How can you ensure successful enrollment of your Phase 1 studies in patients?
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.
On Wednesday, October 31st at 10am PST (1pm EST), WCCT Global will take part in a webinar which will offer drug development companies strategies for overcoming this hurdle. The webinar will be presented by WCCT’s Vice President of Early Clinical Development, Maria Apkarian. Space is limited, so register today!
By attending this webinar, sponsors can learn:
- How to identify the best Phase 1 sites to run your study based on relationships with investigators that are planned to participate in Phase 2-3
- How to maximize the usage and responsibility of Phase 1 sites
- How to position late stage researchers to successfully support patient recruitment for early phase studies
- How to best leverage the knowledge gained from early phase studies and incorporate into late stage trials, including risk identification and prevention
REGISTER FOR THE WEBINAR!
This webinar will focus on how the strategies sponsors can implement to ensure successful enrollment in Phase 1 studies with patients through facilitating relationships between Phase 1 sites and late stage investigators, as well as the potential benefits to late stage trials.