RegeneRx seeks CRO to speed up patient recruitment

By Kirsty Barnes

- Last updated on GMT

Related tags: Patient recruitment, Clinical trial, Contract research organization

Falling foul of the patient recruitment problems that are plaguing
the industry, RegeneRx Biopharmaceuticals has recruited an
undisclosed contract research organisation (CRO) to help it with
the mountainous task.

The CRO will now recruit patients for the biopharma firm's two double-blind, placebo-controlled, Phase II clinical trials planned for the US for a wound healing drug and a chronic pressure ulcer treatment - the latter being the more problematic of the two trials to recruit for.

RegeneRx has faith in its new partner and said it expects full enrollment will now be completed by the second quarter of 2007 - three months later than first planned.

The CRO has been given permission to increase the number of participating investigational sites in order to achieve this.

RegeneRx said it finally enlisted the CRO's help after "patient enrollment was slower than originally anticipated."

This is not surprising. Patient recruitment is now consuming thirty per cent of clinical trial time - more time than any other clinical trial activity - and almost half of all trial delays result from patient recruitment problems.

These delays are costing drug companies over half a million dollars for specialty products and more than $8m (€6.7m) for blockbuster brands in lost sales and are also causing the cost of running clinical trials to skyrocket.

In the US various tactics are already often used in the fight to attract patients, such as incentive payments for both patients and recruiting clinicians, however, these practices are frowned upon by many and leave the system open to fraud.

In light of the current patient recruitment shortage, there is even now talk of re-allowing prisoners to be used as part of drug trials - a practice that was banned in the 1970s after reports of abuse - again this idea has its critics.

In the meantime, many biopharma firms, particularly those with little in-house infrastructure - are turning to external partners, such as CROs, to help them manage some or all aspects of their clinical trials.

These specialists usually succeed in using their contacts and experience to speed up recruitment time, freeing up the precious resources of trial sponsors and ultimately getting trials kick started as soon as possible.

It has been reported that companies using a CRO are able to slash clinical trial times by an average of 30 per cent.

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