Clinical Trial Protocol Design
WHY IS THIS IMPORTANT?
Clinical evidence demonstrating safety and efficacy is not only critical for meeting regulatory requirements (through risk-benefit assessment) to be able to market your device, it’s valuable to clinicians and patients in understanding the preferred use of your device, health systems, and physicians in making purchasing decisions, and payers in evaluating product value and making reimbursement decisions.
Your clinical trial design can be maximized to serve a dual market access purpose, allowing you to generate evidence for multiple stakeholders.
Before conducting your study and generating evidence, your clinical protocol must be approved by regulators and institutional review boards. Your protocol should detail your study objective(s), the rationale for conducting the study, study design, methodology, key definitions of primary events, situations requiring data to be excluded, data management and analysis techniques, and more.
DID YOU KNOW?
The cost to conduct a pivotal study is typically in the millions. Depending on your device’s risk stratification (i.e., class designation), it may not be necessary to conduct a clinical trial for market release in the US. Class I and many Class II devices are typically exempt from needing to conduct clinical studies. In the EU, however, Class I & II devices require clinical evidence of safety and efficacy.
PMA pathways (for Class III devices) typically require manufacturers to provide data from a pivotal study, while 510(k) pathways only require evidence of equivalency to a predicate device.
Study success does not always imply device approval, and study findings often influence device modifications.
HOW WE CAN HELP
From simpler, single-arm trial designs to factorial trials, our experts can help you select the most appropriate study design to generate the evidence your stakeholders need.
Our experts can maximize your pre-approval clinical studies by carefully adding economic endpoints to your planned clinical protocol, collecting crucial payer- and provider-focused data alongside safety and efficacy data in a faster, more cost-effective way. If your studies are already underway and don’t include economic data, we can implement several possible strategies to collect this data.
With a collective 20+ years’ worth of successful FDA and IRB submissions, we can help develop your clinical protocol and handle IRB submissions.
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Maximize Your Pre-Approval Clinical Studies