Implementing the EU Voluntary Harmonization Procedure for Accelerated Clinical Trial Approval

BY: Franz Buchholzer 11. July 2011 09:42

Traditionally, clinical trial application (CTA) approval in EU member states was subject to national legislation. Consequently, assessment of a CTA that was filed simultaneously in several member states often resulted in varying final decisions and unnecessary delays. Country-specific modifications to the application often occurred due to changes requested by the different competent authorities and ethics committees. In some cases, a clinical trial might be approved in one member state and rejected in another. The entire procedure could be extremely time-consuming and the country-specific modifications might dilute the scientific value of trial results.

In response, the EU Heads of Medicines Agencies (HMA) in 2004 established a Clinical Trials Facilitation Group (CTFG) to coordinate the implementation of the EU clinical trials directive 2001/20 EC across the member states. The directive was guided by calls for harmonization of the assessment of multinational CTAs, as well as by the need to protect clinical trial participants, ensure high-quality research, and bring innovative medicines to patients as quickly as possible. In 2009, the CTFG proposed a Voluntary Harmonization Procedure (VHP) to streamline the assessment of multinational CTAs in order to enlarge the scope of the pilot phase and shorten the timelines.

Despite the fact that all members of the EU (excluding Poland) have accepted the VHP as a valid approach to gaining clinical trial approval, many trial sponsors and CROs have yet to use it. This reluctance is due to a number of factors. One is the perceived risk associated with a new procedure. Lacking familiarity with the process, some sponsors may fear it might not be as effective as promised and may choose to follow established, more commonly used processes. Another factor is the fact that the VHP is free-of-charge: many sponsors believe that non-paid approval procedures are of low value compared to submissions which are subject to a fee.

Although more efficient promotion might have generated wider acceptance of the VHP within the industry, it has proven to be a low-risk and highly beneficial procedure, with more than 50 successful applications completed to date. As more concrete results demonstrate its utility and a greater understanding of its benefits is communicated, more widespread adoption of the VHP can be expected.

The VHP provides two main advantages: time efficiencies and uniformity. Sponsors no longer need to interface individually with different national agencies, repeatedly answering similar questions and losing valuable time. The procedure is fully harmonized and consolidated and all national agencies involved in approving a clinical trial are simultaneously aware of the sponsor’s information, resulting in faster commencement of the trial.

One important benefit of the VHP is that it can be initiated early on, before sponsors have finalized all information about a clinical trial. In such cases, the application form needs to contain detailed, top-line information about the trial, but other information, such as the names of trial sites and/or investigators, can be provided when submitting the country-specific application, following VHP approval.

An additional time-efficient characteristic of the VHP is that once approval has been granted, any modifications to the study protocol requested by the VHP and accepted by the sponsor are incorporated within the procedure, obviating the need to file a protocol amendment. Prior to establishment of the VHP, sponsors wishing to introduce such modifications requested by the agencies of the participating countries during their initial study protocol review could only do so by resubmitting the protocol amendment to each of the concerned agencies.

The VHP procedure allows for incorporation of additional EU countries even after a trial is VHP-approved. In such cases, each additional country may accept the existing VHP approval and allow the sponsor to proceed with the country-specific application, with final approval coming 10 working days after submission of the country-specific dossier. Following the clinical trial approval, additional protocol amendments can be submitted to the VHP Committee for their assessment and approval in a manner similar to the initial approval. The VHP procedure again provides time efficiencies and uniformity in the approval of protocol amendments.

By consolidating multinational CTA activities within a single submission, the VHP procedure offers a streamlined approval process for all technical documentation for every country/agency involved, potentially saving sponsors up to two months’ time in setting up and initiating clinical trials. With the VHP being the CTA approval pathway of the future, sponsors and CROs should consider its use now when planning future pan-European clinical trials.

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