How to Prepare for Early Phase Trials with a Specific Patient Population

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When moving to a Phase 1 clinical trial, your company might decide that you want to include a specific population for several reasons. Whether it’s targeting a particular trait for a cohort(s) of the study or the study is using Ethnobridging, you might have more variables to factor into the study than the average Phase 1 clinical trial. Here are some additional participant-related considerations to keep in mind when planning for your clinical trial.

Consider the Study Design

Are you planning on enrolling the specialty population simultaneously as the general participants? It can be challenging to randomize a full cohort of over 8 participants concurrently in the same way a normal healthy volunteer cohort would be structured. In our experience, allowing for flexibility in scheduling confinement and follow-up visits can be beneficial and attractive to patients and in turn make the study easier to enroll. If the specialty population cohort won’t be enrolled until all NHV cohorts have been completed, then you should be certain that the Phase 1 site is actively working to identify patients during that time such that there are no delays when it is time to randomize.

Consult with Recruiting Physicians for Your Standard of Care

Consult with the recruiting physicians to understand the standard of care for the specific population. For example, there could be a discrepancy between medical requirements in the protocol and common treatments patients are receiving. As long as trial objectives can still be achieved, it may be worthwhile to remove or adjust certain criteria that would exclude otherwise-eligible trial participants.

Strategize Recruitment

Patient recruitment for your first in human clinical trials can take a few forms, such as database mining, community outreach, physician referrals, marketing, and even collaborating with recruitment companies. Recruiting for a cohort with a specific trait or condition is not always straightforward, and you may need to classify patients based on disease severity or state. You will need to develop additional recruitment strategies to determine how recruiting the cohort could impact your budget. You may need to hire a specialist to confirm participants’ eligibility.

Accommodate Patients

Compared to normal healthy volunteers who regularly participate in multiple studies, patient population may not be familiar with how clinical studies are conducted. You may need to accommodate their unique lifestyles, circumstances, and obligations. While general participants may stay in Phase 1 clinical trial units overnight on weekdays, the cohort might require weekend visits. Instead of full cohort check-in dates, you may need open enrollment to avoid disrupting their normal schedules.

Take Procedural Considerations into Account

Procedures in your protocol could potentially deter patients from participating, such as if you need participants to return daily for a complex procedure. Therefore, you will need to assess the value of all your procedures, as they could look better on paper than in practice.

Consider the Impact on Budget

Phase 1 clinical trials are often more expensive than later phases due to increased participant commitment and staffing needs. It’s best to have realistic expectations, considering that participants and specialists are all people, so things like recruiting, accommodating schedules, and managing relationships can impact your budget.

About WCCT Global, an Altasciences company

As a full-service early phase contract research organization (CRO), WCCT Global, an Altasciences company, caters to the biotechnology, pharmaceutical, and medical device industries. Partners sponsoring a clinical trial with WCCT can take advantage of an innovative, collaborative, and agile approach to clinical research. This CRO utilizes specialized regulatory and clinical professionals to create an unmatched research experience for trial sponsors. WCCT also offers partners access to vital resources for early clinical development, such as an 80,000-square-foot clinical pharmacology unit (CPU) with 180 beds for Phase 1 clinical trials. The CPU includes a USP-797 compliant room for sterile drug preparation and a CLIA-certified and CAP-accredited on-site Safety Reference Laboratory. With extensive Phase 1 clinical trial experience, WCCT offers partners expertise in Ethnobridging, First-in-Human, infectious disease and vaccines, ophthalmology and women’s health clinical trials. The CRO is also known as an industry leader in Asian Ethnobridging studies, particularly with Japanese participants.

Learn how WCCT can support your Phase 1 clinical trial at https://sponsor.wcct.com/

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