This study surveyed primary/urgent care providers (PCPs) to identify facilitators and barriers to their support of clinical trial referrals. The findings suggest that increasing provider awareness, streamlining referral processes, and fostering a culture incorporating clinical research into routine patient care could enhance PCP support for clinical trials. Addressing these barriers is critical to improving recruitment efforts and advancing medical research.
Clinical trials have become more complex, due to myriad factors including rising protocol demands, the adoption of decentralized models, and the integration of artificial intelligence. While these innovations promise greater personalization and operational efficiency, they also introduce new layers of logistical and regulatory complexity. Sponsors and CROs should collaborate to design site-centric processes that reduce operational burden, streamline communication, and allow research teams to focus more on patient care and data quality.
Although researchers are required to consider sex as a biological variable, the field of sex-based biology and medicine remains underdeveloped and often mischaracterized as peripheral. This article investigates gender disparities in clinical trials and pharmacology, focusing on adverse drug reactions and highlighting critical areas where differences in drug tolerability between genders are most significant, particularly in the management of insomnia.
Institutional review boards (IRBs) are federally required committees that evaluate research involving human subjects to safeguard participants’ rights, safety, and well-being. Their oversight guarantees adherence to federal laws, institutional policies, and ethical standards. Before starting any study with human participants, researchers must submit their research plans to the IRB for review and approval.
As clinical trials become more complex, leading sponsors are shifting the focus of their clinical research associates (CRAs) from traditional compliance monitoring to proactive, data-enabled site support and oversight. Skill development, structural changes, and the use of advanced analytics are modernizing the CRA role—and the way we monitor clinical trial sites.