Trial regs and CRO management are challenges for vaccine developers, study says

Running vaccine trials in developing countries is a significant challenge due to complex regulations and CRO management difficulties according to new analysis.

The study – published in the current edition of the journal Vaccine X – looked at approaches to clinical development vaccine developers in emerging countries are using. The overall aim is to identify industry needs in terms of organizational development and training.

The authors quizzed members of the Developing Countries Vaccine Manufacturers Network (DCVMN) – a voluntary alliance of health organizations and vaccine manufacturers – many of which make vaccines that hold World Health Organization (WHO) Prequalification status.

One interesting finding is that respondents were more likely to trial candidate vaccines in multiple countries if they employ more than 10 people in their clinical development teams.

Partly this may be due to difficulties working with local suppliers according to the authors, who wrote “Conducting clinical trials in foreign countries may require additional resources to overcoming many barriers such as language barriers, difficulties in establishing relations with local partners, complexity of clinical trial documentation, logistics limitations, and knowledge of local regulations and requirements.”

Vendor management

The study also indicated the important role the contracting sector plays in some aspects - but not all - of vaccine development in emerging economies.

“The great majority of respondents outsourced one or more clinical trial management activities to CROs, such as selection of study sites, monitoring and data management [...] clinical data management and statistical analyses are clinical activities outsourced by around half of the respondents.”

In contrast, the development of clinical trial protocols, investigator brochure and clinical reports are mostly performed in house.

With this in mind, the authors suggest the vaccines industry would benefit from a more structured approach to vendor management, particularly in relation to regulatory compliance.

“Some areas for improvement identified by this survey include the standard process of selecting and managing CROs, as well as verifying through audits whether CROs have a quality system in place. While the majority of respondents is satisfied with the performances of the CROs employed, some believe that Sponsor’s supervision is required for CROs to comply with ICH-GCP.”

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