Clinical Research: Phase I - Phase 4

Driving Product Development And Finding The Fast Track In Early-Phase Oncology Programs

Your company has received funding for a first-in-man trial of a novel oncology compound. The circumstances are typical: limited budget, uncomfortable timeline, a scarcity of skilled clinical trial professionals, and limited knowledge of regulatory hurdles to form a robust clinical strategy. And you recognize that the success of the drug — and possibly the company — depends on the outcome of this trial.

To complicate matters, your target is a newly validated mutated receptor present in a limited number of cancer patients, with no diagnostic test yet approved. You’re also using an antibody-like molecule that inhibits the receptor’s activity, but also stimulates a potent immune response. Neither the class of drug nor the target has ever been tested in a clinical trial, and much of the preclinical data suggests it will synergize with unapproved newer molecules that are now in later-stage trials.

Companies like yours, at the forefront of personalized medicine, are co-developing — at a very early stage — biomarkers and diagnostic kits to define those patients who will best respond to the therapy. These biomarkers and diagnostics also can yield noninvasive information about whether patients are getting the desired pharmacodynamic effect from the drug.

That’s a lot to consider, but you’re not alone. There are many highly skilled people and organizations to help plan and execute such studies. Some contract research organizations specialize in exactly this type of situation and can help you meet your goals, ideally getting involved immediately after (if not before) you meet critical funding milestones. You want to adopt a one-team approach and an agreed-on definition of attainable objectives, combined with a clinical development plan of engaging the agencies and execution of a high-quality, timely trial at a reasonable cost. This will improve the likelihood of meeting study objectives and establish continuity that aids in development of more advanced trials.

This webinar will highlight the many aspects a company must consider in planning and executing a trial, and how a CRO can help throughout the process. They include:

• Regulatory gap analysis leading to a clinical development plan
• Evaluating available data via a gap analysis
• Optimizing the regulatory pathway (accelerated, fast track, etc.)
• Incorporating regulatory feedback to develop a target product profile

• Defining the objectives of the initial trial
• Go/no-go criteria
• Objectives and adaptive designs in early oncology trials
• Proof of concept, mechanism, efficacy, and target
• Investigator and site identification

• Medical perspective
• Cohort management, site management, and eligibility review
• Safety and independent data monitoring committees
• Clinical efficacy endpoints

• Best practice case study
• Gap analysis and steering the clinical development plan
• Regulators and registration
• Optimization of operational key success drivers