Synexus strides forward with "pioneering" patient recruitment model

By Kirsty Barnes

- Last updated on GMT

Related tags Synexus Clinical trial

Synexus has been making business strides of late, thanks to its
"innovative" model for patient recruitment and monitoring
for late stage clinical trials.

The UK-based company has restructured its Global Client Services Division due to " significantly increased demand " for its services.

As part of this, Claire Jackson has been promoted to senior feasibility manager with overall responsibility for the Global Feasibility and Proposals team; Rachael Buck has been promoted to senior project manager with responsibility for one of the two Global Project Management teams, with the second team leader to be announced shortly; and Wendy Baird has been promoted to global contracts manager.

They will all report to Jane Restorick, executive vice president of Global Client Services, and will work with the Synexus country managers in the UK, Bulgaria, Hungary, India, Poland and South Africa.

In the final quarter of 2007, Synexus was awarded contracts to recruit for and run 12 late-stage clinical trials across the world, totalling more than £20m worth of new business, from some of the world's major pharmaceutical companies, including GSK, Pfizer, Sanofi-Aventis, MSD, Boehringer Ingelheim, Janssen Cilag and Reckitt Benckiser.

The trials range in duration from just three months to over five years and will ultimately involve more than 8,000 patients from the UK, India, South Africa and Eastern Europe for studies investigating such conditions as: osteoporosis, osteoarthritis, sexual dysfunction, diabetes and insomnia.

The firm, which specialises in late-stage clinical trials, attributes the increased demand for its services to its " unique " hub-site model, which it said it is " pioneering " within the industry.

It was developed to address the bottleneck in drug development, which the CRO says is largely contributed to by the "inadequate" traditional method of recruiting patients.

Traditionally, biopharma companies and CROs have organised trials by contracting with large numbers of GPs, individual primary care physicians and hospital consultants who conduct the trials on a part-time basis with small groups of patients (on average five) in their surgeries or hospitals.

According to Synexus, this is both costly and difficult to co-ordinate and manage as each GP or consultant will report separately and requires individual monitoring and contract arrangements.

" It can also be very, very difficult to enforce timelines as it is reliant on a large number of investigators setting up and processing their patients, but only when time permits ," said the firm.

" With studies involving 20,000 plus patients, is enormously expensive and wholly impractical ".

Synexus' model is centred around a network of 14 hub sites across the world - in the UK, Poland, Hungary, Bulgaria, South Africa and India - from where it can handle thousands of patients each, as each has access to between 500,000 and three million potential patients.

The firm said that the benefit of its model is that "it ensures the same high standard of good clinical practice (GCP) at any Synexus site anywhere in the world and drastically reduces set-up and monitoring costs - often by a factor of 10 ".

According to the company, cost is becoming increasingly important as companies can spend millions before recruiting a single patient.

Synexus pointed to the example of one large pharma firm that said it spent $17m on opening sites that did not recruit a single patient; $35,000 on average on finding and contracting with a single investigator; and that 60 per cent of investigators who sign up will recruit one or less patients to the study.

Additionally, the pharma company said that typically 75 per cent of sites are new to the company in any study and on average there are around five patients recruited per site.

In comparison, Synexus said its hub-site model is designed so that there is "just one contract which can cover up to fourteen sites and the cost of monitoring a handful of sites, with thousands of patients, falls dramatically...

The economies of scale that exist by comparison are immediately recognisable ".

As an example of the success that this model is achieving within the industry, Synexus recently heralded the fact that it has achieved a new record for an organisation which recruits and runs clinical trials, with more than 10,000 patients currently enrolled in late stage clinical trials at its 14 hub sites.

Michael Fort, company CEO said: " We are hoping by next year we will have doubled this number as we increase the capacity of our existing hub sites and open new sites in the US and Eastern Europe ". "

This expansion is being driven from industry which wants to reduce costs and professionalise the recruitment and running of late stage clinical trials ."

Meanwhile, Synexus has also recently announced that it is extending the scope of its studies to include Phase IV (post-marketing surveillance trials) trials following the recent running of successful Phase IV studies for major pharmaceutical companies.

Increasingly regulatory authorities are demanding that drug firms conduct Phase IV trials to monitor their use in other populations not covered in the original trials; the effects of drug interaction; and to detect any rare or long-term side effects.

However, Phase IV trials have become increasingly expensive and slow and many doctors are deterred from participating in such trials due to time pressures and limited opportunities to recruit patients.

Synexus said it uses its hub-site model to faster and more effectively enrol patients in Phase IV studies and " dramatically " reduce costs.

Chris Hannigan, executive vice president of Synexus said: " 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 ".

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