A course for clinical trial personnel in clinical study designs, randomization, allocation schedules, and interactive response systems

Abstract

This continuing education course for professionals involved in all areas of clinical trials integrates concepts related to the role of randomization in the scientific process. The course includes two interactive lecture and discussion sections and a workshop practicum. The first interactive lecture introduces basic clinical trial issues and statistical principles such as bias, blinding, randomization, control groups, and the importance of formulating clear and discriminating clinical and statistical hypotheses. It then focuses on the most commonly used clinical study designs and the corresponding patient randomization schemes. The second interactive lecture focuses on the implementation of randomization of patients and drug supply through allocation and component ID schedules. The workshop practicum, conducted in small groups, enables students to apply the lecture concepts to real clinical studies. Flexibility was built into the workshop practicum materials to allow the course content to be customized to specific audiences, and the interactive lecture sessions can be stretched to cover more advanced topics according to class interest and time availability.

A course in constructing effective displays of data for pharmaceutical research personnel

“…This is further magnified by our deliberate attempts to reach the widest possible audience. Taken on balance, these criticisms are not alarming, and they are consistent with other highly successful courses and seminars that we have offered .…”

“…The workshop and related interactive, hands‐on, and cooperative learning paradigms have been, and continue to be, strongly endorsed and generally shown to be effective in statistical education efforts . The workshops in our course were built around a mix of continuous and categorical datasets taken from our professional experiences , internal and external scientific literature, textbooks , and the mass media (e.g., Consumer Reports ).…”

Clinical trial implementation: a primer for neurosurgeons

“…The first step of designing a clinical trial is to define a specific research question with well-defined objectives that can be formulated into testable statistical hypotheses. 9 This involves a number of considerations, including defining an appropriate study population that will be generalizable to the patients with the disease of interest, as well as logistical considerations such as the projected study costs and the feasibility of patient recruitment. 10,11 Other important requirements for conducting a neurosurgical RCT include clinical equipoise, or uncertainty between two different interventions, and reasonable competence among surgeons regarding a newly introduced surgical procedure if such a procedure is being compared with a well-established intervention.…”

Use of telephone and web interfaces of interactive response technology at clinical investigator sites in clinical trials

“…Overall, the results regarding training and user support can be interpreted to reflect a need of better user support by the study sponsor and the IRT service provider. Golm et al 12 noticed while giving training courses to clinical study staff, that site personnel often have very little knowledge about the mechanics of randomization or the wider picture of how randomization, blinding, treatment allocation, and IRT intertwine. In addition to practical end user training, these aspects should be covered to help the clinical end users understand how IRT fits into the overall conduct of a particular study.…”