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March 4, 2024

How To Implement Decentralized Clinical Trials

Implementing decentralized clinical trials (DCTs) involves leveraging digital health technologies and adapting trial processes to enable remote participation and reduce the need for physical site visits[1]. 

Here are some steps to consider when implementing decentralized clinical trials:

1. Planning and Design: Strategically plan and design the trial to incorporate decentralized elements. Consider factors such as the target patient population, trial endpoints, and data collection methods[1].
2. Technology Infrastructure: Invest in appropriate digital and remote monitoring technologies that enable remote data collection, virtual visits, and telemedicine. These technologies should ensure data security and compliance with regulatory requirements[1][4].
3. Patient Recruitment and Informed Consent: Develop effective strategies for remote patient recruitment and informed consent processes. Provide clear, easily understandable information about the trial, risks, benefits, and privacy protection. Utilize electronic consent methods[1][3].
4. Study Operations: Streamline trial processes and adapt them for remote participation. This includes home drug delivery, remote patient monitoring through wearables or mobile health apps, and virtual study visits. Prioritize patient-centricity and aim to provide a seamless experience for participants[1][2].
5. Data Collection and Management: Establish robust systems for collecting, managing, and analyzing remote patient data. Implement mechanisms to ensure data integrity, security, and privacy. Adhere to applicable regulations and guidelines[1].
6. Site Collaboration and Training: Collaborate with investigational sites to ensure proper implementation of the trial protocol. Provide comprehensive training on remote trial processes, use of technology, and adherence to ethical and regulatory considerations[1][2].
7. Regulatory Considerations: Stay updated with regulatory guidance and requirements for decentralized clinical trials. Engage with regulatory authorities to address any concerns or questions regarding the implementation of these approaches[1][2][5].
8. Risk Management: Identify and mitigate risks associated with the remote conduct of the trial. Regularly monitor and evaluate trial progress, patient safety, data quality, and adherence to protocols. Implement strategies to address any issues that arise[1].

 

It is important to note that the implementation of decentralized clinical trials may vary depending on the specific trial requirements, regulatory environment, and available resources. Consulting with experts and referring to relevant guidelines and publications can provide further guidance for successful implementation[1][2].

 

Sources:

1. McKinsey – Stepping up the decentralization of clinical trials
2. FDA – FDA Takes Additional Steps to Advance Decentralized Clinical Trials
3. Nature – Empowering clinical research in a decentralized world
4. The Mayo Clinic Proceedings – The Digitization and Decentralization of Clinical Trials
5. The Lancet Digital Health – Decentralised clinical trials: ethical opportunities and challenges

 

Conclusion:

Clinical Trial auditing should be a part of every trial as the Clinical Trial audit may be the last step before health authority review and GxP Solutions is your partner for compliance. 

GxP Solutions is a leader in Clinical Trial auditing services, QA services, and training. Consider us your in-house consultant to help you with your departmental goals. 

GxP Solutions Auditing Services and Training Courses cover:

• Good Clinical Practice (GCP) Training
• Good Laboratory Practices (GLP) Training
• Good Clinical Laboratory Practices (GCLP) Training
• Good Pharmacovigilance Practices (GVP) Training
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• Good Distribution Practices (GDP) Training
• Computer System Validation (CSV) Training