In CRO, Patient Recruitment, Phase 1 Clinical Trials

8 Questions to Ensure Successful Patient Recruitment in Phase 1 Clinical Trials

Phase 1 Clinical Trials are often viewed as “easy” to recruit due to the fact that they are typically performed in “normal healthy volunteers” (NHVs), people with limited or no underlying health conditions that are evaluated to establish a baseline for how a drug will perform in the body. However, there are instances in which non-traditional patient populations (also known as “otherwise normal”) or even patients with chronic conditions will be incorporated into the trial. When this is the case, there are additional complexities and nuances that need to be considered when planning the project’s overall patient recruitment and retention strategies.

Planning should begin at the earliest stages and Sponsors, Outsourced CROs, and Clinical Sites should ask pointed questions in order to help shape the strategy and ensure all items have been considered. To prevent delays caused by low patient accrual, we recommend the below list of questions as a starting point for discussions:

Patient Recruitment Questions for Phase 1 Clinical Trials

1. Are the Inclusion and Exclusion criteria typical for the age group being assessed?

If not, it may be difficult to identify subjects who can fulfill those criteria due to their age. For example, if the study is assessing an elderly population, it may be unrealistic to expect that their vitals are in the same range as the standard NHV aged 18 to 55.

2. Are there any gender specific requirements which could influence the rate of enrollment?

Perhaps the study is enrolling women of child-bearing potential and the inclusion criteria specifies that a normal Pap smear result is required to qualify. Additional time to confirm the result (or to perform a Pap smear at some time during the screening window) will need to be accounted for when making enrollment projections and planning for the initiation of cohorts.

3. Are there any ethnic requirements for enrollment?

If so, there may be language barriers and other cultural sensitivities which will need to be considered when creating subject-facing materials. Additionally, when there is an ethnic requirement, the site should employ staff who can speak in the native language and be involved throughout the recruitment period and during the study to collect accurate data and ensure subjects remain enrolled.

4. When incorporating patients, does the eligibility criteria reflect the standard of care in a healthcare setting?

While the investigational product of course needs to be tested in a population that meets specific criteria, sometimes that criteria is unrealistic compared to how care is truly being administered. For example, patients may commonly be prescribed medication with a regimen that reflects consistent use, but the protocol requires that it is used less regularly. This disparity would likely cause difficulty when identifying eligible participants.

5. If necessary to obtain certain study data, are invasive procedures thoughtfully incorporated to reflect subject needs and preferences?

Sponsors should assess the value of requiring invasive procedures and consult with medical experts when determining a frequency which is both realistic for the subjects and will still allow for the collection of necessary data. If subjects are required to return frequently for invasive procedures, they are likely to drop out from the study or decline to participate in the first place. Another question to ask is whether obtaining data for exploratory endpoints is worth the burden it will place on potential participants.

6. Is the structure of study commitments appealing to the subject population being assessed?

In other words, is the scheduling of in-patient visits versus outpatient visits ideal for that population? Typically, NHVs prefer studies with longer in-patient stays and short follow-up periods, whereas specialty and patient populations prefer studies with more outpatient visits due to other obligations, including the management of their own healthcare schedule. If there is a long follow-up period, additional measures focused on subject retention will need to be implemented.

7. How will patient cohorts be enrolled?

It may prove difficult to enroll a full cohort of patients in the same fashion that NHVs are enrolled. Alternately, an open, “rolling” enrollment can be utilized to accommodate individual subject schedules and more accurately reflect the rate of recruitment for that sub-group and will be more appealing to subjects since they can more flexibly manage their non-study obligations. It would be unfortunate to lose otherwise eligible participants due to a study schedule that was burdensome.

8. Are stipends commensurate with subjects’ expectations?

In 2020, clinical research participants are well-networked, know what their time is worth and will even “shop around” for Phase 1 clinical trials with the best-paying stipends. Sponsors must also consider varying stipend expectations due to the location of the study site. Furthermore, if subjects are required to undergo invasive procedures, the stipend should reflect those as well.

Obtaining answers to these questions early on will help those responsible for subject identification understand how various factors can either positively or negatively impact the success of patient recruitment in Phase 1 clinical trials. Failing to consider various nuances of recruitment in an early phase setting is likely to result in project delays that could have been avoided and may even prevent valuable data from being collected.

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