Roderik F Viergever

A checklist for health research priority setting: nine common themes of good practice

Health research priority setting processes assist researchers and policymakers in effectively targeting research that has the greatest potential public health benefit. Many different approaches to health research prioritization exist, but there is no agreement on what might constitute best practice. Moreover, because of the many different contexts for which priorities can be set, attempting to produce one best practice is in fact not appropriate, as the optimal approach varies per exercise. Therefore, following a literature review and an analysis of health research priority setting exercises that were organized or coordinated by the World Health Organization since 2005, we propose a checklist for health research priority setting that allows for informed choices on different approaches and outlines nine common themes of good practice. It is intended to provide generic assistance for planning health research prioritization processes. The checklist explains what needs to be clarified in order to establish the context for which priorities are set; it reviews available approaches to health research priority setting; it offers discussions on stakeholder participation and information gathering; it sets out options for use of criteria and different methods for deciding upon priorities; and it emphasizes the importance of well-planned implementation, evaluation and transparency.

Mapping of available health research and development data: what's there, what's missing, and what role is there for a global observatory?

The need to align investments in health research and development (R&D) with public health demands is one of the most pressing global public health challenges. We aim to provide a comprehensive description of available data sources, propose a set of indicators for monitoring the global landscape of health R&D, and present a sample of country indicators on research inputs (investments), processes (clinical trials), and outputs (publications), based on data from international databases. Total global investments in health R&D (both public and private sector) in 2009 reached US

The quality of registration of clinical trials.

240 billion. Of the US

Trends in global clinical trial registration: an analysis of numbers of registered clinical trials in different parts of the world from 2004 to 2013

214 billion invested in high-income countries, 60% of health R&D investments came from the business sector, 30% from the public sector, and about 10% from other sources (including private non-profit organisations). Only about 1% of all health R&D investments were allocated to neglected diseases in 2010. Diseases of relevance to high-income countries were investigated in clinical trials seven-to-eight-times more often than were diseases whose burden lies mainly in low-income and middle-income countries. This report confirms that substantial gaps in the global landscape of health R&D remain, especially for and in low-income and middle-income countries. Too few investments are targeted towards the health needs of these countries. Better data are needed to improve priority setting and coordination for health R&D, ultimately to ensure that resources are allocated to diseases and regions where they are needed the most. The establishment of a global observatory on health R&D, which is being discussed at WHO, could address the absence of a comprehensive and sustainable mechanism for regular global monitoring of health R&D.

Mapping global health research investments, time for new thinking - A Babel Fish for research data

Background Lack of transparency in clinical trial conduct, publication bias and selective reporting bias are still important problems in medical research. Through clinical trials registration, it should be possible to take steps towards resolving some of these problems. However, previous evaluations of registered records of clinical trials have shown that registered information is often incomplete and non-meaningful. If these studies are accurate, this negates the possible benefits of registration of clinical trials. Methods and Findings A 5% sample of records of clinical trials that were registered between 17 June 2008 and 17 June 2009 was taken from the International Clinical Trials Registry Platform (ICTRP) database and assessed for the presence of contact information, the presence of intervention specifics in drug trials and the quality of primary and secondary outcome reporting. 731 records were included. More than half of the records were registered after recruitment of the first participant. The name of a contact person was available in 94.4% of records from non-industry funded trials and 53.7% of records from industry funded trials. Either an email address or a phone number was present in 76.5% of non-industry funded trial records and in 56.5% of industry funded trial records. Although a drug name or company serial number was almost always provided, other drug intervention specifics were often omitted from registration. Of 3643 reported outcomes, 34.9% were specific measures with a meaningful time frame. Conclusions Clinical trials registration has the potential to contribute substantially to improving clinical trial transparency and reducing publication bias and selective reporting. These potential benefits are currently undermined by deficiencies in the provision of information in key areas of registered records.

Health care providers and human trafficking: what do they know, what do they need to know? Findings from the middle East, the Caribbean, and central america.

Objectives To analyse developments (and their causes) in the number and proportion of clinical trials that were registered in different parts of the world after the International Committee of Medical Journal Editors (ICMJE) announced in 2004 that it would require registration of clinical trials as a condition for publication. Setting The International Clinical Trials Registry Platform (ICTRP). Design The ICTRP database was searched for all clinical trials that were registered up to 31 December 2013. Results The ICTRP database contained data on 186 523 interventional clinical trials. The annual number of registered clinical trials increased from 3294 in 2004 to 23 384 in 2013. Relative to the number of clinical trial research publications, the global number of registered clinical trials increased fivefold between 2004 and 2013, rising particularly strongly between 2004 and 2005. In certain regions, especially Asia, the annual number of registered trials increased more gradually and continued to increase up to 2013. In India and Japan, two countries with marked but more gradual increases, these increases only happened after several local measures were implemented that encouraged and enforced registration. In most regions, there was a trend toward trials being registered at local registries. Conclusions Clinical trial registration has greatly improved transparency in clinical trial research. However, these improvements have not taken place equally in all parts of the world. Achieving compliance with registration requires a coalescence of global and local measures, and remains a key challenge in many countries. Poor quality of registered trial data and the inaccessibility of trial protocols, results and participant-level data further undermine the potential benefits of clinical trial registration. National and regional registries and the ICTRP have played a leading role in achieving the successes of trial registration to date and should be supported in addressing these challenges in the future.

Global trends in health research and development expenditures – the challenge of making reliable estimates for international comparison

Today we have an incomplete picture of how much the world is spending on health and disease-related research and development (R&D). As such it is difficult to align, or even begin to coordinate, health R&D investments with international public health priorities.Current efforts to track and map global health research investments are complex, resource-intensive, and caveat-laden. An ideal situation would be for all research funding to be classified using a set of common standards and definitions. However, the adoption of such a standard by everyone is not a realistic, pragmatic or even necessary goal.It is time for new thinking informed by the innovations in automated online translation - e.g. Yahoos Babel Fish. We propose a feasibility study to develop a system that can translate and map the diverse research classification systems into a common standard, allowing the targeting of scarce research investments to where they are needed most.

Pharmacokinetic research in children: an analysis of registered records of clinical trials

Background: Human trafficking is a crime that commonly results in acute and chronic physical and psychological harm. To foster more informed health sector responses to human trafficking, training sessions for health care providers were developed and pilot-tested in the Middle East, Central America, and the Caribbean. This study presents the results of an investigation into what health care providers knew and needed to know about human trafficking as part of that training program. Methods: Participants attended one of seven two-day training courses in Antigua and Barbuda, Belize, Costa Rica, Egypt, El Salvador, Guyana, and Jordan. We assessed participants’ knowledge about human trafficking and opinions about appropriate responses in trafficking cases via questionnaires pre-training, and considered participant feedback about the training post-training. Results: 178 participants attended the trainings. Pre-training questionnaires were completed by 165 participants (93%) and post-training questionnaires by 156 participants (88%). Pre-training knowledge about health and human trafficking appeared generally high for topics such as the international nature of trafficking and the likelihood of poor mental health outcomes among survivors. However, many participants had misconceptions about the characteristics of trafficked persons and a provider’s role in responding to cases of trafficking. The most valued training components included the “Role of the Health Provider,” “Basic Definitions and Concepts,” and “Health Consequences of Trafficking.” Discussion: Training health care providers on caring for trafficked persons has the potential to improve practitioners’ knowledge about human trafficking and its health consequences, and to increase safe practices when responding in cases of trafficking. This study provides lessons for the design of training programs on human trafficking that aim to help health care providers identify and refer victims, and provide care for survivors.

Global biomedical R&D expenditures

Better estimates of changes in the level and structure of national, regional, and global expenditures on health research and development (R&D) are needed as an important source of information for advancing countries’ health research policies. However, such estimates are difficult to compile and comparison between countries needs careful calibration. We outline the steps that need to be taken to make reliable estimates of trends in countries’ expenditures on health R&D, describe that an ideal approach would involve the use of international sets of deflators and exchange rates that are specific to health R&D activities, and explain which methods should be used given the current absence of such health R&D-specific deflators and exchange rates. Finally, we describe what should be the way forward in improving our ability to make reliable estimates of trends in countries’ health R&D expenditures.

Finding better ways to fill gaps in pediatric health research

Background Reported off-label/unlicensed prescribing rates in children range from 11% to 80%. Research into pharmacokinetic profiles of childrens medicines is essential in the creation of more knowledge on the safety and efficacy of medicines in children. This study investigated how often pharmacokinetic data are collected in clinical trials of medicines in children by analysing registered records of clinical trials. Methods The registered records of all clinical trials in children that were recruiting on 22 May 2009 were identified on the International Clinical Trials Registry Platform using a Clinical Trials in Children search filter. The records of trials in children below 12 years of age, in which the intervention was one or more medicines, were assessed for evidence that pharmacokinetic data would be collected. Results Of 1081 eligible trial records, 257 (24%) declared that pharmacokinetic data would be collected. Of these trials, 199 (77%) recruited in Northern America; recruitment in all other regions was below 20%. Trials recruited most often in children over 2 years of age (74%), and least often in newborn infants (32%). Most trials researched medicines in the field of cancer (29%). Trials investigated one-third of the medicines that were indicated as a priority for pharmacokinetic research by the European Medicines Agency. Conclusions There is a need for increased knowledge of the pharmacokinetic profiles of childrens medicines. The amount of currently ongoing pharmacokinetic research does not seem to address adequately the lack of knowledge in this area. This study sets a baseline for monitoring of future progress on the amount of ongoing pharmacokinetic research in children.