Clinical Trials Strategy
For more information, reach out to our Innovator Support Lead:
Dr. Julia Berzhanskaya
Dr. Martin can help you find answers to the following questions:
- Do you have a clinical development plan driven by the indication you seek, and is it aligned with the regulatory and reimbursement plans?
- Will the clinical trial/s required to achieve your indication be ethical and feasible (time, logistics, cost, etc.)?
- What will you compare yourself to i.e. what drug/device/biologic/molecule will be used as the control arm in the clinical trial and why? Do you need a comparator, or is a cohort study sufficient?
- What level of evidence (I,II,III, or IV) is required for FDA clearance for your indication and to achieve the reimbursement you require? Can you complete both endpoints in the same trial?
- How large of a clinical improvement (margin of superiority) do you expect, or is clinical inferiority sufficient for your value proposition (reduced LOS, OR time, fewer side effects etc.)?
- What are the early projections of the sample size and the type of clinical trial required?
- How difficult will the trial be to recruit for and enroll? 50-60% of trials fail to complete enrollment.
About Kim
Kimberly Martin, PhD is the founder and Principle at Boulder Clinical Science. Dr. Martin is a trained and well published clinical scientist, and brings 25 years of experience in translating drug, device, and biologics products from the bench to the clinic and the market. Dr. Martin spent over 20 years in industry at major firms such as Medtronic/Covidien and Zimmer Biomet in which she led clinical teams in design and execution of clinical trials, and in scientific and healthcare economic due diligence of acquisition target technologies. In her role at Boulder Clinical Science, Dr. Martin has extensive experience assisting small start-up companies with a clinical strategy that dovetails with business needs and regulatory strategy. Dr. Martin has served as a clinical liaison between the company and the FDA to bring hundreds of medical technologies to market. Dr. Martin earned her bachelor’s in molecular biology from the University of Missouri-Columbia and Her Masters and PhD in Clinical Science from the University of Colorado Anschutz Medical Campus.