The Nurse's Role in Recruitment and Retention of Clinical Trial Participants

ONCNG Oncology NursingApril 2009
Volume 3
Issue 2

Recruiting patients to participate in clinical trials is a challenging and time-consuming endeavor, especially when it comes to cancer clinical trials.

Recruiting patients to participate in clinical trials is a challenging and time-consuming endeavor, especially when it comes to cancer clinical trials. Even when barriers to enrollment are overcome, patients must be retained. This may present the greatest challenge, as clinical trials often take many years to complete. With the proper tools, oncology nurses can have a considerable impact on enrollment and retention of clinical trial participants

In the United States, less than 5% of adult cancer patients participate in drug trials annually.1 In some cases, trials have to be terminated because not enough people enroll. Yet, participation is crucial to identify new treatments and improve survival, with the strongest evidence of this coming from the pediatric oncology community. According to Robert Comis, MD, president and chairman of the Coalition of National Cancer Cooperative Groups, “Participation of children with cancer through the good graces of their parents is remarkably higher than the adult level, probably closer to 60%—70%. Many of us, including pediatric oncologists, believe that the tremendous increase in survival seen in pediatric cancer is very much linked to the clinical trials process and opportunities.”2

Why is there such a discrepancy between pediatric and adult enrollment into clinical trials? There are numerous barriers to adult enrollment, but the most prevalent involve patient fears and misperceptions. Three of the most common concerns are:

1) Fear that quality of life will be reduced; 2) concern over being assigned a placebo instead of active treatment; and 3) worry that there will be pronounced side effects.3

Even when a trial manages to enroll enough participants, there is no guarantee the trial will be completed. In some cases, clinical trails take up to 8 years to finish, during which patient retention is crucial. If too many individuals drop out, the trial will end prematurely and the trial results may never be published. Recruitment tools and education help ensure that this does not occur.

With the help of investigators and other staff, oncology nurses can help raise awareness and interest among the public and in their communities about clinical trials. What follows is a list of some of the tools we use at Duke University Medical Center to recruit and retain patients in clinical trials conducted at our institution:

1) Referral lists. We use a referral list from our clinic to contact patients. After a patient is seen by their physician, a nurse will get in touch with them to educate them on the relevant trials that are currently available.

2) Community outreach. Our community outreach program enables some of our trials to be conducted in hospitals and other community practices that have oncologists affiliated with our institution. There are several hospitals in our area, some with their own institutional review board (IRB), that are able to offer these trials, helping to reduce travel for participants.

3)Support groups. We have disease-specific support groups run by social workers. These will sometimes include nurse practitioners who present general, up-to-date information about treatments.

4)Websites. We direct our patients to helpful Websites and invite them to ask any questions about the information presented there or elsewhere. Some particularly useful Websites are,, and

5)Patient handouts. We try to create patient handouts for each trial. The challenge with this is that everything we provide has to be approved by our IRB. So, before you could implement something like this at your institution, you would need to check with your local IRB to determine their regulations.

6)Direct call number. We give our patients the direct call number for the National Cancer Institute (1-800-ACS-2345), which can provide them with information about their diagnosis. This is especially useful for older patients who may not own a computer or have Internet access.

Patients spend considerable time with nurses throughout their treatments and often feel more comfortable around them than around physicians and other health care providers. Nurses can take this opportunity to educate their patients on any trials relevant to them. Numerous recruitment tools and educational materials are readily available to facilitate this, but sometimes all it takes is a little encouragement and enlightening after listening to a patient’s concerns.

Roxanne Williams-Truax, RN, BSN, OCN, is a research nurse clinician with the Duke Clinical Cancer Trials Services at Duke University Medical Center.


1. Wikipedia. Clinical trial. Accessed April 6, 2009.

2. Coalition of Cancer Cooperative Groups. Accessed April 6, 2009.

3. National Cancer Institute. Study Identifies Cancer Patients’ Concerns About Joining a Trial. Accessed April 6, 2009.

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