Clinical Trials
This article was originally published in RAJ Devices
Executive Summary
FDA and Duke University collaborate to improve clinical trials in US
FDA and Duke University collaborate to improve clinical trials in US
The US Food and Drug Administration has announced the launch of a public-private partnership with Duke University to modernise the way clinical trials for drugs, devices and biologicals are conducted. The main goal of the partnership is to develop new standards and identify new methods and technologies to ensure that the design, execution and analysis of clinical trials are of a high quality1.
The partnership will include representatives from the US government, industry, patient advocacy groups, professional societies and academia and it will take several years to develop a complete set of recommendations.
Rachel Behrman, director of the FDA's Office of Critical Path Programs, will chair the partnership alongside Robert Califf, Duke University's vice chancellor for clinical research. Duke University, based in North Carolina, will host the partnership.
Janet Woodcock, the FDA deputy commissioner who leads the FDA's critical path initiative, said that clinical research enterprise needs to evolve in order to ensure the safety of clinical trial participants and improve the health of the public. “It needs to be much more streamlined and efficient, and at the same time it needs to be better equipped to answer the pressing questions that confront both patients and health care professionals,” said Dr Woodcock. “Through this collaboration between FDA and Duke, we are going to work with many stakeholders to lay the foundation for achieving these goals.”
The partnership aims to establish national standards to streamline the current approaches to initiating and conducting clinical trials. There is broad agreement, the FDA says in its statement on the collaboration, that the process is too slow and unnecessarily complicated. Examples of improvements include the development of standardised electronic forms for collecting data as well as standardised contractual agreements that govern the ways in which individual research sites (such as hospitals and physician practices) interact with research sponsors.
Another aim of the partnership is to explore alternative models for institutional review boards in order to minimise duplication of efforts in multisite clinical trials and identifying strategies to enhance the process of obtaining informed consent from clinical trial participants.
Establishing accreditation programmes for both clinical investigators and research sites is another aim of the partnership. Currently, research organisations that co-ordinate large, multisite clinical trials are required to assess and document the qualifications of each investigator and the quality of each research site participating in a clinical trial. The FDA notes that, for a large clinical trial, the process typically involves several visits to each site, requiring months to complete and often delaying the start of the trial. The thinking is that an accreditation system similar to the one used by hospitals could help research organisations more quickly and efficiently verify the abilities of accredited individuals and sites.
The partnership also intends to extend the use of technology to improve data management. Currently, most of the data collected during clinical trials is recorded on paper. Switching to electronic data management systems, says the FDA, would enable researchers to monitor data in real time and help them spot safety problems more quickly. If the electronic systems were standardised across the US, for example, data from one clinical trial could quickly and easily be compared against data from another.
References
1. FDA press release, 23 November 2007