Clinical trials are an essential part of the drug development process, allowing researchers to test the safety and efficacy of new medications and treatments. Traditionally, these trials have been conducted at designated research facilities and hospitals, requiring participants to frequently visit these sites for assessments and procedures.

 

However, advances in technology are enabling a new model of clinical trials – decentralized clinical trials. In decentralized clinical trials, procedures and assessments are conducted remotely, outside of traditional clinics and hospitals. 

 

Participants can complete study activities from the comfort of their own homes through online platforms, connected devices, and local healthcare providers. As technology continues to evolve, decentralized trials are becoming more feasible and potentially offer numerous advantages over traditional, site-based studies.

 

Decentralized clinical trials (DCTs) utilize technology and local healthcare providers to facilitate remote participation in clinical research. DCTs differ from traditional clinical trials by reducing the need for in-person visits to trial sites.

Key features of DCTs include

 

• Telemedicine for remote consultations
• Home health visits and direct delivery of study materials
• Wearable devices and mobile apps for data collection
  
• Electronic informed consent and data capture
  
• Local labs and testing facilities
  

DCTs can be fully virtual with no on-site visits, or hybrid models with a mix of decentralized and in-person components. They aim to improve recruitment, retention, data quality, patient diversity, and access to trials. However, DCTs also pose regulatory, data management, and oversight challenges. Careful planning is required to ensure patient safety, data integrity, and trial validity. DCTs are an evolving approach that can make trials more patient-centric when thoughtfully implemented.

 

How is a decentralized clinical study organized?

 

Conducting a decentralized or remote clinical trials requires careful planning, coordination, and implementation of technology to enable remote participation. Some key elements in organizing a decentralized study include:

 

1.The assessment of the risk

Sponsors and contract research organizations must thoroughly assess the risks associated with remote procedures and monitoring. Additional quality control and training measures may need to be implemented to ensure high quality data collection. 

 

2.Study logistics and patient focus

 

Logistics must be optimized for direct-to-patient shipment of study materials and remote coordination of study visits. There is a greater focus on patient convenience and experience. 

 

3.Remote approval

 

Regulators must approve remote electronic consent procedures, at home self-administration of study drugs, and remote data collection. 

 

4. Online applications and recruitment procedures

 

Participants can learn about trials and apply online. Screening and enrollment procedures can also be conducted remotely via online platforms. 

 

5. Use of telemedicine

 

Virtual video visits replace some traditional in-person assessments. Remote monitoring devices allow continuous data collection. 

 

6. Home Health Care

 

Local home health care providers assist with basic in-person procedures and sample collection. 

 

7. Lab Drawings

 

Rather than visit designated labs, samples are collected by home nurses or at local facilities. 

 

8. Shipments of investigational products (IP) made directly to patients (DTP)

 

Medications are shipped directly to patient homes from central pharmacies. 

 

9. Off-Site Inspection

 

Monitoring teams perform remote source data verification rather than on-site monitoring. 

 

10. Centralized monitoring clinical trials and data visualization

 

Data streams from various sources are compiled and monitored centrally in real-time. 

 

11. Update study plans and protocols

 

Existing protocols may need adjustment for remote procedures and decentralization. 

 

Utilizing digital technology in decentralized trials

 

Decentralized trials rely heavily on various digital technologies to enable remote coordination and data collection. Some examples include: 

 

1. Information on electronic medical devices

 

Connected devices can remotely monitor key metrics like blood pressure, heart rate, glucose levels and more. 

 

2. Digital biomarkers

 

Digital apps and connected devices assess indicators like movement, cognitive function, and sleep quality. 

 

3. Safety monitoring

 

Wearables and at-home medical devices allow continuous safety monitoring. 

 

4. Data security (privacy and security)

 

End-to-end data encryption protects sensitive patient information. Advanced cybersecurity measures must be implemented.

 

Advantages of decentralized clinical trials

 

Decentralized clinical trials have the potential to transform the clinical research process and offer various benefits over traditional trials. Some key advantages include:

 

–>Increased patient diversity and inclusion – By removing geographic barriers, patients from wider geographic areas, socioeconomic backgrounds and races/ethnicities can participate. This leads to more representative, generalizable results.

 

–>Improved patient retention – By enhancing convenience and flexibility for patients, decentralized trials have much higher retention rates. 

 

–>Faster recruitment – Patients can easily learn about trials and enroll remotely from their own homes. This accelerates recruitment timelines.

 

–>Lower costs – Costs are reduced by minimizing unnecessary site visits and streamlining study coordination.

 

–>Real-world data collection – Assessments conducted in the patient’s natural setting provide more ecologically valid, real-world data.

 

–>Increased data quality – Continuous remote clinical monitoring reduces missed assessments and improves data capture.

 

–>Improved patient compliance – Direct-to-patient drug shipments and reminders may improve medication compliance.

 

–>Enhanced safety monitoring – Continuous safety monitoring from home provides earlier alerts to adverse events.

 

 

Recommendations from the FDA for decentralized clinical trials

 

The FDA has voiced support for decentralised clinical trials and provided recommendations for their successful implementation:

 

–>Sponsors should engage with the FDA early in the planning process for feedback.

–>Risk based monitoring clinical trials assessment and mitigation strategies should be documented.

–>Data privacy and cybersecurity measures must be top priorities.

–>Informed consent must be obtained while ensuring participant understanding.

–>Sponsors should establish methods to confirm participant identity remotely.

–>Protocols should define procedures to ensure protocol compliance.

–>Local healthcare providers should be trained to correctly perform delegated study procedures.

–>Centralized monitoring and quality control are important for multisite studies.

 

Conclusion

 

Decentralized clinical trials have immense potential to facilitate more efficient, accessible, and participant-focused research. They provide an opportunity to collect real-world data and include diverse patient populations. However, careful planning is required to address regulatory, data quality, and privacy concerns. 

 

Sponsors and regulators will need to continue evolving decentralized trial frameworks to ensure rigorous research standards are upheld. As technology and remote coordination platforms continue maturing, decentralized trials are likely to become more prevalent in the coming years. Their unique advantages could make decentralized studies the new gold standard model for clinical research.

 

Need support in monitoring your clinical trials

Monitoring is a critical component of clinical trial conduct to ensure participant safety, data quality, and adherence to study protocols. However, traditional on-site monitoring can be time-consuming and expensive. ClinVigilant offers innovative technology solutions to enable remote and risk-based monitoring of clinical trials.

 

ClinVigilant’s decentralized clinical trial platform digitizes the entire clinical trial process for patients, sites, and sponsors. It allows remote trial conduct through video and text chats between sites and patients. The platform also creates audit trails of all interactions and data exchanges, enabling real-time monitoring of study compliance, data quality, and safety events across sites. 

 

ClinVigilant’s modular, customizable products can interface with patient devices and wearables to collect study endpoints. The company also provides services like medical writing, site management, and data analytics to further support clinical trial monitoring needs.

 

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