Pharmaceutical companies gearing up for cancer vaccine trials following FDA draft guidance

Pharmaceutical companies are gearing up for an increase in running late phase cancer vaccine trials following draft guidance issued by the FDA last week.

The draft guidance stated that studies for cancer vaccines should “enroll patients with no evidence of residual disease” which means that healthy people have to be recruited.

Synexus, the world's largest multi-national company focused on the recruitment and running of clinical trials at its own Dedicated Research Centres, has already run several large late phase clinical trials for cancer vaccines and has a tried and tested recruitment methodology which rapidly finds and randomises thousands of healthy people.

Concern has been expressed that cancer vaccine trials, which cannot recruit through the usual investigator channels, will take significantly longer than is the case today, exacerbating the problems of cancer trials failing to recruit their target numbers, being notoriously late to complete and burdening the sponsor with mounting costs.

Michael Fort, Synexus’ chief executive, says the model Synexus uses across its 17-strong research centre network, will not only achieve the recruitment targets that sponsors face with their cancer vaccine trials when they reach Phases II and III, but will also put a ceiling on costs: “We have considerable expertise when it comes to finding healthy trial participants. Our ability to recruit and randomise large numbers of subjects, worldwide, puts Synexus in a strong position to deliver these numbers quickly and cost effectively.”

Fort goes on to cite the recent prostate study Synexus conducted as an example of what the company regularly achieves: “We devised a direct mail and advertising campaign targeting a million candidates for this trial and within 10 months had conducted nearly fifty thousand telephone screenings leading to forty four thousand PSA tests and two thousand biopsies. We randomised over fifteen hundred patients for this trial at 7 centres. Each Synexus centre enrolled more than any other site and far more quickly.”

With dedicated research centres across the UK, CEE, South Africa and India, Synexus can recruit a wide variety of patients according to the demands of the protocol. Fort stressed the need to be involved at the earliest stage so that the feasibility study can identify the best recruitment programme in each country.