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 dropouts of study participants from research programs. We have to make life easier for the study participants and 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. Nowadays, sponsors of clinical trials are allowed to select from a wide variety of options, starting from conventional to completely decentralized or a hybrid prototype. DCTs are distinguished from the conventional counterparts by vivid features:
- Remote Patient Monitoring (RPM):
- Approach towards patient centricity: A patient’s convenience is kept on top priority in by letting them in trails participation from their home’s comfortness, thus lowering recurrent visits to the sites.
- Sensors and Wearables: To gather information in real time RPM has incorporated the usage of sensors and wearables to enable the non-stop health monitoring of a patient and efficacy of the treatment. The monitors, investigators, and the whole team keep track of this data regularly. For any such medical urgency tracking of this live data can be implemented for immediate action without any wastage of time.
- Telemedicine and Visits Virtually:
- Sessions conducted remotely: Interactions virtually between healthcare personnels and patients are facilitated by telemedicine, thus lowering clinic visits physically. This type of frequent interaction helps patients to stay in continuous touch with the clinicians involved in the trial.
- Video Calling and Interviewing Remotely: Interviews related to study, collection of data and assessments, can be carried out by video calling, improving the patient’s accessibility. Due to DCT there is no need for patients to take work off thus reducing the attrition rates.
- Collection of Data in a Decentralized way:
- Informed Consent in Electronic Form: The utilization of informed consent in the electronic way makes it patient friendly to remotely analyze and sign consent forms.
- ePRO (Electronic Patient-Reported Outcomes): Electronically, a patient’s signs and symptoms can be reported, giving rise to a better and process of data collection accurately. The data of the patient is available in a click to be reviewed by the investigator and provide needed medical conclusions in the patient’s interest.
- Delivery of Drug to Homes:
- Shipping to patients directly: Patients can directly receive medications to their homes ensuring delivery in time and delivery of investigational medicines in control.
- Adherence Monitoring: To support and track medication adherence, employment of technologies is carried out to boost safety of patients and accuracy of data.
- Examining in a centralized format and management of data:
- Monitoring of Sites Remotely: Monitoring tools available in a centralized form helps CROs and sponsors to guarantee compliance of protocol and monitoring of data without frequently visiting sites.
- Centralized Management of Data: The collection of data is centralized from different sources boosting the quality of data, analysis, and standardization. This lowers timelines for compilation and assessments.
- Decentralized Sites for Investigation:
- Locally Available Clinicians: In a few cases, a group of regional providers of healthcare may be involved in DCTs who acts as investigators, aiding in a wider participation of patients.
- Settings Based on Community: The execution of trials can be carried out in settings based on community, lowering the obligation on conventional medical hubs.
- Privacy and Security of Data:
- Safe Platforms: Implementation of strict measures of security of data are performed for protecting the information of patients and safeguard agreement with regulations of privacy.
- Technology of Blockchain: For safe and clear handling of data of the trials some of the DCTs employ blockchain.
- Adaptive Designs of Trials:
- Adjustments in Real-Time: Adaptive design of trials is often used by DCTs designs allowing adjustments in real-time grounded on data, which is emerging, improving the results and efficiency of a trial.
- Considerations Regulatory in Nature:
- Regulatory Support: Authorities involved in health are gradually more in support of DCT approaches, and there is evolution of regulatory bodies for the accommodation of DCTs.
- Documents of Guidance: Particular guidance may be provided by regulatory bodies for conducting and implementing DCTs.
There may be differences in the aspects of the evolving concept of (DCTs) decentralized clinical trials, exhibiting its nature as dynamic. Currently, adopting is ongoing for DCTs, shaping the responsive and technological advancements in the frameworks of regulatory bodies.
