The arguments in favor of a clinical decision in medical device trials
Clinical adjudication, also known as endpoint or event adjudication, has become a critical part of the clinical research ecosystem. Currently, many trials involve external adjudicators, usually physicians, to validate the sponsor’s interpretation of the data and provide an additional layer of unbiased confirmation that regulators may need to approve new therapies.
The FDA pays close attention to medical devices and uses a much more rigorous pre-market approval (PMA) process than the traditional 510 (k) when a predicate device is not available. For manufacturers of new and potentially high-risk devices, this means that general controls will be insufficient to prove their safety and effectiveness, and rigorous scientific documentation will be required to bring them to market. This rigor motivates Class III medical device trial sponsors to engage experienced independent third parties to help ensure that the meticulous clinical investigation requirements of the ART application are properly met and to mitigate the risk of delays.
The Clinical Investigations section of the PMA app includes study protocols, safety and efficacy data, adverse reactions and complications, device failures and replacements, patient information, patient complaints. patients, data tables of all individual subjects and results of statistical analyzes, among other details. information.
These are all important parameters in assessing the impact of a device on disease progression, although clinical endpoints that measure the effect on morbidity and mortality represent the highest standard for patients. , providers and regulatory authorities. The emphasis on evaluation criteria is the driving force behind the growing engagement of independent referees in these carefully supervised trials.
Benefits of clinical arbitration
Compared to drug trials, device trials are generally smaller; difficult to blind, randomize and control; and strongly depend on the technique of the doctor. Perhaps more importantly, the endpoints are very diverse. Clinical judgment adds value to these trials by bringing in impartial and highly specialized experts to evaluate a device against pre-established criteria to determine patient safety and clinical efficacy.
Specific problems that frequently arise in device trials and which can be addressed with clinical judgment include:
- Study bias. The study team may be inherently biased because they truly believe in the safety of the device under study. Despite the best intentions, there may also be bias arising from a lack of clinical balance among researchers, pressures from institutional quality assurance programs, and the financial implications of overcoding events. Engaging independent parties who are not invested in the device or connected to the sponsor eliminates these problems.
- Inconsistent event definitions. Definitions of clinical events / endpoints often do not match between sites around the world, creating potential discrepancies in how events are classified and reported. For example, what constitutes a myocardial infarction varies from country to country. This problem is only magnified in large multicenter and increasingly global trials, but can be solved by centralized decision-making, which pre-establishes consistent event definitions.
- Lack of scientific rigor. Evaluation of clinical events / endpoints by an independent panel of adjudicators ensures the process is conducted with a rigor that can withstand scrutiny by various study stakeholders, from regulatory bodies to patients.
Manufacturers of medical devices would be wise to adopt independent clinical judgment as soon as possible, as safety standards are likely to become even more stringent over time. As the scientific community continues to advance the capabilities and inventions of medical devices, the pressure will only increase to bring the devices to market faster. Proof of efficacy without causing harm can be guaranteed by a thoughtful and independent clinical evaluation process.