Technological innovation in clinical trials could slow once again as the global health crisis eases and sponsors calculate their return on investment (ROI) for the innovations they adopted during the pandemic. Experts say remote monitoring, telemedicine and the increased use of decentralized trial approaches have proven their worth and are here to stay. Read More
The FDA’s Office of Good Clinical Practice (OGCP) receives letters from clinical trial professionals inquiring about agency policy on a variety of topics. Following are two inquiries and the OGCP’s answers. Read More
Bottlenecks can have punishing consequences on clinical trials and operational teams, forcing studies to get stuck in limbo when the delay lingers — and when bottlenecks become the norm, team members can grow frustrated and overloaded with a cascade of sudden tasks, potentially creating a resource and morale issue. Bottlenecks are particularly problematic for CROs as they can take a bite out of return on investment and raise oversight inquiries from sponsors. Sometimes, that stems from budget-busting overtime when teams move from idling into working long hours once the bottleneck breaks. Read More
In its ongoing effort to replace EU clinical trial policies with UK-specific guidance, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued three clinical trial guidances on registering and publishing results of trials, submitting safety reports and making substantial changes to trial applications. Read More
The Association of Clinical Research Professionals (ACRP) has formed a diversity advisory council to assist the association’s efforts to promote greater diversity in the clinical trial workforce. Read More
Digital solutions company Vibrent Health has partnered with Eastern Virginia Medical School’s Sentara Healthcare Analytics and Delivery Science Institute (HADSI) and George Mason University (GMU) to launch a national study on the long-term effects of the COVID-19 pandemic to help sponsors and researchers develop and adjust trial strategies for future public health crises. Read More
