Skip to main content Accessibility help

We use cookies to distinguish you from other users and to provide you with a better experience on our websites. Close this message to accept cookies or find out how to manage your cookie settings.

Close cookie message
×
Hostname: page-component-669899f699-vbsjw Total loading time: 0 Render date: 2025-04-29T01:57:44.421Z Has data issue: false hasContentIssue false

9 - Implementation

Getting the Right Interventions to Market

from Part II - Rethinking Research

Published online by Cambridge University Press:  13 March 2025

Karen B. Schmaling  and
Robert M. Kaplan
Karen B. Schmaling
Affiliation:
Washington State University
Robert M. Kaplan
Affiliation:
Stanford University
Get access

Summary

The time lag between when research is completed and when it is used in clinical practice can be as long as two decades. This chapter considers the dissemination and implementation of research findings. It also explores better ways to make research findings understood and used. On the one hand, we recognize the need to get new research into practice as soon as possible. On the other hand, we challenge the trend toward rapid implementation. When results are put into practice prematurely, patients may suffer unnecessary consequences of insufficiently evaluated interventions. We offer several examples of Nobel Prize winning interventions that had unintentional harmful effects that were unknown when the prize was awarded. To address these problems, we support the need for greater transparency in reporting studies results, open access to clinical research data, and the application of statistical tools such as forest plots and funnel plots that might reveal data irregularities.

Keywords

Dunning-Kruger effectforest plotsimplementationmisinformationoutlierspublication biasrapid experimentation
Type
Chapter
Information
Rethinking Clinical Research
Methodology and Ethics
 , pp. 177 - 200
Publisher: Cambridge University Press
Print publication year: 2025

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Book purchase

Temporarily unavailable

References

Onken, L. Implementation science at the National Institute on Aging: The principles of it. Public Policy Aging Rep. 2022; 32(1):39–41.CrossRefGoogle Scholar
Larimer, ME, Kilmer, JR, Cronce, JM, Hultgren, BA, Gilson, MS, Lee, CM. Thirty years of BASICS: Dissemination and implementation progress and challenges. Psychol Addict Behav. 2022; 36(6):664.CrossRefGoogle ScholarPubMed
Hamilton, A, Mittman, BS. Implementation science in health care. Dissemination and Implementation Research in Health: Translating Science to Practice. 2018; 2:385–400.Google Scholar
Schoenwald, SK, McHugh, RK, Barlow, DH. The science of dissemination and implementation. Dissemination and Implementation of Evidence-based Psychological Interventions. 2012:16–42.Google Scholar
Brownson, RC, Colditz, GA, Proctor, EK. Dissemination and Implementation Research in Health: Translating Science to Practice. Oxford University Press; 2017.CrossRefGoogle Scholar
Balas, EA, Boren, SA. Managing clinical knowledge for health care improvement. Yearb Med Inform. 2000; 9(01):65–70.Google Scholar
Morris, ZS, Wooding, S, Grant, J. The answer is 17 years, what is the question: Understanding time lags in translational research. J R Soc Med. 2011; 104(12):510–520.CrossRefGoogle Scholar
Dong, P, Loh, M, Mondry, A. Publication lag in biomedical journals varies due to the periodical’s publishing model. Scientometrics. 2006; 69(2):271–286.CrossRefGoogle Scholar
Khan, S, Chambers, D, Neta, G. Revisiting time to translation: Implementation of evidence-based practices (EBPs) in cancer control. Cancer Causes Control. 2021; 32:221–230.CrossRefGoogle ScholarPubMed
Bickman, L. Improving mental health services: A 50-year journey from randomized experiments to artificial intelligence and precision mental health. Adm Policy Ment Health. 2020; 47(5):795–843.CrossRefGoogle ScholarPubMed
Schmaling, KB, Kaplan, RM. Depression trial results: A cross-sectional study of ClinicalTrials.gov. J Psychiatr Res. 2023; 161:461–466.CrossRefGoogle ScholarPubMed
Emmons, KM, Chambers, DA. Policy implementation science–an unexplored strategy to address social determinants of health. Ethn Dis. 2021; 31(1):133.CrossRefGoogle ScholarPubMed
Kaplan, RM, Koong, AJ, Irvin, V. Review of evidence supporting 2022 US Food and Drug Administration Drug Approvals. JAMA Netw Open. 2023; 6(8):e2327650–e2327650.CrossRefGoogle ScholarPubMed
Kaplan, RM, Koong, AJ, Irvin, V. Food and Drug Administration novel drug decisions in 2017: Transparency and disclosure prior to and 5 years following approval. Health Aff Sch. 2023; 1(2):qxad028.Google ScholarPubMed
Lai, CK, Ng, RW, Leung, SS, Hui, M, Ip, M. Overcoming the rising incidence and evolving mechanisms of antibiotic resistance by novel drug delivery approaches–an overview. Adv Drug Deliv Rev. 2022; 181:114078.CrossRefGoogle Scholar
Vestergaard, M, Frees, D, Ingmer, H. Antibiotic resistance and the MRSA problem. Microbiol Spectr. 2019; 7(2):18.CrossRefGoogle ScholarPubMed
Hrbacek, J, Cermak, P, Zachoval, R. Current antibiotic resistance trends of uropathogens in Central Europe: Survey from a Tertiary hospital urology department 2011–2019. Antibiotics. 2020; 9(9):630.CrossRefGoogle ScholarPubMed
Podschun, R, Ullmann, U. Klebsiella spp. as nosocomial pathogens: Epidemiology, taxonomy, typing methods, and pathogenicity factors. Clin Microbiol Rev. 1998; 11(4):589–603.CrossRefGoogle ScholarPubMed
Magalhães, C, Lima, M, Trieu-Cuot, P, Ferreira, P. To give or not to give antibiotics is not the only question. Lancet Infect Dis. 2021; 21(7):e191–e201.CrossRefGoogle Scholar
Tan, SY, Yip, A. António egas moniz (1874–1955): Lobotomy pioneer and Nobel laureate. Singapore Med J. 2014; 55(4):175.CrossRefGoogle Scholar
Nobel Prize Committee. Nobel Prize for Physiology or Medicine. www.nobelprize.org/prizes/medicine/1950/summary/Google Scholar
Grennan, D, Wang, S. Steroid side effects. JAMA. 2019; 322(3):282–282.CrossRefGoogle ScholarPubMed
Feuerstein, JD, Isaacs, KL, Schneider, Y, et al. AGA clinical practice guidelines on the management of moderate to severe ulcerative colitis. Gastroenterology. 2020; 158(5):1450–1461.CrossRefGoogle ScholarPubMed
Brown, MS, Goldstein, JL. Heart Attacks: Gone with the Century? American Association for the Advancement of Science; 1996. pp. 629–629.Google ScholarPubMed
Sun, J, Li, Y, Zhao, M, et al. Association of the American Heart Association’s new “Life’s Essential 8” with all-cause and cardiovascular disease-specific mortality: Prospective cohort study. BMC Med. 2023; 21(1):1–13.CrossRefGoogle ScholarPubMed
Chou, R, Cantor, A, Dana, T, et al. Statin use for the primary prevention of cardiovascular disease in adults: Updated evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2022; 328(8):754–771.CrossRefGoogle ScholarPubMed
Byrne, P, Demasi, M, Jones, M, Smith, SM, O’Brien, KK, DuBroff, R. Evaluating the association between low-density lipoprotein cholesterol reduction and relative and absolute effects of statin treatment: A systematic review and meta-analysis. JAMA Intern Med. 2022.Google ScholarPubMed
McKinney, RE, Eng, B, York, O. Rapid Experimentation: The Silicon Valley Method of Success. 2019.CrossRefGoogle Scholar
Babineaux, R, Krumboltz, J. Fail Fast, Fail Often: How Losing Can Help You Win. TarcherPerigee; 2013.Google Scholar
Kwon, D, Sorenson, O. The Silicon Valley syndrome. Entrepreneurship Theory Pract. 2023; 47(2):344–368.CrossRefGoogle Scholar
List, JA. The voltage effect. Business Economics. 2023:1–6.Google Scholar
Bradley, CS, Dreifuerst, KT, Johnson, BK, Loomis, A. More than a meme: The Dunning-Kruger effect as an opportunity for positive change in nursing education. ClinSimul Nurs. 2022; 66:58–65.Google Scholar
de Vries, Y, Roest, A, de Jonge, P, Cuijpers, P, Munafò, M, Bastiaansen, J. The cumulative effect of reporting and citation biases on the apparent efficacy of treatments: The case of depression. Psychol Med. 2018; 48(15):2453–2455.CrossRefGoogle ScholarPubMed
Khan, MS, Lateef, N, Siddiqi, TJ, et al. Level and prevalence of spin in published cardiovascular randomized clinical trial reports with statistically nonsignificant primary outcomes: A systematic review. JAMA Netw Open. 2019; 2(5):e192622–e192622.CrossRefGoogle ScholarPubMed
Malmberg, K, Rydén, L, Efendic, S, et al. Randomized trial of insulin-glucose infusion followed by subcutaneous insulin treatment in diabetic patients with acute myocardial infarction (DIGAMI study): Effects on mortality at 1 year. J Am Coll Cardiol. 1995; 26(1):57–65.CrossRefGoogle ScholarPubMed
Mellbin, LG, Malmberg, K, Norhammar, A, Wedel, H, Ryden, L. The impact of glucose lowering treatment on long-term prognosis in patients with type 2 diabetes and myocardial infarction: A report from the DIGAMI 2 trial. Eur Heart J. 2008; 29(2):166–176.CrossRefGoogle ScholarPubMed
Loffler, KA, Patel, SR. Reporting Findings in Sleep Medicine: Is It Time for Some Spin Control? Oxford University Press US; 2023. p. zsad045.Google ScholarPubMed
Shirvani, S, Rives-Lange, C, Rassy, N, et al. Spin in the scientific literature on bariatric endoscopy: A systematic review of randomized controlled trials. Obes Surg. 2022:1–9.Google ScholarPubMed
Wu, J, Ho, W, Klotz, L, Yuan, M, Lee, JY, Krakowsky, Y. Assessing “Spin” in urology randomized controlled trials with statistically nonsignificant primary outcomes. J Urol. 2023; 209(3):494–503.CrossRefGoogle ScholarPubMed
Su, N, Van Der Linden, M, Van Der Heijden, GJ, Listl, S, Schandelmaier, S, Faggion, CM. Published patterns of spin in biomedical literature: A protocol for a meta-research study. BMJ Open. 2021; 11(4):e043784.CrossRefGoogle Scholar
Feldman, R. Advertising Medicine: Who’s Minding the Store? Stanford Technology Law Review. 2022.CrossRefGoogle Scholar
Sachs, EA. Health claims in the marketplace: The future of the FDA and the FTC’s regulatory split. Food Drug Law J. 1993; 48(2):263–283.Google Scholar
McMurray, JJ, Packer, M, Desai, AS, et al. Angiotensin–neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014; 371(11):993–1004.CrossRefGoogle ScholarPubMed
Solomon, SD, McMurray, JJ, Anand, IS, et al. Angiotensin–neprilysin inhibition in heart failure with preserved ejection fraction. N Engl J Med. 2019; 381(17):1609–1620.CrossRefGoogle ScholarPubMed
Mann, DL, Givertz, MM, Vader, JM, et al. Effect of treatment with sacubitril/valsartan in patients with advanced heart failure and reduced ejection fraction: A randomized clinical trial. JAMA Cardiol. 2022; 7(1):17–25.CrossRefGoogle ScholarPubMed
Harman, G. Science and storytelling: Making physicians’ voices the loudest in the room. AMA Website. 2021.Google Scholar
Karatasakis, A, Danek, BA, Karacsonyi, J, et al. Effect of PCSK9 inhibitors on clinical outcomes in patients with hypercholesterolemia: A meta-analysis of 35 randomized controlled trials. J Am Heart Assoc. 2017; 6:e006910. DOI: 10.1161/JAHA.117.006910.CrossRefGoogle ScholarPubMed
Khan, SU, Yedlapati, SH, Lone, AN, et al. PCSK9 inhibitors and ezetimibe with or without statin therapy for cardiovascular risk reduction: A systematic review and network meta-analysis. BMJ. 2022; 377.Google ScholarPubMed
Wang, W, Feng, Z, Bai, J. Effects of alirocumab on cardiovascular events and all-cause mortality: A systematic review and meta-analysis. Rev Cardiovasc Med. 2021; 22(3):873–881.CrossRefGoogle ScholarPubMed
Afonso, J, Ramirez-Campillo, R, Clemente, FM, Büttner, FC, Andrade, R. The perils of misinterpreting and misusing “publication bias” in meta-analyses: An education review on funnel plot-based methods. Sports Med. 2023:1–13.Google ScholarPubMed
Light, RJ, Richard, J, Pillemer, DB, Light, R. Summing Up: The Science of Reviewing Research. Harvard University Press; 1984.CrossRefGoogle Scholar
Diener, MJ. Cohen’s d. The Corsini Encyclopedia of Psychology. 2010:1–1.Google Scholar
Kaplan, RM, Irvin, VL. Likelihood of null effects of large NHLBI clinical trials has increased over time. PloS One. 2015; 10(8):e0132382.CrossRefGoogle ScholarPubMed
Block, J. Covid-19: Researchers Face Wait for Patient Level Data from Pfizer and Moderna Vaccine Trials. British Medical Journal Publishing Group; 2022.Google ScholarPubMed
Stephenson, J. In a first, FDA Warns Company to remedy failure to post clinical trial results. Am Med Assoc; 2021:e211306–e211306.Google Scholar
Kaplan, R. FDA drug approvals: Let us see all the evidence. MedPage. August 23, 2023.Google Scholar
Dunleavy, K. Johnson & Johnson inks $700M deal to resolve talc consumer protection claims from 42 states. Pharma. 2024.Google Scholar
Abramson, JD. Sickening: How Big Pharma Broke American Health Care and How We Can Repair It. Mariner Books; 2022.Google Scholar
Wikipedia. List of largest pharmaceutical settlements. https://en.wikipedia.org/wiki/List_of_largest_pharmaceutical_settlements.Google Scholar

Save book to Kindle

To save this book to your Kindle, first ensure [email protected] is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about saving to your Kindle.

Note you can select to save to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be saved to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

Find out more about the Kindle Personal Document Service.

Available formats
×

Save book to Dropbox

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Dropbox.

Available formats
×

Save book to Google Drive

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Google Drive.

Available formats
×