Clinical trials are one of the most critical and difficult parts of the drug development process. The outcome from the clinical trial determines the next steps of development. Thus credibility of the data is dependent on the quality of study conduct and the quality of data collected as part of the planned research programs. The important determinants in any clinical study are the study participants. The clinical trial protocol should be easy to implement and should not burden the study participants with frequent hospital visits, odd timing for taking the study medicines, affecting their daily schedule etc. Work absenteeism is one of the most frequent reasons for the drop outs of study participants from the research programs. We have to make life easier for the study participants and the digital technology is a perfect answer to make studies more patient friendly without jeopardizing the quality of study conduct and the data generated. Recent improvements in telehealth, remote monitoring, and device integration have made life easier for the patients. The clinical trial conduct is supported by digital technology with application from a decentralized clinical trial platform. This has made clinical study management simpler and live to monitor rather than making frequent physical visits to various locations wherever clinical trials are ongoing. Clinical trial sponsors can now choose from a wide range of choices, from traditional to entirely decentralized study or a hybrid model. Several features distinguish decentralized clinical trials from their traditional counterparts:
- Remote Patient Monitoring (RPM):
- Patient-Centric Approach: DCTs prioritize the convenience of patients by allowing them to participate in trials from the comfort of their homes, reducing the need for frequent site visits.
- Wearable Devices and Sensors: RPM incorporates the use of wearable devices and sensors to collect real-time data, enabling continuous monitoring of patient health and treatment efficacy. This real time data is available for the monitors as well as investigator and team to follow on the daily basis. Any medical urgency can be known from the live data and necessary action can be immediately undertaken without wasting much time.
- Telemedicine and Virtual Visits:
- Remote Consultations: Telemedicine facilitates virtual interactions between patients and healthcare professionals, reducing the need for physical visits to clinical sites. This frequent contact is of help to the patient and they remain in constant touch with the trial clinicians.
- Video Calls and Remote Interviews: Study-related interviews, assessments, and data collection can be conducted through video calls, enhancing accessibility for patients. Patients do not need to take off from their work and patient attrition is considerably reduced by the use of DCT.
- Decentralized Data Collection:
- Electronic Informed Consent: DCTs often utilize electronic informed consent processes, making it easier for patients to review and sign consent forms remotely.
- ePRO (Electronic Patient-Reported Outcomes): Patients can report their symptoms and experiences electronically, contributing to a more efficient and accurate data collection process. The patient data is instantly available for the investigator to review and take necessary medical decisions in the interest of the patient.
- Home Drug Delivery:
- Direct-to-Patient Shipping: Medications can be shipped directly to patients’ homes, ensuring timely and controlled delivery of investigational drugs.
- Adherence Monitoring: Technologies may be employed to monitor and support medication adherence, enhancing data accuracy and patient safety.
- Centralized Monitoring and Data Management:
- Remote Site Monitoring: Centralized monitoring tools allow sponsors and CROs to monitor data and ensure protocol compliance without the need for frequent on-site visits.
- Centralized Data Management: Data collected from various sources are centralized, enhancing data quality, standardization, and analysis. It reduces compilation timelines and analysis.
- Decentralized Investigator Sites:
- Local Clinicians: In some cases, DCTs may involve a network of local healthcare providers who act as investigators, facilitating broader patient participation.
- Community-Based Settings: Trials can be conducted in community-based settings, reducing the burden on traditional academic medical centers.
- Data Security and Privacy:
- Secure Platforms: Robust data security measures are implemented to protect patient information and ensure compliance with privacy regulations.
- Blockchain Technology: Some DCTs leverage blockchain for secure and transparent handling of trial data.
- Adaptive Trial Designs:
- Real-Time Adjustments: DCTs often employ adaptive trial designs that allow for real-time adjustments based on emerging data, improving trial efficiency and outcomes.
- Regulatory Considerations:
- Regulatory Support: Health authorities are increasingly supportive of decentralized approaches, and regulatory frameworks are evolving to accommodate
- Guidance Documents: Regulatory bodies may provide specific guidance for the implementation and conduct of decentralized trials.
The features of decentralized clinical trials (DCTs) can differ, reflecting the dynamic nature of this evolving approach. The adoption of decentralized methodologies is an ongoing trend, shaped by continuous advancements in technology and responsive adjustments in regulatory frameworks. This fluid landscape underscores the adaptability and ongoing refinement of decentralized clinical trial practices.
