Synexus has reportedted that it 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.
Following the issuance of FDA’s draft guidance, pharmaceutical companies are gearing up for an increase in running late phase cancer vaccine trials.
The draft guidance stated that studies for cancer vaccines should enroll patients with no evidence of residual disease, which means that healthy people have to be recruited.
Michael Fort, chief executive at Synexus, said: The model Synexus uses across its 17 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 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 an average of 210 patients compared to 8 at other sites.”
The company said that with 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. MichaelFort stressed the need to be involved at the earliest stage so that the feasibility study can identify the best recruitment programme in each country.