Every person who wants to participate in clinical research should have the opportunity to do so safely. Beyond that, their participation should be with the knowledge that their basic rights and well-being are protected, and all research has been done to provide the best possible outcome.
Although most clinical research is governed by those fundamental rights, that hasn’t always been the case. Guidelines exist for a reason, and the story of Good Clinical Practice is filled with those reasons.
A Quick History of Good Clinical Practice
Controlled clinical trials have been around since 1747 when James Lind infamously organized the first comparative clinical trial aboard Spanish naval ships. Appalled at the high mortality rate of scurvy among sailors, Lind gathered twelve men into six control arms of two and had them test various treatments for scurvy. Low and behold — the two control groups who were assigned citrus treatments of lemon and oranges saw improvements in their scurvy symptoms. Years later, Lind’s findings would help naval fleets understand the relationship between citrus and scurvy and even help influence royal fleets to make citrus a mandatory dietary staple of sailors.
Clinical trials have evolved considerably since the days of Lind. The early 19th century brought about the arrival of the placebo. By the mid-1940s, researchers were introducing new methods such as double-blind controlled trials and randomized curative trials.
These progressions resulted in significant medical outcomes, but it also began to raise questions about the safety, ethics, and protection of human subject participation. Throughout history, there have been a handful of clinical mishaps that brought patient safety to the forefront of conversations. Without standard regulations, there was no reassurance that the rights and safety of clinical trial participants were protected, the research was scientifically sound, and the results were credible.
As the world learned of human experiments being conducted during World War II, they realized the Hippocratic Oath wasn’t enough to keep clinical research universally ethical. Regulations emerged, starting with the Declaration of Helsinki in 1964 by the World Medical Organization. Based on the Nuremberg Code, the aim was the to “provide guidance to physicians and other participants in medical research involving human subjects.” Later, the Belmont Report was issued in 1979 by the National Commission for Protection of Human Subjects of Biomedical and Behavioural Research, establishing three critical principles: respect for persons, beneficence, and justice.
These early frameworks established a solid foundation for ethical, sound practices in clinical research, but they suffered from regulatory inconsistencies across countries, regions, and even city to city. In order to create a standardized, repeatable set of directions, the International Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) developed a universal set of efficacy guidelines for the industry that they published in 1996. These guidelines, titled Good Clinical Practice (ICH-GCP), provide a standard for all clinical trial activity that assures the data is credible and accurate and that the participant’s rights, integrity, and confidentiality are protected.
Guiding Principles of ICH-E6 Good Clinical Practice (GCP)
ICH-GCP is maintained through a set of principles. Since initially introducing ICH-GCP nearly 30 years ago, ICH is responsive to changes in how clinical trials are conducted and developed a “flexible framework” for clinical trial conduct. As such, the most recent revision was released in 2021. The principles cover thirteen core themes for sound and safe clinical trials.
The principles include:
- Ethical Principles – Clinical trials should be conducted in accordance with good clinical practice (GCP) and applicable regulatory requirements.
- Safety as a Priority – Clinical trial activity should be designed to ensure participant rights, safety, and well-being are protected.
- Informed Consent – Clinical trial participants should be well-informed, partaking voluntarily, and freely offer informed consent.
- IRB/IEC – Clinical trials should be objectively reviewed by an independent ethics committee (IEC) or institutional review board (IRB).
- Prior Research – The purpose of clinical research should be scientifically sound and based on established scientific knowledge.
- Qualified Staff – Clinical trials should be conducted by experienced and trained individuals.
- Quality by Design – Clinical trials should be proactively designed with quality built into the study protocol and procedures.
- Anticipate Risks – All trial processes and risks should be proportionate to the inherent risks in the trial and the importance of the information being collected.
- Proper Protocol – Trial protocol should be clear, concise, operationally sound, and well-designed for patient protection and data accuracy.
- Data-Driven Results – The results generated from the trial should be reliable and sufficient to provide confidence in the trial data and results.
- Record Data – All roles, responsibilities, and duties within the clinical trial should be clear and documented.
- IP Management – Investigational products (IPs) should be manufactured in accordance with Good Manufacturing Practice (GMP) and be handled in accordance with product specifications.
- Medical Qualification – Medical care provided to a patient and any medical decision made on behalf of a patient should be the responsibility of a qualified medical physician.
Why Good Clinical Practice is Necessary
Clinical research has been around formally for hundreds of years, but it took until relatively recently for global standards to be enacted. This is largely because clinical research is vast – spanning across diverse industries from medical devices to pharmaceuticals, covering various subjects from humans to animals, and implementing a variety of methods, tools, and data sources.
The volume of clinical research has also boomed in recent years. Ten years ago, there were roughly 137,000 registered clinical trials. As of March 2022, 409,300 clinical trials had been registered worldwide, signally a nearly 200% increase in a decade. And it’s worth noting that this increase persisted even despite the impact from COVID-19.
All these reasons speak to the need for a global standard of operations. As clinical trials continue to rapidly expand in developing countries or with new technology and data sources, they need guidelines to create a foundation for high quality processes in clinical research.
Partners In Good Clinical Practice
Good Clinical Practice is necessary from initial study design to final database lock and everywhere in-between. All stakeholders involved in the clinical trial – including contract research organizations (CROs), sponsors, sites, vendors, and staff – should all understand and embrace the principles of GCP in order to work together towards better health outcomes.
Gain confidence to conduct your trials in an always-compliant ecosystem that was designed with GCP principles in-mind. Speak to one of our experts and learn about how LifeSphere Clinical can be your partner in Good Clinical Practice.