Clinical research has long depended on a practical assumption: participants can reach a designated trial site often enough to complete study procedures. That model works reasonably well for patients living near major research centers, but it can create substantial barriers for people in rural, remote, or underserved communities. A 50-mile radius is sometimes used as…
Rare disease clinical trials face a recruitment problem that is fundamentally different from trials involving common conditions. The patients researchers need may be scattered across countries, treated by a small number of specialists, or still searching for a definitive diagnosis after years of inconclusive testing. This diagnostic odyssey can delay identification of eligible participants and…
Clinical trial failure is not always a consequence of an ineffective therapy. A study can be scientifically promising yet struggle because its protocol is too restrictive, operationally demanding, or poorly aligned with the patients and sites that must execute it. Protocol amendments can then add substantial costs, disrupt site operations, complicate data interpretation, and extend…
Decentralized clinical trials (DCTs) have moved well beyond their emergency-era role as a workaround for disrupted site visits. Telemedicine, home nursing, remote monitoring and digital health technologies are now established components of modern trial design. The FDA’s 2024 final guidance formally addresses trials containing decentralized elements, while European regulators have also developed recommendations for their…