Re: Has PATH done its work?

[Trisha Greenhalgh]

Good idea, and WHAT a job well done.

Prof Trisha Greenhalgh

Global Health, Policy and Innovation Unit
Centre for Primary Care and Public Health
Blizard Institute
Barts and The London School of Medicine and Dentistry
Yvonne Carter Building
58 Turner Street
London E1 2AB
t : 020 7882 7325 (PA) or 7326 (dir line)
f : 020 7882 2552
e: p.gree...@qmul.ac.uk
Twitter @trishgreenhalgh 

From: Richard Lehman <drricha...@gmail.com>
Reply-To: <pathtodata...@googlegroups.com>
Date: Thu, 28 Mar 2013 06:51:03 -0700 (PDT)
To: <pathtodata...@googlegroups.com>
Subject: Has PATH done its work?

Dear All,

I set up PATH as an open Google group in November 2011 to bring together all the people I knew - mostly in the UK and USA - who might want to join together in the fight for access to all data from human trials. Although this had been identified as a moral imperative for two decades, notably by Iain Chalmers, at that point it seemed as if we were as far as ever from making it a reality. So I nervously set up a Google group in response to suggestions from Ben Goldacre and Trish Greenhalgh.

Now, thanks to the efforts of many in this group, the argument is won. The Alltrials campaign has been a runaway success in the UK and is garnering increasing international support. Nobody within industry is coming up with any plausible arguments to favour data secrecy, except those based on their own commercial interests. Since this happened, PATH has gone quiet. That is because the real action is happening elsewhere.

The fight is now going be be a high-level war of attrition lasting many years. We all need to keep active and positive if the new dawn is going to turn into a real transformation within medicine. But I think PATH - an open Google group with all its glitches - may now have served its purpose.

So I suggest we close down PATH and replace it with something better. Any ideas?

Richard

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[Matthew E]

Quick (?) question: Can people trust that the results of any ongoing study registered at clinicaltrials.gov will be published in a timely manner?  I'm guessing someone still on this list is familiar with the regulations and knows the answer.

In other words, can you help me determine whether MedImmune LLC (which is the "Responsible Party") has committed to submit to clinicaltrials.gov the "basic results" as defined at  https://clinicaltrials.gov/ct2/info/results, on the time frame described there, for the MEDI-551 MedImmune trial - NCT02200770?  I think that's the case but I'm finding the regulations quite confusing.  The study is ongoing, but started in 2015.  I find it's hard to figure out what regulations apply to this study.

Actual Study Start Date:	January 6, 2015
Estimated Study Completion Date:	July 26, 2021
Estimated Primary Completion Date:	July 29, 2019

I've read https://clinicaltrials.gov/ct2/info/results and similar pages and still can't figure it out. 

I think participation in the trial is a great idea provided I'm confident that there will be publication of all clinical trial results, regardless of outcome or significance of findings.

As I understand it, the trial has been "registered prospectively" when it was registered at clinicaltrials.gov.  My understanding comes from here:

http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html 

I think MedImmune will need to follow the instructions here: https://clinicaltrials.gov/ct2/manage-recs/how-report .  But I'm not sure. And the study is likely life altering for the participants.

I think the "Responsible Party", "MedImmune LLC" risks Penalties if they aren't followed:

FDAAA 801 establishes penalties for Responsible Parties who fail to comply with results submission requirements. Penalties include civil monetary penalties and, for federally funded studies, the withholding of grant funds.

I don't know what those penalties are or if they apply to the study.

I've contacted the PI, Bruce Cree, and he says study protocol prevents him from committing to anything.  I contacted register{at}clinicaltrials.gov and they didn't answer either, saying "It is up to the Responsible Party to determine whether a study is required to submit results under the law FDAAA 801 (an "applicable clinical trial")."

I think I can be confident that AstraZeneca (which owns MedImmune) can be held to its own Code of Conduct which says: "Compliance with relevant laws and regulations governing research and development is a minimum baseline and underpins AstraZeneca’s own standards." (source: http://archive.is/4iXb2).   (Even though the last post to this list re. GSK wrongdoing was breathtaking.  As was https://www.regulations.gov/contentStreamer?documentId=NIH-2011-0003-0884&attachmentNumber=1&contentType=pdf,  -- PhRMA-CT-gov_NPRM_Comments-3-23-15-final.pdf )
 

-Matthew

[Tom Jefferson]

Matthew, I'll answer your question in a way that for me is 100% correct but may raise a lot of backs in this discussion.

Registers have only one function that is somewhere around 95% reliable: they tell you there is an icerberg ahead. They do not tell you the size, content and shape of the submerged part in a reliable and uptodate manner. They do not pick up submerged icerbergs either, by definition (i.e. all recent trials are registered is a nice story - we have recent evidence of that).

For the part above the waterline, they are better at times than publications (that is not saying much) but there are no methods and overall narrative.

I am happy to expand at the CRIT meeting which I am joining on Skype for the morning panel of the first day.

The policing of the FDAA 2007 is lackadaisical and the maxim that he hold the data holds the high ground applies to registers as well as publications.

Best wishes,

Tom.

Dr Tom Jefferson

Senior Associate Tutor

University of Oxford

Oxford OX2 6GG

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