The COVID-19 pandemic greatly accelerated the digital transformation of clinical trials. Faced with a distinct possibility of bringing clinical trials to a halt due to restrictions on in-person interactions during the pandemic, organizations reached for technologies that already existed, but may not have been broadly used in clinical research. Telemedicine, electronic clinical outcomes assessment (eCOA), electronic patient-reported outcomes (ePRO), electronic informed consent (eConsent), or remote patient monitoring have been around for some time.1 The COVID-19 pandemic prompted regulatory agencies not only to allow but to urge their use to ensure patient safety and the continuity of clinical research.2
The adoption of digital technologies gave rise to a new paradigm, decentralized clinical trials (DCT). These trials shifted the center of clinical trial operations from investigator sites – selected hospitals or clinics where patients traveled to participate in clinical studies – to patients’ homes and laboratories located in patients’ communities.
DCTs are here to stay. Their implementation offers a promise of a reduced burden on patients, thereby increasing the probability of improved enrollment rates and reduced patient attrition,3 ultimately leading to shorter timelines, fewer protocol amendments, and significant cost reductions.4
Challenges remain. As we come out of the pandemic, it is time to consider what’s next in the evolution of clinical trials:
- How do we make clinical trials truly patient-centric?
- How do we optimize operational processes to support the DCT and hybrid clinical trials (HCT, ones that combine DCT and traditional trial models)?
- How do we democratize access to clinical trials by promoting diversity, equity, and inclusion?
- How do we take full advantage of data by developing standardized data governance and management practices and enabling interoperability across data systems?
- How do we evolve ecosystems of connected devices to not only facilitate remote patient monitoring and at-home care but to drive the adoption of digital endpoints?
At Globant, we begin by bringing technology to bear in four key areas:
- Patient identification, recruitment, and engagement
- Remote patient monitoring and at-home care
- End-to-end study process optimization
- Clinical data platforms
Whether you are at the beginning of your journey, need assistance with your DCT strategy, or are already on your way and seeking help integrating new capabilities with your existing systems, reach out. We are here to help you reinvent your clinical trial operations.
References:
- Gruessner, Vera. “The History of Remote Monitoring, Telemedicine Technology.” mHealth Intelligence, 2015.
- “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health. Emergency Guidance for Industry, Investigators, and Institutional Review Boards.” FDA, 2020.
- Reites, John. “5 ways that decentralized clinical trial approaches can reduce study costs.” MedCityNews, 2021.
- Pennic, Fred. “Decentralized Clinical Trials Can Achieve Net Financial Benefits of 5X to 14X.” Hit Consultant, 2022.
