New FDA Program Aims to Develop New Approaches to Clinical Trials, Pharmacovigilance

Posted 15 May 2012 | By Alexander Gaffney, RAC 

A new program announced by the US Food and Drug Administration aims to strengthen global regulatory capacity by working with the World Health Organization (WHO) to support new, innovative approaches to clinical trial designs for vaccine products and postmarketing pharmacovigilance.

"Adequate regulatory oversight throughout the vaccine development life cycle is essential in assuring the safety, purity, and potency of vaccines and other biological," said FDA's Center for Biologics Evaluation and Research (CBER) in a statement in the Federal Register. "With the globalization of markets, the volume of vaccines and biological medicinal products crossing national borders continues to rise, making it even more critical that regulatory knowledge and experience be shared as appropriate to do so, and that global monitoring to ensure product safety be harmonized to the greatest extent possible."

In light of these challenges, both groups are proposing to enter into an agreement in which they will investigate new approaches to designing clinical trials for vaccines.

"In the case of early phase clinical trials, new approaches can more rapidly determine whether novel vaccine candidates are likely to be safe and efficacious, and better approaches to optimizing allocation of study participants between late phase clinical trials and postmarketing safety studies could lead to more rapid access to lifesaving vaccines, while still obtaining the data necessary to ensure vaccine safety," explained CBER.

The project will seek to minimize the number of ineffective candidate vaccines entering into Phase IIb and Phase III clinical trials, identify promising vaccines candidates early on in the development cycle for accelerated testing, establishing "correlates of protection" more quickly and promoting the efficient use of clinical trial resources.

Pharmacovigilance, too, could see new approaches developed under the proposed agreement. FDA said it was particularly concerned about "rare adverse events" not being caught during clinical trials, and said it is "essential to continue monitoring vaccine safety throughout the product life cycle and to obtain and analyze any additional safety information in 'real time.'"

The project hopes to improve how adverse event data is evaluated, the interoperability of global pharmacovigilance systems, approaches to clinical trials in low- and middle-income countries and how social media and mobile communication devices can be used to promote vaccine safety.

The project would also seek to develop a mathematical simulation of a vaccine's development life cycle to better anticipate what constitutes "acceptable vaccine risk."

The proposed agreement between FDA and WHO is scheduled to be signed in June 2012, with work to commence in September 2012.

Read more:

FDA - Cooperative Agreement to Support Innovation in Vaccine Clinical Trial Design and Collaboration: Pharmacovigilance to Advance Global Access to Safe and Effective Vaccines

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