4 Questions to Ask Before Starting a Phase 1 Clinical Trial
Posted by WCCT Global on March 16th, 2021
When it comes time for your biotech product to advance to the early clinical development phases, there are some questions your company should ask itself before continuing. Your company may not be ready yet or may want to look into outsourcing a clinical trial to a partner. Phase 1 clinical trials are the first of many significant resource commitments and can set the tone and pace for the rest of your product development. Here are some questions your company should be ready to answer before starting clinical trials.
Is Your Company Experienced in Clinical Trials?
The first question to ask is how experienced your company is with clinical trials. Has it performed a Phase 1 clinical trial before? Can your company’s staff create a recruitment plan, assess any risks involved, manage data, develop protocols, and more? If not, you can partner with an experienced contract research organization that specializes in clinical trials.
How Will You Recruit?
Can your company come up with a recruitment strategy that will pass muster? For example, clear criteria for inclusion in a study must be established, such as a target age, gender, or ethnicity. This is one of the most critical parts in the early phases of clinical trials, and improper recruiting during a Phase 1 clinical trial can cause significant timeline delays, which will be costly.. Your company will need to manage everything, including the study design, standard of care, recruitment strategy, advertising, and any other concerns unless you work with a CRO.
Do You Have the Proper Resources?
Next, do you have the proper resources? You might need, for example, Phase 1 clinical trial units for overnight studies. Do you have or have access to a laboratory that is both accredited and certified? Is there a clean room for sterile drug preparation available? Resources can be a significant aspect of a Phase 1 clinical trial, and if your company lacks the resources, it is best to partner with a CRO. If the CRO does not have all the resources necessary, the CRO likely has a list of qualified sub-contract vendors.
Do You Need to Do Ethnobridging?
The next question also concerns recruiting, but in a slightly different way. Are you thinking about launching your products in other countries? Then you’ll want to perform Ethnobridging while doing your Phase 1 clinical trial. Ethnobridging helps reduce the cost and production time involved with launching products internationally. A high-quality Ethnobridging process recruits participants in a “global” manner without needing to leave the country, as you will likely do in phase 2 and 3 efficacy trials. Using an Ethnobridging strategy can also eliminate the need to conduct repeat Phase 1 studies in other areas of the world, such as Asia.
About WCCT Global
A full-service contract research organization (CRO), WCCT Global caters to the pharmaceutical, biotechnology, and medical device industries. Utilizing clinical and specialized regulatory professionals, WCCT offers partners a collaborative, innovative, and agile approach with every program the WCCT team delivers. When partnering with WCCT, they can provide resources, including a 75,000-square-foot clinical pharmacology unit (CPU) with 180 beds, ideal for conducting Phase 1 clinical trials, especially with an overnight component. They also offer an on-site Safety Reference Laboratory that is both CLIA-certified and CAP-accredited, as well as a USP-797 compliant room for sterile drug preparation. WCCT has extensive Phase 1 clinical trial experience, with areas of expertise including Ethnobridging, First-in-Human, infectious disease and vaccines, ophthalmology, women’s health, and nicotine and tobacco clinical trials. They are an industry leader in Asian Ethnic Bridging studies, specifically with Japanese participants.
Get the help you need with Phase 1 clinical trials by partnering with WCCT Global at https://sponsor.wcct.com/
Original Source: https://bit.ly/3qz5eTR
