Multicenter Clinical Study Clinical Trial
— Pred-InclusOfficial title:
Prediction of Recruitment Potential of Participating Centers in Clinical Trials by Standardized Translation of Selection Criteria and Queries From the French DRG Database (PMSI)
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.
Status | Not yet recruiting |
Enrollment | 3000 |
Est. completion date | December 2026 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Multicenter trials. - Trials that have been completed between 2012 and 2014. - Sponsors and principal investigators of trials belonging to the public hospital system of the region of Paris (Ile de France). Exclusion Criteria: - Trials in the domain of rare diseases. - Trials involving children. |
Country | Name | City | State |
---|---|---|---|
France | Department of Public Health - Hôpital Ambroise Paré | Boulogne-Billancourt | Hauts-de-Seine |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Ability of coding | Proportion of selection criteria which codable into normalized language (ICD10, CCAM);
Gain of precision and sensitivity, according to each criterion. |
throughout the study: 3 years | |
Other | Resources required | Average amount of time required to coding, overall time required and time required according to each medical domain;
Time required to query the DRF database. |
throughout the study: 3 years | |
Other | Reliability of coding of protocols | Independent translation of a random sample of 30 protocols by 2 physicians, giving 2 queries on the DRG database; then
Calculation of agreement (kappa coefficient) between candidates patients files selected by each query; Assessment of reliability of the data extraction from the whole patient files between the two data extractors. |
throughout the study: 3 years | |
Other | Influence of characteristics of trial and characteristics of site | Development of an regression model analyzing the precision and sensitivity of system, according to the complexity of protocol (design), disease, characteristics of the center (volume, clinical specialization, attractiveness, clinical research activity estimated by a publication score (SIGAPS)); | throughout the study: 3 years | |
Primary | Precision | Precision = Ratio of number of eligible patient files / number of candidate patient files.
The precision will be calculated globally and according to medical domain and aim (therapeutic, diagnostic and prognostic) of modelized clinical studies. |
throughout the study: 3 years | |
Secondary | Sensitivity of system | Ratio of number of candidate patient files / number of already recruited patients. | throughout the study: 3 years |