STATISTICAL PLANNING OF CLINIACL TRIALS, FURTHER RISK MANAGEMENT, INTERACTION OF SPONSOR AND CRO

Abstract

Statistical planning of clinical trials (CT) is the starting point for the project, since its results determine the sample of patients, the size of which completely depends on the design of the future study, the number of involved countries, clinical sites, as well as the strategy of further management - the budget, human resources, vendors, etc. The purpose of the article is to analyze the influence of the selection of the sample size of patients, as well as the main risks, the management of risks that may arise during the KD due to incorrect calculation of the sample, the interaction of the sponsor and the KDO in the management of such risks. The sponsor in the CT is the organization that carries out the development of the drug, as well as invests in the CT, while the contract research organization (CRO) performs part of the project work, functions and responsibilities, that are being delegated by the sponsor. The degree of integration of CRO into CT as a project is important, at the same time, concentration exclusively on the tasks set by the Sponsor may have a negative impact on the quality and volume of final statistical data of the CT, as the presence of insufficient data volume to prove the hypothesis, in fact, is the main risk of "failure" of the project. The key is a correct understanding of the basic initial tasks by the CRO, the logic of constructing the hypothesis proof, the adoption of its main components, even if the CRO is not involved in the process of statistical planning itself. The CRO may not be directly involved in this process - it is important that the Sponsor makes sure before the start of the CT that the vendor in the person of the CRO has accepted the basic concept of the CT. Such interaction and mutual understanding will help to effectively and efficiently build optimal management, control the progress of the project, and resist possible risks in the future.