As per NIH (National Institutes of Health), Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available.
Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can take part. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women.
Clinical trials are conducted in “phases.” Each phase has a different purpose and helps researchers answer different questions. A typical drug development process is shown below.
Our experience with regulatory agencies on five continents covering every stage of development and type of therapeutic, from early planning to post-marketing, includes:
- Small molecules
- Therapeutic proteins and biologics
- Cell and gene therapies
- Combination products
- Drug delivery systems
- Clinical development programs