Synexus' new Phase IV model increases doctor participation whilst reducing time and costs

15 May 2008

Synexus's new Phase IV clinical trial model increases number of doctors involved whilst cutting costs and time

Manchester, England: Synexus – the world’s largest multi-national company specialising in the recruitment and running of late-stage clinical trials – is extending the scope of its studies to include Phase IV trials following the recent running of successful Phase IV studies for major pharmaceutical companies.

Phase IV trials (Post Marketing Surveillance Trials) allow pharma to monitor the wider use of a new medicine with both patients and doctors after the medicine has received its license.

Increasingly regulatory authorities are demanding Phase IV trials to look at use in other populations not covered in the original trials – children and pregnant women – the effects of drug interaction and to detect any rare or long-term side effects.

Phase IV trials have become increasingly expensive and slow. 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.

Synexus with its clients has developed a model which 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.

While the model varies according to the therapy area and the objectives of the study it works as follows.

  • Synexus approaches primary care doctors around its 14 hub sites – in the UK, Poland, Hungary, Bulgaria, South Africa and India.
  • Those doctors who are interested are provided with an in-depth briefing on the medicine and the study.
  • The selected doctors then write to all the eligible patients in their practice –Synexus® can provide help in doing this.
  • Responses from patients are then channeled to Synexus® who undertake the necessary screening procedures.
  • Each patient’s doctor is informed of their enrolment. The doctor provides a report based on the medical history of each patient, an SDV (source verification document) for an agreed fee.
  • As the patients progress doctors are kept up to date through regular briefings.
  • On conclusion of the trial, the doctor receives an in-depth briefing on the results relating to their patients as well as on the whole study.

Chris Hannigan, Executive Vice President of Synexus, commented: “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 over - crowded diary.”

This method has strong appeal to busy doctors, and in the phase IV trials carried out by Synexus it leads to a significant rise in the number of doctors involved.

As well as being more effective in enrolling patients the Synexus model speeds up the enrolment process and dramatically reduces costs.

Cost is increasingly important as companies can spend millions before recruiting a single patient. One large pharma stated that

  • $17 million was spent on opening sites that did not recruit a single patient.
  • $35,000 is spent on average on finding and contracting with a single investigator.
  • 60% of sites recruit one patient or less.
  • Average five patients per site.
  • 75% of sites are new to the company in any study.

 The Synexus network of hub sites can handle thousands of patients each, as each has access to between 500,000 and three million potential patients. The economies of scale that exist by comparison are immediately recognisable.

  • Faster and wider recruitment of doctors.
  • One point of contact; one contract; one data collection point. Resulting in a considerable reduction in costs.
  • Service Quality Management Systems (SQMS) is implemented throughout and all data collection is checked internally prior to the client’s monitor checking the output.
  • Synexus undertakes a comprehensive feasibility assessment before quoting to ensure that it can meet the targets within the timeframe and understands the patient profile and the resources needed to recruit the particular patients.
  • Better patient retention.