What is the legislation regarding clinical trials
Clinical trials are a subject of detailed regulation and control via multiple laws, rules, and acts.
The history of clinical trials is marked by a chain of events that define the need for a strict regulation:
- Dr. James Lind conducted one of the first documented clinical trials in 1747 when he prescribed different therapies to groups of sailors on Captain James Cook’s ship – Salisbury;
- The Berlin Code of Ethics was adopted in 1900;
- The Nurnberg Code was adopted after WWII ended – it is the first regulatory code to define the rights and mechanisms that need to be taken under account when conducting clinical trials;
- The foundations of the Good Manufacturing Practice (GMP) were laid in 1962;
- A couple of years later, the Declaration of Helsinki was approved and accepted (1964);
- The Belmont Report was adopted in 1979;
- The International Conference on Harmonization (ICH) accepted the new rules related to the Good Clinical Practice (GCP).
All of the milestones listed above lead to the establishment of the Good Clinical Practice (GCP) for clinical trials which is currently an international standard.
What does it take for a clinical trial to be approved in Bulgaria?
The Bulgarian Drug Agency and the Ethics Committee for Clinical Trials need to review and approve a clinical trial before it can be offered to a patient willing to participate. Both regulatory organs are subsidiaries to the Ministry of Health.
Every patient who wishes to become a part of a clinical trial needs to be constantly monitored by specialists following a strict and approved in advance study protocol.