Multicenter Clinical Study clinical trials

Prediction of Recruitment Potential of Participating Centers in Clinical Trials by Standardized Translation of Selection Criteria and Queries From DRG Database

This retrospective study aims to assess, on a large number of clinical trials (CT), the usefulness of converting CT eligibility criteria into standardized queries performed on commonly available data, i.e. Diagnosis Related Groups (DRG) databases in order to estimate the potential recruitment of clinical trials centers. Efficacy of this Clinical Trial Recruitment Support Systems (CTRSS) will be checked against thorough examination of patient files. Primary objective is to estimate the precision of the prediction system, i.e. ratio of numbers of eligible patient files / numbers of candidate patient files. As secondary objectives, the study aims: - to measure the recall rate or sensitivity of the system: ratio of number of candidates patient files / number of recruited patients; - to measure the ability of coding: proportion of codable criteria (inclusion criteria or non inclusion criteria) into normalized language; - to measure the time required for coding criteria and the time required to execute the queries on the national DRG database; - to evaluate the reliability of coding process by an independent coding of a random sample of 30 protocols; - to analyse influence of characteristics of the clinical study (design, disease, ...) and of the investigation site (volume, teaching status, ...) on the precision and sensitivity of the prediction system.