Continuing its efforts to streamline the drug development process that spawned the landmark Critical Path Initiative in March 2004, the US Food and Drug Administration (FDA) has hooked up with Durham, North Carolina-based Duke University Medical Center in a collaboration aimed at modernising the way clinical trials are conducted.

Under an agreement between the two parties, Duke University Medical Center will host a Public-Private Partnership to include broad representation from government, industry, patient advocacy groups, professional societies and academia. The participants will work together on developing new standards and identifying new methods and technologies that can improve the safety of clinical trials while boosting the quality of information derived from them and making the whole research process more efficient.

The partnership will be chaired by Dr Robert Califf, vice-chancellor for clinical research at Duke University, and co-chaired by Dr Rachel Behrman, director of the FDA’s Office of Critical Path Programs. It will provide a venue for convening working groups and a national panel of experts under the initiative.

“To ensure the safety of clinical trial participants and to improve the health of the public, the clinical research enterprise needs to evolve,” commented Dr Janet Woodcock, FDA deputy commissioner and chief medical officer, as well as leader of the Critical Path Initiative. “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. Through this collaboration between FDA and Duke, we are going to work with many stakeholders to lay the foundation for achieving these goals.”

The FDA has already entered into a number of partnerships to address priority areas under the Critical Path programme.

More evidence needed
Dr Califf said the public-private partnership reflected societal demand for more evidence about medical practice. "Indeed, there is concern that our research system is falling behind the needs of society to determine the balance of benefit and risk from drugs, devices and surgical procedures,” he added.

“Our system of clinical trials provides the evidence for what the FDA approves and which medical practices are adopted as professional standards. We aim to provide a forum in which the experts in the field can put forward ideas about how to improve the system and then we can do research to inform policy makers about whether suggested changes are likely to have beneficial effects.”

Among the potential avenues the partnership will explore are:

- Establishing national standards for a wide range of research functions to streamline current approaches to initiating and conducting clinical trials. “There is broad agreement that the process is too slow and unnecessarily complicated,” Duke University said. Examples could include developing 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.
- Exploring alternative models for Institutional Review Boards to minimise duplication of effort in multi-site clinical trials
- Identifying strategies to enhance the process of obtaining informed consent from clinical trial participants.
- Establishing accreditation programmes for both clinical investigators and research sites. “Currently, research organizations that co-ordinate large, multi-site 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,” Duke University noted. “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. 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.”
- Extending the use of technology to improve data management. “Switching to electronic data management systems would enable researchers to monitor data in real time and help them spot safety problems more quickly,” Duke University commented. “If the electronic systems were standardised across the nation, data from one clinical trial could quickly and easily be compared against data from another.”

The initiative will begin by identifying simple measures in areas where there is strong consensus across the clinical research community that better procedures can be established. It will take several years to develop a complete set of recommendations, Duke University noted.