Good Clinical Practice is a scientific and ethical quality standard that internationally protects the rights, confidentiality, and clinical trials’ rights. It looks into the performance, design, monitoring, recording, analyses, and clinical trial auditing. In the world today, clinical trials are used for protecting human rights. Acts such as the Drug and Cosmetic Act were initiated to protect human beings. The manufacturers ensure that they deliver safe products following the Acts.
Principles of Good Clinical Practice
Respect for Persons
This principle that every person gets dignity and freedom. It requires that the right information is obtained from the subjects that have been researched already.
This principle states that researchers must have maximum benefits and minimum harm from what they research. If there are any research-related risks, researchers should have a significant reason that’s accompanied by the benefits.
This principle requires that research subjects get equal selection and recruitment and are treated fairly.
International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) work together with Good Clinical Practice (GCP) to protect human subjects’ welfare, rights, and safety. It ensures that humans are not subjected to harm in the case of investigational products, improves the data quality, and ensures new drugs are marketed quicker. Again, this harmonization ensures that the sponsors and the public buy the drugs at a reasonable cost. The compliance of this standard ensures that trial subjects are always protected.
Core Principles of ICH- GCP
- Clinical trials should be initially and ethically conducted following the Declaration of Helsinki
- Expected risks should be weighed before any produced is used on the trial subjects against the benefit anticipated
- The safety, well-being, and rights of trial subjects should be put first and not only interest in science
- The clinical and non-clinical information on any trial product should be adequate to support any clinical trial
- All clinical trials should be scientifically sound and well detailed
- A qualified physician should always be the responsibility for medical care and medical decisions made on behalf of the trial subject
- Any person involved in handling trial subjects should be well educated, trained, and experienced to perform any task
- All information on trial subjects should be taken, recorded, and stored such that if needed, it can be quickly reported, interpreted, and verified
- Information on trial subjects should be confidential, and privacy should be respected.
Importance of Clinical Trials
Clinical trials are based on sound scientific evidence and GCP compliance. It involves understanding the trial participants’ risks and benefits while ensuring they are safe and their rights are protected. Confidentiality on the information of trial subjects is of paramount importance. Qualified physicians are the only ones allowed to carry out any tasks according to GCP guidelines. All stakeholders are made to understand the importance of complying with GCP. The GCP guidelines also ensure that the clinical data obtained is accurate and used during the trial.
Good clinical trials and guidelines help qualified physicians to ensure the safety of the clinical trials. Also, they help determine the risk of any products despite their many benefits. Any person considering to be trial participants should have peace of mind because all their information is kept private. The above guide can help those willing to be trial subjects in the future.