Selecting & Preparing to Open a Trial

"“Should this clinical trial be opened at my site?” This is an important question and the answer isn't always "Yes!"  By selecting trials you can recruit to, your site is far more likely to advance cancer research and avoid the costs of opening trials that will not accrue.  

A clinical trial is more likely to succeed—and more likely to advance science—when the research team and the trial site are well-prepared to recruit and retain participants.. Before your trial opens, set up smooth and successful accrual by writing a trial-specific recruitment and retention plan. Writing this plan enables you to carefully think through all the necessary activities related to accruing participants and keeping them involved.


Lifecycle Strategy 1

Evaluate your institution’s clinical trial portfolio and participant population

Realistically assess your site’s potential to recruit participants for the protocol. Does the trial fill a gap in your institution’s existing portfolio? Or are other trials competing for the same participants? Think about the trial from the participant perspective—consider financial issues as well as study logistics.

Lifecycle Strategy 2

Assess your institution’s infrastructure and resources

Get feedback from key staff, evaluate the financial implications, and assess resource requirements before deciding whether to open a study. Does the protocol require specialized training of staff, testing of specimens, or new equipment? Ensure that your organization can meet the requirements or expand its capacity to perform the protocol.

Lifecycle Strategy 3

Ensure stakeholder commitment

Scientific interest and clinical relevance are keys to generating investigator interest in a trial. A clinical ‘champion’ can help spread the word, generate support, and advocate for necessary resources. Listen to the opinions of the research team and front line staff –their commitment is essential to success.

Lifecycle Strategy 4

Create a clinical trials friendly environment

Creating a ‘culture of clinical trials’ means that everyone—from staff to patients—knows that clinical trials are an essential part of your organization. It means that everyone in the organization, from receptionists, to billing clerks, from lab techs to managers, know their role in the clinical trial process. It means that you talk about clinical trials to patients and you listen to their questions and address their concerns.

Lifecycle Strategy 5

Plan internal processes to conduct the trial

Eliminate recruitment barriers by planning logistical processes and training staff. If it doesn’t already exist, create a study start-up check list. Anticipate issues that are likely to come up and plan solutions early. Improve your protocol knowledge and hone your skills by role-playing the informed consent process with a colleague.

Lifecycle Strategy 6

Write a comprehensive recruitment and retention plan

The importance of writing your plans cannot be overstated. Writing assures that you have done the thinking that will enable the trial to accrue enough participants. Written plans for recruitment and retention should give a brief background on the trial and spell out how you plan to identify potential participants. Include ways to communicate with referring physicians, community members, in-house staff, and participants. Address promotion and evaluation. Above all, tailor plans to your trial and your organization.