• Engaging Risk-Based Quality Monitoring Teams Through Role-Playing

    Clinical Research News | Most pharmaceutical companies today have a dedicated team for risk-based quality management (RBQM) whose job it is to imagine the many ways clinical trials could go wrong to prevent their failure. Gone are the days when averting risk was largely an exercise in source data verification based on the perceived difficulty in study execution, says Marcin Makowski, M.D., Ph.D., head of centralized monitoring and data analytics at GlaxoSmithKline (GSK).

    Dec 1, 2021

  • Roche Announces IMPACT Trial Results, RWE Acquisitions, More

    Clinical Research News | Acquisitions for THREAD, Elsevier, and Global Healthcare Opportunities. Partnerships for international trials and AI-based clinical trial acceleration software. Plus new products from Intuity Medical, Florence, uMotif, and more.

    Nov 30, 2021

  • (Clinical) Trial or Error: The Modernization of Respiratory Clinical Trials

    Clinical Research News | Historically, clinical trials are slow and costly, and of all therapeutic areas, none is more expensive than respiratory trials. How can the pulmonary field that is still struggling to cope with COVID-19, massive wildfires, and the epidemic of lung injury due to vaping, meet the critical need for accelerated drug development and improved clinical care? The answer must come directly from investigators and clinicians doing the work, applying technology in new ways based on what they’ve learned.

    Nov 23, 2021

  • Simplifying CDISC Compliance With Cloud-Based Clinical Metadata Repositories

    Clinical Research News | Although CDISC standards are clearly helping to expedite the review of submissions, many organizations are completing this compliance step at the end of a clinical trial. The data rework involved in this process requires significant time and resources, particularly as metadata is often held in disparate systems and the evolving standards tend to be implemented manually. Clinical metadata repositories (CMDRs) can be used to embed CDISC standards into the study’s design, build and submission.

    Nov 19, 2021

  • Gut Microbiome Linked To Aggressive Prostate Cancer

    Clinical Research News | Evidence has been mounting for decades that what men eat can lower or raise their risk of prostate cancer—including aggressive forms of the disease that can be lethal. But that’s only part of the story.

    Nov 18, 2021

  • COVID Vaccine Trials Offer Lessons For Improving Clinical Trial Diversity

    Clinical Research News | Concerted effort was required to ensure equitable inclusion of Black, Indigenous, and People Of Color (BIPOC) communities in COVID-19 vaccine trials—a complete reversal relative to historic norms. It would have been an impossibility without temporarily slowing or halting enrollment of White individuals so that the demographic composition at final enrollment closely mirrored the larger U.S. population.

    Nov 16, 2021

  • On The Tragic Passing Of Medidata’s Glen de Vries

    Clinical Research News | All of us at Cambridge Healthtech Institute, including the staff of Clinical Research News and the SCOPE conference team, are deeply saddened by last week’s tragic passing of Medidata co-founder Glen de Vries in a small plane crash in New Jersey. Encounters with the clinical trial visionary were always a privilege both for the learning opportunity and because of his especially friendly demeanor.

    Nov 15, 2021