Investigators pharmaceutical physician

The dissemination of information to the scientific commimity is essential for the progress of research. Publications in scientific journals provide a key source of information. In the case of medical research, patients lives may be at stake. There are other reasons for publication. Publication will provide prestige to the investigator, to the sponsor and to the institutions involved in the research. In addition, in some circumstances the published paper will be quoted in reference dictionaries and pharmacopoeia, in advertisements and other promotions. The pharmaceutical physician should take every opportunity to publish high-quality scientific papers, even if the findings are not sensational but provide useful additional information. 

The pharmaceutical physician may conduct his or her studies as an investigator or may be part of a sponsor organisation selecting investigators for a trial. 

There are now several commercial organisations that can provide a list of suitable investigators for a particular indication. Any assumption that the individuals are in fact suitable should be based on an independent assessment. Assessment of suitabihty of a pharmaceutical physician as a principal investigator covers the same issues as selection of an external chnician - although some details will differ. 

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. 

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. 

ANDREW J. FLETCHER, MB, BChir, (Cantab), MS (Columbia), DipPharmMedRCP, FFPM was formerly the Senior Assistant Editor of The Merck Manual, and is Adjunct Professor of Pharmaceutical Health Care at Temple University School of Pharmacy. He graduated from Cambridge University and St. Bartholomew s Hospital, London, briefly trained in Neurosurgery, joined CIBA-Geigy in the UK as Medical Advisor, then European Medical Director for Syntex, and joined Merck, first in the international division after graduating in business studies from Columbia University, New York City, then as Assistant Editor of The Merck Manual. He teaches pharmaceutical medicine, bioethics and medical and scientific writing at Temple University s School of Pharmacy. He is a founder member and former trustee of the Academy of Pharmaceutical Physicians and Investigators (formerly the American Academy of Pharmaceutical Physicians). Dr. Fletcher resides in Ohio. 

It is no longer sufficient for the pharmaceutical physician of a pharmaceutical company to meet a potential investigator in a restaurant and, with a handshake, discuss and agree on any future involvement by the investigator. Experienced senior staff of the sponsor should always visit the investigator site before a new clinical trial starts, even if the investigator has been involved in pre vious studies. Most pharmaceutical companies have checklists and SOPs of the requirements of an investigator site. 

Every person involved in clinical research, be he/ she a monitor, an auditor, a statistician, a medical adviser, a medical director, a head of department, a co-investigator, a company or health service chief executive, or a university vice-chancellor, should be committed to such a policy and to its publicity, not least to act as a deterrent, in a determination to stamp out fraud in clinical research if it is humanly possible. Every international company, every regulatory authority, and every individual pharmaceutical physician should strive to ensure that there is an effective mechanism in place, in every country, by which anyone who commits fraud can be summarily dealt with. Only the utmost vigor in applying this policy will be successful, but it is in the ultimate interests of patient safety that this happens. 

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