Good Clinical Practice: Keeping Clinical Trials Safe, Ethical and Effective
Good clinical practice (GCP) is vital in clinical research, as it shapes how trials are designed, conducted and evaluated. Far from being a simple checklist for sites and sponsors, GCP is designed to protect participants, ensure ethical conduct and maintain data integrity. This blog unpacks GCP, outlining how it keeps clinical trials both safe and effective.
What is GCP?
GCP is a set of guidelines in place to safeguard patients and ensure reliable trial results and data integrity. This isn’t just at one or two set points during a clinical trial – GCP is in effect at all times, from ideation until the drug goes to market, and everything in between. These guidelines also outline responsibilities for institutional review boards (IRBs), investigators, sponsors and monitors surrounding:
- Informed consent
- IRB review
- Staff training
- Data management systems
- Continuous monitoring and auditing
- Quality control
These aren’t just seemingly random guidelines for researchers to abide by; they are principles set forth by key governing bodies within life sciences. In 1996, the International Council of Harmonisation (ICH) established these principles together with representatives from the European Union, the United States, and Japan. Further, the Food and Drug Administration (FDA) has mandated that studies conducted under an investigational new drug (IND) application or investigational device exemption (IDE) must comply with GCP standards as well.
Why GCP Matters
Clinical research is a highly experimental and regulated industry; research teams want to understand if their drug or therapy is safe to use on a broad scale. The only way to do this is through an adequate participant pool. However, it can be a lot to ask of participants to join in on a trial, and it may be a hard sell if there aren’t any guidelines established to keep them safe and protected.
GCP ensures participants’ rights, integrity and confidentiality are respected at all times during a trial. It also confirms the data collected during a trial is both credible and accurate. Essentially, GCP plays an incredible role in ensuring clinical trials are legitimate, use factual data and protect participants.
GCP also does more than just build trust amongst participants. It’s a way to show the general public that clinical trials are legitimate methods of care. There are already several myths to clinical research , and having GCP in place can be a way to dispel these misconceptions and reinforce the credibility of trials as a valid form of medical treatment.
Key Principles of GCP
There are several foundational elements to GCP that make it the bedrock for participant protection and trial credibility.
Ethical Conduct
Ethical conduct is in place to ensure participants are protected, but it also benefits other trial aspects. The idea is that if more participants feel safe and protected in the trial, the more likely they will feel respected and willing to share factual information. Clear, accurate information leads to better quality data, which makes it easier to track outcomes and understand how the drug affects participants.
Informed Consent
One of the best ways research teams can establish trust with participants is through the informed consent process . A continual conversation between participants and staff, the informed consent process is in place to ensure participants understand the trial in its entirety, including potential risks and benefits. A thorough informed consent process can lead to a higher likelihood of participants feeling safe and protected during the trial.
KEY PRINCIPLES OF GCP: Ethical Conduct. Informed Consent. Data Integrity. Protocol Adherence.
Data Integrity
While many GCP principles prioritize keeping the participants protected, they also focus on the importance of data integrity. This is to ensure research staff are doing their due diligence and maintaining correct record-keeping and documentation during a study. It’s also helpful for staff to have something to point back to as they are dissecting their findings.
Protocol Adherence
Following an approved protocol is necessary for a multitude of reasons, but from a GCP standpoint, it confirms the validity of the trial. Failing to adhere to the protocol leads to deviations, which usually leads to biased trial results.
Who Follows GCP and Why?
Every clinical researcher, sponsor and contract research organization (CROs) should care about and follow GCP. In this highly regulated industry, it’s paramount to ensure a trial is held to the highest standard. This means participants are protected, research is conducted ethically and there is trust from the public.
Additionally, many organizations rely on grants and their reputation as they are looking to secure studies and funding. Failure to follow GCP could have negative consequences, and result in less grant money and tarnished reputations. At the end of the day, the GCP guidelines are protecting research staff just as much as participants.
At the end of the day, GCP is more than just a set of guidelines – it safeguards ethical, credible and patient-centric clinical trials. When research teams adhere to GCP, they uphold the integrity of their work while building trust with participants and the public. As clinical research continues to evolve, it’s essential to have GCP advance safe, effective medical treatments.
Trust Sabai With Your GCP Needs
At Sabai, our IRB stands ready to help sites and sponsors navigate GCP requirements. As a central IRB, we understand how GCP is crucial to successful research and how to review protocols to ensure GCP is integrated throughout a study.