Decentralized clinical trials (DCT) employ a method of conducting clinical trials where parts or all of the trial happen outside a traditional physical clinic or trial site. Clinical trial studies are conducted via telemedicine, mobile/local healthcare providers & digital/mobile technologies.
Covid-19 fuels the Adoption of Decentralized Clinical Trials Market
Covid-19 pandemic has adversely impacted all the healthcare services globally and the clinical industry was no different. More than 2000 trials registered on ClinicalTrials.gov were terminated because of the challenges of doing clinical research during the Covid-19 pandemic. Covid-19 adversely impacted participant recruitment, retention, the safety of trial subjects, protocol compliance, and highlighted the need for safe, reliable, and secure remote capabilities, which in turn led to a renewed focus on digitization.
In the wake of the Covid-19 pandemic, decentralized clinical trials (DCT) emerged as an important tool using which patients can be recruited remotely, physician visits/patient consent can take place via telemedicine, and mobile technology can be used for remote data collection.
Regulatory Hurdles Likely to Affect the Adoption of Decentralized Clinical Trials Market
Clinical trial regulations have not kept pace with the digital tools and technologies used for decentralized clinical trials. For instance, for wearable devices, there is a need to create an ecosystem where data from different devices and technologies are standardized, validated, and exchanged without data integrity issues.
Regulatory agencies follow a variety of approaches to DCTs, but currently, there is no international standard. The DCT regulatory landscape is continuously changing, and hence clinical-trial sponsors need to align their studies with the most up-to-date guidelines. For multi-regional clinical trials, there is a need to recognize the increased regulations and limited possibilities for variation in research methods. A customized strategy and consideration for complexity in the clinical trial design are required for all global clinical trials that implement decentralization.
The global decentralized clinical trials market is an emerging market and is set to gain momentum in the upcoming years due to its ability to harness technological developments to improve the efficiency, participant experience, and generalizability of clinical studies.
Competitive Landscape Analysis: Decentralized Clinical Trials Market
The global decentralized clinical trials market is marked by the presence of top market players such as ICON, Parexel, IQVIA, Covance, Thermo Fisher, LEO Innovation Lab, Huma, Medidata (part of Dassault), Oracle, CRF Health, Medable, Signant Health, and Clinical Ink, among others.
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