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

NCT03019068 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2025-03-20

No results posted yet for this study

Summary

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.

Conditions

  • Multicenter Clinical Study

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Philippe AEGERTER, MD, PhD · Department of Public Health - Hôpital Ambroise Paré (APHP)

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03019068 on ClinicalTrials.gov