Continuity of Physician Participation in Phase I Clinical Research

Abstract

As the competition for research dollars becomes more keen, contract research organizations (CROs) are evolving into larger entities. As a result, Phase I units affiliated with CROs have grown in size and personnel in order to accommodate multiple studies performed simultaneously. To maintain the quality of the study and safety of subjects in these larger units, it is imperative to maintain an adequate clinical staff that is capable of ensuring necessary safety, ethical, and quality standards. Multiple physicians are required to competently manage the large number of studies being performed at any one time. This is where potential problems may occur, in that multiple interpretations of the same situation are possible. Areas subject to differing interpretations may include: screening, entrance, interim and exit physical exams; interpretation of electrocardiograms (EKGs); assessment of adverse experiences (AEs); and clinical importance of an event, process, medical history, physical exam, or lab.

In order to ensure subject safety as well as quality research, it is essential to have good project management and study coordination throughout the course of the clinical trial. Adequate project management, coupled with creative physician scheduling, will ensure single physician participation throughout the duration of a study. This will minimize the opportunity for errors of an interpretative nature, thereby increasing the quality of a clinical trial while providing for subject safety and maintaining ethical integrity.