An Overview
With high-paced technological advancement and incessant innovations, the healthcare sectors are transcending beyond excellence. The advent of the COVID-19 pandemic has reshaped the way clinical studies function, by availing the use of telemedicine and wearable devices. Often referred to as “direct-to-participant trials” or “virtual studies”, decentralized clinical trials mitigate the dependence on conventional-style research facilities and data intermediaries, by allowing researchers to test the participants remotely. Rather than disrupting the course of clinical studies, decentralized clinical trials (DCTs) saw immense popularity and acceptance among HCPs, researchers, and patients. The article focuses on the current position of DCTs and their future scenarios.
How DCTs have evolved with the current health regime?
Initiated as a pragmatic approach to COVID-19, DCTs have now been fully embedded in clinical study programs. On-site clinical studies evoked skepticism among the participants, limiting a considerable patient population to undergo testing and trials. DCTs have infused confidence and flair amongst the enrolling participants as they get to partake in the trials from the comfort of their homes.
Convenient data collection and remote monitoring ease the complex traditional practices. Currently, major pharmaceutical companies are using this methodology to test participants and keep track of their blood pressure, heart rate, sleep cycle, and physical activity via wearable devices. It won’t be completely right to say that DCTs have replaced conventional on-site trials as the trials are subjective to disease conditions, the availability of telemedicine, and many other factors. Mostly DCTs are preferred for diseases with advanced telemedicine like diabetes, cardiovascular, pulmonary diseases, and the most recent COVID-19. Simply put, DCTs are suitable for low-to-medium complexity conditions. Typically, DCTs use the following practices to enroll participants and assess the outcomes of clinical trials:
- The participating candidate gets to fill up an e-consent form
- Telemedicine is availed to the candidate
- Clinical outcome assessment is carried out with the help of ePROs
- Drug impact is evaluated via biosensors or wearable devices
What does the future hold for DCTs?
DCTs have a whip hand when compared to on-site clinical trials. With remote data collection and monitoring, research organizations save a copious number of resources. Moreover, such trials bring with them diverse patient inclusion, enabling a wide range of studies for a particular drug candidate. The advancement of biosensors and medical devices with little to negligible error can eliminate the technological downsides of DCTs while giving a boost to such trials.
As far as the database is concerned, companies are shifting their focus to blockchain technology, which eliminates the need for a centralized third-party server. DCTs are widening the horizons of clinical studies by cutting costs, adding convenience, and maximizing the trial retention rate. The hybrid model of DCTs has gained wide popularity when it comes to testing long-duration diseases, which require periodic attention of researchers and medical facility that cannot be ferried to home.
Conclusions & Perspectives
Even though DCTs have revolutionized the arena of clinical trials, it would be completely arbitrary to say that DCTs are going to eliminate the need for on-site clinical trials. Though the frequency of on-site visits can be minimalized, it would be rather difficult for decentralized clinics to test patients for the diseases that require constant medical attention.
About Octavus Consulting
Octavus is a dedicated consulting company that offers a one-stop market solution to life science enterprises, biopharma, MedTech, diagnostic centers, digital health companies, animal healthcare, and startups.
Since 2017, Octavus has worked closely with various conventional and non-conventional CROs to deliver numerous projects ranging from Human intelligence gathering on competitors to their activities. We have worked on the analysis of various trends for CROs, helped them with data analytics to design intelligent trials for their clients (including Trial design dashboards using excel, power BI & Tableau), and conducted site-level due diligence gathering and primary intel gathering before investments. We have been working with some new tech based CROs where we support their teams with data analytics for their DCT studies and disease landscapes. We are a team of professionals with decades of experience in the industry. Our SEO-friendly content generation and social media marketing via our media division PharmaShots has helped numerous life science businesses outperform in the market.
Feel free to reach us bd@octavusconsulting.com for more information related to digital health & digital therapeutics