Different Types of Clinical Trials in the U.S.
Clinical trials for drugs, devices, and diagnostics differ primarily in their objectives, regulatory requirements, and the specific methods used to assess safety and efficacy.
Key differences between clinical trial types
Purpose and Endpoints: Drugs are primarily about therapeutic effects, devices about functional performance, and diagnostics about accuracy and reliability.
Regulatory Pathways: Different regulatory frameworks exist for each category, reflecting their unique risks and benefits.
Study Design: Drug trials are typically more standardized in their phase structure, while device and diagnostic trials might have more varied designs based on the specific technology and intended use.
It’s important to note that the regulatory landscape is continually evolving, especially with the advent of new technologies and combined products (e.g., drug-device combinations). Therefore, staying informed about current regulations and guidelines is crucial for anyone involved in clinical research.
The eight types of clinical trials
Treatment Trials: Test new treatments, medications, or therapies, including drugs, devices, procedures, or behavioral interventions, and can separated into randomized controlled trials and non-randomized trials.
Prevention Trials: Focus on strategies to prevent diseases or conditions and may involve use of vaccines, medications, lifestyle changes, or behavioral interventions.
Diagnostic Trials: Aim to improve or develop new methods for diagnosing diseases or conditions.
Screening Trials: Assess effectiveness of screening methods for the early detection of diseases or conditions in individuals who may not yet show symptoms.
Supportive Care: Also referred to as quality of life trials, they investigate ways to improve the overall well-being and quality of life of individuals with chronic illnesses.
Observational Trials: Gather data by clinicians observing participants in their natural environments or by analyzing existing their medical records.
Crossover Trials: Participants receive multiple, randomized treatments so that each person acts as their own “control,” helping to minimize the impact of individual variability.
Compassionate Use: Also known as expanded access trials, they provide access to experimental treatments for individuals with life-threatening or serious conditions who do not qualify for conventional clinical trials.