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Lack of transparent reporting of trial monitoring approaches in randomised controlled trials: a systematic review of contemporary protocol papers

Victoria Yorke-Edwards1, Shao-Fan Hsieh1,2, Macey L. Murray1,3,4, Carlos Diaz-Montana1, Sharon B. Love1, Matthew R. Sydes1,5

1MRC Clinical Trials Unit at UCL, 2Clinical Drug Development MSc Programme, Division of Medicine, UCL, 3Health Data Research UK, 4NHS DigiTrials Programme, NHS Digital, 5BHF Data Science Centre, Health Data Research UK

Introduction

  • Monitoring is essential to ensure patient safety and data integrity in clinical trials as per Good Clinical Practice.
  • The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) checklist guides authors to include monitoring in protocols.
  • We investigated the reporting of monitoring in published protocol papers for contemporary randomised controlled trials.

Methods

  • Systematic search in PubMed to identify eligible protocol papers published between 1st January and 31st May 2020 in BMJ Open, Contemporary Clinical Trials, Contemporary Clinical Trials Communications, JMIR Research Protocols, Medicine (Baltimore), PLOS ONE, Trials and journals published by BioMed Central (BMC)
  • Articles then classified by whether they reported monitoring.
  • Descriptive data summarised, including whether protocol papers detailed the monitoring approach (e.g. central or on-site), frequency of monitoring, monitoring scope (e.g. what is being monitored) and which organisation would conduct the monitoring.

Results

Some definitions:

Monitoring: Methods used by a sponsor to oversee the conduct of, and reporting of data from, clinical trials

On-Site Monitoring: Trial team visit sites to check processes and procedures and conduct Source Data Verification.

Central Monitoring: Centrally-collected data (such as that in the trial database) are checked to detect systematic errors such as missing data, procedural errors or suspected fraud.

Central and On-Site Monitoring are increasingly being combined, often as part of Risk-Based Monitoring

 

Conclusion

Poor reporting of monitoring hinders judging the validity of a trial and jeopardises the value of protocol papers and trial credibility.

Protocol writers, journal editors and protocol paper authors: We need transparent reporting of monitoring

Include: approach, frequency, scope, organisation