Future goals center on the continued use of developing computational technologies to assist in integrating electronic medical records and clinical research data, as well as changing the way data is stored, analyzed, and published, in an effort to provide open knowledge platforms. Other CMTF plans include continued private-academic partnerships as a means of combining private sector innovations with the richness of academic clinical data. Creating the tools to convert written clinical notes into standardized data will alleviate some of the data management workload by eliminating the need for manual data abstraction and entry.

Improvements to how researchers acquire, store, analyze, and disseminate data will undoubtedly inform all other CMTF strategies, not only in content, but in expediency. The CMTF plans to grow a biomedical data science workforce specifically versed in these new modalities, including federal funding of biomedical data science undergraduate and graduate programs, as well as grants, fellowships, and continuing education workshops.


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Though the CMTF emphasizes that its strategies are not meant to replace the new HHS or NIH guidelines, insights gained from the Cancer Moonshot will certainly advise institutional-level reporting. Independent collaborations are also placing a strong emphasis on how clinical data are managed.

In the short-term, research institutions can look to more compliant centers as “role models,” though if there is not a more substantial change, the impending FDAAA and NIH changes could simply add fuel to the fire. With a variety of well-funded initiatives working in tandem, many with the ability to implement change from the ground up, all researchers stand to benefit from news ways of handling data. It’s up to each institution, however, to adhere to the FDAAA and NIH guidelines. Yet with exponential increases in trial volume and complexity, it seems that trial reporting has the potential to remain an issue bigger than institution-level reporting.

References

  1. Kaiser, J. What Vice President Biden’s moonshot may mean for cancer research. Science. 2016 Jan 13. doi: 10.1126/science.aae0226
  2. Cancer Moonshot. National Cancer Institute website. https://www.cancer.gov/research/key-initiatives/moonshot-cancer-initiative. Accessed October 2016.
  3. FACT SHEET: At Cancer Moonshot Summit, Vice President Biden announces new actions to accelerate progress toward ending cancer as we know it. Whitehouse.gov website. https://www.whitehouse.gov/the-press-office/2016/06/28/fact-sheet-cancer-moonshot-summit-vice-president-biden-announces-new. Updated June 28, 2016. Accessed October 2016.
  4. Report of the Cancer Moonshot Task Force. Whitehouse.gov website. https://www.whitehouse.gov/sites/default/files/docs/final_cancer_moonshot_task_force_report_1.pdf. Updated October 17, 2016. Accessed October, 2016.
  5. How to encourage trial reporting. Nat Med. 2016;22(8):823. doi: 10.1038/nm.4167
  6. HHS takes steps to provide more clinical trials to the public. National Institutes of Health website. https://www.nih.gov/news-events/news-releases/hhs-take-steps-provide-more-information-about-clinical-trials-public. Updated September 16, 2016. Accessed October 2016.
  7. Anderson ML, Chiswell K, Peterson ED, Tasneem A, Topping J, Califf RM. Compliance with Results Reporting at ClinicalTrials.gov. N Engl J Med. 2015;372(11):1031-9. doi: 10.1056/NEJMsa1409364
  8. Chen R, Desai NR, Ross JS, et al. Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. BMJ. 2016;352:i637. doi: 10.1136/bmj.i637
  9. Trends, Charts, and Maps. ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/resources/trends. Updated February 2016. Accessed October 2016.