Tracing Pharma-Industry’s Approach to Decentralized Clinical Trials (DCT)
Avisek Ghose
Market Access | Business Development | EMEA | Medical Device & Pharma | Translating Market Insights into Actionable Business Strategies
"Discovering DCT trends is valuable because this can pinpoint which elements are practical and which are not. It is important to see what piece of the puzzle will bring efficiencies.” - Nico O'Kuinghttons , Vice President of DCT at 迈达普 .
Decentralized Clinical Trial (DCT) minimizes or eliminates the need for #patients to physically visit the trial sites and therefore its benefits lead DCT to growing adoption within the #pharma #industry.
??DCT (or its components) adaptation significantly increased throughout 2020-21 particularly for the COVID-19 related trials. The use of decentralized components in drug trials peaked in 2021, with a 45% increase compared to 2020. Although it slowed down in 2022, it remained significantly higher than in 2020. It is estimated that DCT volume will rise by 17% by the end of 2023.
Uptake by the decentralization method
A decade ago, Phase III trials were the most likely to utilize decentralization. But in recent years growth in use has been particularly strong for Phase II trials, which now make up almost one in every two decentralized trials.
Landscape of DCT can be sub-grouped into six major categories, each reflecting a distinct form of remote or virtual trial design:
1?? Decentralization to home or alternative sites
2?? Digital data collection,
3?? Use of ePRO / eCOA / eDiary
4?? Remote Patient Monitoring (RPM) via web-sensors, mobile devices, trackers etc.
5?? Telemedicine
6?? Digital / electronic Consent from the patient
??Related read: Artificial Intelligence in Clinical Trials
"There are disease spaces where decentralization seems yet to take off. While DCT in some therapy areas, such as oncology, may be hard to keep track of, it does not mean there is lack of involvement among players. It is all about intent – DCT allows the opportunity for patients to participate in trials who may not have access to a typical clinical trial site." - ? Craig Lipset co-founder and co-chairman of Decentralized Trials & Research Alliance (DTRA) .
??Large commercial sponsors led DCTs in the past decade, but in recent years the landscape has become more nuanced (characterized by subtle and often appealingly complex aspects). More universities, governmental organizations, and non-profit firms hae become increasingly proactive in utilizing decentralization. Academic centres are on the frontlines of scientific breakthroughs, so it is not surprising they are also increasingly becoming more engaged with DCTs.
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“There is also an increase in private-public partnerships that also help this trend. These types of partnerships are valuable as they help facilitate large-scale research that any individual institution may find challenging to execute.” - Rachel Colite Vice President at Cogstate .
DCT uptake by country
One of the key appeals to #decentralization is the potential to remove geographical barriers for #clinical #trial participants. However, running DCTs may be easier in some countries than others and certain cultural differences might cause more burden to patients than traditional trials.
"This trend can be attributed to how friendly local regulators are on engaging with decentralized clinical trials. There are countries whose regulators are particularly outspoken, progressive, and engaged on this topic. And as such, they will attract trials with DCT elements." - Craig Lipset co-founder and co-chairman of Decentralized Trials & Research Alliance (DTRA)
High-income countries tend to set the pace with new approaches as their economies have the means to adapt. Data privacy also needs to be a part of the DCT conversation. DCT uptake that requires data collection will have to be in places where data privacy regulations and compliance are also up to speed.
Disclaimer:
Content of this Newsletter is inspired by the original article "DCT Tracker: tracing industry’s adoption of decentralized clinical trials" published by Clinical Trials Arena on 03.Feb.2022 and supported by other publicly available insights.
?? Coming up next:?How Should We Assess Innovation in Oncology Reimbursement Decision Making (Tue. 25.07.2023)
About the Author
Avisek Ghose is a healthcare market researcher, driven by marketing passion. A seasoned consultant and trained bio-imaging specialist who shares his insights and outlook about recent trends, challenges and opportunities about early market access strategies, HEOR and HTA issues in Medtech, Pharma and Diagnostic products.
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