Introduction to clinical research
Clinical research involves investigating health and illness in individuals. It primarily encompasses two types: observational studies and clinical trials.
1. Observational studies: These studies observe individuals in everyday settings, collecting data and analyzing changes over time. For example, researchers might survey older adults about their exercise habits and conduct monthly memory tests to explore the link between physical activity and cognitive health. While they don't assess specific medical interventions, observational studies can help identify new treatments or prevention strategies for clinical trials.
2. Interventional trials: These research studies evaluate a medical, surgical, or behavioral intervention in individuals. They are the main method researchers use to assess the safety and effectiveness of new treatments or prevention strategies, such as new drugs, diets, or medical devices (like pacemakers). Typically, a clinical trial aims to determine whether a new treatment is more effective or has fewer harmful side effects than current options.
Other objectives of clinical research include:
- Developing methods for early disease diagnosis, often before symptoms appear
- Identifying strategies to prevent health issues, especially in healthy individuals at higher risk
- Enhancing the quality of life for those living with life-threatening diseases or chronic conditions
- Exploring the impact of caregivers and support groups.
Trial design
Clinical trial design is a crucial element of interventional trials, aiming to optimize, streamline, and economize the trial process. A clinical trial's primary objective is to assess an intervention's efficacy, safety, or risk-benefit ratio, with goals that may include demonstrating superiority, non-inferiority, or equivalence. A well-designed study, grounded in a robust hypothesis derived from clinical practice, plays a key role in advancing evidence-based practices. High-quality, well-powered trials contribute significantly to the meta-analytical evidence base, expanding our understanding of dermatological practice. The design of a clinical trial outlines the sequence and structure of activities aimed at uncovering cause-and-effect relationships, as defined by the research question. All trials begin with a single group of participants (the COHORT), chosen to represent a specific disease population. This cohort is then divided into two or more groups, each receiving either an intervention or a comparator. The groups are observed for the OUTCOME of interest, and the difference in outcomes between the groups is calculated to assess the effect of the intervention.
These four factors are commonly summarized using the acronym PICO:
- Population
- Intervention
- Comparator
- Outcome
