Loading presentation...

Present Remotely

Send the link below via email or IM

Copy

Present to your audience

Start remote presentation

  • Invited audience members will follow you as you navigate and present
  • People invited to a presentation do not need a Prezi account
  • This link expires 10 minutes after you close the presentation
  • A maximum of 30 users can follow your presentation
  • Learn more about this feature in our knowledge base article

Do you really want to delete this prezi?

Neither you, nor the coeditors you shared it with will be able to recover it again.

DeleteCancel

Make your likes visible on Facebook?

Connect your Facebook account to Prezi and let your likes appear on your timeline.
You can change this under Settings & Account at any time.

No, thanks

Open Access to Clinical Trial Data

No description
by

Gillian Gresham

on 21 February 2015

Comments (0)

Please log in to add your comment.

Report abuse

Transcript of Open Access to Clinical Trial Data

Open Access to Clinical Trial Data
Why the push?
We are in an era of:
Open-access
Electronic data
Registered trials
Patient-centeredness
More research on reporting biases
Selective reporting
Publication bias
Push against industry
Why is open-access important?
1.
Ethical obligation to share
: A patient's right to know
2.
Efficacy:
Improving health outcomes
3
. Safety:
Enhancing patient safety
4
. Scientific credibility:
A way to "verify" published data
5.
Replication
of study results
6.
Reinforcing integrity
into industry-sponsored trials


Overview
Background/Rationale
What is open-access?
Why the push?
Advantages
Why is open access important?
Challenges and their solutions
What are some challenges we are currently facing?
Conclusion/Looking ahead
Public opinion
What next?
Discussion

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
4. Authorship
-Who owns the data?
-Publication?
5. Scientific misuse
-Are people qualified to perform the analyses they are requesting with this new data?
Some examples....
BACKGROUND
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




SYSTEMATIC REVIEWS/
META-ANALYSES
-Aggregate/summary data
-Can only use what we're given
RCTs
-Summary statistics from the analysis of study population
-"Gold" standard
-Dependable?
Independent patient data
Data from the case report forms
-In its purest, rawest form
-How can we get this?

Definition:
"Deidentified records of individual patients obtained from the case report forms, either handwritten or electronic, of clinical trials"
Gillian Gresham

International push
Privacy/confidentiality
Several regulations already in place:
-HIPAA
-Common Rule
-NIH

Problem:
Lack of harmonization among these regulations

Solution:
Standardization of definitions (IPD and anonymized data)
-Reinforcement of privacy policies (journals!)
Informed consent
Current: -
Informed consent required on ethical basis
-Requirement of journals to publish

Problem: -
How to contact patients? (moved? died?)
-Cost/time extensive to re-consent all patients for all trials
-Not feasible

Solution:
-"Blanket" consent in anticipation of data sharing
-An equal universal agreement between researchers, participants, public alike (data belongs to the public)
Ownership of data
Current: -
Trial sponsor owns the data
-Trial is conducted, analyzed and published (PI/sponsor)

Problem
: -Property rights of data
-RCT vs. analysis of available data
-Competition
-Publication
Solutions:
-Incentives fom journals
-Time to publish before sharing
-Recognition/citation


Scientific misconduct
Current:-
Peer-reviewed

Problem:
Open access = greater potential for abuse or misuse of data
-Unqualified/less experienced researchers acquiring the data and making false inferences

Solution
:
-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)
Conclusions
-Current and controversial topic
-Some challenges that must still be addressed
-Currently working on systematic and standardized approach: Learned intermediary entity
-Engage patients
-Journal policies
-Control and enforcement on the conditions on use of data
Discussion
-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?
Thank you!
Any Questions?
Key References
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:
Examples:
Full transcript