Improving Enrollment in Cancer Clinical Trials

Nancy B. Connolly

Dona Schneider

Ann Marie Hill

ONF 2004, 31(3), 610-614. DOI: 10.1188/04.ONF.610-614

Purpose/Objectives: To identify successful strategies for clinical trial recruitment.

Design: Survey research.

Setting: New Jersey institutions actively recruiting patients for clinical trials.

Sample: 84 clinical research nurses directly involved with patient recruitment were surveyed, and 50 responded (60% response rate).

Methods: Focus group; 34-item, direct mail questionnaire; follow-up telephone interviews; and descriptive statistics.

Main Research Variables: Strategies for patient recruitment and retention.

Findings: Respondents agreed most strongly about the importance of emphasizing to patients that treatment would not be compromised and keeping physicians informed of available protocols. Respondents felt the most effective strategies for increasing public awareness of clinical trials were to highlight participants in past trials and to stress the value of clinical trials through campaigns sponsored by nonprofit organizations. Compared to other respondents, those from cancer centers were significantly less concerned about educating physicians on the value of clinical trials. Focus group and telephone interview participants reported that patient retention in cancer trials was a lesser issue because enrollees tend to be motivated to continue.

Conclusions: Successful recruitment may depend on how a patient is approached about participation, keeping physicians abreast of available trials, and the level of awareness the public or a patient has about clinical research prior to considering it as a treatment option.

Implications for Nursing: Research nurses often are the first to interact with patients considering clinical trial participation and remain involved throughout the trial experience. Depending on the research setting, they are likely to be more informed about available protocols than physicians. Research nurses are in a position to build rapport with and advocate for patients. Strategies to increase enrollment and retention should actively involve these key personnel.

Jump to a section


    Barrett, R. (2002). A nurse's primer on recruiting participants for clinical trials. Oncology Nursing Forum, 29, 1091-1098.

    Collyar, D.E. (2000). The value of clinical trials from a patient perspective. Breast Journal, 6, 310-314.

    Crosson, D., Slevin, R., & Keany, J. (1993). Role of the cancer information service in a national education initiative on cancer clinical trials. Journal of the National Cancer Institute Monographs, 14, 131-137.

    Ehrenberger, H.E., & Aikin, J.L. (2003). Article highlights importance of clinical trial nurses [Letter to the editor]. Oncology Nursing Forum, 30, 12.

    Ellis, P.M. (2000). Attitudes towards and participation in randomized clinical trials in oncology: A review of the literature. Annals of Oncology, 11, 939-945.

    Finn, R. (2000a). Oncologist's role critical to clinical trial enrollment. Journal of the National Cancer Institute, 92, 1632-1634.

    Finn, R. (2000b). Surveys identify barriers to participation in clinical trials. Journal of the National Cancer Institute, 92, 1556-1558.

    Grunfeld, E., Zitzelsberger, L., Coristine, M., & Aspelund, F. (2002). Barriers and facilitators to enrollment in cancer clinical trials: Qualitative study of the perspectives of clinical research associates. Cancer, 95, 1577-1583.

    Joseph, R. (1994). Viewpoints and concerns of a clinical trial participant. Cancer, 74, 2692-2693.

    Lara, P.N., Higdon, R., Lim, N., Kwan, K., Tanaka, M., Lau, D.H., et al. (2001). Prospective evaluation of cancer clinical trial accrual patterns: Identifying potential barriers to enrollment. Journal of Clinical Oncology, 19, 1728-1733.

    Loh, W.Y., Butow, P.N., Brown, R.F., & Boyle, F. (2002). Ethical communication in clinical trials. Issues faced by data managers in obtaining informed consent. Cancer, 95, 2414-2421.

    Roberson, N.L. (1994). Clinical trial participation: Viewpoints from racial/ethnic groups. Cancer, 74, 2687-2691.

    Tattersall, M. (2002). Cancer clinical trial recruitment: The emerging role and perspectives of clinical research associates and data managers [Editorial]. Cancer, 95, 1397-1400.

    Underwood, S.M., & Alexander, G.A. (Eds.). (2000). Participation of minorities and women in clinical cancer research [Special issue]. Annals of Epidemiology, 10(Suppl. 8).

    Wright, J.R., Crooks, D., Ellis, P.M., Mings, D., & Whelan, T.J. (2002). Factors that influence the recruitment of patients to phase III studies in oncology: The perspective of the clinical research associate. Cancer, 95, 1584-1591.