• 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

  • Advances In Precision Medicine And Artificial Intelligence Are Set To Transform Cancer Treatment

    Clinical Research News | It’s time for healthcare organizations to open clinical trial options to patients at the beginning of the patient journey, not the terminus.

    Nov 12, 2021

  • What’s Behind Growing Adoption Of Cell-Based Vaccine Platforms

    Clinical Research News | Cell-based vaccines, initially developed to add speed and scale to pandemic response efforts and reduce dependency on chickens in the vaccine manufacturing process, have over the past few years also shown to be more reliably effective than traditional, egg-based products.

    Nov 10, 2021