Role of ICH- GCP in Clinical Trials

ICH GCP Clinical Trials
Standard

The main aim of ICH-GCP (International Conference on Harmonisation – Good Clinical Practice) clinical trials guidelines is preserving and protecting the rights of humans throughout the globe. The need to regulate and control usage of drugs or medicine or devices in clinical trials for humans led to the formation of the ICH-GCP guidelines.

What are Clinical Trials?

Clinical trialsare scientific studies that explore safety and effectiveness of a treatment, medical strategy or device in humans. These studies may also help in choosing the best medical approaches for certain diseases or illnesses in a group of people. Clinical trialsare research studies that prevent, treat, screen or diagnose diseases. Decision making in healthcare is possible through high quality data of clinical trials. These studies follow strict and scientific standards which preserve and protect rights of patients and help produce reliable results in clinical trial.

ICH-GCP (International Conference on Harmonisation – Good Clinical Practice)

To avoid any malpractices and overcome inconsistencies in clinical trial, the International Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) issued these guidelines. The Nuremberg Code, the Declaration of Helsinki, the Belmont Report, International Conference on Harmonization (ICH-GCP) Code of Federal Regulations have provided the foundation for the guidelines that have formed the basis of the ICH-GCP. Pharmaceutical companies and representatives of authorities of European Union, United States, Japan, Australia, Canada, the Nordic countries and WHO are enforced to follow these guidelines. The guidelines provide a unified standard in these regions for mutual acceptance of clinical information and data by the regulatory bodies or authorities.

Good Clinical Practice (GCP) is an international, scientific, ethical and harmonised standard for conducting, monitoring, auditing, recording and reporting in clinical trials. It assures to report and record results or data of trial subjects with accuracy and protects their integrity, rights and confidentiality. ICH-GCP represents quality standards that improve data quality, minimise unwanted exposure of humans to investigational products, enhance marketing prospects of new drugs and makes trials cost-effective for sponsors. The regulatory bodies, sponsors, investigators, project monitors, patients, ethical committee or review board are required to be aware of ICH-GCP.

Importance of ICH-GCP

The role of ICH-GCP is to improve ethical awareness, trial concept and methods, public safety, cost effectiveness of research and development, competitiveness, data recognition and marketing structure. Conducting clinical trials in accordance with ICH-GCP guidelines has reduced the occurrence of frauds and accidents.

Every trial is accessed for risk benefit ratio, clinical design and protocol, complete information of the investigational product, informed consent of subjects, ethical compliance and approval, qualified medical physician and clinical staff. The aim of imposing informed consents in the guidelines is to protect the integrity, rights, safety and confidentiality of trial participants. Also as per ICH-GCP, the product under study is manufactured as per GMP i.e. Good Manufacturing Practices.

Clinical trial information and records are easily retrievable and accessible for accuracy, interpretation and verification of the reports. The subjects and regulatory authorities have to be informed of premature termination or suspension of any trial with an explanation. In case of any compensation, the method and manner of which should meet regulatory requirements.

Online Course in Tropical Medicine

James Lind Institute (JLI) provides an online program in Post Graduate Diploma in Clinical Research that helps understand the guidelines required to be followed in clinical trials. JLI also provides very detailed courses in allied clinical research domains like pharmacovigilance, medical writing, quality assurance, regulatory affairs and clinical data management.

For more information please visit: www.jliedu.com

 

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