Sponsor-Facilitated Relationships Between Late Stage Researchers and Phase 1 Sites: A Novel Model for Early Phase Studies

Typically, early phase studies are conducted in somewhat of an isolated fashion, evaluating safety and pharmacokinetic/pharmacodynamic data in healthy volunteers (for non-oncology/rare disease studies) at clinical pharmacology units first. Target patient populations are occasionally incorporated into these early phase trials, with the objective of efficiently gaining insight into how the drug might perform during future testing. The issue with this model is that the studies are conducted mostly in a vacuum — at units that largely won’t be involved during Phases 2-3 — and without the oversight from the investigators who will be responsible for the patients and outpatient conduct in later stages of testing.

Incorporating patient populations into early phase studies is not a new practice, however, the current model of identifying one, or multiple, Phase 1 units with access to the patient population and conducting the study at that location still comes with many challenges. Fundamentally, Phase 1 sites don’t have access to historical records or charts to narrow down eligibility, as physician offices and late phase researchers do, and are reliant upon patient’s self-diagnosis, which leads to ineffective enrollment. While Phase 1 sites can expect a certain level of response to their marketing efforts, these may not be enough to meet the previously agreed-upon enrollment expectations and can be considerably inefficient and costly. Conversely, late phase researchers don’t have the Phase 1 unit inpatient capabilities that the project requires.

How can drug development companies overcome this hurdle? WCCT Global believes that the key to successful studies with patient populations is for sponsors to facilitate relationships between the sites hosting their early phase studies and the investigators they plan on utilizing for Phase 3. By involving late stage investigators into Phase 1 study planning and conduct, sponsor companies can achieve more successful patient enrollment, gain valuable input on future study designs based on investigator feedback, as well as identify potential risks and strategize on prevention for late stage programs. Furthermore, with this valuable information, financial investments can be better protected by producing early efficacy signals during early phase testing. In this webinar, WCCT Global will discuss strategies for the successful alignment of late-stage focused investigators and sites into the Phase 1 model and best practices for implementation.

Speaker

Maria Apkarian, Vice President, Early Clinical Development, WCCT Global

Ms. Apkarian has been working in the clinical research industry since 1999, starting her career as a Phlebotomist for a Phase I unit. Having held numerous positions during the span of her career, she has gained an excellent balance of leadership expertise, practical clinical skills, and insight into the drug development process. Maria is well-versed in all aspects of a CRO and clinical site management including coordinating, regulatory affairs, project management, staffing, training, clinical monitoring, business operations, partner relations, and medical consulting. As a specialist in early phase studies, Maria possesses relevant knowledge in specialty therapeutic areas such as Pediatrics, Gynecology, Pulmonology, Rheumatology, Renal, Ophthalmology, Gastroenterology, and Oncology.

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