two chances to be a blip

Posted on Wednesday 21 January 2015

It looks as if the idea of Data Transparency has finally become mainstream. Pharmalot is reporting on the report from the Institute of Medicine [Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk]. Johnson & Johnson has signed on to the Yoda Project at Yale [Johnson & Johnson Will Make Clinical Data Available to Outside Researchers]. Add in the NIH commitment to require the use of as it was intended [Honoring Our Promise: Clinical Trial Data Sharing], the EMA’s new policies [EMA opts for trial data transparency], and that makes for an encouraging start for the coming year. But in every one of these moves towards Data Transparency, there’s a question of what can and will be withheld. What is Summary Data? What is Commercially Confidential Information? Who can look at the data? At this point, we can caution and question until we’re blue in the face, but we won’t really know until we actually see what’s released and to whom. So in as much as the idea of Data Transparency is beginning to bloom, the proof that we will actually be able to thoroughly vet and count on any given Randomized Clinical Trial lies in the future as these advertised modes of access become realities.

two chances…

So below, we’re offered two chances to comment on the coming changes in Data Transparency policy – with the Europeans Medicines Agency and the NIH. The last time the EMA asked, many of us responded and they actually changed what they were doing. And I got a note from the main poopah. And this time, I got a personal request to comment [well sort of personal as in "Dear all"]. But my point holds. If there were ever a right time to respond, this is our moment. Same with the NIH. We‘re on their radar now and it’s time to start being a blip. Please click the red underlined links…

Dear all,

Please be aware that we have today launched a public consultation on how the transparency rules of the European Clinical Trial Regulation will be applied in the new clinical trial database.  More information on the consultation is available in our press release and full details and how to submit comments is available on our website, here. Given your expertise and interest in the area of clinical trials and transparency, we would highly value your input into this public consultation.  The deadline for comments is 18 February 2015.

For a brief background:
The European Clinical Trial Regulation aims to create an environment that is favourable to conducting clinical trials in the European Union, with the highest standards of safety for participants. The Regulation transforms the level of information publicly available for each clinical trial carried out in the European Union by requiring transparency on the authorisation, conduct, and results of the trial.  The Regulation will apply to clinical trials that are registered once the Regulation is in operation [not before 28 May 2016]. The key instrument to deal with clinical trials in a transparent way is the new clinical trial portal and database. It will be used for submission and maintenance of clinical trial applications and authorisations within the EU. It will serve as the source of public information on the clinical trial applications assessed, and all clinical trials conducted in the EU. According to the European Regulation, the European Medicines Agency [EMA] is responsible for the development and maintenance of the portal and database, while the authorisation and oversight of clinical trials will remain with the EU Member States.

The document under consultation sets out proposals for the application of the transparency rules of the European Clinical Trial Regulation in the new clinical trial database for stakeholders to review and comment on.  The proposals aim to balance the right of patients and the public to access extensive and timely information on clinical trials, and developers’  and researchers’ need to benefit from investments. This will support the EU as a suitable location for innovative, cutting-edge research and development of medicines. Please note that this public consultation refers only to the practical application of transparency rules for the clinical trial portal and database that is established within the European Clinical Trial Regulation. The European Clinical Trial Regulation is distinct from EMA’s policy on the publication of clinical data, which has already come into force (January 2015). We look forward to receiving your feedback [here].

Many thanks and kind regards,

Commenting on the NPRM and proposed NIH Policy
The public may comment on any aspect of the NPRM or proposed NIH Policy. Written comments on the NPRM should be submitted to docket number NIH-2011-0003. Commenters are asked to indicate the specific section of the NPRM to which each comment refers. Alternatively, written comments on the proposed NIH Policy should be submitted electronically to the Office of Clinical Research and Bioethics Policy, Office of Science Policy, NIH, via email at:
mail: at 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, or by fax: at 301-496-9839. The agency will consider all comments in preparing the final rule and final NIH Policy.

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