Good Clinical Practice Principles for Sponsors and Investigators

Good Clinical Practice (GCP) serves as the foundation for maintaining patient safety and data integrity, providing a framework that safeguards patients while facilitating scientific advancements.

In this post, we’ll highlight good clinical practice principles and examine recent updates that are relevant to sponsors and investigators.

The History of Good Clinical Practice

The development of modern clinical research and the history of vaccines includes numerous practices that would be deemed unethical today. For example, Edward Jenner, often referred to as the father of vaccination, tested his theory on an 8-year-old child by exposing him to smallpox after inoculating him with cowpox. Most researchers are also familiar with the Tuskegee Study, where 600 Black men, 399 of whom had syphilis, were denied treatment so researchers could study the progression of the disease. This unethical study contributed to widespread distrust of the medical community among African Americans that persists today. Similarly, in 1951, cancerous cells were taken from Henrietta Lacks without her consent, leading to the creation of an immortal cell line used in numerous medical advancements. Tragically, neither Lacks nor her family received recognition or compensation.

These historical abuses highlighted the need for stringent ethical standards in clinical research. The Nuremberg Code, created in 1947 in response to Nazi war crimes, was one of the first significant attempts to establish guidelines for ethical medical research.

Along with the Declaration of Helsinki and the Belmont Report, it laid the foundation for today’s Good Clinical Practice guidelines. Clinical trials must also comply with every applicable regulatory requirement to ensure the rights, safety, and well-being of participants.

What Are the Good Clinical Practice Guidelines?

Good Clinical Practice is governed by a comprehensive set of regulations and standards globally, but its core principles are distilled from the International Conference on Harmonization (ICH). These principles can be grouped into five key concepts:

1. Conduct Clinical Trials Ethically: Always prioritize the well-being and rights of participants.
2. Protect Human Subjects: Ensure that all participants provide informed consent and understand the risks and benefits involved.
3. Design a Robust Plan and Adhere to It: Develop a clear, detailed protocol and ensure it is followed rigorously.
4. Select Qualified Study Staff: Ensure that all personnel involved in the trial are adequately trained and qualified.
5. Maintain Good Documentation: Accurate, thorough documentation is essential for the integrity of the trial.

Central to these principles is the concept of informed consent. Participants, or their guardians in cases involving children or those unable to consent, must be fully informed about the study, including its potential risks and benefits. This consent must be properly documented and revisited throughout the trial as needed.

Recent Updates to Good Clinical Practice Guidelines

As clinical research methods and technology evolve, so must the guidelines that govern them. The FDA and other regulatory bodies have issued several updates in recent years that sponsors and investigators should know. Sufficient non-clinical and clinical information must be available to support the initiation of a proposed clinical trial, emphasizing the importance of ethical guidelines and participant safety in the process.

It is crucial for all parties involved in clinical trials to stay informed about these updates to ensure compliance and the integrity of their research. Additionally, all information related to clinical trials must be handled and stored in a manner that safeguards sensitive data, reinforcing compliance with applicable regulatory requirements and maintaining privacy and confidentiality rules.

New Guidelines on Diversity Action Plans

In June, the FDA issued a draft guidance for sponsors detailing how to submit Diversity Action Plans to increase enrollment of historically underrepresented populations. Sponsors must submit Diversity Action Plans for all Phase 3 clinical studies for drugs or devices.

“Participants in clinical trials should be representative of the patients who will use the medical products,” FDA Commissioner Robert M. Califf said in a statement. “The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data we have about patients who will use the medical products if approved.”

Guidance for Decentralized Clinical Trials (DCTs)

The COVID-19 pandemic accelerated the adoption of decentralized clinical trials, which use electronic data capture systems and remote monitoring to make clinical trials more accessible. The FDA has provided detailed guidance on conducting decentralized clinical trials to ensure data integrity and participant safety while expanding the reach of clinical research​.

Key recommendations for sponsors and investigators include:

• How to design decentralized trials to ensure diverse participation and convenience for patients while maintaining data collection standards
• How to manage electronic informed consent
• How to conduct safety monitoring for decentralized trials

Integration of eSource Data

In its latest guidance on the use of electronic health record data in clinical investigations, the FDA has emphasized the importance of using electronic source data while recognizing the challenges of implementing these technologies. It has and has called for better system integration and data management practices​, including:

• Encouraging the use of interoperable or fully integrated systems to minimize errors and improve data accuracy
• Emphasizing the importance of validating data exchange between systems
• Requiring clear communication of who has access to EHR data
• Requiring EHR data to meet FDA inspection and record retention requirements.

These updates help sponsors maintain high standards of data quality and participant safety in clinical trials.

Artificial Intelligence in Clinical Trials

The FDA is also developing guidelines for the use of AI in clinical trials, particularly in data analysis and patient monitoring. In a recent FDA interview, Dr. Khair ElZarrad highlighted the growing role of AI in clinical trial design and research.

He discussed how AI can enhance the efficiency of trials by predicting outcomes, identifying patient populations, and optimizing trial protocols. However, he emphasized that AI should complement, not replace, human judgment, and the integration of AI must be approached with caution to ensure data integrity and ethical standards are maintained.

How To Apply Good Clinical Practice

Applying Good Clinical Practice principles in clinical trials ensures research progresses ethically while protecting the wellbeing of trial participants. At Remington-Davis, we understand the critical importance of GCP and are committed to helping sponsors and investigators navigate these complex guidelines.

With over 30 years of experience conducting clinical research and a team of physicians who bring decades of specialized expertise, we have a deep understanding of the evolving landscape and how to help sponsors conduct trials that comply with GCP while using the latest advancements in technology and methodology.

For more information about how Remington-Davis can support your clinical trial needs, contact us today.