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© d-Wise 2013 Page 1
Seeing is Believing: How Clinical Trial
Data Transparency is Changing How an
Entire Industry Thinks a...
The good ole’ days…
 Patient-level clinical trial data, summary
tables, study reports and other associated
evidence are d...
What changed?
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/06/WC500144730.pdf Industry’s initial reacti...
Industry’s Thoughtful Response
http://phrma.org/sites/default/files/pdf/PhRMAPrinciplesForResponsibleClinicalTrialDataShar...
Transparency in the News
© d-Wise2013 Page 5
Transparency:
The Basic Process
Proposal RequestSite
ReviewPanel
Transparency
Analytics Repository
Proposal
request Approv...
 For processing investigator requests:
– Many, but not all, sponsors are using
www.clinicalstudydatarequest.com
– JnJ/Jan...
 For determining what trials to include:
– Much less agreement between organizations
– Some companies going back very ear...
Is there a standard industry approach?
(Well, sort of….)
 Varied paths are being taken for…
– Organizing the independent ...
 How will the data be delivered
– CDISC (mostly, probably, hopefully)
– Consistently de-identified
 Why is this importan...
 There are no required data standards for the Transparency
Analytics Repository
 CDISC is a likely approach but research...
Amgen
Sources: Applied Clinical Trials compilation of company web site data, June 30, 2014
Sea Change in Open Science and ...
Patient-Level Trial Transparency Status
Top Pharma
Sources: Applied Clinical Trials compilation of company web site data, ...
What is the FDA saying about Patient-Level
Clinical Trial Data Transparency?
 FDA has been not posted guidance or regulat...
http://w
3/06/WC5
ww.ema.europa.eu/docs/en_GB/document_library/Other/201
00144730.pdf
What is the EMA saying about Patient...
What’s next?
 Biopharmaceutical companies will continue to implement
Clinical Trial Data Transparency solutions
 Many co...
Questions ?
Contact information:
Dave Handelsman
dave.handelsman@d-wise.com
919 5920607
© d-Wise2013 Page 17
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Seeing Is Believing: How Clinical Trial Data Transparency is Changing How an Entire Industry Thinks about Data

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Seeing Is Believing: How Clinical Trial Data Transparency is Changing How an Entire Industry Thinks about Data

  1. 1. © d-Wise 2013 Page 1 Seeing is Believing: How Clinical Trial Data Transparency is Changing How an Entire Industry Thinks about Data Dave Handelsman Senior Director, Industry Strategy 15-Oct-2014
  2. 2. The good ole’ days…  Patient-level clinical trial data, summary tables, study reports and other associated evidence are delivered to regulatory authorities as part of the drug approval process.  Some evidence is additionally shared on sites like clinicaltrials.gov (summary results, synopses, etc.)  Patient-level clinical trial data is not shared with anyone except the regulators. © d-Wise2013 Page 2
  3. 3. What changed? http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/06/WC500144730.pdf Industry’s initial reaction © d-Wise2013 Page 3
  4. 4. Industry’s Thoughtful Response http://phrma.org/sites/default/files/pdf/PhRMAPrinciplesForResponsibleClinicalTrialDataSharing.pdf © d-Wise2013 Page 4
  5. 5. Transparency in the News © d-Wise2013 Page 5
  6. 6. Transparency: The Basic Process Proposal RequestSite ReviewPanel Transparency Analytics Repository Proposal request Approved Rejected Re-apply? Approved research artifacts https://clinicalstudydatarequest.com/ (for manycompanies) Data Documents © d-Wise2013 Page 6
  7. 7.  For processing investigator requests: – Many, but not all, sponsors are using www.clinicalstudydatarequest.com – JnJ/Janssen is using YODA (Yale Open Data Access) – Bristol Myers Squib using DCRI (Duke Clinical Research Institute) © d-Wise2013 Page 7
  8. 8.  For determining what trials to include: – Much less agreement between organizations – Some companies going back very early – e.g., late 1990’s – Some companies will only include patient-level data from new trials started after the decision to be transparent – Others are somewhere in the middle  Key challenges: – Informed consent – widely varied interpretations – Locating and delivering data – Data de-identification / anonymisation / privacy Go to www.clinicalstudydatarequest.com and click on a sponsor to learn more © d-Wise2013 Page 8
  9. 9. Is there a standard industry approach? (Well, sort of….)  Varied paths are being taken for… – Organizing the independent review boards – Defining the business rules regarding how analyses and other artifacts are extracted from the system to support publications and claims  Key differences that influence participation: – Executive commitment – Legal perspective – Availability of resources © d-Wise2013 Page 9
  10. 10.  How will the data be delivered – CDISC (mostly, probably, hopefully) – Consistently de-identified  Why is this important? – Efficient analysis and review by the independent researcher – Patient privacy protection – Pooling clinical trial data across multiple companies Dave’s initial reaction © d-Wise2013 Page 10
  11. 11.  There are no required data standards for the Transparency Analytics Repository  CDISC is a likely approach but researchers will have to be ready to interpret / understand / prepare the available transparency data to investigate their research proposal It’s already happening…. © d-Wise2013 Page 11
  12. 12. Amgen Sources: Applied Clinical Trials compilation of company web site data, June 30, 2014 Sea Change in Open Science and Data Sharing: Leadership by Industry, Circ Cardiovasc Qual Outcomes, published online June 2, 2014; http://www.forbes.com/sites/harlankrumholz/2014/06/02/time-to-assess-pharma-progress-in-data-sharing/ © d-Wise2013 Page 12 Email request Internal review, and “as appropriate” Not included in Forbesanalysis Bayer www.clinicalstudydatarequest.com Independent centralized reviewpanel • http://www.forbes.com/sites/harlankrumholz/2014/06/0i2nd/ictaimtiones-tthoat-ahasvseebseesn-paphparorvmedab-yEU for further regulatory review orsubmissions Company Research request type Review Board AvailableData AbbVie Email request Internal review, with appeal All data for medicines and indicationsapproved Sources: independent; external board for final in the US and the EU • Applied Clinical Trials compilatiode ncis oio fn companyweb site data, June 30, 2014 • Sea Change in Open Science anidndDepaentdaenSthexaterrinnagla:dLviesoarsdership by Industry, Circ Cardiovasc AstraZene Qca ualONo ut tp co ost med es,published onlinN e/A June 2, 2014; Not statedonline Jan 2014 – present; Data on new medicinesand progress-in-data-sharing/ and/or US regulatory agencies without plans Biogen Idec Email request (developing a Not posted Not included in Forbesanalysis request/approvalportal) Boehringer Ingelheim www.clinicalstudydatarequest.com Independent centralized reviewpanel Not included in Forbesanalysis BristolMyers Squibb Company-specific requestportal External scientific review provided by DCRI facultymembers. Jan 2008 – present Celgene Email request External Scientific Review Board Not included in Forbesanalysis Eli Lilly www.clinicalstudydatarequest.com Independent centralized reviewpanel Interventional clinical studies forapproved indications of medicines on the market in the US andEU EMDSerono Not posted External scientific review board Not included in Forbesanalysis GlaxoSmithKline www.clinicalstudydatarequest.com Independent centralized reviewpanel Dec 2000 – present; All global interventional clinicalstudies
  13. 13. Patient-Level Trial Transparency Status Top Pharma Sources: Applied Clinical Trials compilation of company web site data, June 30, 2014 Sea Change in Open Science and Data Sharing: Leadership by Industry, Circ Cardiovasc Qual Outcomes, published online June 2, 2014; http://www.forbes.com/sites/harlankrumholz/2014/06/02/time-to-assess-pharma-progress-in-data-sharing/ © d-Wise2013 Page 13 Company Research requesttype ReviewBoard AvailableData Janssen Pharma Internal requestportal External review provided by Yale Schoolof medicine’s Open Data AccessProject (YODA). Data from interventional trials for productsand indications approved in both the EU and US(older studies may be difficult toaccess) Lundbeck Not posted. “Lundbeck and a thirdparty will be subject to a formal agreementthat will address ownership and access to data.” Specific criteria listed onsite Not included in Forbesanalysis Merck Emailrequest Internal review, external review boardas needed Sept 2007 – present; Trials approved by EU andUS regulatory agencies and accepted for publication; Trials for which results are posted onClinicalTrials.gov Novartis www.clinicalstudydatarequest.com Independent centralized review panel Jan 2014 – present; Phase II – III trials for new medicines or indications approved by the EU andUS regulatoryagencies Novo Nordisk Emailrequest Independent review board, dataaccess granted within a web-basedsystem. Not included in Forbesanalysis Otsuka Not yetdeveloped. Not yetdeveloped. Not included in Forbesanalysis Pfizer Internal requestportal Independent review panel Global trials that ended after Sept2007; Trials for which results are posted onClinicalTrials.gov Purdue Pharma Not posted; PhRMA-certified tofollowing jointprinciples. Information notavailable Not included in Forbesanalysis Roche www.clinicalstudydatarequest.com Independent centralized review panel Jan 1999 – present; Trials from terminatedprograms; Phase II – III trials, and some Phase IV trials, for new medicines that have been approved by the EU andUS regulatoryagencies Sanofi www.clinicalstudydatarequest.com Independent centralized review panel Jan 2014 – present Trials approved by EU and US regulatory agencies and accepted forpublication
  14. 14. What is the FDA saying about Patient-Level Clinical Trial Data Transparency?  FDA has been not posted guidance or regulation or anything official  At conferences, when asked about patient-level clinical trial data, FDA has been consistent in their response Dave’s paraphrasing of FDA: Decisions regarding patient-level clinical trial data are between the pharmaceutical company and the patient. FDA has no intention of making submitted patient-level trial data available as the EMA has indicated, and has no intention of requiring pharma to make that data available. © d-Wise2013 Page 14
  15. 15. http://w 3/06/WC5 ww.ema.europa.eu/docs/en_GB/document_library/Other/201 00144730.pdf What is the EMA saying about Patient-Level Clinical Trial Data Transparency? http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/10/WC500174796.pdf © d-Wise2013 Page 15
  16. 16. What’s next?  Biopharmaceutical companies will continue to implement Clinical Trial Data Transparency solutions  Many companies will converge on a single stack of technologies  TransCelerate has recently gotten involved from a CSR redaction and patient privacy perspective  There are divergent opinions regarding the types of trials to include, risks associated within including trials associated with compounds not submitted for approval, business process consensus, etc. © d-Wise2013 Page 16
  17. 17. Questions ? Contact information: Dave Handelsman dave.handelsman@d-wise.com 919 5920607 © d-Wise2013 Page 17

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