Global Decentralized Clinical Trials Market is set to witness a healthy growth rate of 10% to reach $14.2 billion by 2026

Decentralized clinical trials (DCTs) 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 Pandemic spurs Adoption of Decentralized Clinical Trials Market

Covid-19 has adversely impacted health services internationally 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 Hamper Adoption of Decentralized Clinical Trials Market

Clinical trial regulations have not kept pace with the digital tools used for decentralized 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.

Increasing Adoption and Financial Backing of DCTs by Pharmaceutical, Medical Device Companies, and Contract Research Organizations (CROs)

In recent years, due to Covid-19 pandemic, there has been an increase in the use of the DCT model by the pharmaceutical, medical device companies and contract research organizations (CROs):

• To reduce contact, improve the patient experience and keep studies on track during the Covid-19 pandemic.
• Due to the growing trend toward more patient-centric trials.
• The formation of industry stakeholder groups to facilitate collaboration and research.
• The possibility of reducing trial time and costs. Cost savings arising from diverse sources, including fewer sites (i.e., less investigator fees and costs for patient visits, and other site costs), less patient travel costs, and less site monitoring and management fees.

·   Moreover, fundings from top pharmaceutical companies to virtual clinical trial specialists is likely to boost the decentralized clinical trials market. For instance, in August 2020, Science 37, an American clinical research company that specializes in decentralized clinical trials, secured $40 million in funding from Novartis, Amgen, Sanofi, PPD, and Google’s VC arm.

The global decentralized clinical trials market is a booming market and is expected to gain further momentum in the coming 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 decentralized clinical trials market is marked by the presence of key 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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