The digital shift in clinical trials brings the potential to significantly improve both clinical data quality and the patient experience, while also accelerating the time it takes to get new drugs to market. Understanding where the greatest positive impact can be made with decentralized approaches is the first step towards the future of clinical trials.
Learn what new clinical trial methods will continue in the post-COVID world.
Organizations have accelerated their plans to shift to decentralized clinical trial models that leverage remote data collection technologies and processes to engage with patients, rather than in-person visits. Here are five things to consider when framing your DCT strategy.
In a centralized trial, the patient participates in a limited number of face-to-face appointments with the clinician at a healthcare facility. In a DCT, the patient interacts with the clinician and submits information remotely and fluidly without a physical appointment.
In a centralized trial, data is manually collected during the in-person appointment at a single point in time; however in a DCT, large amounts of data are collected at multiple points in time, revealing previously unknown relationships in data.
In a centralized trial, patient data is captured and entered into different systems multiple times and processes are repeated, creating redundancy. In a DCT, patient data flows automatically into a central platform where it is available as needed across all processes.
In a centralized trial, data is entered by the clinician manually or captured on paper in multiple places, introducing a greater chance for inaccuracy. Wearables and sensors used in a DCT can capture data directly from the patient, eliminating manual data entry and reducing errors.
In a centralized trial, patient data is captured at set moments during in-person patient visits in a clinical environment. In a DCT, patient data is remotely collected “as it happens,” allowing patients to be studied in an unobtrusive manner in real-life situations.
Research insights into how the pandemic changed clinical trial operations.
Patient recruitment and retention in clinical trials remain top challenges and cause significant delays in clinical trials. Make it easier for patients to participate in clinical trials, adopt new patient-facing clinical trial software, change the way you think about clinical trials. Get patient data faster and improve the data quality.
Clinical trial data quality is a top challenge in adopting DCT methods and the primary concern of study teams when it comes to remote data collection. Get new data from new sources for a better picture; use eClinical solutions that can handle it all and maintain quality and compliance.
The pandemic has accelerated adoption of DCT methods, but sponsors/contract research organizations are not set up to support these efficiently. Resolving data collection, synergy, and monitoring complexities offers an immediate impact on study costs and timelines. Be on the forefront of innovation. Be a leader. Embrace the digital transformation of clinical research.
Natalie Gagliordi, Senior Writer, Oracle
The methods utilized during the pandemic are likely to have a lasting impact on the future of clinical trials, according to a new research study conducted by Informa Pharma Intelligence and Oracle.Read the complete post
In this episode, Kathy speaks with Covance’s Director of Decentralized Trials, Jane Myles, and Vice President and Head of Decentralized Trials, Bola Oyegunwa, about how they’re driving the implementation of decentralized trials globally, and what they think the core tenants are that the industry should abide by when executing decentralized trials.
The COVID-19 pandemic has—without warning—turned clinical trial operations on its head, forcing the industry to re-evaluate how to engage with patients and acquire patient data without direct, in-person access. Explore the impact on clinical trials in this new paradigm.
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