Addressing Challenges in Cancer Trials Accrual: A Look in the Mirror

The problem

Cancer research professionals know that participation in cancer treatment clinical trials is a key measure for delivery of quality cancer care. For example, “the best management for any patient with cancer is in a clinical trial,” according to the National Comprehensive Cancer Networkguidelines. And, according to a recent Institute of Medicine (IOM) committee report, all participating physicians should “strive to make participation in clinical trials a key component of clinical practice and to achieve…high accrual rates of 10 percent or more.”(1)  Yet-- adult trial participation in the U.S. remains under 3%,(2,3,4) with even lower participation rates among ethnic and racial minorities and people over 65.(5,6,7) Only between 9 and 20 percent of cancer patients are informed about the option of participating in a cancer treatment trial.(8,9,10,11,12) Even at major cancer centers, oncologists may not approach all eligible patients about participation(13,14) and patients from minority groups or who are 65 or older may be less likely to be approached, regardless of eligibility.(15,16,17,18,19) Because cancer treating institutions are credentialed by the access they provide to clinical trials, it is critical to identify practical, evidence-based approaches to maximize the efficiency of recruitment, accrual, and retention efforts.

Oncology professionals struggle with accrual for many reasons, well documented in the literature.(20)  Often overlooked are barriers related to ineffective operational procedures(21,22) poor community relationships, and ineffective physician-patient communication.(23,24) The Education Network to Advance Cancer Clinical Trials (ENACCT), a nonprofit clinical trials advocacy organization, has conducted research, training and consulting work with over 30 cancer centers and community oncology practices. Over the past seven years, ENACCT has noted a number of persistent challenges to accrual, often well within the control of the local institution or oncology practice:

Challenges around procedures and policies

• A systemized process for trial selection is seldom employed, often relying on individual physician interest. This leads to poor patient/trial match, inconsistent organizational commitment to a study, and low accrual rates.(25)

• About 30% of accrual sites (substantially more based on ENACCT’s experience) have no systematic approach to screening patient charts for patient eligibility.(26)

• Very few institutions have outlined any requirements for its physicians to enroll patients into the institution’s open trials(27).

Challenges around clinician behavior and skills

• In most accrual sites, approximately 70% of patients are recruited by 30% of participating physicians and 33% of affiliated physicians do not accrue any patients(28)

• Due to poor screening systems, all eligible patients are not approached about participation

• The quality of the discussion around clinical trials as a treatment option is highly variable, with no best practices as to when and how the topic should be introduced in relation to standard of care.(29,30)

• Assessment of comprehension of the consent process is seldom implemented.

• Assumptions about treatment preferences (i.e., standard care)(31,32) are often made before discussions about cancer clinical trials  are ever raised.

Getting down to solutions

How do the policies and procedures of your own institution or clinic ensure that each and every patient has meaningful access to clinical trials?  In institutions/clinics who offer trials, we need to ensure that a) 100% of cancer patients are screened for clinical trial eligibility and  b) 100% of eligible patients are approached about clinical trial participation. We must improve commitment to trials for all staff —from the front desk to the medical assistant to the accruing physician; and strengthen provider skills in better communication around cancer trials.(33,34,35) In those institutions who don’t offer trials, we must ensure education and referral is more than a brochure and a phone number in a new patient folder.  

(See Commission on Cancer Program Standards 2012, Version 1.1: Ensuring Patient-Centered Care)

Developing realistic and practical procedures to ensure meaningful access can help institutions/clinics efficiently reach the 2015 minimum clinical trial accrual percentages outlined by the Commission on Cancer. Over the past few years, ENACCT has been working with community oncology practices and cancer centers to examine their policies and procedures and help them make changes for more efficient accrual, especially for minority populations,  based on the broad goals and actions outlined in the table below.

We can all point to numerous barriers to accrual outside of our control, but by taking an honest look in the mirror, we can make impactful changes within our control to help maximize access to clinical trials for all of our patients.

REFERENCES CITED

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2 Christian MC & Trimble EL. Increasing participation of physicians and patients from underrepresented racial and ethnic groups in National Cancer Institute-sponsored clinical trials. Cancer Epidemiology Biomarkers & Prevention. 2003;12(3):277s-283s.

3 Cancer clinical trials: A resource guide for outreach, education, and advocacy. (2006). Retrieved from the NCI web site: http://www.cancer.gov/clinicaltrials/resources/outreach-education-advocacy.

4 Digest Page: Boosting Cancer Trial Participation. (2008). Retrieved from the NCI web site: http://www.cancer.gov/clinicaltrials/digestpage/boosting-trial-participation.

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7 Stewart et al. Participation in Surgical Oncology Clinical Trials: Gender-, Race/Ethnicity-, and Age-based Disparities. Annals of Surgical Oncology. 2007;14(12):3328–3334.

8Comis RL & Miller, J. D. Cancer clinical trials awareness and attitudes in cancer survivors. Philadelphia: Coalition of Cancer Cooperative Groups; 2005.

9 Comis RL, Miller JD, Aldige CR, Krebs L, Stoval E. Public attitudes toward participation in cancer clinical trials. Journal of Clinical Oncology : official journal of the American Society of Clinical Oncology 2003;21:830-5.

10 Comis RL, Miller JD, Colaizzi DD, Kimmel LG. Physician-related factors involved in patient decisions to enroll onto cancer clinical trials. Journal of Oncology Practice / American Society of Clinical Oncology 2009;5:50-6.

11 Fenton L, Rigney M, Herbst RS. Clinical trial awareness, attitudes, and participation among patients with cancer and oncologists. Community Oncology 2009;6:207-13.

12 Ford JG, Howerton MW, Bolen S, et al. Knowledge and access to information on recruitment of underrepresented populations to cancer clinical trials. Evidince Report Technoly Assessessment (Full Rep) 2005:1-11.

13 Albrecht TL, Eggly SS, Gleason ME, et al. Influence of clinical communication on patients' decision making on participation in clinical trials. Journal of Clinical Oncology : official journal of the
American Society of Clinical Oncology 2008;26:2666-73.

14Hinshaw LB, Jackson SA, Chen MY. Direct mailing was a successful recruitment strategy for a lung-cancer screening trial. Journal of Clinical Epidemiology 2007;60:853-7.

15 Sateren WB, Trimble EL, Abrams J, et al. How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials. Journal of Clinical Oncology : official journal of the American Society of Clinical Oncology 2002;20:2109-17.

16 Ford JG, Howerton MW, Lai GY, et al. Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review. Cancer 2008;112:228-42.

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18 Simon MS, Du W, Flaherty L, et al. Factors associated with breast cancer clinical trials participation and enrollment at a large academic medical center. Journal of Clinical Oncology : official journal of the American Society of Clinical Oncology 2004;22:2046-52.

19 Wendler D, Kington R, Madans J, et al. Are racial and ethnic minorities less willing to participate in health research? PLoS Medicine 2006;3:e19.

20 Nass SJ, Moses HL, Mendelsohn J. (eds) National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program. Committee on Cancer Clinical Trials and the NCI Cooperative Group Program. 2010. Institute of Medicine of the National Academies.

21 Ulrich CM, James JL, Walker EM, Stine SH, Gore E, Prestidge B, Michalski J, Gwede CK, Chamberlain R, Bruner DW. RTOG physician and research associate attitudes, beliefs and practices regarding clinical trials: implications for improving patient recruitment. Contemporary Clinical Trials. 2010 May;31(3):221-8.

22 Umutyan A, Chiechi C, Beckett LA, et al. Overcoming barriers to cancer clinical trial accrual: impact of a mass media campaign. Cancer 2008;112:212-9.

23 Comis RL, Miller JD, Colaizzi MA, Kimmel LG. Physician-related factors involved in patient decisions to enroll onto cancer clinical trials. Journal of Oncology Practice 2009;5(2):50-6.

24 Albrecht TL, Eggly SS, Gleason MEJ, et al. Influence of Clinical Communication on Patients' Decision Making on Participation in Clinical Trials. Journal of Clinical Oncology: official journal of the American Society of Clinical Oncology 2008;26(16): 2666-73.

25 Dilts DM & Sandler AB. The ‘Invisible’ Barriers to Clinical Trials: The impact of Structural, Infrastructural, and Procedural Barriers to Opening Oncology Clinical Trials. Journal of Clinical Oncology: official journal of the American Society of Clinical Oncology 2006;24(28):4545-52. 

26 Ulrich CM, James JL, Walker EM, Stine SH, Gore E, Prestidge B, Michalski J, Gwede CK, Chamberlain R, Bruner DW. RTOG physician and research associate attitudes, beliefs and practices regarding clinical trials: implications for improving patient recruitment. Contemporary Clinical Trials 2010 May;31(3):221-8.

27 Petrelli NJ, Grubbs S, Price K. Clinical trial investigator status: you need to earn it. J Clin Oncol. 2008 May 20;26(15):2440-1.

28 Klabunde CN, Keating NL, Potosky AL, Ambs A, He Y, Hornbrook MC, Ganz PA. A population-based assessment of specialty physician involvement in cancer clinical trials. J Natl Cancer Inst. 2011 Mar 2;103(5):384-97.

29 NCCN Trends™ Surveys and Data, March 2012 http://www.nccn.org/about/news/ebulletin/2012-05-14/trends.asp

30 Ulrich CM, James JL, Walker EM, Stine SH, Gore E, Prestidge B, Michalski J, Gwede CK, Chamberlain R, Bruner DW. RTOG physician and research associate attitudes, beliefs and practices regarding clinical trials: implications for improving patient recruitment. Contemporary Clinical Trials 2010 May;31(3):221-8.

31 NCCN Trends™ Surveys and Data, March 2012 http://www.nccn.org/about/news/ebulletin/2012-05-14/trends.asp

32 Ulrich CM, James JL, Walker EM, Stine SH, Gore E, Prestidge B, Michalski J, Gwede CK, Chamberlain R, Bruner DW. RTOG physician and research associate attitudes, beliefs and practices regarding clinical trials: implications for improving patient recruitment. Contemporary Clinical Trials 2010 May;31(3):221-8.

33 Wendler D. Are racial and ethnic minorities less willing to participate in health research? PLoS Medicine 2006 Feb;3(2):e19. Epub 2005.

34 Ford, J.G., et al. Knowledge and access to information on recruitment of underrepresented populations to cancer clinical trials. Evidence Report: Technology Assessment (Summary), (122) 1-11.

35 Teal CR, Shada RE, Gill AC, Thompson BM, Frugé E, Villarreal GB, Haidet P.  When best intentions aren't enough: helping medical students develop strategies for managing bias about patients. Journal of General Internal Medicine 2010 May;25 Suppl 2:S115-8.

36 NCI template at http://ncccp.cancer.gov/files/CT_Screening_Accrual_Log_v8.2_20120608.pdf37 Wujcik D, Wolff SN. Recruitment of African Americans to National Oncology Clinical Trials through a clinical trial shared resource. J Health Care Poor Underserved. 2010 Feb;21(1 Suppl):38-50.

38 Petrelli NJ, Grubbs S, Price K. Clinical trial investigator status: you need to earn it. J Clin Oncol. 2008 May 20;26(15):2440-1.

39 NCI NCCCP Recommendations for Medical Staff Conditions of Participation http://ncccp.cancer.gov/files/NCCCP-Conditions-of-Participation.pdf

40 Wendler D. Are racial and ethnic minorities less willing to participate in health research? PLoS Medicine 2006 Feb;3(2):e19. Epub 2005.

41 Ford, J.G., et al. Knowledge and access to information on recruitment of underrepresented populations to cancer clinical trials. Evidence Report: Technology Assessment (Summary), (122) 1-11.

42 Teal CR, Shada RE, Gill AC, Thompson BM, Frugé E, Villarreal GB, Haidet P.  When best intentions aren't enough: helping medical students develop strategies for managing bias about patients. Journal of General Internal Medicine 2010 May;25 Suppl 2:S115-8.

43 Wujcik D, Wolff SN. Recruitment of African Americans to National Oncology Clinical Trials through a clinical trial shared resource. J Health Care Poor Underserved. 2010 Feb;21(1 Suppl):38-50.