Clinical research: time for sensible global guidelines

Abstract

Clinical research is being slowly strangled by bureaucracy because guidelines that were developed for product-registration trials are being applied rigidly to all types of clinical research. 1 McMahon AD Conway DI Macdonald TM McInnes GT The unintended consequences of clinical trials regulations. PLoS Med. 2009; 3: e1000131 Crossref PubMed Scopus (64) Google Scholar , 2 EditorialFaltering cancer trials. New York Times. http://www.nytimes.com/2010/04/25/opinion/25sun1.htmlDate: April 24, 2010 Google Scholar Complex, often confusing, and readily misinterpreted regulations, and their consequent spiralling costs, are a dangerous disincentive to medical progress. 2 EditorialFaltering cancer trials. New York Times. http://www.nytimes.com/2010/04/25/opinion/25sun1.htmlDate: April 24, 2010 Google Scholar , 3 Yusuf S Bosch J Devereaux P et al. Sensible guidelines for the conduct of large randomized trials. Clin Trials. 2008; 5: 238-239 Crossref Scopus (48) Google Scholar The problem is already serious and is now being exported to the developing world—which can least afford it. Populations in developing countries are under-represented in all areas of clinical research, yet those regions of the world that carry the highest disease burdens obviously stand to gain the most from clinical investigation and improvements in prevention and treatment. This is a time of increased awareness and support for the health problems of developing countries. It is a time of great opportunity for progress. But we are seriously worried that the increasingly complex and expensive standards and regulations—created with the noble intention of protecting patients and ensuring the quality of research and thereby improving health—will not achieve these laudable objectives in the developing world. Indeed they might actually limit research, concentrating it to relatively few wealthy organisations and thereby slowing progress. We need to reverse this trend and aim for a sensible balance. There is a need for new evidence-based guidelines that are appropriate for all types of clinical research. These would be welcomed by researchers everywhere and would be particularly beneficial to research in resource limited settings.