Ethical Deliberations on Using Placebos in Clinical Trials

Clinical Researcher—December 2018 (Volume 32, Issue 10) PEER REVIEWED Pranali M. Wandile, MS, CCRP   A placebo-controlled, double-blind, randomized clinical trial is the historical gold standard for clinical research, and is fundamental to the development of evidence-based medicine. Research has shown that placebos produce strong, genuine psychobiological effects in both laboratory and clinical settings. Although […]

Best Practices for Patient Engagement in Drug Development: A Brief Background on Patient Engagement

Clinical Researcher—December 2018 (Volume 32, Issue 10) RECRUITMENT & RETENTION Debra Michaels   The expectation of patients to be engaged in healthcare decision making and medical product development has been on a steady increase since the early 1980s, when AIDS activists demanded the dedication of adequate resources to research treatments for a disease that was […]

Achieving a “Win-Win” by Using Technology for Recruitment

Clinical Researcher—December 2018 (Volume 32, Issue 10) DATA-TECH CONNECT Loretta M. Byrne, RN, MS, CCRP   If you are reading this article, we are part of the same industry, and you know all too well the challenges involved when conducting a clinical trial. Recruitment of research study participants is one of the most challenging aspects […]

Winning Hearts and Souls

Clinical Researcher—December 2018 (Volume 32, Issue 10) EXECUTIVE DIRECTOR’S MESSAGE Jim Kremidas   Clinical research is a team sport. If the people conducting the trial aren’t working as a seamless team, you’re looking at a trial with such potential problems as adverse events, missed enrollment targets, and other inefficiencies threatening quality and extending already costly […]

Real-World Evidence: Bridging the Gap Between Clinical and Commercial Development

Clinical Researcher—December 2018 (Volume 32, Issue 10) GOOD MANAGEMENT PRACTICE Heather Fitzpatrick Medlin, MSW   In the highly competitive drug discovery landscape, real-world evidence (RWE) plays an increasingly vital role in commercialization strategies. In fact, the best clinical trial designs deploy RWE to work in tandem with every stage of the product life cycle to […]