Investing in Clinical Science: Make Way for (Not-So-Uncommon) Outliers
Authors: Michael S. Lauer
Journal: Annals of Internal Medicine (2014)

Editorials6 May 2014Investing in Clinical Science: Make Way for (Not-So-Uncommon) OutliersMichael S. Lauer, MDMichael S. Lauer, MDFrom National Heart, Lung, and Blood Institute, Bethesda, Maryland.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M14-0655 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail In 2007, Nassim Nicholas Taleb published his acclaimed bestseller, The Black Swan: The Impact of the Highly Improbable (1). Taleb, a financier turned philosopher who predicted the 2008 economic crash, argued that "black swan" events drive most human history. Black swan events have 3 salient characteristics: They are "outside the realm of regular expectations"; are not predicted, lending themselves to explanation only after the fact; and have "extreme impact." The inventions of the personal computer and the Internet, the collapse of the Soviet Union, and the September 11 terrorist attacks were black swan events.The reports of the Women's Health Initiative ...References1. Taleb NN. The Black Swan: The Impact of the Highly Improbable. 1st ed. New York: Random House; 2007. Google Scholar2. Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, et al; Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA. 2002;288:321-33. [PMID: 12117397] CrossrefMedlineGoogle Scholar3. Anderson GL, Limacher M, Assaf AR, Bassford T, Beresford SA, Black H, et al; Women's Health Initiative Steering Committee. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA. 2004;291:1701-12. [PMID: 15082697] CrossrefMedlineGoogle Scholar4. Humphrey LL, Chan BK, Sox HC. Postmenopausal hormone replacement therapy and the primary prevention of cardiovascular disease. Ann Intern Med. 2002;137:273-84. [PMID: 12186518] LinkGoogle Scholar5. Gordon D, Taddei-Peters W, Mascette A, Antman M, Kaufmann PG, Lauer MS. Publication of trials funded by the National Heart, Lung, and Blood Institute. N Engl J Med. 2013;369:1926-34. [PMID: 24224625] CrossrefMedlineGoogle Scholar6. Roth JA, Etzioni R, Waters TM, Pettinger M, Rossouw JE, Anderson GL, et al. Economic return from the Women's Health Initiative estrogen plus progestin clinical trial. A modeling study. Ann Intern Med. 2014;160:594-602. LinkGoogle Scholar7. Cutler DM, Kadiyala S. The return to biomedical research: treatment and behavioral effects. In: Murphy KM, Topel RH, eds. Measuring the Gains from Medical Research: An Economic Approach. Chicago: University of Chicago Pr; 2003:110-62. Google Scholar8. Press WH. Presidential address. What's so special about science (and how much should we spend on it?). Science. 2013;342:817-22. [PMID: 24244958] CrossrefMedlineGoogle Scholar9. Hlatky MA, Ray RM, Burwen DR, Margolis KL, Johnson KC, Kucharska-Newton A, et al. Use of Medicare data to identify coronary heart disease outcomes in the Women's Health Initiative. Circ Cardiovasc Qual Outcomes. 2014;7:157-62. [PMID: 24399330] CrossrefMedlineGoogle Scholar10. Reith C, Landray M, Devereaux PJ, Bosch J, Granger CB, Baigent C, et al. Randomized clinical trials—removing unnecessary obstacles. N Engl J Med. 2013;369:1061-5. [PMID: 24024845] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From National Heart, Lung, and Blood Institute, Bethesda, Maryland.Disclaimer: The views expressed in this editorial are those of the author and do not necessarily reflect those of the NHLBI, the National Institutes of Health, or the U.S. Department of Health and Human Services.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M14-0655.Corresponding Author: Michael S. Lauer, MD, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 8128, Bethesda, MD 20892; e-mail, [email protected]nih.gov. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoEconomic Return From the Women's Health Initiative Estrogen Plus Progestin Clinical Trial Joshua A. Roth , Ruth Etzioni , Teresa M. Waters , Mary Pettinger , Jacques E. Rossouw , Garnet L. Anderson , Rowan T. Chlebowski , JoAnn E. Manson , Mark Hlatky , Karen C. Johnson , and Scott D. Ramsey Economic Return From the Women's Health Initiative Estrogen Plus Progestin Clinical Trial Joshua A. Roth , Ruth Etzioni , Teresa M. Waters , Mary Pettinger , Jacques E. Rossouw , Garnet L. Anderson , Rowan T. Chlebowski , JoAnn E. Manson , Mark Hlatky , Karen C. Johnson , and Scott D. Ramsey Metrics Cited ByWorking Together to Address Women's Health in Research and Drug Development: Summary of the 2017 Women's Health Congress Preconference SymposiumPredicting Productivity Returns on InvestmentWHI estrogen plus progestin trial a good return on investment 6 May 2014Volume 160, Issue 9Page: 651-652KeywordsClinical trial reportingClinical trialsDisclosureHealth economicsHeartHormone replacement therapyHormonesInternetLungsObstetrics and gynecology ePublished: 6 May 2014 Issue Published: 6 May 2014 PDF DownloadLoading ...