Patient recruitment and clinical trial management specialist Synexus has expanded its scope to Phase IV post-marketing surveillance trials.

The UK-based company says it has developed with its clients a model that “involves more primary care doctors and their patients in Phase IV trials without the doctor having to actually run the trial, whilst providing each doctor with better information on the performance of the trial”.

As Synexus points out, regulatory authorities are increasingly demanding Phase IV clinical trials to look at use of drugs in populations not covered by the original trials (e.g., children and pregnant women), examine the effects of drug-drug interactions and detect any rare or long-term side-effects.

At the same time, Phase IV studies “have become increasingly expensive and slow”, the company says. “Many do not achieve the objective of wide usage, as few primary care doctors want to become involved in clinical trials due to time pressures. Furthermore, those doctors who do become involved are limited to recruiting patients on an opportunistic basis, which takes a long time.”

With the Synexus model, the company approaches primary care doctors around its 14 hub sites in the UK, Poland, Hungary, Bulgaria, South Africa and India. Interested doctors are given an in-depth briefing on the relevant medicine and study. The selected doctors then write – with help from Synexus, if needed – to all the eligible patients in their practice.

Responses from patients are channelled to Synexus, which conducts the necessary screening procedures. Each patient’s doctor is informed of their enrolment and the doctor provides a source verification document for an agreed fee.

As the patients progress through the trial, doctors are kept up-to-date through regular briefings. Once the study is completed, they receive an in-depth briefing on the results for their own patients and the study as a whole.

“We have put together a model where the patient’s GP receives more information on the trial than ever before, without having to squeeze trial appointments into an already overcrowded diary,” commented Chris Hannigan, executive vice president of Synexus.

In the Phase IV trials already carried out by Synexus, the new model led to a significant rise in the number of doctors involved, the company said. As well as enabling more effective patient enrolment, the Synexus model speeds up the enrolment process and dramatically reduces costs, the company added.