OECD Calls for Regulatory Harmonization to Support Global Clinical Trials System

Posted 25 February 2013 By Alexander Gaffney, RF News Editor

The Organization for Economic Co-operation and Development (OECD), a long-standing global governance group focused on economic issues, has called for countries around the globe to harmonize their clinical trials regulations in an attempt to save both costs and lives.

Background

In a statement, OECD said it was troubled by "increasingly complex and inconsistent clinical trial regulations," which it said were causing delays, increasing costs and leading to fewer clinical trials conducted by non-commercial entities, such as academics.

"These regulatory processes have taken on different forms in different countries, and many countries or regions are currently revising or adapting them in response to the evolution of science as well as to ethical or practical demands," it continued. "Clinical trials are increasingly evolving from projects conducted at single sites and sponsored by single institutions into global multi-site collaborative undertakings. However, the disparities in regulations between countries may create obstacles for the development of international co-operation in clinical research."

Those obstacles can be considerable. "In the EU alone, the number of applications for clinical trials fell by 25% between 2007 and 2011," OECD wrote, primarily due to the complexity and cost of conducting clinical trials.

"Such regulatory complexity has detrimental consequences," the report states. "Many well-conceived clinical trials that are aimed at addressing important public health problems either cannot be conducted or are so delayed that their impact is dramatically reduced. This is particularly true for the conduct of international clinical trials which involve multiple centers, and for trials initiated by academic structures which do not have well-developed administrative support."

And while the EU is scrambling to reconfigure its clinical trials regulation in response to that decrease, OECD argues in its memorandum that the endemic nature of the problems means it's time to start looking at harmonizing clinical trials regulations across countries and regions.

The group explains that the benefits of harmonization in general would be massive, and notes that it could have a particularly beneficial effect for those suffering from rare diseases, where increased costs to conduct trials are squeezing investment out of a space that has historically not been all that profitable.

The organization may be in a good position to call for harmonization, as it boasts 34 member countries, including the US, most of Europe, and other up-and-coming and developed countries like Japan, South Korea, Turkey, New Zealand, Australia, Canada and Israel. With a budget of €347 million, it's also well-positioned to have the funding to push for its recommendations with further action and dedicated staffing.

Specific Recommendations

OECD specifically calls for a risk-based approach with a focus on what can be done to facilitate cooperation between academic groups conducting nonprofit clinical research, though it notes that the same principles might prove useful for all clinical trials, including those conducted by industry.

OECD's broader point: To balance the risks of enrollment in a clinical trial with the costs that might prevent others from ever enrolling in a trial-itself a risk to public health.

At the core of the harmonized approach should be a definition of risk, and how it is to be understood relative to different diseases, conditions, patients, products and the trial's design. "Risk assessment in clinical trials should be considered as a dynamic process, and be continuously reviewed and updated during the conduct of the trial," OECD noted.

The basic regulations recommended should be familiar to most anyone who has ever conducted a clinical investigation. In order to mitigate risk, the research should undergo review by an ethics review board, be approved by a regulatory body, report safety incidents to regulators and carry insurance.

But other aspects of the regulations seem geared toward reducing the costs associated with conducting a trial. States should assume the costs of the medicine if it is already approved and used off-label, the report recommends.

Similarly, pharmacies participating in trials should be allowed to repackage and re-label medicinal products without needing to follow good manufacturing practices (GMP) authorization. "Depending on the study objective and protocol, it should be possible to distribute the medicinal product from the shelf, with or without a trial-specific label," the report notes.

Further, products already approved should be allowed to conduct additional clinical trials without needing to generate an investigational medicinal product dossier, and should be allowed to adapt the trial master file and replace the investigator brochure by the summary of product characteristics.

And even the standard risk mitigation methods-insurance, for example-should be conducted in proportion to the risk associated with the trial, OECD said.

The recommendations now move the OECD's member states, which much decide what-if anything-to do with them.

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Categories: OECD

Tags: Orphan Diseases, harmonization, Latest News, research, Rare Diseases, clinical trials

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