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Open Access to Clinical Trial Data
Transcript of Open Access to Clinical Trial Data
Why the push?
We are in an era of:
More research on reporting biases
Push against industry
Why is open-access important?
Ethical obligation to share
: A patient's right to know
Improving health outcomes
Enhancing patient safety
. Scientific credibility:
A way to "verify" published data
of study results
into industry-sponsored trials
What is open-access?
Why the push?
Why is open access important?
Challenges and their solutions
What are some challenges we are currently facing?
What are some challenges?
1. Privacy and confidentiality
-How to go about de-identification of electronic IPD
-How to ensure anonymity
2. Informed consent
-Informed consent required to share data
-How can we consent patients from previous trials?
3. Need for incentives
-Expensive (time and cost)
-Who is going to de-identify/screen
-Who owns the data?
5. Scientific misuse
-Are people qualified to perform the analyses they are requesting with this new data?
Open-Access: Available to all!
"Unlimited online access to peer-reviewed scholarly research."
Other terms: transparent data sharing/IPD data sharing/ trial data sharing
"Allows scientists to expedite the translation of research results into knowledge, products and procedure to improve human health"(2)
Push for open-access
Institutes/agencies: NIH, EMA (UK), FDA, clinicaltrials.gov
Pharmaceutical Companies (Since 2012):
Johnson&Johnson, Boehringer Ingelheim, GlaxoSmithKline, Roche, Sanofi, ViiV Healthcare, AstroZenica and Pfizer
-Can only use what we're given
-Summary statistics from the analysis of study population
Independent patient data
Data from the case report forms
-In its purest, rawest form
-How can we get this?
"Deidentified records of individual patients obtained from the case report forms, either handwritten or electronic, of clinical trials"
Several regulations already in place:
Lack of harmonization among these regulations
Standardization of definitions (IPD and anonymized data)
-Reinforcement of privacy policies (journals!)
Informed consent required on ethical basis
-Requirement of journals to publish
How to contact patients? (moved? died?)
-Cost/time extensive to re-consent all patients for all trials
-"Blanket" consent in anticipation of data sharing
-An equal universal agreement between researchers, participants, public alike (data belongs to the public)
Ownership of data
Trial sponsor owns the data
-Trial is conducted, analyzed and published (PI/sponsor)
: -Property rights of data
-RCT vs. analysis of available data
-Incentives fom journals
-Time to publish before sharing
Open access = greater potential for abuse or misuse of data
-Unqualified/less experienced researchers acquiring the data and making false inferences
-Rigorous and objective evaluations of the data
-Independent examinations of the patient level data, and requiring assessment
-evaluation of scientific skills prior to permitting access-
Ex. Yale University Open Access Data project (YODA)
-Current and controversial topic
-Some challenges that must still be addressed
-Currently working on systematic and standardized approach: Learned intermediary entity
-Control and enforcement on the conditions on use of data
-Are we headed in the right direction?
-What challenge concerns you the most? The least?
-Would you want your data shared? Would you want to be consented?
-Would you trust published reports more?
-Would you USE it or is it too time-consuming?
1. Institute of Medicine. Sharing clinical research data: workshop summary. Washington, DC: 2013.
2. Gøtzsche PC. Why we need easy access to all data from all clinical trials and how to accomplish it. Trials. 2011
3. Doshi P. From promises to policies: is big pharma delivering on transparency? BMJ. 2014
4. Doshi P, Goodman SN, Ioannidis JP. Raw data from clinical trials: within reach? Trends Pharmacol Sci. 2013
Clinical Trials Management 2014
Levels of data: