1. THE UNTOLD STORY: MONITORING MECHANISMS
THE UNTOLD STORY: MONITORING MECHANISMS & PROCESSES OBSERVED IN THE ATTEND TRIAL
Syrigapu A1, Tugnawat DK1 , Murthy GVS1, Lindley RI2, Pandian JD 3, Felix C4, Gandhi DBC 3, Verma SJ 3, Alim M 4, Maulik PK 4, on behalf of the ATTEND collaborative group. 1. Indian Institute of Public Health, Hyderabad, Telangana, India. 2. University of Sydney, Sydney, Australia, 3. Christian Medical College, Ludhiana, Punjab, India. 4. George Institute for Global Health, Hyderabad, Telangana, India.
Reasons for non-adherence to GCP and study protocol were documented by identifying the barriers and intensive on-site re-training was given to ensure better adherence to study protocol and GCP.
Introduction
Methods & Material
Many clinical trials are not intensively monitored.
The ATTEND trial, an Investigator initiated academic, prospective, randomised controlled trial was performed with an agreed monitoring plan according to ICH/Good Clinical Practice (GCP).
The trial was monitored by independent monitors from the Indian Institute of Public Health, Hyderabad, India.
This ensured compliance with the trial protocol and GCP, to provide protection to the trial subjects and assure quality and credibility of the data.
A Total 1250 patients were randomised from January 2014 to February 2016.
A checklist was designed to validate the data obtained by trial staff from source documents.
Trial staff were trained and retrained at regular intervals and clarification was provided wherever needed.
Monitoring Visits
Procedure
We carried out site initiation visits followed by the monitoring visits, when the site recruited 10%, 40-50% and at or above 50 % of the target subjects followed by a study close out visit at each trial site.
Data / Observations
Conclusion
65 trial staff were trained to ensure quality and credibility of the data.
There was gradual reduction in number of protocol deviations (PD) and data clarification forms (DCF) after each monitoring visit.
All randomized patients were confirmed by available signed informed consent form (ICF) and by examination of source documentation.
Site initiations and Study close out visits completed for 14 centers.
Recruitment
The provision of an independent monitoring team for the ATTEND trial led to enhanced quality.
Re-training of trial staff to ensure better compliance with GCP and the study protocol which should lead to better data integrity.