The Importance of a Clinical Trial Strategy

Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions. Collecting those data is a time- and money-consuming endeavor that can put a company’s existence at risk. Companies need to take a mindful approach to clinical studies to mitigate risk and have the best chance at success. Below are some considerations for medical device manufacturers to better achieve this goal.

Defining the Product

Understanding how well-defined your medical device is will correlate with your readiness to conduct clinical trials. Early on, a company may conduct a feasibility trial to understand the safety of the device and to observe any efficacy signals that predict future study success. The device should have a high-level intended use, but the feasibility study will provide insight into the final intended use and indications.

When moving to a pivotal trial, it is imperative companies understand their intended use, indications, and desired claims. FDA’s market authorization will be based on the results of the clinical trial. Understanding the claims necessary to successfully market the device helps ensure the trial is designed to generate evidence not only of safety and efficacy, but also of clinically meaningful benefits that support clinician adoption and reimbursement. A successful clinical trial requires support from all business partners to ensure the data collected meets the needs of the clinical, regulatory, technical, and commercial teams.

Assessing a Clinical Study

There are three main pathways to investigate a medical device. The assessment depends on the risk associated with the investigational device. The pathways differ in oversight, regulatory requirements, and overall resource requirements. A medical device investigation can be considered a minimal risk, nonsignificant risk (NSR), or significant risk (SR) study.

A minimal risk or NSR studies are those where the level of risk only requires study review and approval by an Institutional Review Board (IRB) to receive an Investigational Device Exemption (IDE). In an NSR study, the IRB acts as a proxy for FDA and has certain reporting obligations. A minimal risk study has an expedited review pathway beyond that of even the NSR study. In bypassing FDA, there are other requirements, such as limited documentation and annual reporting, that are abbreviated for these lower-risk studies. Many companies strive to fit within a minimal risk or NSR study, but an honest assessment is required to avoid the risk of capturing data that FDA may refuse to accept based on a disagreement with the risk classification.

An SR study is one that involves an investigational device where the risk level mandates review by FDA. An IDE for an SR device is much more time-intensive and has deeper documentation, reporting, and other requirements. As FDA is involved in the approval of an IDE for an SR device, it is an opportunity to gain FDA alignment without a separate pre-submission.

FDA has a guidance document that walks companies through a risk-based assessment to properly categorize clinical trials. Proper classification of a proposed clinical study is key to a successful pre-market development program.

Key Considerations

Companies should take any available opportunity to burn down risks related to their clinical trials, especially considering the resources required. Companies are advised to:

• Have an FDA Communication Plan: Companies that engage FDA create a more certain outcome than those that do not. There are almost no small companies that can afford a failure when it comes to a pivotal trial. Gaining FDA alignment may be the difference between placing your product on the market and going under.

• Associate with Proper Experts: Clinical studies require proper execution. Working with expert statisticians, clinicians, regulatory counsel, and many others, is the key to proper execution and market success. Finding the right partners early on can save a lot of time and resources on issues that would have otherwise arisen late in the trial.

Any clinical trial is a key moment in a company’s lifecycle. Having the proper strategy to conduct a trial is paramount to success. Keeping in mind these key considerations will only increase the odds for success.

Contact Gardner Law

If you have questions about your clinical program, whether you are just beginning the journey or about to launch a pivotal trial, reach out to Gardner Law.