The emergence of (DCTs) decentralized clinical trials model transformed the clinical study field, leveraging technologies digitally by shifting away from conventional visits of patients and examining. Digital technologies have virtually enabled all the required activities of visits of patients in person including verification of data and monitoring of sites. The DCT model is innovative in nature and aims to be patient-centric in nature and potentially offers benefits in cost, time, and human efforts. By the incorporation of technologies remotely and platforms digitally, DCTs potentially optimizes the different prospects of the conduct of a trial, impacting recruitment of patients, collection of data, and overall management of trials. In this situation, the realization of price-effectiveness of DCTs is done in a streamlined method, reducing burdens of logistics, and increasing the engagement of patients. A glimpse of the growing DCT landscape is provided by the introduction and the stage is set to explore various ways in which DCTs may provide the sponsors and researchers with benefits in cost, and the wider ecosystem of healthcare. Some of the potential benefits and cost points connected to DCTs are outlined below:
- Recruitment of Patients and their Retention:
- In line with the experience currently, a large flexibility has been provided by DCTs to participation, reducing the travel burden, optimizing time and efforts and improving the convenience overall. Potentially this leads to the enrollment at a faster rate and increases the retention rate, lowering the total cost of each patient. The digital division (the break between those with technology access vs those without) and issues pertaining to the engagement of patients virtually must be taken into consideration.
- Site Monitoring and Management:
- Physical site visits for study monitoring are time consuming, tedious and expensive. DCTs have considerably reduced the need for extensive physical site visits for monitoring and management, as many activities can be conducted remotely. This has resulted in cost savings associated with travel, site visits, and monitoring resources. Robust technology infrastructure and data security measures are crucial to ensure the integrity of remotely collected data.
- Data Collection and Management:
- Collection of data is streamlined and the process of management by (EDC) electronic data capture and remote tools for monitoring, possibly causing a reduction in errors and ensuring data access in real-time. This potentially helps to save costs and increase efficiency. Initially investing in training and technology might be necessary, and concerns pertaining to the privacy of data and safety must be addressed with care.
- Infrastructure and Logistics:
- DCTs can reduce the need for physical infrastructure and logistics associated with traditional trial sites. This may result in cost savings related to facility maintenance, utilities, and other overhead expenses. The implementation of virtual trial technologies requires a well-established and reliable technology infrastructure.
- Compliance with Regulations and Oversight:
- Streamlined processes and remote monitoring can contribute to more efficient and high quality of the clinical research programs. The technology is capable of meeting the regulatory compliance and oversight, potentially reducing the time lags and associated costs. Adaption of frameworks of regulations in provisions of guidelines and rules may be required for adaptation for accommodating the exclusive features of DCTs, and guarantee must be taken by sponsors to adhere to the progressing regulatory situation.
- (PROs) Patient-Reported Outcomes:
- DCTs facilitates outcomes of the reports of patients gathering by employing tools digitally, possibly leading to accuracy improvement and data completion along with the reduction of load on patients and sites. Validation of digital tools and strategies for addressing potential biases in self-reported data are important considerations.
- Geographic Reach:
- DCTs can broaden the geographic reach of clinical trials, potentially accessing a more diverse patient population without the need for multiple physical sites. Cultural and regional differences, as well as varying healthcare infrastructures, need to be considered to ensure the generalizability of study results.
In summary, in decentralized clinical trial studies, cost benefits primarily arise from reduced travel, reduced requirements of physical infrastructure, potential increase patient recruitment and retention due to improved convenience, streamlined data collection processes, and capability of more efficient regulatory compliance. While initial investments in technology are required, the potential for faster enrollment, reduced monitoring costs, and broader geographic reach contribute to the overall cost-effectiveness of decentralized approaches, making them an attractive option for advancing clinical research. Additionally, the specific circumstances of each trial and the characteristics of the target patient population will influence the overall cost-effectiveness of decentralized approaches.
