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. Telemedicine, local/mobile healthcare providers, and digital/mobile technology are used to perform clinical trial studies.
Some of the main factors propelling the global decentralized clinical trials (DCTs) market include the advantages of DCTs, Covid-19, growing adoption by pharmaceutical, medical device companies, and research organizations (CROs), formation of industry stakeholder groups like the Decentralized Trials & Research Alliance (DTRA) to facilitate collaboration and research, favourable funding & regulatory outlook, and surge in M&A activities. However, concerns around patient data privacy are likely to hamper the growth of the decentralized clinical trials (DCTs) market.
Covid-19 Spurs Adoption of Decentralized Clinical Trials (DCTs) Market
Internationally, Covid-19 had a negative influence on health care, and the clinical industry was not an exception. The challenges of doing clinical research during the Covid-19 pandemic resulted to the termination of more than 2000 trials that were registered on ClinicalTrials.gov. Covid-19 harmfully 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.
Decentralized clinical trials (DCT) have become a vital tool in the wake of the Covid-19 pandemic, providing for the remote recruitment of patients, physician visits/patient consent can take place via telemedicine, and mobile technology can be used for remote data collection.
“The Covid-19 pandemic compelled several sponsors to incorporate virtual elements such as telemedicine, remote electronic medical record access for monitors, and virtual monitoring of data & study documentation into their trials.” – Senior Director, Leading DCT Solution Provider, United States
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Regulatory Hurdles Likely to Hamper Adoption of Decentralized Clinical Trials (DCTs) Market
The digital tools utilized for decentralized trials have not kept up with the market’s clinical trial regulations. 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.
Growing Adoption and Financial Backing of DCTs by Pharmaceutical, Medical Device Companies, and Contract Research Organizations (CROs)
Due to Covid-19, pharmaceutical, medical device companies and contract research organizations (CROs) have all increased their usage of the DCT model in recent years:
- 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
Additionally, funding from large pharmaceutical companies to specialists in virtual clinical trials is probably going to expand the market.
- 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 decentralized clinical trials (DCTs) market is a booming market that 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 of Decentralized Clinical Trials (DCTs) Market
The global decentralized clinical trials (DCTs) market is marked by the presence of 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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