How to Conduct a Clinical Trial with Good Clinical Practice

Clinical trials are essential for developing new treatments and improving health outcomes for patients. However, conducting a clinical trial is not a simple task. It requires careful planning, execution, and reporting to ensure the quality and validity of the data and the safety and well-being of the participants. This is where Good Clinical Practice (GCP) comes in.

GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects¹. GCP aims to provide a unified standard for the ICH regions (the European Union, Japan, the United States, Canada, Switzerland, Brazil, Australia and South Korea) to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions².

GCP is based on the principles of respect for human dignity, protection of human rights, and assurance of the welfare of the participants². GCP also ensures that the data generated from the trial are credible, reliable, and accurate².

To comply with GCP, a clinical trial must follow certain steps and procedures. Here are some of the main aspects of GCP that you need to know if you want to conduct a clinical trial:

1. Protocol

The protocol is the document that describes the objective, design, methodology, statistical considerations, and organization of a clinical trial². The protocol must be approved by an independent ethics committee (EC) or institutional review board (IRB) before the trial can start². The protocol must also be registered in a public database before enrolling the first participant².

The protocol must include information such as:

• The title and identification number of the trial
• The name and contact details of the sponsor and the investigator
• The background and rationale for the trial
• The objectives and endpoints of the trial
• The inclusion and exclusion criteria for selecting the participants
• The sample size and power calculation
• The randomization and blinding methods
• The intervention(s) and comparator(s) to be used
• The schedule and duration of visits and assessments
• The data collection and management procedures
• The statistical analysis plan
• The ethical considerations and informed consent process
• The safety monitoring and reporting procedures
• The quality assurance and quality control measures
• The dissemination and publication plan

2. Informed Consent

Informed consent is the process of obtaining voluntary agreement from a potential participant to take part in a clinical trial after providing them with adequate information about the trial². Informed consent is a fundamental principle of GCP that respects the autonomy and dignity of the participants².

The informed consent process must include:

• Providing a written informed consent form (ICF) that contains all the relevant information about the trial in a clear, concise, and understandable language
• Explaining the purpose, procedures, risks, benefits, alternatives, confidentiality, compensation, and rights of the participants in the trial
• Answering any questions or concerns that the participants may have
• Obtaining a signed and dated ICF from each participant or their legally authorized representative before enrolling them in the trial
• Providing a copy of the ICF to each participant or their legally authorized representative
• Documenting the informed consent process in the source documents and case report forms (CRFs)
• Updating and re-consenting the participants if there are any changes or new information that may affect their decision to continue in the trial

3. Safety Reporting

Safety reporting is the process of collecting, evaluating, and communicating any adverse events (AEs) or serious adverse events (SAEs) that occur during or after a clinical trial². Safety reporting is crucial for protecting the participants from harm and ensuring their welfare².

The safety reporting process must include:

• Defining what constitutes an AE or an SAE according to the protocol
• Recording all AEs or SAEs in the source documents and CRFs
• Assessing the severity, causality, expectedness, and seriousness of each AE or SAE
• Reporting all SAEs to the sponsor, EC/IRB, regulatory authorities, and other relevant parties within a specified time frame according to the protocol
• Following up on all AEs or SAEs until resolution or stabilization
• Implementing corrective and preventive actions to prevent recurrence or mitigate risks

4. Data Management

Data management is the process of ensuring that the data collected from a clinical trial are accurate, complete, consistent, reliable, and secure². Data management is vital for ensuring the quality and validity of the data and facilitating its analysis and interpretation².

The data management process must include:

• Developing a data management plan that describes how the data will be collected, verified, entered, stored, transferred, analyzed, reported, archived, and destroyed
• Designing CRFs that capture all the relevant data required by the protocol
• Training the study staff on how to complete the CRFs correctly and consistently
• Implementing data validation checks and queries to identify and resolve any errors or discrepancies in the data
• Performing data quality audits and reviews to ensure compliance with GCP and the protocol
• Maintaining data security and confidentiality by using encryption, passwords, backups, and access controls
• Retaining the data and the source documents for a specified period of time according to the protocol and the applicable regulations

5. Statistical Analysis

Statistical analysis is the process of applying statistical methods and techniques to summarize, describe, and interpret the data from a clinical trial². Statistical analysis is essential for testing the hypotheses, evaluating the efficacy and safety of the intervention(s), and drawing conclusions and recommendations from the trial².

The statistical analysis process must include:

• Developing a statistical analysis plan that specifies the objectives, endpoints, methods, assumptions, and procedures for the statistical analysis of the trial
• Performing the statistical analysis according to the pre-specified plan using appropriate software and tools
• Reporting the results of the statistical analysis in a clear, concise, and transparent manner using tables, figures, and text
• Interpreting the results of the statistical analysis in light of the clinical significance, limitations, and implications of the trial
• Adhering to the principles of data integrity, reproducibility, and transparency in the statistical analysis

6. Reporting and Publication

Reporting and publication is the process of disseminating and sharing the findings and outcomes of a clinical trial with the scientific community and the public². Reporting and publication is important for advancing scientific knowledge, informing clinical practice, and improving health outcomes².

The reporting and publication process must include:

• Preparing a clinical study report (CSR) that summarizes all the aspects and results of the trial in a comprehensive and standardized format
• Submitting the CSR to the sponsor, EC/IRB, regulatory authorities, and other relevant parties as required by the protocol and the applicable regulations
• Registering the trial results in a public database within a specified time frame according to the protocol and the applicable regulations
• Preparing a manuscript that presents the main findings and conclusions of the trial in a concise and accurate manner
• Submitting the manuscript to a peer-reviewed journal that follows ethical standards and guidelines for publication
• Disclosing any conflicts of interest, funding sources, acknowledgments, or contributions related to the trial
• Following the principles of authorship, attribution, citation, and plagiarism in reporting and publication

Conclusion

Conducting a clinical trial with GCP is not an easy task. It requires a lot of planning, coordination, documentation, monitoring, evaluation, and communication. However, it is also a rewarding task that can contribute to scientific discovery, innovation, and improvement of human health. By following GCP, you can ensure that your clinical trial is ethical, scientific, and quality-driven.

1gcp.nidatraining.org2ema.europa.eu3ema.europa.eu4gcp.nidatraining.org5gcp.nidatraining.com6cpd.partners.org