Author: ahuschens

The clinical trial landscape for new medicines and medical devices continually expands. Working with a software provider that has extensive experience in this area is becoming increasingly important for sponsors and clinical research organizations (CROs).  Although similar goals are shared, there are inherent differences between clinical trials for the two product types.

Regulatory requirements, clinical study designs, and the on-site team composition reflect this disparity, making drug trials typically longer and more complex than device trials. In this blog post, we’ll explore the key distinctions and show you how ClinFlows can support you along the way by simplifying complex study workflows, especially concerning medical imaging and data exchange.

Navigating the Regulatory Maze

Pharmaceuticals: A Rigorous Approval Process

In the United States, market approval for medicines is regulated by the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA). After extensive clinical studies, manufacturers submit a New Drug Application (NDA) or Biologics License Application (BLA). This process ensures that new medicines are safe and effective for public use.

In Europe, the responsible regulatory authority is the European Medicines Agency (EMA). In collaboration with National Competent Authorities (NCAs) drugs are approved centrally or through national regulatory routes, depending on the market entry strategy chosen by the manufacturer.

Despite both regions demanding rigorous testing and post-market monitoring, the structure and execution of these regulations differ, impacting timelines and complexity.

Medical Devices: Risk classification is key

For manufacturers of medical devices, it is a different situation. Here, the regulatory focus shifts to a detailed examination of engineering, mechanical function, and the device’s performance (efficiency) in the body.

Unlike pharmaceuticals, medical devices are categorized by risk classes:

• Low- to Moderate-Risk Devices: Class I/II in the USA and Class I/IIa in Europe. Comparable data are often available for these devices, potentially bypassing the need for clinical investigations.
• High-Risk Devices: Class III devices, in the USA, and Class IIb/III devices, in Europe, require more extensive scrutiny.

In the United States, the FDA’s Center for Devices and Radiological Health (CDRH) manages market authorizations of high-risk devices through a Premarket Approval (PMA). For low-risk devices, the 510(k) process is utilized.

In Europe, the Medical Device Regulation (MDR 2017/745) mandates clinical investigations for all Class IIb/III devices with Notified Bodies assessing data for CE marking.

Clinical Trials: Different Paths to Market

Pharmaceuticals: Standard Progression through Phase 1-3

Clinical drug trials are highly structured and typically follow these phases:

1. Phase I: Evaluates safety and dosage in a small group of healthy volunteers.
2. Phase II: Explores efficacy and side effects in a larger patient group with the target condition.
3. Phase III: Confirms effectiveness, monitors side effects, and compares the drug to commonly used treatments in large populations.

Drug development can often take up to 10+ years, with a few exceptions, such as specific fast-track or orphan drug designations. The long timelines are mainly caused by the extensive clinical testing required and the fact that manufacturers cannot speed up the process by risk classification and clinical equivalent data of existing therapies.

Medical Devices: A More Flexible Approach

• Pilot Studies: Evaluate safety and functionality in a small group of patients
• Pivotal Studies: Confirm safety and efficiency in a larger patient population, akin to Phase III in pharmaceuticals.

Bringing a medical device from concept to approval takes approximately 3 to 7 years.

Phase IV: Ongoing Surveillance for Both

Phase IV refers to post-market surveillance studies to continuously monitor the product’s safety and efficacy or performance in the general population. Both pharmaceuticals and medical devices engage in this crucial phase to ensure long-term patient protection.

The Stakeholders on-site: Who’s Involved?

Behind every successful clinical trial is a dedicated team of professionals on-site:

• Investigators: In pharmaceutical trials, investigators are usually physicians with extensive expertise in a specific therapeutic area. In medical device trials, investigators can also be surgeons, specialized clinicians, or technical experts.
• Clinical Research Coordinators and Study Nurses: Manage daily study operations, patient coordination, and data collection.
• Technical Staff: Certain clinical investigations require medical imaging staff on site for DICOM data collection and image-based patient eligibility checks. Additionally, device trials, often involve highly trained technicians and programmers to set up, maintain, and calibrate devices. In drug trials, there is no need for this technical expertise.

Understanding the different team compositions and tasks on-site in drug and medical device trials can enhance collaboration between sponsors, CROs, and software providers and help to efficiently manage your clinical workflows.

How ClinFlows Can Simplify Your Clinical Study?

When it comes to medical imaging, ClinFlows is your trusted partner.

In early-phase trials, patient data and medical images (DICOMs) need to be reviewed to determine eligibility.  We provide you with the necessary tools to quickly and safely exchange this information with other stakeholders, for second opinions and/or screening reviews. You can ensure that the right patients participate in the trial while saving great time and travel expenses.

Do your projects involve central imaging reads? Then quality checks of images, timely communication, and data handling between different electronic systems can sometimes be a challenge. With almost 15 years of experience, we know about the particularities of medical image exchange in clinical drug and medical device trials. We can tailor our online solutions to your specific needs, making complex workflows easily manageable.

Ready to optimize your clinical trials? Contact ClinFlows today to discover how we can assist with medical imaging and data exchange.