Data Monitoring Committees and clinical trials: from scientific justification to organisation

Clara Locher, Silvy Laporte (), Peggy Derambure, Olivier Chassany (), Cécile Girault, Alix Avakiantz, Claire Bahans, Dominique Deplanque (), Pierre Fustier, Anne Françoise Germe, Behrouz Kassai Koupai (), Louis Lacoste, Nadine Petitpain, Matthieu Roustit, Tabassome Simon (), Cecile Train and Michel Cucherat ()
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Clara Locher: Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou], CIC - Centre d'Investigation Clinique [Rennes] - UR - Université de Rennes - Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou] - INSERM - Institut National de la Santé et de la Recherche Médicale, Irset - Institut de recherche en santé, environnement et travail - UA - Université d'Angers - UR - Université de Rennes - EHESP - École des Hautes Études en Santé Publique [EHESP] - INSERM - Institut National de la Santé et de la Recherche Médicale - Biosit : Biologie - Santé - Innovation Technologique - Structure Fédérative de Recherche en Biologie et Santé de Rennes
Silvy Laporte: CHU ST-E - Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne], SAINBIOSE - Santé Ingénierie Biologie Saint-Etienne - CIS-ENSMSE - Centre Ingénierie et Santé - Mines Saint-Étienne MSE - École des Mines de Saint-Étienne - IMT - Institut Mines-Télécom [Paris] - UJM - Université Jean Monnet - Saint-Étienne - INSERM - Institut National de la Santé et de la Recherche Médicale
Olivier Chassany: AP-HP - Assistance publique - Hôpitaux de Paris (AP-HP)
Cécile Girault: FFCD - Fédération Francophone de Cancérologie Digestive
Claire Bahans: CHU Limoges
Dominique Deplanque: CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
Anne Françoise Germe: CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille], GHICL - Groupe Hospitalier de l'Institut Catholique de Lille - UCL - Université catholique de Lille
Behrouz Kassai Koupai: LBBE - Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 - UCBL - Université Claude Bernard Lyon 1 - Université de Lyon - VAS - VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement - CNRS - Centre National de la Recherche Scientifique
Louis Lacoste: CHU de Poitiers [La Milétrie] - Centre hospitalier universitaire de Poitiers = Poitiers University Hospital
Nadine Petitpain: CRPV Lorraine - Centre Régional de PharmacoVigilance de Lorraine - CHRU Nancy - Centre Hospitalier Régional Universitaire de Nancy
Matthieu Roustit: CHUGA - Centre Hospitalier Universitaire [CHU Grenoble]
Tabassome Simon: AP-HP - Assistance publique - Hôpitaux de Paris (AP-HP)
Michel Cucherat: HCL - Hospices Civils de Lyon

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Abstract: Clinical trials often last several months or even several years. As the trial progresses, it can be tempting to find out whether the data obtained already answers the question posed at the start of the trial in order to stop inclusions or monitoring earlier. However, knowing and taking into account interim results can sometimes compromise the integrity of the results, which is counterproductive. To minimise this risk and ensure that the treatments are assessed reliably, safety and/or efficacy criteria are monitored during the study by a Data Monitoring Committee. After receiving the results confidentially, the Data Monitoring Committee assesses the benefit/risk ratio of the study treatment and recommends that the trial be continued, modified or terminated. Data Monitoring Committee members issuing these recommendations have an important responsibility: a hasty decision to end the trial may lead to inconclusive results unable to answer the initial question and, inversely, delaying the decision to end the trial may expose the subjects to potentially ineffective or even harmful interventions. The Data Monitoring Committee's task is therefore particularly complex. With this in mind, the round table discussion at the Giens workshops was a chance to review the scientific justification for creating Data Monitoring Committees and to recall the need for their members to receive comprehensive training on the complexities of multiple analyses, confidentiality requirements applying to the results and the need for them to be aware that recommendations to end a trial must be based on data that is robust enough to assess the benefit/risk ratio of the treatment studied.

Keywords: Benefit/risk ratio; Data Monitoring Committee; Integrity; Interim analyses (search for similar items in EconPapers)
Date: 2024
Note: View the original document on HAL open archive server: https://hal.science/hal-04350974v1
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Published in Therapies, 2024, 79 (1), pp.111-121. ⟨10.1016/j.therap.2023.12.002⟩

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Persistent link: https://EconPapers.repec.org/RePEc:hal:journl:hal-04350974

DOI: 10.1016/j.therap.2023.12.002

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