What Are Clinical Trials?

Clinical trials are carefully designed research studies where volunteers collaborate with researchers to test new ways to understand, prevent, detect, or treat diseases. These studies evaluate the safety and effectiveness of new approaches such as new drugs, medical devices, medical products and diagnostic tests on human subjects.

Each trial follows a detailed protocol approved by regulatory agencies like the FDA in the United States and by Institutional Review Board (IRBs), ensuring ethical practices and reliable results.

While many people associate clinical trials with testing new medicines, they encompass much more. Researchers study everything from surgical procedures to lifestyle interventions, such as diet or exercise plans, to improve health outcomes and to answer research questions.

Clinical trials are crucial for advancing healthcare, bringing new therapies to patients, and enhancing overall quality of life. Learn more about how clinical trials work and clinical trial protocols.

Clinical trials transform innovative ideas into real-world medical solutions. They provide the data needed to:

• Ensure a treatment’s safety and effectiveness.

• Compare new treatments to current standards of care.

• Understand potential risks, side effects and possible benefits.

• Identify how treatments work for specific conditions.

These studies are integral to the drug approval process, offering critical evidence for regulatory agencies to decide if treatments should become available to a large number of patients.

Participation in clinical trials provides access to cutting-edge treatments and offers potential benefits, especially for those with medical conditions unresponsive to standard therapies. Healthy volunteers also play an essential role in advancing medical innovation, helping researchers answer critical research questions and develop therapies for previously untreatable conditions.

While participation involves potential risks, every trial is carefully reviewed by an institutional review board to ensure that the study is conducted ethically and safely, protecting the well-being of all participants.

Please read on article on "Why Participate in Clinical Research" for more information.

Clinical trials fall into two main categories: Interventional Clinical Trials and Observational Clinical Trials. Interventional studies test treatments, while observational studies monitor participants without interventions.

Interventional trials actively test the impact of specific experimental treatments, procedures, or preventative measures. Participants are divided into groups, with one group receiving the intervention (e.g., a new drug or medical device) and the other group (called control group) receiving a standard treatment or a placebo.

These trials are conducted in phases, from small group Phase 1 trials to large groups Phase 3 trials, ensuring a thorough evaluation of safety and efficacy. Learn more about clinical trial phases.

Types of interventional studies can include:

• Treatment Trials: Assess the safety and effectiveness of new therapies.

• Prevention Trials: Explore ways to prevent diseases or stop them from recurring.

• Diagnostic Trials: Develop more accurate and earlier diagnostic methods.

• Quality of Life Trials: Improve care and comfort for people with chronic conditions.

Observational trials (also called clinical research or studies) do not involve specific treatments or interventions. Instead, researchers monitor participants over time, collecting data on health outcomes, risk factors, and disease progression.

These studies are essential for answering research questions, understanding the natural history of diseases and optimizing existing treatments.

Before reaching clinical trials, potential treatments undergo the drug development process: a rigorous process to ensure they are safe and promising:

• Drug Discovery: Scientists screen thousands of compounds to identify candidates.

• Preclinical Testing: The most promising compounds are tested in labs and animals.

• IND Submission: Researchers submit an Investigational New Drug (IND) application to regulatory agencies, outlining safety data and trial protocols.

• Clinical Trials: After approval, the treatment progresses through Phase 1, 2, and 3 trials to assess safety, efficacy, and side effects.

• NDA Submission: A New Drug Application (NDA) is submitted for regulatory approval.

This stringent process ensures that only the safest and most effective experimental treatments make it to patients.

Clinical trials are the cornerstone of medical progress, bridging the gap between laboratory research and real-world patient care. They enable researchers to translate groundbreaking discoveries into treatments that improve lives and set new standards in healthcare.

Understanding clinical trials is key to appreciating how new therapies, medical devices, and diagnostic tools become available. Whether you’re a potential participant or a curious reader, clinical trials play a vital role in shaping the future of medicine.

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