A new trial monitoring plan (TMP) template for clinical trials: output from a Delphi process.

Abstract

Background: Monitoring is a crucial part of trial conduct and ensures that participants' data is fairly represented, and future healthcare information is enhanced. This project aims to improve trial monitoring by creating a trial monitoring plan (TMP) template with input from individuals experienced in monitoring clinical trials.

Methods: A review of monitoring plans received from UK Clinical Research Collaboration (UKCRC) registered clinical trials units (CTU)s created the basis for a preliminary TMP template and a Delphi survey. The TMP template was finalised after 2 rounds of a Delphi survey and a two-part consensus meeting including trialists with experience and expertise in monitoring clinical trials.

Results: We received 31 monitoring plans from UKCRC-registered CTUs and reviewed over 800 monitoring items for inclusion in a TMP template, selecting items based on guidelines such as Good Clinical Practice (GCP) and our monitoring experiences. For certain items, further expert input was required. A total of 66 items were chosen for a Delphi survey involving 47 participants from 25 UK CTUs and industry. After the first round, all 66 items were retained, and six additional items were suggested by Delphi participants. In the second round, 37 items reached consensus for inclusion in the TMP template. The Delphi process was followed by a consensus meeting with 9 participants from 9 UK CTUs and industry. Participants in the consensus meeting voted on the 32 further items that had not reached the definition of consensus within the Delphi, regarding each item's inclusion in or exclusion from the TMP template. The voting resulted in 18 items being excluded, leaving 14 items to be included in the TMP template. The process overall resulted in a standardised TMP template with input from many individuals with interest, experience, or expertise in monitoring clinical trials.

Conclusion: A TMP template was developed building on the currently used monitoring plans and with input from those experienced in clinical trial monitoring. Using a centrally developed good quality TMP template should contribute towards maintaining consistency in monitoring standards across all CTUs, resulting in higher research quality and improved quality assurance. Its use should provide reassurance to participants that their participation is carefully monitored to ensure that their data or any samples provided are treated with confidentiality, integrity, and respect and that their rights and well-being are protected.