Thursday, 17 September 2015

How can clinical trials better reflect local priorities?

Clinical trials are valuable as they have the potential to reduce disease burdens by helping developing safe and effective new therapies and vaccines. Although they are conducted in many countries around the world the local benefits are not guaranteed.

For example, although so-called emerging markets are routinely included in global clinical trial programmes, the focus is primarily on the disease of interest to the international sponsor and may not necessarily reflect local priorities. While some non-governmental organisations (NGOs) do conduct clinical studies with local partners that are focused on diseases reflecting urgent local needs, these trials represent a minority of trials in emerging markets.

Imbalances certainly exist between the burden of disease in emerging regions and the types of trials in these locations, indicating that certain diseases are being under-investigated relative to their morbidity and mortality. A recent study of randomized trials published in the PubMed database found little association across disease areas between burden of disease and the quantity of randomized trials. The findings strongly suggested that clinical trials being conducted in low income regions were less suited to local healthcare needs than are those conducted in high income regions.

A continuing problem in aligning clinical trials with public health priorities is that little reliable information exists on how much different countries are spending on health and disease-related R&D. One ambitious idea proposed by WHO is the Global Observatory for Health R&D platform. The project is being planned and developed in a phased approach and its success depends on attracting sufficient funding and support from WHO member countries and organisations involved in international healthcare. 

This ambitious plan does have a number of obstacles standing in its way. For example, the platform will be designed to build on existing sources as much as possible. However, since existing sources in many countries are limited, technical support will be needed for the countries in order to establish a system to monitor national R&D investments and pipelines. This means openly acknowledging the considerable gaps that exist in the capacity of many partners to produce this data. An initial estimate is that the Global Observatory for Health R&D platform will require $11.5 billion to be developed and run for the first 5 years. At present it is unclear who will fund the necessary projects, and this means that any proposed timelines must be viewed with caution.

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