Clinical research is a vital aspect of healthcare that aims to study the safety and efficacy of medical interventions using various types of Clinical trials, which are conducted in different Therapeutic areas and disease indications. As of 2023, the most common therapeutic area within the clinical drug development space is oncology, representing nearly 50% of active clinical trials worldwide. However, when looking within oncological drug trials, it becomes more difficult to pinpoint the most common indication.
Although the terms “therapeutic area” and “indication” are fairly ubiquitous in the clinical research field when discussing the expertise of sponsors and contract research organizations (CROs), they are often used interchangeably, possibly leading to confusion. Read on to learn in detail the differences between therapeutic area and indication in clinical research, along with examples of each for reference.
Understanding Therapeutic Areas of Clinical Research
A therapeutic area is a broad category of medical conditions that require similar medical interventions based on the pathophysiological features of the condition. For example, oncology is a therapeutic area that focuses on the diagnosis, treatment, and prevention of cancer; other therapeutic areas include cardiology, neurology, immunology, and infectious diseases. Therapeutic areas are essential in clinical research because they provide a framework for organizing clinical trials.
By focusing on a specific therapeutic area, researchers can design clinical trials that are specific to the medical condition under study. This approach ensures that the study population is relevant to the research question, and the study outcomes are meaningful. Therapeutic areas are also used to categorize medical interventions. For example, the United States Food and Drug Administration (FDA) classifies therapeutic products based on their therapeutic area and intended use. The FDA also provides guidelines for standards in developing priority therapeutic areas in clinical research, the status of which can be found here.
Understanding Indication in Clinical Research
Indication refers to the specific medical condition or disease for which a medical intervention is intended. In clinical trials, indication is used to describe the target population of the study. The indication is often specific to a therapeutic area, which is a broad category of medical conditions that share similar pathophysiological or pathological features. For example, a clinical trial may target patients with advanced non-small cell lung cancer (NSCLC) as the indication for the study. Indications are critical in clinical research because they define the population under study and determine the specific outcomes that the study aims to achieve. Clear indications can help to generate data that can be used to improve healthcare outcomes for patients with various medical conditions.
The Relationship between Therapeutic Area and Indication
Although therapeutic areas and indications are related, they are not the same thing. Therapeutic area provides a framework for organizing clinical research, while indication provides the specific focus of the clinical trial. It is important to note that research focusing on a specific medical condition or disease can be conducted across multiple therapeutic areas. For example, a clinical trial studying the effectiveness of a new drug in treating hypertension (cardiology therapeutic area) can be conducted across multiple indications such as diabetes, heart failure, or stroke.
Additional Examples of Therapeutic Area and Indication in Life Sciences
To illustrate the difference between therapeutic area and indication, consider the following three examples of clinical trials:
- A clinical trial evaluating the safety and efficacy of a new gene therapy in helping patients with age-related macular degeneration (AMD). This trial focuses on a therapeutic area of ophthalmology and its specific indication is AMD.
- A clinical trial evaluating the safety and efficacy of a new drug in treating patients with rheumatoid arthritis. This trial focuses on a therapeutic area of immunology and rheumatoid arthritis is its indication.
- A clinical trial evaluating the safety and efficacy of a new drug in treating patients with Alzheimer’s disease. This trial focuses on a therapeutic area of neurology and its indication is Alzheimer’s disease.
Therapeutic Areas and Indications in Clinical Research
In conclusion, therapeutic area and indication are fundamental concepts in clinical research that describe different aspects of a clinical trial, and understanding their differences is essential for designing and interpreting clinical trials accurately. A therapeutic area is a broad category of medical conditions, while an indication is a specific medical condition or disease. By using appropriate therapeutic areas and indications, researchers can ensure that their clinical trials are focused, well-designed, and provide meaningful results.
The Role of Therapeutic Areas in CRO Research Services
A CRO is an expert clinical trial company that provides research services to the pharmaceutical, biotechnology, and medical device industries, offering a range of services for sponsors. The term “therapeutic area” is typically an important point of differentiation between these organizations, as sponsors specifically seek out CROs for their specialized expertise across medical diseases. Some choose to hone their experience on one therapeutic area alone, whereas other CROs build a multidisciplinary team that can support multiple disease domains.
Vial is a next-generation, tech-first CRO that is a global leader across nine therapeutic areas: Oncology, dermatology, ophthalmology, gastroenterology, central nervous system (CNS), cardiology, medical device, rare disease, and digital therapeutics. Each of Vial CRO’s are equipped with a curated team of executives and clinical professionals to deliver faster, more efficient clinical trials at dramatically lower costs for biotech sponsors. By deploying technology at every step, we are driving efficiencies in speed and cost savings for innovative biotech companies of all sizes.
Visit Vial CRO’s website or contact a Vial representative today to discover how we are empowering scientists and helping people live happier, healthier lives.
This post first appeared on Why Choose A Site Network For Your Clinical Trials?, please read the originial post: here
