Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people, and new ways to improve health.
The ethical and legal codes that govern medical practice also apply to clinical trials and responsibility for the safety of the subjects in a clinical trial is shared between the sponsor, the local site investigators and the various institutions and IRB/IECs that supervise the study. In addition, most clinical trials are well-regulated with built in safety parameters to protect the participants.
Nations throughout the world have regulations that govern the conduct of clinical research, and many nations expect researchers to follow specific guidelines, such as the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice.
Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human
subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
The ICH Guideline for Good Clinical Practice has been adopted by the European Union, United States, Japan, Australia and by many other countries in the world, among which is also Croatia. This guidance should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities.
All clinical trials conducted in Croatia must be approved by the Central Ethics Committee (consisting of members who collectively have the qualifications and experience to review and evaluate the scientific, medical and ethical aspects, of the proposed trials) and Ministry of Health in accordance with law, and adhere to strict regulations protecting the rights of participants.
Finally, patient well-being and safety are a constant concern throughout the long development process for a new medicine , during which researchers keep trying to find a new treatment which positively affects a disease state, improves a patient’s quality of life and is safe. That represents core philosophy of drug development today, but no science, not even modern medicine, can ensure absolute safety and complete lack of risk regarding human health and wellbeing.
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