Learn more about Clinical Research

Clinical research is medical research that involves people to test new treatments and therapies (US National Institutes of Health). 

Each new drug or treatment must go through clinical trials before its benefits and risks can really be known and a marketing authorisation for the condition for which it will be marketed can be granted by competent health authorities.

For medicinal products for instance, on average, one of every 10,000 potential medicines investigated by pharmaceutical companies is approved for patient use. This means that the other 9,999 candidates did not meet the criteria to become an effective drug which shows the importance of clinical research and its regulations.

Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials that involve the participation of human subjects. It is expected from regulatory agencies that any clinical trial that is part of a marketing authorisation application is conducted in compliance with ICH GCP (The International Conference on Harmonisation’s topic E6 (R1) – Guideline for Good Clinical Practice). ICH: E 6 (R2): Guideline for good clinical practice – Step 5 (europa.eu)

Compliance with this standard provides public assurance that the rights, safety, and wellbeing of trial subjects are protected and that the clinical trial data are credible and accurate.

Health authorities and ethics committees authorise the conduct of a clinical trial only after they have received from the sponsor of the trial satisfactory information about the study and the compound to be tested as this information enables them to assess the risk benefit ratio for trial subjects and the protection of their rights. 

Gaining approval of a drug takes on average 15 years of Research & Development (R&D). This very lengthy approval process requires a lot of resources and clinical research professionals are key players in the whole process.