Health Care Professional Service in Decentralized Clinical Trials

Decentralized Clinical Trials (DCTs) have been a game changer and a much-needed aid in the painstaking process of long-drawn clinical trials. With patient-centric approaches and remote patient engagement strategies, DCTs are here to stay for a long time. The day-to-day advancements in cutting-edge technologies gave clinical research organizations and scientists the much-needed fuel to sustain and scale DCTs to where it is today. At the same time, technology wouldn’t be effective without the crucial engine-like role played by dedicated healthcare professionals across the globe.

?Now, more than ever, there is an obligation to strive for perfection in the science and practice of inter-professional team-based health care.

?‘Integrated care’, while representing a range of approaches, has been positioned as a promising solution with potential to benefit patients and health systems. Telemedicine, mobile and local Health Care Professionals (HCPs) (e.g., family physicians, general practitioners) have been involved extensively in healthcare delivery.

?Also, the Electronic Health Records (EHR) and Regulatory databases are regularly updated by the HCPs. This data is used as decision making in some of the RWD based DCT trials. Hence, the HCP way of diagnosis and reporting plays a key role in assessing the adverse events relevant to trial Investigational Products (IP).

?The Clinical Trials Transformation Initiative (CTTI)—a public–private partnership to improve clinical trials—launched a multi-stakeholder Decentralized Clinical Trials (DCTs) Project on addressing the actual and perceived legal, regulatory, and practical challenges with DCT design and conduct.

CTTI’s recommendations cover protocol design, use of telemedicine and mobile healthcare providers, medical product supply chain, investigator delegation and oversight, and safety monitoring considerations. By implementing these recommendations, sponsors, contract research organizations, and others can help advance successful medical product development using mobile technologies and methodologies in DCTs.

Let’s take a quick look at a few of the roles played by healthcare professionals in Decentralized Clinical trials (fully-virtual or in hybrid mode),

1. ?Patient Interactions and engagement: This is a crucial aspect of any trial, and healthcare professionals seamlessly involve in this through online platforms (E-visits, E-consent, Tele Health) and in-home visits???

?Key Benefits: Better patient recruitment and retention by breaking existing barriers to enrolment and participation.?

?2.????Continuous monitoring and evaluation: Wearable devices with real-time monitoring sensors and online patient-reported outcome surveys help healthcare professionals monitor the participants and document through various stages of a clinical trial.?

?Key Benefits: Reduced burden on traditional health systems (as compared to conventional clinical trial approaches)

?3.????Continuity of Care: DCTs have significant potential to limit participant withdrawal as healthcare professionals have the flexibility and digital options to offer continuity of care even through unprecedented situations like the COVID-19 pandemic. Additionally, patient touch points and laboratory tests can be in localized patient communities as part of DCTs.?

?Key Benefits: Data integrity improves by avoiding unexpected gaps in follow-up data collection.

?Overall, healthcare professionals act as crucial enablers for stepping up DCTs. They improve the adoption of health technologies for clinical trials. And this positively impacts the efficiency and outcome of modern-day clinical trials.?

?

For more information -??

Visit our website -?www.paradigmit.com?

Or you can write us at?[email protected]?

Follow us for more -?https://www.dhirubhai.net/company/paradigmittechnologyservices/?viewAsMember=true