Overview of literature monitoring practice of clinical trials vigilance units in French institutional sponsors – A study from the REVISE working group - 10/03/23

Doi : 10.1016/j.therap.2023.02.008

Astrid Prioul ^a,⁎ , Dorine Fournier ^a, Cécile Lefeuvre ^a, Sophie Duranton ^b, Pascale Olivier ^c, Emeline Blanc ^d, Laure Peyro-Saint-Paul ^e, Sophie Ruault ^f, Aurélie Jamet ^g, Catherine Mouchel ^a
^a Service de pharmacologie clinique, unité de vigilance des essais cliniques, CIC Inserm 1414, CHU de Rennes, 35033 Rennes, France
^b Direction de la recherche, unité de vigilance des essais cliniques, CHU de Poitiers, 86021 Poitiers cedex, France
^c Service de pharmacologie médicale et clinique, centre de pharmacovigilance, de pharmacoépidémiologie et d’informations sur le médicament INSERM UMR 1027, CIC 1436, CHU de Toulouse, 31059 Toulouse, France
^d Direction de la recherche en santé, unité de vigilance des essais cliniques, Hospices civils de Lyon, 69229 Lyon, France
^e Vigilance recherche clinique, CHU de Caen, 14033 Caen, France
^f Maison de la recherche clinique, CHU de Rouen, 76031 Rouen, France
^g Vigilance des essais cliniques, CHU d’Angers, 49933 Angers, France

^⁎Corresponding author. Service de pharmacologie clinique, unité de vigilance des essais cliniques, CIC Inserm 1414, CHU de Rennes, 2, rue Henri-Le Guilloux, 35033 Rennes cedex, France.Service de pharmacologie clinique, unité de vigilance des essais cliniques, CIC Inserm 1414, CHU de Rennes2, rue Henri-Le GuillouxRennes cedex35033France

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Summary

Introduction

The evaluation of clinical trial (CT) safety is the main task of CT vigilance units. In addition to the management of adverse events, the units must review the literature to identify information that may impact the benefit-risk assessment of studies. In this survey, we investigated the literature monitoring (LM) activity of French Institutional Vigilance Units (IVU) from the working group “REflexion sur la VIgilance et la SEcurite des essais cliniques” (REVISE).

Material and methods

We sent a questionnaire of 26 questions, divided into four themes, to the 60 IVU: (1) Presentation of the IVU and the LM activity; (2) Used sources, queries and criteria for selecting articles; (3) Valuation of the LM and (4) Practical organisation.

Results

Of the 27 IVU that responded to the questionnaire, 85% of them carried out LM. This was mainly provided by medical staff to improve general knowledge (83%), to detect Adverse Reactions (AR) not listed in the reference documents (70%) and to detect new safety information (61%). Due to lack of time, staff, available recommendations and sources, only 21% of IVU conducted LM for all CT. On average, units reported four sources: ANSM information (96%), PubMed database (83%), EMA alerts (57%) and the subscription to APM international (48%). The LM had an impact on the CT of 57% of the IVU such as changing the conditions of a study (39%) or suspending a study (22%).

Discussion/Conclusion

LM is an important but time-consuming activity with heterogeneous practices. According to the results of this survey, we proposed seven ways to improve this practice: (1) Target the highest risk CT; (2) Refine the PubMed queries; (3) Use other tools; (4) Create a decision flowchart for the selection of PubMed articles; (5) Improve training; (6) Value the activity and (7) Outsource the activity.

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Keywords : Clinical trials, Patient safety, Safety management, Review Literature