Cmed and Tessella join forces on adaptive trials
pharmafile | May 11, 2009 | News story | Research and Development |Â Â Cmed, digiÂ
UK contract research organisation Cmed Research has bolstered its ability to carry out adaptive clinical trials on behalf of clients via a collaboration with healthcare IT company Tessella.
The success rates for drugs in clinical development are declining with the success rate for a drug entering phase I and progressing to actual launch falling by 23% between 2001 and 2006, while the time taken to take compounds from phase I to III has been increasing.
One solution proffered to offset this decline is the adoption of adaptive trials, which allow information gathered during the initial stages of a trial to be used to modify later stages. That can have a number of benefits, such as allowing more doses to be included in a phase II dose-ranging study, without significantly increasing the number of study participants or timeline required.
Cmed and Tessella both offer software to help carry out adaptive studies, and will now work more closely together to ensure that their respective packages work effectively alongside each other.
Cmed's flagship software is Timaeus, which is used to capture and organise clinical data. Timaeus has become popular for adaptive trials because it can capture, manage and report data in near real-time.
Meanwhile, Tessella's main interest in the adaptive trials area lies in its FATES package, which can be used to analyse the data coming from studies and advise how the design can be tweaked to improve the chances of a successful outcome.
Timaeus real-time capability is important "because it minimises the delay in the availability of response data and therefore adaptation of the trial," said Tom Parke, head of clinical technologies at Tessella.
That aside, adaptive designs still account for only a tiny fraction of the total number of trial protocols undertaken each year worldwide.
Along with concerns about regulatory acceptance of adaptive trials and a lack of understanding about the techniques required to carry them out, rapid access to clinical data is one of the main obstacles to the widespread adoption of the approach, according to a recently published report from Perceptive Informatics.
Perceptive, which is a unit of international CRO Parexel, believes formal guidance from the US Food and Drug Administration and other regulatory bodies would give the use of adaptive trials a major boost.
"Formal FDA guidance on adaptive trials implementation is expected later this year and should help to alleviate regulatory acceptance concerns," commented Bill Byrom, senior director of product strategy at Perceptive.
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