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The FDA has advanced its agenda to increase public involvement in drug development with a new draft guidance on developing, modifying and choosing clinical outcome assessments (COA) that produce information most meaningful to patients.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
The FDA’s draft guidance on trial diversity plans has spurred an influx of comments from industry stakeholders requesting a variety of revisions, such as more clarity on timing, details on how the agency will appraise plans, recommendations for improving the diversity of trial staff and expansions in other areas. Read More
Newly released data from a study on the costs and benefits of decentralized trials (DCT) demonstrate in hard numbers that using DCT methods can gain a sponsor or site as much as 25 times the original investment and score performance improvements in several areas. Read More
Among the many voices involved in the ongoing discussion about increasing diversity in clinical trials, one group has received less attention from sponsors, sites and regulators alike: transgender and nonbinary people. More effort needs to go into including these populations, according to one transgender advocate, including staff site training and special accommodations. Read More
Sites may be tempted to take on any trial offered, not wanting to turn away business or offend sponsors, but one site in Watertown, Mass., has discovered that shifting to a smaller-scale approach can pay important dividends. Read More
As the clinical trials industry implements more complex trial designs in the quest to achieve greater speed and efficiency, sites must be nimble enough to take on the retraining and increased protocol amendments that come along with these innovations. Read More
In this second of two parts on the developing participant diversity movement, sponsor, CRO and site representatives discuss the impact of the FDA’s recent draft guidance and the efforts they already are making to increase inclusivity in their trials.Read More
This is the first of two parts on the developing participant diversity movement. In this part, WCG subject matter experts discuss the significance of the recent FDA guidance on trial diversity planning and how sponsors and sites should work together to position their trials and medical products for agency approval. Next week, part two will look at inclusion strategies sponsors and sites already are using.Read More