Developing a Trial

Successful clinical trial accrual begins at the protocol writing stage. The earlier in the trial's lifecycle that you plan for accrual, the more likely the trial is to recruit enough participants to answer its scientific questions. Many clinical trials close without accruing a single participant.

Beyond the scientific merit of a proposed clinical trial, protocol developers should think carefully about how the field as well as potential participants might receive the trial.

In developing a protocol, consider competing trials, the availability of the study population, and ways to reduce the study burden on sites and participants.


Lifecycle Strategy 1

Consider national and local stakeholder enthusiasm for the trial

Take a realistic look at the state of the science on this topic. How much interest do you expect to find for your trial among your colleagues, institutional leadership, and researchers across the country?

Lifecycle Strategy 2

Evaluate the trial for recruitment feasibility

In order for a trial to be “recruitable,” study sites must see enough potential participants who meet the eligibility criteria (e.g., who have a particular type and stage of cancer or relevant biomarker). Trials have failed because no one checked this.

Lifecycle Strategy 3

Choose study sites carefully

In recruitment, a site’s past performance can predict future success. A strong recruitment history suggests that a site's staff is experienced with clinical research and that they know the patient population, how to reach them, and how to select trials that fit the site’s strengths.

Lifecycle Strategy 4

Prepare trial-specific materials

People who feel familiar and comfortable with the concept of a clinical trial are more open to being part of one. Try to see your material as a participant would. Always keep trial-specific materials participant friendly, culturally appropriate and balanced when describing the costs, benefits, and goals of the trial.