Phase II & III of Clinical Development
Clinical research is an important part of the process of gaining better knowledge and understanding of human health and disease as well as the development of new and effective therapies for treating these diseases. Clinical trials represent an essential component of evidence based medical research.
Clinical trials are research studies involving people (healthy volunteers or patients) that test the safety and efficacy of a new treatment. A ‘treatment’ in this context could mean:
- A medicine.
- A medical device - such as a cardiac stent (used for narrow or weak blood vessels).
- A surgical procedure.
- A test for diagnosing an illness.
A clinical trial can also compare whether a new treatment is better than existing alternatives. No matter how promising a new treatment may appear during initial laboratory tests, clinical trials are necessary to prove and identify benefits and risks in humans. ‘Better’ in this context does not necessarily mean ‘with a better efficacy’ but may also signify ‘fewer side effects (Adverse Drug Reactions, ADRs)’ or ‘better handling, less burden’ and more. This is sometimes reflected in clinical trial designs which look for equivalence or non-inferiority to an existing treatment.
Clinical trials are designed by groups of doctors, scientists and other specialists. The trial design is usually based on a thorough analysis of existing research, and the recognition that certain questions about treatment, symptom control or side effects need to be answered. To draw up the best possible trial design, discussions involve medical staff, nurses, patients, statistical experts and support staff, as well as representatives from companies or funding agencies. The background, design and plan for the study are contained in a document known as the protocol.