4 Pitfalls to Avoid in Phase 1 Clinical Trials
Posted by WCCT Global on February 8th, 2021
A Phase 1 clinical trial will be one of the most critical parts of your clinical development program. It sets the tone and pace for the rest of development and will be the first of many significant resource commitments on your company’s part. For example, if you’re a start-up biotech firm, early clinical development is absolutely critical in keeping your company’s momentum going. Here are some frequently seen pitfalls for clinical trials and how to avoid them.
Improper Volunteer Recruitment
One of the most important parts of first in human clinical trials is recruiting. If you have improper volunteer recruiting methods, it can cause significant timeline delays, which will be costly. You need to establish clear criteria for inclusion, for example, the target age, gender, and ethnicity. The study design will matter, as volunteers have different levels of familiarity and interest in clinical trials. You might need to advertise more, for example, for studies that require overnight stays. There should also be proper contingency planning, as unexpected life events can affect volunteers.
Not Having the Proper Equipment and Resources
Another crucial aspect of a Phase 1 clinical trial is having the right equipment and resources to carry out the trial. That means you might need to outsource to phase 1 clinical trial units, specifically set up to carry out clinical trials. If you are a biotech start-up, you might not have such a facility, especially if you need to keep volunteers overnight for the study. Or, you might not have a pharmacy or laboratory with the necessary equipment or available staff. It’s a good idea to find a contract research organization (CRO) to partner with that has the right resources to help your clinical development.
Not Understanding Factors in Budgeting
There are a number of factors that affect budgeting for a Phase 1 clinical trial. Managing the study design and resourcing, developing a recruitment strategy to accommodate a specialty subject population, stipends for volunteers, and other procedural considerations can all affect a budget. It’s best not to underestimate the budget and try to plan as much as possible. Try to team with a CRO with experience in Phase 1 clinical trials to help you create a more accurate budget projection.
Lack of Experience with Phase 1 Clinical Trials
Not having experience with Phase 1 clinical trials can be a significant detriment to your study. How, then, does your company get experience if it is a new start-up? How do you know whether to keep your participants overnight, how to structure study visits (e.g. scheduling phone calls versus in-person appointments), or what stipend will entice participants to join the study? Much of this information and insight is only gained through experience; but a reputable Phase 1 CRO will partner with you to help lead a successful clinical trial, as well as share the knowledge and experience with your team.
About WCCT Global
WCCT Global is a full-service contract research organization (CRO) catering to the pharmaceutical, biotechnology, and medical device industries. With specialized regulatory and clinical professionals, WCCT offers an innovative, collaborative, and agile approach to every program delivered. They offer their partners a 75,000-square-foot clinical pharmacology unit (CPU) with 180 beds, perfect for Phase 1 clinical trials. They also offer an on-site, CLIA-certified and CAP-accredited Safety Reference Laboratory and a USP-797 compliant pharmacy. With extensive Phase 1 clinical trial experience, WCCT’s areas of expertise include First-in-Human, SAD/MAD, PK/PD, BA/BE, and devices. They focus on Ethnobridging, First-in-Human, infectious disease and vaccines, ophthalmology, women’s health, and nicotine and tobacco clinical trials and are an industry leader in Asian Ethnic Bridging studies, specifically with Japanese participants.
Partner with WCCT Global to help your company gain experience by sponsoring a Phase 1 clinical trial at https://sponsor.wcct.com/
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