Academic journal article Bulletin of the World Health Organization

Use of Data from Registered Clinical Trials to Identify Gaps in Health Research and development/Utilisation Des Donnees Provenant D'essais Cliniques Enregistres En Vue Didentifier Les Disparites En Matiere De Recherche et De Developpement Dans le Domaine De la Sante

Academic journal article Bulletin of the World Health Organization

Use of Data from Registered Clinical Trials to Identify Gaps in Health Research and development/Utilisation Des Donnees Provenant D'essais Cliniques Enregistres En Vue Didentifier Les Disparites En Matiere De Recherche et De Developpement Dans le Domaine De la Sante

Article excerpt

Introduction

More than two decades ago it was shown that only 5% of the world's resources for health research and development (R&D) were spent on the health problems of developing countries, which then represented 93% of the world's burden of preventable mortality. (1,2) The lack of a rational link between the health R&D that was needed and that which was being conducted resulted in the existence of "neglected populations"? This mismatch, which still exists, had and has two main causes. First, the distribution of R&D funding has been--and remains--largely determined by market forces rather than by a more equitable system that is based on health needs. (4,5) Second, even when funding for health R&D is distributed by philanthropic or governmental donors, many high-burden diseases and priority areas of R&D can remain badly underfunded. (6) This indicates a lack of appropriate mechanisms for the prioritization and coordination of such R&D. (7) To start addressing these problems, a sense of agreement on a common R&D agenda will have to grow among funders of health R&D--something that, to date, has proven difficult to achieve. (7) As a first step towards such a common agenda, the current composition of the "global landscape" of health R&D needs to be explored so that the gaps in this landscape and neglected populations can be identified. If we are to change how we spend our money on health R&D, we first need to know how we are spending it now.

Unfortunately, we know very little about what health R&D is being conducted, where and how it is being conducted, and who is conducting it. (8) Databases of registered clinical trials may offer a new resource for gaining insight into the health R&D "landscape". In the past decade, trial registration has become broadly accepted as an ethical and scientific responsibility. (9-16) Enforcing regulations, policies and legislation has been crucial to the success of trial registration. There has been relevant national legislation, (12) the editors of many medical journals have made trial registration a prerequisite for the publication of trial results, (9,13-15) such registration may also now be a prerequisite for the ethical approval of a trial's protocol (11,17) and a self-regulating pharmaceutical industry has also promoted trial registration. (16) On several continents, many publicly accessible, online registries have been established to allow investigators to register their clinical trials. (18) In 2005, the International Clinical Trials Registry Platform (ICTRP) was established by the World Health Organization (WHO) to create a platform for linking these clinical trial registries and provide a single point of access to information on all clinical trials conducted globally. (11) Over the last 8 years, the ICTRP has grown into a platform that combines data from 15 different clinical-trial registries, both national and regional, and offers access to more than 200 000 registered records of clinical trials.

This study was conducted to explore what can be learnt from the clinical trial records available on the ICTRP database about the current composition of the "global landscape" of health R&D. We were especially interested in the distribution of trials across different diseases and countries and the identification of any major gaps in the "landscape".

Methods

Study sample

By using an automated random sampling function that is available as part of the ICTRP's data management system, we randomly selected from the ICTRP database 5% of all the records for interventional clinical trials that were registered as actively recruiting participants on 10 August 2012. A 5% sample was considered to be sufficient to produce results that could give a general view, but not too large to hamper the manual extraction of relevant data. For trials that were registered in more than one registry, we included only the record with the earliest registration date. …

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