Assessing the Operational Complexity of a Clinical Trial: The Experience of the National Institute of Mental Health

Clinical Researcher—March 2020 (Volume 34, Issue 3) PEER REVIEWED Sharon L. Smith, DNP; Galia Siegel, PhD; Ashley Kennedy, PhD   In recent years, the National Institutes of Health (NIH) has prioritized strengthening the stewardship of clinical trials.{1,2} The intent of these reforms is to improve the management and oversight of clinical trials research, increase transparency […]

Expediting Drug Development Regulatory Pathways Globally

Clinical Researcher—March 2020 (Volume 34, Issue 3) PEER REVIEWED Aman Khera   Medicine and healthcare are evolving at an impressive rate. Artificial intelligence models, for example, are beginning to aid the detection of cancer and other serious diseases. The onset of digital therapeutics is creating innovative avenues for improved interventions. To keep pace with such […]

Advanced Clinical Research Systems: The Top-Down Approach

Clinical Researcher—March 2020 (Volume 34, Issue 3) SPECIAL ADVERTISING SUPPLEMENT   The clinical research process, especially as it relates to data, primarily functions off paper source documentation and manually transcribed data into electronic data capture (EDC) systems. Most clinical research sites are still utilizing paper regulatory processes. Due to these primarily paper-based systems, there are […]

Tool or Bludgeon: Technology Can Support Clinical Trial Sites or Undermine Them. How Are You Using It?

Clinical Researcher—March 2020 (Volume 34, Issue 3) SITE STRATEGIES Diane Carozza   The last thing an overburdened investigator site needs is for a sponsor to insist upon the use of yet another potentially pricey, isolated, and complicated technology solution to facilitate the conduct of (possibly) just one new study. However, that’s what’s happening every day […]

Eliminating Standalone Technical Specs Helps Accelerate Study Start-Up

Clinical Researcher—March 2020 (Volume 34, Issue 3) DATA-TECH CONNECT Drew Garty   The average time from protocol completion to study start-up is four months.{1} For data managers, the primary deliverable is the technical specification document that provides detailed instructions for configuring the electronic data capture (EDC) and other eClinical systems. The more complex the trial, […]