Some pharmaceutical physicians are involved in clinical pharmacology programmes and phase I trials, which are usually conducted in dedicated clinical pharmacology units and involve the first dosing of a drug to (usually healthy) humans for safety and tolerability testing, measurement of pharmacological effects and pharmacokinetic profiling. Depending upon the treatment indication and the type of drug being evaluated, phase I trials may also be performed in patients, eg in oncology studies.
Clinical study programmes developed by clinical pharmacologists represent the only service in the specialty of pharmaceutical medicine with frequent, direct contact with healthy volunteer or patient research participants. Pharmaceutical physicians have medical responsibility for the safety of participants and must have up-to-date knowledge of resuscitation techniques and treatment of medical emergencies. They regularly conduct physical examinations for fitness and suitability of participants in a particular clinical study. Whether to progress to a phase I trial is a challenging ethical decision and it is vitally important that pharmaceutical physicians consider this very carefully, to maintain the appropriate benefit-risk balance.
All research studies involving human participants must be formally reviewed and approved by an independent ethics review procedure designed to ensure that the dignity, rights, safety and wellbeing of all participants are given primary consideration and to monitor the implementation of the sponsor’s code of practice on research studies. Potential participants in a research study, eg a clinical trial of a medicine, must be given sufficient information to allow them to decide whether or not to take part in the study (consent). Research always involves a degree of risk because researchers cannot predict the outcome with certainty. It may also involve additional burdens or intrusions on participants, exceeding those involved in normal care. An ethics committee has to be assured that any anticipated risks, burdens or intrusions will be minimised for the people taking part in the research and are justified by the expected benefits for the participants or for science and society.