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UK govt asked to make trials more transparent

18 September 2013 | Regulatory | By BioSpectrum Bureau

Singapore: The United Kingdom Science and Technology Committee has described the current lack of transparency of many clinical trials as "unacceptable", adding that it has not been impressed with Government efforts to tackle the problem to date.

Committee chair Mr Andrew Miller, said that, "Many of the trials taking place today are unregistered and unpublished, meaning that the information that they generate remains invisible to both the scientific community and the public. This is unacceptable, undermining public trust, slowing the pace of medical advancement and potentially putting patients at risk."

He added, "We consider that all trials conducted on NHS treatments-and all other trials receiving public funding-should be prospectively registered and their results published in a scientific journal. While the focus should be on implementing this change for future trials, the Government must also do what it can to ensure that historic trials are registered and published, particularly where they have been publically funded."

The committee also asked the Government to take steps to facilitate greater sharing of the raw data generated during a trial.

Mr Miller further said, "We are not in favour of the uncontrolled release of potentially sensitive patient data, even in anonymised form. However, raw trial data is currently underutilised and could be of significant scientific value if shared in a responsible and controlled way, with the knowledge and consent of patients."

Unfortunately, the UK governance landscape means that researchers can struggle to get trials up and running in this country. Recruiting participants can also be a challenge, even though many patients welcome the opportunity to take part in a trial.These problems are not insurmountable and we are confident that the Government is aware of the need to resolve them. But it is now time for the Government to translate its words into effective action," Mr. Miller stated.

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