Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Sep 1;128(17):3145-3151.
doi: 10.1002/cncr.34357. Epub 2022 Jun 29.

Envisioning clinical trials as complex interventions

Kristian D Stensland  1   2 , Laura J Damschroder  3 , Anne E Sales  2   3   4 , Anne F Schott  5 , Ted A Skolarus  1   3
Affiliations

Envisioning clinical trials as complex interventions

Kristian D Stensland et al. Cancer. .

Abstract

Clinical trials are critical components of modern health care and infrastructure. Trials benefit society through scientific advancement and individual patients through trial participation. In fact, billions of dollars are spent annually in support of these benefits. Despite the massive investments, clinical trials often fail to accomplish their primary aims and trial enrollment rates remain low. Prior efforts to improve trial conduct and enrollment have had limited success, perhaps due to oversimplification of the complex, multilevel nature of trials. For these reasons, the authors propose applying implementation science to the clinical trials context. In this commentary, the authors posit clinical trials as complex, multilevel evidence-based interventions with significant societal and individual benefits yet with persistent gaps in implementation. An application of implementation science concepts to the clinical trials context as means to build common vocabulary and establish a platform for applying implementation science and practice to improve clinical trial conduct is introduced. Applying implementation science to the clinical trials context can augment improvement efforts and build capacity for better and more efficient evidence-based care for all patients and trial stakeholders throughout the clinical trials enterprise.

Keywords: clinical trials; complex interventions; health services research; implementation science; quality improvement.

PubMed Disclaimer

Conflict of interest statement

Laura J. Damschroder reports a grant (paid to her institution) from the VA Quality Enhancement Research Initiative Program (QUE 20–025); payments as an expert implementation science consultant on National Institutes of Health‐funded projects; honoraria from Dartmouth College, Intermountain Healthcare, New York University, Oregon Health Sciences University, University of Illinois, University of Chicago, University of Michigan, University of Zurich, Upstream USA Inc, Yale University, McGill University, Agenica de Qualitat I Avaluacio Sanitaries de Catalunya, Brown University, Karolinska Institutet, Northwell Health, Stanford University, University of Kentucky, University of Limerick, University of Pittsburgh, University of Wisconsin, University of Texas Health Sciences Center; and participation on a Data Safety Monitoring Board for National Institutes of Health/National Institute on Drug Abuse. Anne Sales is a co‐investigator on three grants from National Institutes of Health; has received honoraria for a lecture at the University of Kentucky; and is the Chair of the Data and Safety Monitoring Board for four asthma‐related projects for the National Heart, Lung, and Blood Institute. Ted Skolarus reports grants from the National Institutes of Health/National Cancer Institute (R01 CA242559 and R37 CA222885) and royalties from UpToDate. Kristian Stensland reports a grant from the National Institutes of Health/National Cancer Institute (T32 CA180984).

Figures

FIGURE 1
FIGURE 1
Conceptual model of a smoking cessation intervention. (A) Description of core components and adaptable periphery. (B) Examples of applied core components and adaptable periphery in a hypothetical smoking cessation intervention.
FIGURE 2
FIGURE 2
Conceptual model of a clinical trial as a complex intervention. (A) Description of core components and adaptable periphery. (B) Examples of applied core components and adaptable periphery in a hypothetical clinical trial.
See this image and copyright information in PMC

References

    1. Guidelines NCCN. NCCN clinical practice guidelines in oncology: prostate cancer. Published online February 2, 2021. Accessed February 5, 2021. https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf
    1. May M. Clinical trial costs go under the microscope. Nat Med. Published online March 6, 2019. doi:10.1038/d41591-019-00008-7 - DOI
    1. Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials: race‐, sex‐, and age‐based disparities. JAMA. 2004;291(22):2720. doi:10.1001/jama.291.22.2720 - DOI - PubMed
    1. Stensland KD, McBride RB, Latif A, et al. Adult cancer clinical trials that fail to complete: an epidemic? J Natl Cancer Inst. 2014;106(9):dju229. doi:10.1093/jnci/dju229 - DOI - PubMed
    1. Treweek S, Pitkethly M, Cook J, et al. Strategies to improve recruitment to randomized trials. Cochrane Database Syst Rev. 2018;2:MR000013. doi:10.1002/14651858.MR000013.pub6 - DOI - PMC - PubMed

Publication types