4 Keys to a Successful Phase 1 Clinical Trial

Many of the factors that can lead to a successful Phase 1 clinical trial involve the setup of the trial itself. Early clinical development, especially Phase 1 trials, will set the pace, standards, and trajectory for the remainder of the clinical development program. Having the right staff and resources can help avoid delays and hidden costs, streamlining the clinical trial and producing a successful study. Here are some of the factors to keep in mind that can help increase your chance for a smooth, successful clinical trial.

Access to Potential Participant Databases

When your organization moves to first in human clinical trials, you need participants. If you have access to potential participant databases before you start recruiting, then the work of establishing a pool of potential participants has already been done. Generally, it’s easiest to partner with a contract research organization that already has access to databases or specific populations of potential participants. This contributes to the overall success of the clinical trial by streamlining your recruiting process and allowing you to choose from participants who will be less likely to drop out of the study.

Streamlined Recruiting

A streamlined recruitment process can mean getting more participants in less time than a less organized process. Additionally, recruiting materials are vital to helping with the recruitment process. A staff that is experienced in creating recruiting materials and criteria can help your organization start the clinical trial sooner. Best of all, when your staff has experience creating participant-facing materials, those recruiting materials can help ensure that participants are well-informed about the clinical trial even before going through the recruitment process.

Trained Staff

From a staff that understands regulations to those that can create the proper documents to doctors and nurses that understand the specific procedures for your organization’s clinical trial, utilizing trained staff from the beginning of the clinical trial process can help ensure the trial operates smoothly and successfully. While you can certainly seek out staff members that have the necessary experience on your own, it could be worth partnering with a CRO that already has direct experience with Phase 1 clinical trials and offers access to their trained staff. Because of their expertise, the staff may even be able to advise on other matters, such as participant transportation, stipends, creating appropriate trial procedures, and other vital processes.

Availability of Essential Resources

Having the resources your organization needs to conduct the clinical trial from the start can make a significant difference in whether your trial is ultimately successful or not. Instead of obtaining resources as your trial progresses, having access to all the necessary resources, like Phase 1 clinical trial units, can inform your processes and procedures before they even begin. Knowing what is readily available to you can help make the startup process more efficient, whether you have access directly or through a vendor. A CRO can help here, as well. The best CROs are typically able to offer the resources you might need, or they will have a list of approved vendors for any resources they don’t have on hand, eliminating the need to search for those resources elsewhere.

About WCCT Global, an Altasciences company

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

Learn more about partnering with WCCT for a clinical trial at https://sponsor.wcct.com/

Original Source: https://bit.ly/2Vry4fi