The backbone of implementing Decentralized clinical trials (DCTs) is the efficiently running digital platform. DCT requires a customized DCT platform that has capability to receive and transmit the data accurately from various sources. Thus, DCT is an innovative shift in the traditional paradigm of clinical research, leveraging technology to facilitate remote participation and data collection. DCTs offer notable advantages such as increased patient accessibility, reduced logistical burdens, and potentially faster trial timelines and relies heavily on the infrastructure that supports working of the DCT platform. Let us look into the basic requirements to implement DCTs.
- Digital Support:
- The study participants must have access to reliable internet connection. Patients who lack access to reliable internet connections or digital devices may face challenges participating in decentralized trials. The receipt of real-time accurate data could be a problem.
- Familiarity to digital technology
- All the stakeholders such as the sponsor team, investigator and team, patient, regulatory bodies etc. should have some familiarity with the digital technology and should be able to operate the interface/wearable device as applicable independently. The DCT platform should be compatible with various wearable devices such as smart watch, mobile phones of different makes and operating systems.
- Patient Engagement:
- Patients should find the wearable divide easy to use and patient friendly. It must cue the patient for the necessary input data as well as provide reminders for medication intake, weight measurement etc. Patient should find its use easy and whenever in doubt the device should connect the patient to their healthcare professional/study investigator/coordinator. Such features improve patient engagement and their continued participation in the research project.
- Data Security and Privacy Concerns:
- Clinical studies generate a lot of patient data. It is important that the data generated remain secure at all times. The digital platform should be capable of handling the security and confidentiality of the input as well as output data and must ensure end-to-end encryption.
- Customization of the platform:
- The digital platform should be robust to receive customized data as per the study protocol. The DCT platform should have inherent quality to accept and implement the customized changes for each project without jeopardizing the study data. Use of different technologies, input and output devices should not affect the working of the DCT platform.
- Regulatory Acceptance:
- The DCT platform should be in compliance with the regulatory norms in terms of informed consent, patient data protection and GCP guidelines.
- Site selection
- The clinical trial sites should have a reliable secure internet connection and computer literacy among all the team members. If the hospital pharmacy and/ or lab is involved, they should also be able to access the required interface of the platform easily. The user ID and passwords must be unique and secure. The site must be trained to use the software as expected to comply with the protocol with objectives of patient safety and data quality.
- Interaction with Investigational Staff:
- DCT leads to reduced face-to-face interactions between patients and investigational staff, and it should not result in any confusion. The DCT platform should possess a dashboard/chat box for the teams to connect for any queries.
To summarise, the success of decentralized clinical trials is very much dependent on technology. The technology is advancing fast and therefore, the DCT platform must be free of any technical glitches and/or barriers and should deliver accurate data. Concerns related to data security, patient engagement, regulatory acceptance, and logistical complexities should remain minimal and offer reduced cost time and increased accuracy as advantages over the traditional clinical trial conduct.
