership to improve clinical trials-launched a multi-stakeholder Decentralized Clinical Trials (DCTs) Project to provide recommendations on addressing the actual and perceived legal, regulatory, and practical challenges with DCT design and conduct in the United States. METHODS: Informed by qualitative group interviews and an expert meeting, CTTI engaged stakeholders to identify key challenges to implementing DCTs and possible solutions. RESULTS: The CTTI DCT project team used the interview findings and expert feedback to develop recommendations that will drive broader use of DCTs. CONCLUSIONS: CTTI's recommendations cover protocol design, use of telemedicine and mobile healthcare providers, medical product supply chain, investigator delegation and oversight, and safety monitoring considerations. By implementing these recommendations, sponsors, contract research organizations, and others can help advance successful medical product development using mobile technologies and methodologies in DCTs.

Detection of intimate-partner violence among members of a managed behavioral health organization.

This column describes a creative effort on the part of a national behavioral managed care plan to identify cases of domestic violence in its covered population. Although the screening efforts by intake counselors and clinicians yielded a lower rate of domestic violence than would have been expected, the effort established a baseline or benchmark from which the organization can now work. Clinical benchmarks are critical to developing an understanding of best practices. In this case, the benchmark finding initiated a best practices process through which this organization--and, hopefully, others--will continue to create better methods for identifying and helping people who experience domestic violence.