Identify target minority therapeutic clinical trial enrollment proportions and identify gaps between actual and target enrollment.

We’ll begin with recruitment goals

Recruitment goals for minority participation need to be developed to gauge the success of recruitment strategies and to enable study personnel to know if and when the strategies need adaptation.

Recruitment strategies should be crafted to specifically meet the recruitment goals. Multiple targeted strategies may be needed.

Next, identify your center’s target minority therapeutic clinical trial enrollment proportions.

Ideally a cancer center’s trial enrollment will reflect the proportions of racial and ethnic groups in its catchment area. The best target enrollment will reflect cancer cases within the catchment area.

You can also access state population data for comparison to your center’s enrollment.

Census for state population data can be found on the census.gov website.

Or search for your state’s cancer case population. For example, in Minnesota you can search on apps.health.state.mn.us/ by ethnicity and by age.

Compare your cancer center’s catchment area to state.

Does your cancer center use a catchment area a smaller or larger area than a state? If so, what are strategies for identifying ideal enrollment proportions for non-state catchment areas? For example counties surrounding your metro, or a catchment area that includes neighboring states.

Use the gathered information to create enrollment targets

Your targeted enrollment should be at a minimum the same proportion of racial and ethnic minorities as the proportion of cancer cases within your catchment area.

We’ve developed three learning activities…

Identify a hypothetical cancer center’s minority enrollment targets.

Identify gaps between actual and target enrollment.

And monitor accrual and percent of enrollment target over time.

First, let’s identify a hypothetical cancer center’s minority enrollment targets

If you haven’t downloaded the worksheet, do so and determine the target enrollment for Whites and Native Hawaiians/Pacific Islanders using both state population data and cancer cases.

Begin by Inputting Targets

Input Targets for Minority Enrollment in Clinical Trials
Input Targets for Minority Enrollment

For Race/Ethnicity – White

24.28 percent Population Based Target

9 percent Cancer Case Based Target

For Native Hawaiian/Pacific Islander

9.37 percent Population Based Target

11.4 percent Cancer Case Based Target

Next, We’ll Identify Gaps Between Actual And Target Enrollment

Your trial has currently enrolled 736 subjects.

38 are Native Hawaiian/Pacific Islander and 271 are white.

Now compute the actual enrollment and identify the gaps.

Compute Actual Representation by dividing the number enrolled of a specific race/ethnicity by the total number enrolled

Compute Actual Representation of Minorities in Clinical Trials
Compute Actual Representation

 

Compare Actual and Target Enrollment

Comparing Actual and Target Enrollment in Clinical Trials
Comparing Actual and Target Enrollment by Race/Ethnicity

Among Whites, the gap for population based and cancer case based is none, whites are over represented in your trial

But for Population based Native Hawaiian/Pacific Islander, only 55.07% of your target are enrolled. Your trial has a 44.93% enrollment gap

And for Cancer case based Native Hawaiian/Pacific Islander, 45.26% of target is enrolled with a gap of 54.75%.

Notice, using a population based target results in a smaller enrollment gap, but is a less accurate representation of potential trial enrollees.

Now, you can identify enrollment gaps.

Identify Gaps Between White and Minority Enrollment
Identify Enrollment Gaps

Monitor Accrual and Percent of Enrollment Target over Time

First, create a baseline of where the cancer center currently stands. Track how close you are to your targeted goal. What is that percentage? Recalculate your enrollment again every 6-12 months. Are you closer to your goal? Do you need to apply an intervention to close significant enrollment gaps?

Here’s a sample chart tracking progress.

Monitor Accrual and Percent of Enrollment Target Over Time
Quarter 1 Shows a Marked Decrease–Apply Another Intervention if Needed

Quarter 3 shows an increase over Quarter 2. An intervention is applied at the end of Quarter 3 and Quarter 4 shows an even larger enrollment increase. It looks like your intervention was successful.

But Quarter 1of the next year shows a steep decline. Perhaps your intervention wasn’t as effective as you had hoped.

You reassess and apply an additional intervention if needed. The following three quarters show a consistent increase in enrollment.

Now that you have your targeted enrollment, compare the current proportions of racial and ethnic minorities enrolled in your trials.

Have you met your target? Great!

If you haven’t met your target, identify where the gaps are:

  • For African Americans, Hispanic Whites, and/or other racial and ethnic groups?
  • In certain age groups?
  • For certain cancer sites?

Pinpointing the gaps will help you determine what interventions may be most effective.

In summary

Ideally a cancer center’s enrollment of racial and ethnic minority patients will be representative of those populations in its catchment area. It is essential to identify goals for minority recruitment and track progress toward those goals.

This presentation has been brought to you by EMPACT, enhancing minority participation in clinical trials.