Publishing clinical trials meetings

The first solution is the prospective promulgation of a set of criteria that every author must meet. Many journals publish their own specific guidelines or criteria, and these do not differ greatly in qualitative terms. In the practicality of publishing clinical trials, the following would be typical ... 

Note in Proof. The management approach discussed in Section 3.1.3 had its first trial, with positive results, by Bakker et al., as reported at the 1994 European Clinical Pharmacy meetings. The abstract is published in Supplement 6 of Pharm. World Sci., p. G28, 1994. 

The sample of patients selected for a clinical trial may not be representative of the entire population of patients with that disease. Patients entered into a trial usually are selected according to the severity of their disease and other characteristics inclusion criteria) or are excluded because of coexisting disease, concurrent therapy, or specific features of the disease itself (exclusion criteria). It always is important to ascertain that the clinical characteristics of an individual patient correspond with those of patients in the trial. For example, the Randomized Aldactone Evaluation Study (RALES) showed that treatment with the mineralocorticoid-receptor antagonist spironolactone was associated with a 30% reduction in death in patients with severe congestive heart failure. Hyperkalemia, a potential adverse effect, was seen only rarely in this study, which excluded patients with serum creatinine levels >2.5 mg/dL. With the expanded use of spironolactone after RALES was published, numerous patients, many of whom did not meet the RALES inclusion criteria, developed severe hyperkalemia. Therefore, knowledge of the criteria for selecting the patients in a trial must inform the application of study results to a given patient. 

The medical statistician also has the opportunity to join a number of specialist societies. The International Society for Clinical Biostatistics organizes an annual conference, as does the Society for Clinical Trials, and proceedings of these meetings are published in Statistics in Medicine and Clinical Trials, respectively. There are a number of organizations specifically for statisticians working in the pharmaceutical industry, such as the UK based PSI (Statisticians in the Pharmaceutical Industry) and there is a European Federation of Statisticians in the Pharmaceutical Industry (EFSPI), of similar national societies. Other national organizations such as the American Statistical Association and the French Association pour la Statistique et ses Utilisations have specialist sections. 

---