Clinical Study Reports 101: Tips and Tricks for the Novice

Clinical Researcher—September 2020 (Volume 34, Issue 8) PEER REVIEWED Sheryl Stewart, MCR, CCRP   The tenets of Good Clinical Practice (GCP), promulgated by the International Council for Harmonization (ICH), require that investigator-initiated trials (IITs), especially those involving an Investigational New Drug application to the U.S. Food and Drug Administration (FDA), have the principal investigator (PI), […]

The COVID-19 Effect: How to Maintain the Speed-to-Market Medical Model

Clinical Researcher—September 2020 (Volume 34, Issue 8) SPECIAL FEATURE Astha Bhatia, BDS, MPH   In 1962, Dr. Frances Kelsey, who joined the staff of the U.S. Food and Drug Administration (FDA) two years prior, was honored by President John F. Kennedy for her refusal to rush approval to officially market a sleep aid called Kevadon® […]

Opinion: The Significance of Clinical Trial Transparency During the COVID-19 Pandemic

Clinical Researcher—September 2020 (Volume 34, Issue 8) PEER REVIEWED Dr. Kumari Priyanka, BDS, PGDCR; Tejas Thomas, MSc, PGDCR   Clinical trials lay the foundation for biomedical research to generate robust evidence on the safety and effectiveness of proposed treatments and/or preventive interventions for eventual use in routine clinical care. Clinical trials directly engage volunteer participants […]

Risk-Based Monitoring of Clinical Trials: COVID-19 and Paving the Road to the Future

Clinical Researcher—September 2020 (Volume 34, Issue 8) SPECIAL FEATURE Sandra "SAM" Sather, MS, BSN, CCRC, CCRA, FACRP; Jennifer Lawyer, RN, BS   Clinical research professionals are accustomed to sponsors requiring onsite monitoring to ensure human subject protection, data integrity, and quality. During the COVID-19 pandemic, however, clinical research sites have reduced the number of staff […]

RACE for Children Act Aims to Improve Pediatric Cancer Care

Clinical Researcher—September 2020 (Volume 34, Issue 8) RECRUITMENT & RETENTION Lynne Georgopoulos, RN, MSHS, RAC; S. Y. Amy Cheung, PhD   Approximately 1.8 million new cases of cancer will be diagnosed in the U.S. in 2020.{1} Less than 1% of them will be diagnosed in pediatric patients.{2} Although pediatric cancer is rare, it is the […]