Clinical research physician investigators

Modern clinical research requires considerable cooperation and partnership between the investigator, the sponsor and the regulatory authorities. In consequence, the investigator will need to treat certain outsiders with the same amount of trust that is shown to nursing staff and fellow physicians. Violations of confidentiality of subjects are rare from sponsor staff and certainly no more frequent than that experienced from hospital staff. 

The principle of beneficence entails helping people to further their interests. As the primary moral principle quoted in medical codes and oaths, the principle of beneficence is fundamental to the practice of medicine and clinical research. For example, concerns about beneficence motivate physicians, pharmacologists, pharmacists, and clinical investigators, all of whom share the goal of conducting studies that will ultimately benefit society by producing or refining effective treatments. 

Clinical protocols and investigator information—detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. Also, information on the qualifications of clinical investigators—professionals (generally physicians) who oversee the administration of the experimental compound—to assess whether they are qualified to fulfill their clinical trial duties finally, commitments to obtain informed consent from the research subjects, to obtain review of the study by an IRB, and to adhere to the IND regulations. 

Physicians report that they participate in clinical research mostly because it is scientifically rewarding, but they are also attracted to the financial rewards and the opportunities to improve patient care (Lamberti, 2005). With clinical trials numbering in the tens of thousands, there is industry-wide concern that there may be a 15% shortfall in the number of qualified US investigators in the next few years (Zisson, 2001). There are several factors contributing to this dilemma. 

The sponsor/CRO must go through a formal assessment procedure before placement of a study. Some of the most important areas requiring assessment are described in Table 12.2. All studies involving research of investigational medications and devices require qualified investigators, and the internationally accepted standard for qualified usually encompasses three main criteria medically qualified, that is legally licensed to practise medicine as a physician experienced in the relevant therapeutic specialty and experienced in clinical research. 

There has been much published on the incidence, detection and prosecution of publication fraud, rather less on fraud and misconduct in clinical research, but we should be equally concerned about research fraud. The Consensus Conference on Misconduct in Biomedical Research convened by the Faculty of Pharmaceutical Medicine and the Royal College of Physicians of Edinburgh in 1999 defined research misconduct as behavior by a researcher, intentional or not, that falls short of good ethical and scientific standards . Frank Wells, co-founder of MedicoLegal Investigations Ltd., the only specialist research fraud investigation company in Europe, prefers the generation of false data with the intention to deceive . 

By law, Medicare does not cover any drugs administered outside of the hospital or a physician s office, and the program does not pay for clinical research (487). Furthermore, to be covered by Medicare, drugs must be reasonable and necessary, a criterion that the Health Care Financing Administration (HCFA) has interpreted. .. to exclude. .. those medical and health care services that are not demonstrated to be safe and effective by clinical evidence (487). HCFA has taken this to mean that experimental and investigational drugs are not covered. 

Saver JL, Kidwell C, Eckstein M, Ovbiagele B, Starkman S. Physician-investigator phone elicitation of consent in the field A novel method to obtain explicit informed consent for prehospital clinical research. Prehosp Emerg Care. 2006 10 182-185... 

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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