Is YODA-enabled clinical data-transparency more than smart externalization of clinical data-mining & analysis?

The day started with a news item on Xconomy declaring "J&JOpens Data Vault to Yale, in ‘Unprecedented’ Transparency Move" - Surely an important development on something that's been propounded for long - below is my comment on this piece;

---------------------------------------------------------------------------------------------

Way back in March 2008 a fellow member initiated a discussion topic titled ”Radical Transparency for Drug Safety?” on Pharmaceutical Discussion Group that I manage. The brief engagement that this topic generated ended up identifying the following as ‘key aspects that need to be addressed’ before radical transparency becomes acceptable to pharma;

• Enabling climate (safe harbor) &
• Some incentivization

Well, it appears Yale cracked this code, of de-risked data-sharing after beta-testing it on rhBMP-2 Project based on Medtronic’s data-sharing, well enough to get J&J aboard this transparency express.

A brief read of the Data Use Agreement of the rhBMP-2 project shows what emboldened, motivated J&J with agreeing to share all its data publicly. Below is a list of clauses within the data use agreement broadly catagorized into the key aspects stated above;

Safe Harbor
Reproduced Text in “quotes”

Section 2.3 - No Direct Identifiers

“The Data will not include any direct personal identifiers ofthe study subjects to whom the information relates, nor will it identify which clinical investigators or sites contributed the data for a particular subject. Within the Data, subjects and investigators are identified by unique identification numbers, and User will not have access to the keys that relate the identification numbers to the identities of the subjects or investigators”

Section 5 - Confidentiality of Data

Across sub-sections 5.1 (obligations of Confidentiality) through to 5.4 (Survival of Obligations)

Section 6 - Subject Protection

“The Data may contain certain information that can be used by itself or in combination with other available information to identify a specific study subject (“Study Subject Personal Data”)”

This section is detailed further through sub-sections/ clauses 6.1 (no re-identification) through to 6.4 (safeguards)

Section 8 – Publications

Prevents user sharing any ‘redacted portions’ of the data fro being referred in any publication.

To the credit of Medtronic & YODA though section 6.3 (Non-Disclosure) allows user to share study subject personal data with the “regulatory authorities, upon lawful request by such authority” – It will be interesting though if a similar openness would be retained in the J&J data use agreement, given the much larger data set & hence greater regulatory implication.

Incentivization
Reproduced Text in “quotes”

Section 7 - Reporting and Use of Results

Obligates user to share all data generated from the analysis/ reserach into the sponsor data with YODA and the sponsor. Further YODA retains the right to make this report public (or not…)

Section 9 - Inventions

“In the event that User utilizes the Data to develop any inventions or discoveries, whether patentable or not (“Inventions”), User will assign to Medtronic all proprietary interests in said Inventions and in the event that User is statutorily prohibited from assigning its interest, User will grant, or ensure that the inventor grants, to Medtronic a fully paid, perpetual, worldwide, exclusive, royalty-free irrevocable transferable license for all purposes, including sub license and assignment to each such Invention without further consideration. User will cooperate with Medtronic to ensure execution and delivery of all documentation that Medtronic reasonably deems necessary to perfect Medtronic’s rights in the Inventions.”

The sheer scope of the section 9 along with the safe harbor provisions listed above makes this exercise come across more as externalization of clinical data-mining & analysis by the sponsor organization – I have no reason to believe J&J will have it any different except that the safe-harbor provisions may be more detailed, as mentioned above.

Finally, the one unstated intent of any pharma opening up its own data banks is to build pressure on the other peers and thus have insight into competitor clinical data that till date eluded them.

All said, it’s great to see transparency starting to be practiced rather than just debated about & hopefully this’ll give pharmaceutical research a chance to impact lives better than it could before.

More power to radical transparency.

Will the Indian Mobile makers pay a price for the judicial ambiguity (& their own..) on 'Essential Patents' & FRAND terms?

In his characteristic & incisive style, 'Spicy IP' Prashant Reddy unravels for debate, the ongoing litigation between Ericsson & Micromax Informatics Ltd. after Ericsson sued Micromax (and Mercury Electronics Ltd.) a few months ago for allegedly infringing 8 of its telecom patents for a range of wireless technologies, including 3G, AMR and Edge - read the artcile here @ http://spicyipindia.blogspot.in/2013/05/the-ericsson-micromax-patent-litigation.html 

Looking at the haste in which the Delhi High Court granted an ex-parte interim injunction against Micromax, I cannot but agree with the writer's initial assessment that Indian regulatory apparatus & companies are not geared up for fighting complex & strategic IP litigations.

I however don't share Prashant's (rather gloomy) view that "it is unlikely they (Indian companies) will take the extra-effort to counter-attack Ericsson in a bid to pre-empt future action by other patentees" - like i said earlier in a article of mine, commerce & the promise of it is a good enough reason for any company to learn the ropes of the trade. It also should be understood that, even if it makes immense sense, someone like Micromax may not really be able to go all proactive since they aren't exactly the Apple OR Samsung & their margins, I would expect, will be minimal.

The need is however crystal clear - It's about time Indian regulators, judiciary & indian tech-companies that have to mostly deal with dangerous dampeners like royalty-stacking et al take a crash course in what they need to expect & how they could make strategic litigation a part of their daily lexicon.

below is my comment posted on the above article on Spicy IP;

vishrasayan said...

Excellent insight Prashant!

It appears as though the displaced-vanguards of the mobile technology such as Motorola, Ericsson have re-strategized their revenue generation to monetizing their patents rather than depending on competitive selling :-)

I also see your point about the Indian regulatory, judicial apparatus & the companies themselves prepping way too less on litigations and that's bothersome – this lack of comprehension also resonates with the lack of precise articulation I wrote about some-time ago on my blog… hopefully this will change.

I do agree the potential for royalty-stacking in mobile technology makes it much complex and hence the need for a middle-path, but healthcare too comes with its own complexity of access to latest innovation - I have read your earlier post on compulsory licensing – it appears to me there’s a dichotomy in your justification of premium for innovation (patents) in healthcare and not applying the same yard-stick for the mobile technology…?

1:22 PM

Your message bothers me Esther and how....

Should I Bother With Your Message? Persuade Me! on LI by Esther Dyson 

http://www.linkedin.com/today/post/article/20130116205459-28157-should-i-bother-to-read-your-message-persuade-me?goback=%2Eptf_*1_*1_*1_*1_recentPosts_*1&trk=who_to_follow-b

With all respect to the departed soul, I'm starting to get why Aaron Schwartz decided to end his life...... sender of a message pays on a social network? - Monetizing a few lines as though it were a validated piece of patented intellectual property? – bad enough reason for any cyber-socialist to give-up on hope and die! 

I remember & believe that cyber communities/ DBs started out in a spirit of sharing knowledge, thinking & perspective with whoever displays a similar trait to engage & evolve. If companies like LI & FB monetize this engagement for their own stock valuations, I still understand, particularly seeing how FB is struggling with its sub-par listing & trading post such a hyped-up public issue. What I don't understand is the increasing tribe of self-appointed thought-leaders & experts who believe a mere mail to them deserves a valuation!!!!! – Is it that I should’ve been a citizen of Pandora OR Is this really the most obscene manifestation of assumed self-importance? 

If I have a need that requires me to pay to someone just so that he/she receives my mail in a non-spam folder & for which he/she may not necessarily respond even, I’d think my need itself is ill-articulated &/or illegitimate and the person whom I’m trying to pay to get through to isn’t worth reaching out to after all 

Indeed, a good self-image is important in life..., but gents & ladies extreme self-importance is avoidable - never forget the “Rule Number 6” (http://dannyhageman.wordpress.com/2011/06/21/never-forget-rule-number-six/) 

Cheers