CLINICAL TRIALS ARTICLES

• Key Takeaways From The FDA Guidance On DCTs

  The FDA brought out “The Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency” in a bid to continue clinical trials during the COVID-19 pandemic. There were several measures that were included like the use of EHRs and the use of digital health devices. In May, this year, they provided guidelines for conducting DCTs. In this article we will explore some of the highlights of the FDA guidance for DCTs.

• How Program Managers Can Help Reach Development Milestones

  Though commonly misunderstood, the program manager fuses the varied projects within the larger program and strategically places them into an integrated development plan so companies can successfully reach (and announce via press releases) each milestone while preparing for the next.

• Understanding Data Collection And Management In DCTs

  For decentralized clinical trials (DCTs), it is important to specify the risks up front and determine if — and how — this approach can be applied to each protocol. Further, from a data collection and management standpoint, there is plenty to consider in terms of data flow management through multiple sources and systems.

• Adjusting Industry Expectations of Investigators: Why It Matters

  Considering less than 3% of physicians engage in clinical research, with a high percentage leaving after just one trial, what can be done to get more investigators interested in participating — and staying involved?

• Staff Burnout — A Threat To Clinical Operations Output

  There are several measures that pharma companies and CROs can take to mitigate the issue of staff burnout.

• Debunking BYOD Myths In Clinical Trials

  By adopting BYOD, life sciences can expand the collection of quality data sets during clinical trials to drive the development and approval of life-changing therapies for the patients that need them.

• Clinical Trials Vendor-Management Best Practices

  An organization's vendor-management discipline and risk-management strategies are critical to ensure operations continuity, which has a direct impact on the ability to keep clinical trials running and serve the patients involved.

• Why Your Clinical Operations Must Have A Metrics-Driven Culture

  Identifying and implementing metrics alone doesn’t ensure success. An organization must be data literate regardless of whether it operates as a data provider, consumer, or both.

• 8 Strategies For Leading High-Performing Hybrid Teams In Clinical Research

  Here are some key strategies for hybrid team leadership we can consider in the clinical trial ecosystem.

• A Quick Transition To Late-Stage Clinical Trials

  “Moving into Phase 3 not only expands the resources you need internally, but some things require a much larger amount of capital, and often a public listing so you can raise larger amounts of money,” says Eric Dobmeier, president and CEO, Chinook Therapeutics.