Open Access Policy

Introduction

The World Medical Association developed the Declaration of Helsinki 2013 as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. The Declaration provides guiding principles concerning Research Registration and Publication and Dissemination. Specifically, it states:

“Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.”

In accordance with the Declaration, Global Alliance for TB Drug Development (TB Alliance) upholds open access to the results of our clinical trials and is committed to information sharing and transparency. On 13 June 2017, TB Alliance signed a joint statement with other signatories including some of the world’s largest funders of medical research and international non-governmental organizations, agreeing on new World Health Organization (WHO) standards on reporting clinical trial results.

TB Alliance complies with these WHO standards, ensuring that our trials and results will be accessible via WHO’s International Registry Platform, a unique global database of clinical trials that compiles data from 17 registries around the world. To that end, TB Alliance will continue to submit the details of all our clinical trials to clinicaltrials.gov, the largest clinical trials database of privately and publicly funded trials run by the United States Library of Medicine at the National Institutes of Health. Clinicaltrials.gov is an International Committee of Medical Journal Editors (ICMJE)[1] approved registry. Other registries might be considered as long as they are connected to the WHO International Registry Platform. TB Alliance affirms the following principles for reporting, monitoring, and publishing the results of our clinical trials that we fund, co-fund, sponsor, or support. 

General Principles

1. Registration of clinical trials

TB Alliance will register all clinical trials (at any phase) before research initiation. The clinical trial registry will be made before the first subject receives the first medical intervention in the trial or as soon as possible afterwards. Clinical trial registry records will be updated as necessary to include final enrolment numbers achieved, and the date of primary study completion. If clinical trials are terminated, their status will be updated to note the date of termination, and to report the numbers enrolled up to the date of termination.

2. Reporting timeframes for clinical trials

TB Alliance agrees to make publicly available summary results of clinical trials in a timely manner following primary study completion. There are two main modalities for this to occur: by posting to the results section of the clinical trial registry and by journal publication. We will work towards a timeframe of 12 months from primary study completion (the last visit of the last subject for collection of data on the primary outcome) as the global norm for summary results disclosure.

TB Alliance intends for all study results to be published through one or more peer reviewed articles. Recognizing that timeframes for writing, peer review and publication are not completely within our control, we set an indicative timeframe of 24 months from study completion as our goal.

We will work to ensure that study protocols are made publicly available no later than the time of the summary results disclosure as part of the clinical trial registry summary results information, including amendments approved by ethics committees/institutional review boards.

3. Trial ID in clinical trial publication

The Trial ID or registry identifier code/number will be included in all publications of clinical trials, and will be provided as part of the abstract to PubMed and other bibliographic search databases for easy linking of trial related publications with clinical trial registry site records.

4. Registration and reporting of past trials

TB Alliance understands that reporting of previous trials further realizes the value of funding. We have therefore ensured data from past clinical trials are registered online and publicly available.