There’s considerable buzz around the idea of letting trial participants use their own electronic devices to run trial apps, and the strategy has risen in popularity alongside the decentralized trials (DCT) movement. For sites unfamiliar with BYOD (bring your own device) trials, planning and prepping with the technology in mind is essential to managing this still evolving model successfully. Read More
The clinical trial payment process has long been frustrating for sites as well as sponsors and their CROs, with uncertain invoicing procedures, misunderstandings around payment terms and data entry complications often leading to late, incorrect or missed payments. Add to the picture the trend toward increased trial complexity, adoption of new technologies and the use of decentralized trial (DCT) methods, and all parties are feeling the pinch of payment problems more than ever. Read More
Sponsors, sites and academic institutions generally agree that the clinical trials industry needs formalized education programs and requirements for trial professionals, especially in light of a new survey that shows large competency gaps in several core areas.
As CSDD continues to watch industry efforts to bring innovations on board, Getz said the center hopes to eventually document case examples and best practices that successfully and sustainably speed up the process.
While the pandemic’s impact on clinical trials has been evident — trials paused or closed, new trial starts delayed, enrollment and retention declining — some hard data from two renowned research institutions have cast light on the pandemic experience. Read More
There’s been considerable skepticism about using decentralized trial (DCT) approaches in cancer trials, with procedural complexity, nature of disease and other considerations lending themselves more to in-person visits. But a new survey shows cancer patients have greater interest in trials when remote technology cuts down on travel and other participation burdens. Read More
The FDA may have stressed the importance of sponsors having effective, feasible diversity plans for each trial in its recent guidance, but true diversity can’t be achieved without site involvement, experts agree. Read More
Digital health solutions have seen tremendous growth in the past decade and represent a promising sector of products that can be relevant to both clinical research and clinical care. But a pervasive issue remains: There’s little clinical evidence that these tools are effective or reliable. Read More
With the number of days sites spend negotiating trial budgets rising by 62 percent in the past two years, experts say the best way to cut down on the process is to document standard costs, fees and coverage allowances and have those numbers at the ready when budgeting begins. Read More
The FDA has advanced its agenda to increase public involvement in drug development with a new draft guidance on developing, modifying and choosing clinical outcome assessments (COA) that produce information most meaningful to patients. Read More
