Latest Developments in Clinical Trial Transparency



Gerald Clarke
07/02/2013

Large industries are occasionally regarded as slow to change with enormous effort required to overcome this inertia. The pharmaceutical industry and associated regulators appear to be defying this expectation as the campaign for better access to clinical trial data rapidly built up momentum and has achieved impressive results that many may have thought would be impossible. In the last week, the EMA has released its draft policy on publication and access to clinical trial data and the BMA has voted to make non-publication of clinical trial data clinical misconduct.

At the Annual Representative Meeting of the British Medical Association (BMA), a motion was tabled and agreed on which has profound implications for clinical research being undertaken in the UK. The motion states that:

“i) Selective non-publication of unflattering clinical trial data is research misconduct.

ii) Registered medical practitioners who give grounds to believe they have been involved in such conduct should have their fitness to practise assessed by the GMC”

This uncompromising motion lays out clearly the feeling among doctors that this problem is serious enough to warrant fitness to practice proceedings which can result in (depending on the severity of the infraction) a doctor being struck off. Belfast Medical student David Carroll said “the next generation will look back on this issue and be astonished that we ever let it happen in the first place.”

Just two days previously, the EMA laid out its draft policy on the publishing of clinical trial data. The draft separates clinical trial data into 3 categories which will determine what sort of access there will be provided:

Category 1- Commercially Confidential Information

“This applies to information such as details of the investigational medicinal product itself, some in vitro studies, or bioanalytical data characterising the product”. This information will not be freely available to access in order to protect commercially confidential information.

Category 2- Open Access

This is information for which protection of personal data is not a concern. It includes all data where there is no personal information included or the information has been de-identified. This data will be freely available for download in an open source fashion from the EMA website.

Category 3 – Controlled Access

This is “raw CT data” and includes all data where there may be a PPD concern. Data which falls into this category can be protected in two ways; the first is de-identification of the data which protects the patient from identification. The second way is through the control of access to these data to people who meet certain requirements which should protect the data from being used for an unsuitable reason.

This draft policy is in open consultation until 30thSeptember and it will go into force next year.

The transparency lobby has had some truly dramatic results so far and if it can maintain momentum, there doesn’t appear to be anything that can stop it.

 

What do you think about these stories? How do you think transparency will change clinical trial practise? Leave a comment below