Journal Article

An audit to evaluate an institute’s lead researchers’ knowledge of trial registries and to investigate adherence to data transparency issues in an Italian research institute registry

Pandolfini, Chiara, Bonati, Maurizio

2018

Overview

Background Clinical trial registries have been a priority topic in the past few years in promoting data transparency and accountability. In this context, in 2011, the IRCCS - Istituto di Ricerche Farmacologiche “Mario Negri” set up a registry to collect data on all studies in which the institute’s researchers are involved. In this study we present a self-audit in order to detect the lead researchers’ general knowledge on registries, the completeness and quality of the randomized controlled trial (RCT) data inputted in an Italian research institute’s registry, and the researchers’ adherence to both registration requirements and the institute transparency goal, aiming to improve standards and leading to greater awareness of the issues involved. Methods A questionnaire-based audit was conducted. To interview researchers we included questions ranging from general knowledge on registries (e.g., what are the aims of registries?) to questions about their knowledge of the Mario Negri’s registry, questions on selected trials and registration, included information on the protocol, and the results. Results The audit sample covers 12 of the 47 RCTs at the institute’s Milan branch, representing all the possible lead researchers responsible for RCTs at the institute. The researchers have more than a basic knowledge of trial registries and their aims. All the researchers reported that they know of the ClinicalTrials.gov registry and most of them reported that they frequently use it; however, only a few know about the World Health Organization’s registry platform (International Clinical Trials Registry Platform). The most cited registry aims reported were increased transparency and reduced publication bias. Of the studies registered in the institute’s registry, 92% had at least one data item missing in the registry record. Concerning trial registration in the international registries, all 12 respondents said their trial had been registered and specified the registry name, but often they had not inputted the associated trial ID code in the corresponding field of the institute’s registry. Concerning two important issues on data transparency and ethical standards, namely registration timing and result reporting, 11 stated that their trial was registered before starting recruitment, and for five of six closed trials they stated that their results have been already published—for one trial within 1 year after its completion. Conclusions Researchers should guarantee correct reporting of trials and their data as a rule of great ethical value. Institutional self-audits should be performed periodically in order to improve clinical trial disclosure.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Academies and Institutes - ethics / Academies and Institutes - organization & administration / Academies and Institutes - standards / Accountability / Attitude of Health Personnel / Audits / Biomedicine / Clinical trial registration requirements / Clinical trial registries / Clinical trials / Collaboration / Data Accuracy / Ethical aspects / Ethical issues / Evaluation / Guideline Adherence - ethics / Guideline Adherence - organization & administration / Guideline Adherence - standards / Guidelines as Topic - standards / Health Knowledge, Attitudes, Practice / Health Sciences / Humans / Italy / Knowledge / Management Audit / Medical Audit / Medical ethics / Medical research / Medical researchers / Medicine / Medicine & Public Health / Observational studies / Pharmaceutical industry / Questionnaires / Randomized controlled trial (RCT) / Randomized Controlled Trials as Topic - ethics / Randomized Controlled Trials as Topic - methods / Randomized Controlled Trials as Topic - standards / Registration / Registries / Research centers / Research Design - standards / Research institutes / Research Personnel - ethics / Research Personnel - organization & administration / Research Personnel - psychology / Researchers / Review / Statistics / Statistics and research methods / Statistics for Life Sciences / Transparency