Pharmaceutical physicians clinical trials

The basic ethical questions raised by clinical research should never be underestimated. The pharmaceutical physician will need to be aware that failure, intentionally or because of misguided enthusiasm, to protect the health and well-being of each study subject can have very serious consequences. In an age where the medical profession is constantly under scrutiny, the drug industry is heavily criticised and the communication industry extremely active, mistakes in clinical trials are pimished. Therefore, before a study is commenced, a review should be made that the scientific approach is current, the motivation is clear, the processes are imambiguous, and there should be sufficient data to judge the safety and effectiveness of the interventions proposed. 

This section aims to provide sufficient information for the pharmaceutical physician to effectively prepare and support a clinical trial. However, clinical trials come in many forms and what is appropriate for a single-centre non-sponsored trial is totally inappropriate for a multicentre global study sponsored by a big pharmaceutical company or institution. Similarly, a Phase 1 non-patient volunteer study... 

In studies where subjects are mentally or physically unable to give proper consent, special arrangements will need to be made. Where appropriate, the ICF will be read to the subject in the presence of a witness, or consent will be provided by the next of kin or the subject s representatives. Studies in which the study subjects cannot provide informed consent will become more frequent as more difficult indications, for example, trauma, stroke, dementia and the handicapped or very young children, become the focus of clinical trials. The pharmaceutical physician should ensure that established mechanisms for consent are followed with agreement of the lEC and in compliance with ICH GCP chapter 4.8, FDA Title 21 CFR Part 50 sections 24-273 gpj p)ii-ective Articles 4 and 5. ... 

The pharmaceutical physician who is in charge of an in-house clinical pharmacology unit or who holds an appropriate external clinical appointment will need to decide whether it is feasible for clinical trials to be carried out in his or her... 

The pharmaceutical physician should be involved in the selection of CROs and SMOs. He or she is often best qualified to judge the professional competency of the physicians involved in any contractual work. There needs to be a clear imderstanding as to who will provide medical advice to the investigator and to the nonphysicians in the clinical trial teams, who will be responsible for the assessment of the medical... 

However, tempting it is for the pharmaceutical physician, the investigators and the sponsors to use advertising, they should be aware that there are certain guidelines and regulations to observe before embarking on any advertisement for a clinical trial. 

The expertise of the pharmaceutical physician when employed by a sponsor will be used to support the clinical trial team in four main areas during a clinical trial. 

Laboratory safety data When the CRFs arrive at the data manager s office, questions will arise relating to laboratory safety data. Queries may occur at the investigator site and advice can be requested from the pharmaceutical physician associated with the clinical trial in the sponsor company. 

Similarly, clinical trial strategy teams bring together CRSs with statisticians, data managers, regulatory executives, pharmaceutical physicians and marketing managers to discuss the clinical data that is needed, and the time-scales and costs, to achieve specific commercial objectives. 

The pharmaceutical industry presents many new challenges to such a person which include the interface with pharmacy and pharmacology, toxicological research, human volunteer studies, clinical trials and post-marketing surveillance to name just a few. Product safety is a factor which impacts on all of those endeavours and the pharmaceutical physician will be expected to work and provide advice within that framework. It will be clear to anyone that evidence of lack of safety in a medical product is not good news for the company concerned and that some level of protective action will often be required which in extreme circumstances may involve product withdrawal. It is, therefore, essential that the pharmaceutical physician should be absolutely clear what constitutes lack of safety in relation to the intended use of the product. 

The facts of the matter are that physicians have turned to pharmaceutical products in an attempt to provide symptomatic relief for their patients problems based on observations of patients receiving the products in other situations. The companies involved have responded by undertaking the clinical trials needed to prove the benefit and gain approval for these products so responding to a market need. 

Clinical trials examine the safety and efficacy of interventions, or treatments, in human subjects. This book focuses on pharmaceutical clinical trials. The word subject is used deliberately here, since all participants in clinical trials are subjects, even if they are under the care of a personal physician, and therefore patients in that context, at the time of the trial. The key difference between clinical care and clinical research is that clinical research is conducted for the general good of the population at large, not for the specific individual benefit of the participants in the study, while clinical care is concerned with the specific well-being of each individual patient. 

It will be interesting to watch the future in this area to see how medications previously requiring a doctor s prescription that move to OTC status are handled, and how nutraceuticals, herbals, homeopathic, and naturopathic drugs, without the benefit of rigorous, randomized clinical trial or outcome data are handled as well. Similarly, we can be certain that there will be excitement galore when the nations in Central America and the Middle East decide to control pharmaceuticals and to end the practice of lay-person purchases of virtually any product without the benefit of a physician s order. Separation of pharmacy and physician functions will occur in the Far East in the not too distant future, causing even more excitement or grief. 

---