Abhrasnata Das
Today, the key obstacles to clinical trial success continue to be patient recruitment and retention. According to sources, between 50 and 60 percent of research in 2018 was unable to enlist enough participants, which resulted in less definitive findings and delays in the studies' conclusion. Furthermore, statistics show that approximately 85 percent of clinical trials fall short of their enrollment deadline because they are unable to attract and keep subjects. Even though patient recruiting and retention sometimes consume one-third of a study's expenditure, 80 percent of trials do not wrap up on schedule. Additionally, failure to attain projected enrolment results in the termination of 19 percent of registered clinical studies.
The healthcare sector is investigating the potential of decentralized clinical trials (DCT) and developing hybrid protocols that will give it a competitive edge and enable the delivery and scaling of treatments to patients who are geographically dispersed. In this article, we have pointed out the key advantages that DCT will bring to the table.
Better Patient Recruitment and retention Utilizing strategies that keep research participants enthusiastically engaged and driven to complete the experiment is key to effective retention. It's important to recognize and promote the patient experience. Attrition is more likely to occur when participants feel that the patient load is heavy. Dropout rates are impacted by elements like regularly scheduled onsite visits. Without affecting the study, patient centricity in the form of fewer site visits may be achieved. Clinical trials must be conducted successfully not just in terms of recruiting patients, but also in terms of keeping them interested and inspired to continue participating. An alarming 30% dropout rate is seen among patients who agree across all research trials.
Therefore, the likelihood of success should rise by enhancing the patient experience through protocol optimization to reduce the perceived patient burden. DCTs lessen the workload for both patients and caregivers by requiring fewer or no site visits, which helps to increase patient retention.
Better Data Visibility DCTs provide for catching the full picture and how the new therapy could affect various patient groups because they have access to a wider population through a larger geographical footprint. DCTs can gather more data from patients over time by using mobile technology than can be done with conventional site-based clinical investigations. Consequently, they offer data that is more applicable to a real-world environment than site visits, which are constrained by the frequency and duration of visits. The fact that data is dispersed over several proprietary systems that are frequently independent and incompatible with one another is one of the main issues with the conventional paradigm of conducting clinical trials. One of the major expenses related to remote trials falls within this area.
Technology systems (e-consents, e-PROs, wearables, applications, telehealth, etc.) that synchronise all the numerous digital efforts in trial conduct for analysis, monitoring, cleaning, and submission are necessary for DCTs. However, over time and with the scaling of numerous products and research, the foundation of established and integrated software platforms will be reflected on the quality and quantity of data.
Increased flexibility A classic clinical trial in life science research is often planned around the research facilities, where members of the clinical operations team keep an eye on trial data for a local community. To complete visits for the research, participants must go to the location. Their regular routines might be significantly disrupted by this procedure. DCT, on the other hand, uses a patient-centered strategy and virtual tools like telemedicine and wearables to conduct remote visits and track data.
Making participation in the research more flexible by enabling options like data submission from any location and home blood drawsThe most significant criteria that participants take into account when determining whether or not to participate in a research are the location of the clinical facility and the travel time required to get there. DCTs allow for remote data collection and monitoring, lowering participation barriers by preventing participants from having to travel far to access the site. Even hybrid studies might lessen the load on patients in certain ways.
Future With Technology Decentralized trials use contemporary technology to transmit clinical research data, however technology use also presents a significant barrier to protocol adherence. For instance, wearable technology used to gather participant data is still in its infancy and has not yet found widespread acceptance. Before being licenced for broad usage, the bulk of these biometric devices still need to be validated by the clinical trial operations team to fulfil regulatory requirements. Utilization of technological equipment also depends on the accessibility of intranet infrastructure, different transmission techniques, physical components like batteries, and technical help for problem-solving. A DCT experiment may encounter difficulties as a result of all of these factors.