Good Clinical Practice (GCP) in Clinical Trials—Explained
Several milestones built the foundation of what we now call Good Clinical Practice (GCP) in terms of clinical trials.
In the 1960s, scientists, medical professionals, and the general public were concerned about the ethical aspects and participant safety in clinical trials. The World Health Organization (WHO) have taken upon themselves to form scientific groups in the following decades. Their purpose was to evaluate the old and formulate new clinical trial principles.
In 1992, WHO outlined the Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products.
GCP Principles by WHO
There are 14 Good Clinical Practice principles put forth by WHO:
- Ethical Conduct
- Research Protocol
- Risk Identification
- Benefit-Risk Assessment
- Review by Independent Ethics Committee/Independent Review Board
- Protocol Compliance
- Informed Consent
- Continuing Review/Ongoing Benefit-Risk Assessment
- Investigator Qualifications
- Staff Qualifications
- Confidentiality/Privacy of Records
- Good Manufacturing Practice
- Quality Systems
ICH Guidelines for GCP Regarding Clinical Trials
With WHO’s principles as their basis, in 1997, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) made great strides in finalizing GCP. This was endorsed by the Food and Drug Administration (FDA). The reasons for drawing up Good Clinical Practices arose from the need for:
- A more efficient research process
- Drug research to be time-effective and less expensive
- Expediting the drug-to-market process
The goal was to comprise unified standards for clinical trial practices.
What Are the ICH-GCP Principles?
According to ICH, there are 13 Good Clinical Practice Principles:
- Ethical Conduct of Clinical Trials—participants’ safety and rights
- Compared benefits and risks—benefits should justify the risks
- Participants’ safety, well-being, and rights are more important than the interests of scientists
- The available clinical and nonclinical information supports the clinical trial
- Clinical trials must be scientifically sound and have a clear protocol
- The Independent Ethics Committee (IEC)/Independent Review Board (IRB) should approve clinical trials before they start
- Any medical care or decisions should be made by qualified medical professionals
- Each individual involved in conducting a clinical trial should be qualified
- Every clinical trial participant should freely decide to take part in it. They should give their informed consent before the trial begins
- Accurate reporting, verification, and interpretation of all clinical trial information
- Confidential records
- Investigational products—drugs, treatment, and medical devices—should be manufactured in compliance with Good Manufacturing Practice (GMP)
- Organized systems need to assure the quality of every aspect of a clinical trial
What Are the Goals of GCP Principles?
GCP should be a standard for the conducting, monitoring, and reporting of clinical trials. Working in accordance with GCP is vital to participants’ well-being.
The GCP goals are to:
- Make sure the clinical trial data is reliable
- Uphold the rights and safety of human subjects
- Represent the standards of clinical research conduct
The FDA describes GCP as ethics combined with quality data, which is what the medical professionals should strive for.
Who Is Responsible for Making Sure GCP Principles Are Upheld?
Apart from medical professionals and other people involved in a clinical trial, various organizations and boards are responsible for ensuring GCP compliance in clinical trials.
Some of them are:
- Contract Research Organizations (CROs)
- Clinical Research Coordinators (CRCs)
- Clinical Investigators (CIs)
Why Do I Need To Know About GCP?
As a participant, you should know that medical professionals are obligated to follow certain rules.
If you are worried about the risks and your rights during a clinical study, it helps to be familiar with GCP.
Once you know that many organizations ensure your safety and privacy, you can focus on finding the best clinical trial for yourself or your loved one.
DoNotPay—The Best Clinical Trial Finder
Participating in a clinical trial can be challenging enough, so the search for it should be as effortless as possible.
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You can count on DoNotPay to fast-track the process of applying for a clinical trial. In case you want to give it a go by yourself, take a look at a few of the trustworthy websites where you can sign up for a clinical study:
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