Past
Prospective randomized clinical trials provide the highest quality evidence to guide changes in practice. However, these trials are expensive to conduct and take significant time from design to completion. Once presented and published, it can take up to 17 years for a clinical trial to be widely disseminated and incorporated into practice1–2. In addition, other changes in diagnosis and treatment can reduce the relevance of the findings and hinder implementation. Altogether, this limits the benefit to patients from these clinical trial findings.
Present
There is stronger awareness of the lost opportunities when trials do not meet their targeted accrual goals3. The National Clinical Trials Network (NCTN) has set time limits to decrease the time from concept development to protocol activation and encourages collaboration between the different cooperative groups to enhance enrollment. Additionally, ongoing clinical trials are increasingly being discussed at national meetings, such as the Society of Surgical Oncology (SSO) and American Society of Clinical Oncology, which increases awareness. Results from recently completed clinical trials are presented at national meetings and at times appear in publication in tandem to minimize delay between presentation and peer-reviewed publication. The Education Committee of the American College of Surgeons Clinical Research Program (ACS CRP) has focused on several methods for increasing awareness about ongoing and recently completed oncology trials in order to hopefully reduce the time with which clinical trial results can be delivered to the public. The committee organizes investigator meetings at national meetings (such as the SSO annual meeting) to allow for updates by the investigators and feedback from clinicians who are currently enrolling patients. They also publish monthly articles in the ACS Bulletin about ongoing trials and recently reported surgical oncology trials.
The Dissemination and Implementation Committee of the ACS CRP has developed a process of presenting clinical trial results for multidisciplinary review and discussion at tumor boards4. Several Commission on Cancer accredited hospitals participated in the initial pilot studies where short videos were developed to provide the key findings from clinical trials. Survey instruments were used prior to and following the video to assess knowledge gaps and barriers to implementation. Some of these videos and survey tools are now available on the ACS learning management system at https://learning.facs.org/.
Future
To maximize the dissemination and implementation of clinical trial findings, future trials can incorporate aspects of clinical trial implementation in the study design. The Effectiveness-Implementation hybrid design studies the efficacy of the clinical intervention while simultaneously evaluating the implementation of the clinical intervention5. Deploying implementation strategies a priori may help bridge the gap between clinical trial data and real-world cancer care.
Footnotes
Publisher's Disclaimer: This Author Accepted Manuscript is a PDF file of an unedited peer-reviewed manuscript that has been accepted for publication but has not been copyedited or corrected. The official version of record that is published in the journal is kept up to date and so may therefore differ from this version.
Financial Disclosure: The follow authors have no relevant financial disclosures: Park, Mamounas, Katz, Unzeitig, Carpizo, You, Francescatti, Boughey
Kelly K. Hunt reports the following disclosures: Medical Advisory Board – Armada Health and Merck & Co., research funding to my institution – Endomag, Lumicell, OncoNano
References:
- 1.Contopoulos-Ioannidis DG, Alexiou GA, Gouvias TC, Ioannidis JPA. Medicine. Life Cycle of Translational Research for Medical Interventions. Science. 2008;321(5894):1298–9. [DOI] [PubMed] [Google Scholar]
- 2.Morris Z, 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):510–20. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Park K, Mamounas EP, Katz MGH, et al. Clinical Trials for the Surgical Oncologist – Opportunities and Hurdles. Ann Surg Oncol. 2020;27(7):2269–75. [DOI] [PubMed] [Google Scholar]
- 4.Dickson-Witmer D, Blair S, Boughey JC. ACS CRP Dissemination and Implementation Committee Issues Call for Participants in Pilot Project. ACS Bulletin June 1, 2017. (https://bulletin.facs.org/2017/06/acs-crp-dissemination-and-implementation-committee-issues-call-for-participants-in-pilot-project/) [PubMed]
- 5.Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation Hybrid Designs: Combining Elements of Clinical Effectiveness and Implementation Research to Enhance Public Health Impact. Med Care. 2012;50(3):217–26. [DOI] [PMC free article] [PubMed] [Google Scholar]