“Clinical research” refers to studies, or trials, that are done in people. As the developers design the clinical study, they will consider what they want to accomplish for each of the different Clinical Research Phases and begin the Investigational New Drug Process (IND), a process they must go through before clinical research begins.

Researchers design clinical trials to answer specific research questions related to a medical product. These trials follow a specific study plan, called a protocol, that is developed by the researcher or manufacturer. Before a clinical trial begins, researchers review prior information about the drug to develop research questions and objectives. Then, they decide:

• Who qualifies to participate (selection criteria)
• How many people will be part of the study
• How long the study will last
• Whether there will be a control group and other ways to limit research bias
• How the drug will be given to patients and at what dosage
• What assessments will be conducted, when, and what data will be collected
• How the data will be reviewed and analyzed.

The testing of a drug in humans to determine its safety and pharmacologic effectiveness. Clinical R&D is done in phases, which progress from very tightly controlled dosing of a small number of subjects (Phases 1 and 2) to less rigidly controlled studies involving large numbers of patients in Phase-3, Phase-4 and Phase-5 studies. Research in which people, or data or samples of tissue from people, are studied to understand health and disease. Clinical research helps find new and better ways to detect, diagnose, treat, and prevent disease.

Meta-Analysis: A way of combining data from many different research studies. A meta-analysis is a statistical process that combines the findings from individual studies.

Systematic Review: A summary of the clinical literature. A systematic review is a critical assessment and evaluation of all research studies that address a particular clinical issue. The researchers use an organized method of locating, assembling, and evaluating a body of literature on a particular topic using a set of specific criteria.

Randomized Controlled Trial: A controlled clinical trial that randomly (by chance) assigns participants to two or more groups. There are various methods to randomize study participants to their groups.

Clinical research is often conducted at academic medical centers and affiliated research study sites. These centers and sites provide the prestige of the academic institution as well as access to larger metropolitan areas, providing a larger pool of medical participants. These academic medical centers often have their internal Institutional Review Boards that oversee the ethical conduct of medical research.

Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV is 'post-approval' studies.

Media Contact: 
Allison Grey 
Journal Manager 
Journal of Clinical chemistry and Laboratory Medicine
Email: jcclm@molecularbiol.com