GOOD CLINICAL PRACTICE GUIDELINES- A STANDARD FOR CLINICAL TRIALS
INTRODUCTION:
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that comprise the participation of human subjects.
Compliance with this standard renders public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their emergence in the Declaration of Helsinki, and that the clinical trial data are acceptable. The GCP guidelines should be followed when generating clinical trial data that are submitted to regulatory authorities. The principles established in this guideline may also be enforced in other clinical investigations that may affect the safety and well-being of human subjects who are taking part in the clinical trials.
This blog is aimed to certify the studies are scientifically and ethically sound and that the clinical properties of the pharmaceutical substances under investigation are aptly documented.
The guidelines follow to establish two cardinal principles: the protection of the rights of human subjects who are participating in clinical trials and the authenticity of biomedical data generated.
CLINICAL TRIALS:
A systematic study of pharmaceutical products on humans to discover or authenticate the clinical, and pharmacological aspects and adverse effects, with the object of determining their safety and efficacy. Clinical trials look at new ways to prevent, detect, or treat disease. Treatments might be new drugs or new combinations of drugs, new surgical procedures, or the application of new devices in the field of science. The goal of clinical trials is to determine if a new test or treatment works and is safe.
IMPORTANCE OF ICH-GCP:
The role of ICH-GCP is to improve ethical awareness, trial concepts and techniques, public safety, the cost-effectiveness of research and development, data recognition, and marketing structure. Conducting clinical trials by ICH-GCP guidelines has reduced the occurrence of fraud and accidents in the current scenario. The aim of imposing informed consent in the guidelines is to protect the integrity, rights, safety, and confidentiality of trial participants who are involved in clinical trials.
GOAL OF GCP:
• To provide a unified standard to facilitate the mutual acceptance of clinical data by the
regulatory authorities.
• To remove redundancy in the development and review process.
PURPOSE OF GCP:
• To harmonize the regulations and guidelines for drug development and to conduct clinical trials effectively.
GCP-13 PRINCIPLES:
Ethics
Clinical trials should be conducted by the ethical principles that have their
origin in the Declaration of Helsinki and are compatible with GCP and the applicable
regulatory requirements.
Trial risk vs trial benefit
Before a trial is initiated, foreseeable risks and inconveniences should be weighed
against the anticipated benefit for the individual trial subject and society. A trial should be
initiated and continued only if the anticipated benefits justify the risks involved in the process of a clinical study.
Trial participants
The rights, safety, and well-being of the trial subjects are the most critical
considerations and should prevail over the interests of science and society.
Information on the Medicinal Product
The available non-clinical and clinical information on an Investigational Product should be
enough to support the proposed clinical trial.
Good quality trials
Clinical trials should be scientifically proven and described in a clear, detailed protocol.
Compliance with the study protocol
A trial should be conducted by the protocol that has been received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favorable
opinion
Medical decisions
The medical care given to, and medical decisions made on behalf of, subjects should
always be the responsibility of a qualified physician, medical practitioner, or, when appropriate, a qualified dentist.
Trial staff
Each individual involved in conducting a trial should be qualified in terms of education, training, and experience to perform their task in the clinical study.
Informed consent
Freely given informed consent should be obtained from every subject before the clinical trial
Participation to protect their rights and safety.
Clinical trial data
All clinical trial information should be recorded, handled and stored in such a manner that allows its accurate reporting, interpretation, and verification.
Confidentiality
The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules by the applicable regulatory requirements.
Good Manufacturing Practice
Investigational products should be manufactured, handled, and filed by applicable good manufacturing practice (GMP). They should be used by the approved protocol.
Quality assurance
Systems with procedures that provide the quality of every aspect of the trial should be
implemented.
CONCLUSION:
GCP is an essential aspect of clinical trials and research. It requires us to follow strict protocols that ensure the safety of participants involved in the clinical trials and that each study complies with local laws and regulations which are established.
GCP helps remove bias from the equation and ensures that all participants are treated equally, regardless of race or gender as previously only animals were used in the clinical so to avoid that good clinical practices include the guidelines to protect the safety and efficacy of everyone. The goal is to make sure that your study results are valid and reliable so they can be used in future studies or treatments for patients who are in need.
REFERENCES:
1. https://www.longdom.org/peer-reviewed-journals/gcp-53686.html#
2. https://www.researchgate.net/journal/Good-Clinical-Practice-Journal-1350-0961
3. https://apps.who.int/iris/bitstream/handle/10665/43392/924159392X_eng.pdf
4. https://www.openaccessjournals.com/peer-reviewed-articles/gcp-10802.html
5. https://www.ahajournals.org/doi/full/10.1161/CIRCULATIONAHA.115.019902?cookieSet=1
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