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CTIS is the online system for the regulatory submission, authorization and supervision of clinical trials in the EU and the European...
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With the emergence of COVID-19, the need to adapt the way in which clinical trials are executed has become one of the most discussed topics amongst industry experts. Pandemic restrictions and social distancing requirements call for increased demand for the use of telemedicine in to facilitate decentralized clinical trials (DCTs) and mitigate potential disruption to clinical projects. Indisputably, with their numerous benefits, decentralized trials are a promising alternative concerning the future of clinical trials and subsequent trial design.
How efficient are DCTs and how can sponsors and CROs benefit from this approach?
Understanding the importance of incorporating digital technologies within the clinical study and trial design process is the key to more efficient trial execution and overall mitigation of specific risks such as pandemics. While DCT’s reduce the burden on physical sites, there are many other positive attributes that patients, sponsors, and CROs can benefit from:
Patient´s clinical data can be harvested from a variety of different settings due to the advancement in technologies, such as telemedicine, wearables, and sensory-based technologies, thus making trial participation more convenient and safer for patients.
Sponsors and sites often experience patient recruitment challenges, dependent upon location and rarity/complexity of the indication. DCTs minimize physical patient visits to sites and thereby significantly reduce the patient´s logistical and financial burdens, such as lost wages, childcare constraints, and transportation costs and thus provides more incentives for the patient to enroll in the study.
By narrowing geographic barriers for patients of diverse populations, age, or ethnic minorities underrepresented in traditional onsite designs, more diverse data can be collected. Moreover, some digital tools may collect data continuously, transmitting them directly to researchers, thereby improving the detection of specific and naturally occurring events that are unlikely to occur during a study site visit.
DCTs often utilize technologies that maintain real-time and consistent communication with the patient.
However, if you plan to conduct a clinical study whereby the project encompasses a decentralized model, there are multiple challenges that CRO, sponsors, and patients can potentially encounter:
In some studies, face-to-face examination of the patient is necessary to obtain more accurate data after physical examination. For example, for studies that involve more debilitating illnesses or require extensive diagnostic procedures like advanced imaging and biopsies, it wouldn’t be plausible to rely solely on digital health tools to obtain the relevant patient clinical data in line with the study protocol. Such patients which fall under these categories will require in-hospital stays, closer physical monitoring, and more rigorous face-to-face observations by clinicians and investigators.
Advancement in digital health technologies has created challenges with regard to maintaining the appropriate standards for privacy, safety, ethics, and regulation. Digital technology and remote monitoring require advanced security measures to protect against data breaches during collection, transmission, and data storage.
Patients may have a lack of access to digital technologies and devices and may generally have a preference for in-person review as opposed to online visits. Many factors can contribute to the patient´s preference, such as age, disability, location, network, etc.
Sponsors must align their trial with up-to-date regulatory guidance, which frequently changes and often differs from country to country.
As the approach to the design of clinical trials evolves over time, the need for closer cooperation between research teams and data scientists in respect of data collection, analysis, and security will need to become more closely aligned.
The COVID-19 pandemic has been the underlying catalyst in the implementation of decentralized trials. The pharmaceutical and life science industries strive to bring patient centricity to the forefront by making the participation of patients in clinical studies more convenient, with better retention rates. CROs and sponsors are joining forces to discover novel ways to incorporate telemedicine technologies within clinical trials best, thus creating a more strategic approach to trial virtualization.
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