How to ensure compliance before your medical device trial begins

By Sandra Maddock, IMARC

The only way to gain the FDA approval you need to bring your medical device to market is to ensure compliance at every stage in the clinical trial lifecycle.

That starts long before you sign up your first subject.

The planning stage is crucial because it sets expectations for how your team will work together to collect data, monitor results and protect your trial’s subjects.

In this post, the first in a three-part series, we’ll cover five important steps you can take to ensure compliance before you start your medical device trial.

Have a regulatory strategy

A regulatory strategy aligns compliance activities with the business strategy, direction and structure your team needs to bring your medical device to market.

Developing this strategy is a team effort that starts by identifying important questions about the product. For instance, is your device considered substantially equivalent to another device already on the market? If so, it may be eligible for the 510(k) FDA approval process, which may or may not require human testing.

If it’s a new device unlike anything else on the market, it will need to undergo the full premarket approval process. You will also need to consider the type of medical device, its intended use and the implications.

Establish study protocols

Assuming your device requires a clinical trial, you need to establish protocols for moving forward with your trial.

Proper protocol development is a balancing act.

You want to ensure you are protecting patients without making your trial overly restrictive to the point that it will be difficult to enroll enough people. It can be helpful to review recommendations from relevant industry groups as you consider your study protocol. For instance:

• The American Society of Echocardiography recommends against using echocardiograms before or during surgery for patients with no history or symptoms of heart disease
• The Society of Nuclear Medicine and Molecular Imaging recommends against routine annual stress tests using a nuclear heart scan after coronary artery surgery
• Several groups advocate for reducing the use of CT, PET and MRI scans for a variety of ailments

Once the protocols are in place, your entire team will need to follow them to the letter. Any planned protocol deviation — such as enrolling subjects whose age falls outside the exclusion criteria — must have prior IRB approval. Unplanned protocol deviations will likely catch an auditor’s attention and could compromise your data.

Conduct a risk assessment

Every medical device trial requires a different approach depending on the risks involved.

Some require intensive training of investigators or study staff, specialized equipment, and/or close oversight. While some may require frequent monitoring visits, others may only need an initial monitoring visit, remote data review and subsequent visits as needed. That’s why it’s critical to understand those risks before you begin. For instance:

• Are your study subjects seriously ill, elderly or very young?
• How experienced is the staff at the investigative site(s)?
• Does the site have a previous history of missing data, errors or protocol deviations?
• How complex is the study? Are your endpoints subjective or objective?
• What is the geographic distribution of the clinical sites?

Enlisting a contract research organization (CRO) with experience in risk-based monitoring can help you identify issues you may not have considered.

Develop risk-based study plans

Once you understand the risks, you have a responsibility to mitigate them as much as possible.

That may mean adjusting your approach to project management, communication, training, data management and/or monitoring or outsourcing additional support. For instance, you may need to hire engineers to assist in training the sites, imaging experts to train ultrasound techs, additional monitors to provide adequate oversight, or even onsite research coordinators to assist the clinical sites with the demands of the clinical trial.

Train your team

The FDA requires that investigators involved in the clinical research process be qualified by training and experience, and that those to whom they delegate be qualified. However, there are no standard clinical research training requirements specified by law. That means that each clinical research team may have different degrees of knowledge and experience.

To ensure your clinical trial is conducted in a well-controlled, compliant manner, start with ensuring your project team is well-trained on the regulatory requirements. A strong project team is better positioned to support the clinical sites involved in their trial if they are knowledgeable about the regulatory requirements. In turn, provide robust clinical research training to the clinical sites to ensure human subject protection and data integrity. Everyone involved in the trial should understand the FDA requirements and how to apply them. To learn more about the benefits of training your team and justifying it in your budget, check out this resource.

Taking the next step

Having a well-planned clinical trial is the best way to ensure compliance and be sure your device ultimately makes it to market.

Given all that must be done before that, you are no doubt eager to get started as soon as possible. However, if there was ever a time to apply the old adage, “measure twice, cut once,” it is during the planning stages of a clinical trial.

Taking the time to assess your trial’s risks, making plans to mitigate them and providing your team with proper training will help you avoid FDA violations and costly delays later.

IMARC has two decades of experience overseeing medical device trials in a variety of areas. Our team works closely with yours at every stage in the process, from assessing risks and developing protocols to reviewing your trial master file at the end of the study.

Our monitors can provide valuable third-party oversight throughout your trial or serve as auditors to spot-check your in-house monitors. We can help you manage your entire trial or serve as consultants to help you address one specific area. We can also train your team to be as self-sufficient as possible, which is the most cost-effective approach to compliance. If you would like to learn more about the benefits of planning your regulatory strategy, writing a solid protocol, assessing risks, writing strong study plans, or training your team please contact us.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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