Understanding the Complexity and Uniqueness of Phase I Trials

In clinical research, working with organizations that understand the ins and outs of the phase of your trial is key to a smooth, collaborative relationship. When Advarra announced its acquisition of IntegReview IRB, it gained the ability to provide a more customized service for IRB review during early phase research. Together, Advarra and IntegReview IRB’s expanded suite ensures the highest quality ethical oversight and unparalleled customer service at every phase of research.

What Makes Phase I or Early Phase Studies Unique?

While each phase in research poses specific nuances, perhaps the most particular and crucial phase is Phase I, or early phase studies. The purpose of a Phase I trial is for researchers to find the maximum tolerated dose that can be safely given in the research. Doses are given until a side effect outweighs the expected benefit of the hoped-for treatment or until researchers reach the desired effect. Once a safe dose is identified, the investigational drug is eligible to move on to a Phase II trial to measure its efficacy.

Early phase trials are extremely fast-moving; more so than the succeeding phases. Typically in a Phase I trial, researchers are only working with a handful of participants – roughly 15 to 30 – to ensure the utmost safety as they learn more about the drug. The protocol and consent may go through a number of revisions as information relating to side effects becomes apparent, impacting the initial calculations relating to the doses set out in the protocol. This process typically takes several tries to understand what the correct dosage should be and understand the side effects that offset each dosage.

Phase I research may enroll only healthy volunteers or may be geared to a specific health condition. Phase I research involving healthy volunteers typically involves payment to subjects and often limitations on travel and movement during participation in the study. Phase I research that focuses on a specific condition such as pancreatic cancer will enroll a population that most likely has exhausted all existing treatment options and thus may well view participation in the research as a therapeutic option.

An IRB’s Role in a Phase I Study

Since Phase I studies differ from later phases, an IRB needs to understand the implications in order to best work with their sites. Speed and flexibility are pivotal, and utilizing an IRB that will understand and work with a site to answer questions quickly is important to getting an early phase study off the ground. Working in an early phase study leaves little room for variation, and time is of the essence when recruiting potential participants. Sites need to partner with an IRB that understands how critical it is to turn approval back to them in a timely manner, so the study moves forward.

IntegReview IRB joins Advarra’s robust array of clinical research technology, services, and expertise, expanding the scope to assist clients in Phase I studies. With more than 20 years’ experience in the clinical research industry, IntegReview IRB is the market leader in early phase clinical research, enabling Advarra to provide clients with expanded, comprehensive review solutions. With each of their five Boards meeting daily, IntegReview IRB understands the nature of a Phase I trial by providing flexibility for their clients. Together with Advarra, both organizations will work to advance clinical research by enhancing research operations for all.

To learn more about Advarra acquiring IntegReview IRB, read the press release.

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