1. Big Data for Breast Cancer: A Patient/Advocate Perspective Jane Perlmutter October 8, 2015

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3. Topics What is Big Data & why is it important? What are some issues & concerns to patients/advocates? What can we learn about these issues from examples of Big Data projects? How can we make a difference?

4. What is Big Data?

5. The Three Vs of Big Data

6. JP View of What Big Data Is (and Isn’t) Types of Data/Examples Quantity/ Quality of Data Inference Method Interventional— Randomized Clinical Trials Small / ExcellentAnalysis of Variance Observational— Registries, Surveys Medium / FairRegression Unstructured— Social Media, research articles Large/ChallengingArtificial Intelligence, Natural Language Processing Big Data—Combining Multiple Types & Data Sources Large / PoorMulti-dimensional Analyics and Visualization Tools

7. Types of Health Data Patient Records Patient Charts Electronic health records (EHRs) Billing/Payment History Patient Provided Input Patient reported outcomes Passively collected patient data Social media Clinical Trials Data ‘omics Data Mutations Copy number alterations INDELs/SNPs RNA/protein expression Epigenetics Metabiome...

8. Why Big Data?

9. JP View of Why Big Data Risk Immature methodology  erroneous inferences Breach of security  loss of privacy Hoarding of data  slowing progress Promise Better predictions about heath risks Faster development of treatments More rapid progress toward precision medicine More efficient use of health resources

10. Patient/Advocate Issues Patient/Advocate issues are not unique to them Sponsors & Investigators share these concerns, though they sometime take a backseat to technical & scientific issues Patients/advocates have a different filter, are more focused on these issues, and can bring them to the forefront

11. Patient/Advocate Issues Research Priorities Data Quality & Representativeness Data Control & Sharing Who Pays & How is it Sustained Security & Privacy Informed Consent & Returning Results

12. OHRP’s NPRM OHRP--Office of Human Research Protection Common Rule--Rule of ethics regarding biomedical and behavioral research involving human subjects in the US NPRM--Notice of Public Rule Making (9/8/15)

13. Announced New Requirements Written consent is required for all research use of biospecimens, even those that have been stripped of identifiers Must specify that biospecimens might be used for commercial profit, but not patient profit Must specify whether and how relevant research results (individual and/or aggregate) will be disclosed to patients Some exempt and all non-exempt research must provide privacy safeguards for biospecimens and identifiable private information. – Surveys, interviews, educational tests, etc. – Secondary research Defines data security protections that are required and that they must be described in consent documents

14. Cancer Big Data Examples and Some Issues They Raise ‘Omics: Visualization, analysis and download of large-scale cancer genomics data sets for research Learning Systems: Real world data for quality improvement and research Clinical Trials: Data sharing from clinical trials for research

15. Other Interesting Health Examples Surveillance: Multi-source data to monitor unidentified toxicities and drug interactions Infrastructure: For comparative effectiveness research and other patient-centered health research Patient Entered Data: Patient support and information sharing Artificial Intelligence Processing:

16. Ensure patients/advocates are “at the table” and heard when decisions are made about Big Data projects Inform patients/advocates and the public about potential benefits and concerns associated with health data Be discriminating in providing support to excellent projects by encouraging patients and researchers to share data Learn more How to Make a Difference?

17. Take Home Messages Big Data has lot’s of potential, but its more complicated than we can imagine – Technical issues – Political/economic issues – Patient ethical issues Including patients/advocates from the beginning will lead to better, faster, and more acceptable results