It is almost impossible to overestimate the degree of commitment clinicians have to helping their patients. Their commitment to do good is called the beneficence principle by bioethicists. Clinical researchers, like other clinicians, are bound by this principle. However, they are also committed to generating information useful in the future treatment of patients. In clinical trials this involves adhering to a set of guidelines based on the research protocol.
This research study was born out of the concern that the goals of clinical research and the goals of clinical care do not always mesh smoothly in clinical trials. Clinical trials are designed to generate reliable and valid data that will answer clinically important questions with the aim of promoting human health in the future. Ordinary clinical care is focused on improving the medical condition of the presenting patient. We do not know how often these two commitments come into conflict with each other or how clinical researchers resolve their competing commitments. This study seeks to find out how often such situations arise and how they are resolved.
We began our study by conducting interviews with those involved in clinical research-physicians, psychologists, nurse clinicians and others. Because they provide the clinical care themselves and recruit patients to trials, some of these interviewees, although not all, reported that providing care in a trial is occasionally quite complicated. The basic purpose of the interviews was to figure out exactly what kind of questions we should be asking in the survey. We sought to know what situations these research clinicians face on a daily basis, and what their resolution to those conflicts has been.
From these interviews we have extrapolated a set of questions that we feel will render important and valid data. These questions have been grouped together in a survey format which we piloted with a group of clinical trialists. As generally happens, the first version of the survey needed substantial revision.
From the interviewees feedback we revamped the survey and feel that it is now ready for widespread dissemination. Our survey was created online and will be taken online, although a hard copy can be made available. Ultimately, we hope that our study will better inform those designing and managing clinical trials of the problems facing research clinicians so that they can start developing mechanisms whereby researchers will be able to better manage the choices that their clinical staff members make.