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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline

« IGFR Therapies Wipe Out. And They're Not Alone. | Main | Another Prospective Alzheimer's Trial »

October 11, 2012

GSK Opens Up Its Trial Data

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Posted by Derek

GlaxoSmithKline took an unusual step today: they announced that they're opening up clinical trial data:

"GSK is fully committed to sharing information about its clinical trials. It posts summary information about each trial it begins and shares the summary results of all of its clinical trials – whether positive or negative – on a website accessible to all. Today this website includes almost 4,500 clinical trial result summaries and receives an average of almost 10,000 visitors each month. The company has also committed to seek publication of the results of all of its clinical trials that evaluate its medicines – regardless of what the results say – to peer-reviewed scientific journals.

Expanding further on its commitments to openness and transparency, GSK also announced today that the company will create a system that will enable researchers to access the detailed anonymised patient-level data that sit behind the results of clinical trials of its approved medicines and discontinued investigational medicines. To ensure that this information will be used for valid scientific endeavour, researchers will submit requests which will be reviewed for scientific merit by an independent panel of experts and, where approved, access will be granted via a secure web site. This will enable researchers to examine the data more closely or to combine data from different studies in order to conduct further research, to learn more about how medicines work in different patient populations and to help optimise the use of medicines with the aim of improving patient care."

I very much applaud this step, and I very much hope that the rest of the industry follows suit. We're getting a lot of flack - and we deserve it - for the way that we handle clinical trial data, with accusations of cherry-picking, data-burying, and all the associated sins. (Ben Goldacre has a book out on the drug industry, which I'm going to read more of before posting on, and he's taken the industry to task on this very point in it). The only cure for this will be to open the books as much as possible - saying "Trust us" will not cut it, and (unfortunately), neither will trying to say "None of your business".

Here's a look at this idea from John Carroll at FierceBiotech. So, Pfizer, Novartis, Merck, all the rest of you? What's the response?

Comments (14) + TrackBacks (0) | Category: Clinical Trials | Why Everyone Loves Us


COMMENTS

1. MAZ on October 11, 2012 11:41 AM writes...

kudos!

Permalink to Comment

2. Tim on October 11, 2012 12:19 PM writes...

Ben Goldacre sounds skeptical: "@bengoldacre: Odd to see promises of transparency from GSK reported with uncritical fanfare. GSK make and break promises. More later"

[http://twitter.com/bengoldacre/status/256315746261561344]

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3. Curious Wavefunction on October 11, 2012 12:28 PM writes...

Will all the complete raw data be available? Or would it be like the "information" we can access through the FOIA in which massive sections can be redacted?

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4. ddddddd on October 11, 2012 12:43 PM writes...

A step in the right direction. Thanks for posting this, Derek.

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5. BenefitOftheDoubt on October 11, 2012 1:22 PM writes...

I'm normally quite cynical about these types of maneuvers by GSK but there is an interesting comment about the impact of GSK opening up their malaria compounds by "MatTodd" (one of the last) on this piece:
http://www.guardian.co.uk/society/2012/oct/11/glaxosmithkline-clinical-trials-data
I've checked the name and the comment does appear to come from a genuine researcher. If this data does prove useful, then the leopard may well and truly have changed its spots. I remain skeptical but am willing to be convinced of their good intentions.

Permalink to Comment

6. terri on October 11, 2012 3:06 PM writes...

...personally, I think it's too little too late. And, besides, how do we know for SURE we're seeing EVERYthing?? Pfizer shook my confidence in big pharma 5 years ago. I took two regimens of Chantix and endured two, long, PAINful hospital stays plus a psyche unit.

Never before that nightmare, did I have any reason to question ANYbody's integrity. I TRUSTED my doctor, big pharma, my pharmacist and esPECIALLY FDA!!! I was a fool. A middle-aged, gullible, NAIVE, fool.

I trust NO ONE anymore involved in ANY of the medical entities. I learned the hard and PAINful way...that just because someone SAYS a drug is safe...it is. No, my horrendous experience w/Chantix rocked me to the core. They're all liars!! Greedy liars. We're just a number folks!! The sooner we realize that...the better!!

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7. Mad Med Chemist on October 11, 2012 3:29 PM writes...

In an ideal world, this is a great idea (yay - more data = better results right?). In the real world, this means more under-powered post-hoc meta-analysis without controls leading to conflicting data and/or pseudo-safety signals and physician confusion (i.e., poorer patient outcomes). All it takes is one ambitious, misguided (or delusional) academic looking to make a name for themselves and whole treatment paradigms come under needless fire (e.g., vaccines). I can understand some of the conflict in the CNS space where the disease models are vague/ambiguous and struggle with reproducability, but by and large the industry does a good job in other spaces (assuming no out and out malfeasance on the part of the researchers).

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8. johnnyboy on October 11, 2012 5:57 PM writes...

@3: You're kidding, right ? Have you ever seen the amount of raw data associated with a clinical trial ?

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9. Colonel Boris on October 11, 2012 6:00 PM writes...

@ No. 5: I can assure you that Mat Todd is a real person (worked in the same department for a few years) and an excellent advocate of open-source science.

Permalink to Comment

10. Curious Wavefunction on October 11, 2012 6:21 PM writes...

@8: When I say "raw" I mean "original". In fact one might have a sensible discussion about how the very process of whittling down raw data and presenting it might introduce certain biases.

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11. Mark Murcko on October 11, 2012 6:46 PM writes...

Actually, I think in the future (2030?) all the raw data will be put out into the public domain for any competent statistician to analyze before the FDA approves a new medicine and "the public" will have a defined period of time to comment upon the data. One can imagine an intermediate step (2025?) where only a set of perhaps a dozen "approved" individuals get access to the data. But that won't last; it will end up being open to anyone. There will be bounties for individuals who identify problems in the data or point out possible side effects that are later verified. Cheers / Mark

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12. petros on October 12, 2012 7:07 AM writes...

It's a potentially valuable development but their CT database currently lacks any information on many discontinued compounds.

And if you look how little data is available on many of the compounds supplied to the NCATS initiative there is clearly a long way to go

Permalink to Comment

13. Network Pharmacology Blog on October 12, 2012 4:41 PM writes...

If this initiative leads to data for a range of trials being available this could be fertile information for future drug discovery but only with a change of approach.

The obvious place relates to safety and side-effect where specific similar issues are observed in different trials. By looking at the binding habits of differing compounds with, for instance the same side-effects, at lower binding affinity levels and then comparing these to the important patterns of proteins in the proteomic systems of relevance.

This trend of system level impact can be created much more readily if the clinical data is available and therefore this looks a potentially important step.

Hopefully it is the correct data but it will also require the correct approach with the correct tools.

Permalink to Comment

14. InfMP on October 15, 2012 9:03 PM writes...

hate to say it, but how about vertex. class action lawsuit!

Permalink to Comment

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