Biomedical subjects
Publications and source records attributed to R Le Paillier.
The complexity of the scientific and economic environment causes the managers of health domains to take into account an increasing number of variables. The decision making cannot only depend on intuition and medical good sense. Through simple mathematical recall, the authors show technologies of decision analysis which apply to therapeutic strategy and drug development.
Today all the pharmaceutical managers are convicted of the need for quality in clinical trials. The reliability of trials is conditioned by the quality of conception, accomplishment and data collection. By an example of realization, the authors describe a computerized system for the management of all clinical trials and epidemiology studies whatever the type and the phase of trials and studies. They also describe standard systems for the optimal management of trials with decision analysis to secure a continuity in data process from the investigator to the registration authorities' files.
Decision analysis has been widely used in business, first in operational research, later in economic studies. It is now spreading to medical training. We review methodology of decision analysis which is simple, rational and based on the environmental conditions. When clinical judgments are uncertain, the most appropriate strategy is helped by the use of standard/bayesian probabilities quantifying the risks of each strategy, and the design of decision trees visualizing each outcome. If the probabilities are not suitable, other mathematical concepts such as Markov process are interesting but are still being worked on. Multicriteria analysis, a branch of graph theory, is also a flexible and reliable tool allowing differentiation and ordering strategies. It also takes into account the psychological characteristic of the decision makers. We then illustrate decision analysis by describing computerized systems for monitoring clinical trials, fitted to control the trial data able to estimate the different strategies.
Among the molecules under development or registration proposes for licensing among the pharmaceutical firms, the choice of one molecule is often difficult. The methods of decision analysis can allowed the formalization of this choice. Multicriterion analyses (ELECTRE 1 and 2) have the capacity to integrate the qualitative criteria and to incorporate concordance and discordance indicators in the judgement. The objective of this study is to present the bases of the multicriterion method and to give an example of application in the clinical cardiovascular domain to select one anti-hypertensive molecule among a preselection of 9, by using 12 differently weighted judgment criteria. Five molecules were selected by the ELECTRE 1 method and only one by the ELECTRE2 method.
The reliability of trials in clinical research is principally conditioned by the quality of the conception, the realization and the data recording in the hypothesis of pertinent trials with an adequate methodology. The author describes the application in the cardiovascular domain, the realization and the use of numeric Case Report Forms DCRF working with a 'notebook' microcomputer and easy to use software which allows the conduct of quality clinical trials in accordance with good clinical practice. The numeric CRF is a tool to monitor in real time the data from trials (ongoing data trials) and ensures the continuity from the investigator site to the statistical department. An example of realization of a phase III multicentre clinical study is presented to evaluate the efficacy of two antihypertensive calcium-channel blockers.