Global
Decentralized Clinical Trials (DCTs) Market valued at $8.8 billion (2021),
is set to witness a healthy growth rate of 10% to reach $14.2 billion by 2026.
Benefits of DCTs, Covid-19, growing adoption by
pharmaceutical, medical device companies & contract research organizations
(CROs), formation of industry stakeholder groups such as Decentralized Trials
& Research Alliance (DTRA) to facilitate collaboration and research,
favorable funding & regulatory outlook, and surge in M&A activities are
some of the key factors driving the decentralized clinical trials market
growth. However, concerns around patient data privacy are likely to hamper the
growth of the market.
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.
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Covid-19 Spurs Adoption of Decentralized Clinical Trials
Market
Throughout 2020 and 2021, the Covid-19 virus spread rapidly
and relentlessly across the globe and adversely impacted a multitude of
industries worldwide. With lockdowns implemented, social distancing mandated,
and widespread apprehension – Covid-19 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.
“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
Benefits Offered by Decentralized Clinical Trials (DCTs)
Fuels its Market Demand
The decentralized clinical trials market is an exciting and
fast-growing market that allows the incorporation of several technologies into
clinical trials. The demand for DCTs is majorly being driven by its advantages:
Advantages for the Patients:
- Enhanced
patient convenience and experience
- Less
burden for travel
- Reduced
time-consuming in-person visits/ Less disruption of daily life
Advantages for the Sponsor/Investigator:
- Improved
patient recruitment and retention
- Reduced
workload for trial investigators
- Access
to a more & diverse patient pool/ Improved data diversity
- Better
compliance
- Reduced
drop-out rates
- Real-time
communication with patients, among others
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.
Training site personnel and patients on using digital
tools/devices to ensure full compliance with the study protocol is another
challenge that is hampering its adoption. The coordination of home-based
procedures that require a skilled healthcare practitioner is also a treatment
challenge that decentralized studies need to overcome.
Growing Adoption and Financial Backing of DCTs by
Pharmaceutical, Medical Device Companies, and Contract Research Organizations
(CROs)
In recent years, due to Covid-19, 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. Example:
- Decentralized
Trials & Research Alliance (DTRA) – It enables the collaboration of
stakeholders to accelerate the adoption of patient-focused, decentralized
clinical trials and research within life sciences and healthcare through
education and research
- Clinical
Trials Transformation Initiative (CTTI)’s ‘Decentralized Clinical Trials’
Initiative – CTTI has issued several recommendations to speed the use of
decentralized clinical trials. Recommendations offer guidance on
overcoming legal, regulatory, and practical hurdles for planning and
conducting decentralized clinical trials
- 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, funding from big pharma companies to virtual
clinical trial specialists is likely to boost the 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.
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Favorable Regulatory Outlook of Key Regulatory Agencies
Set to Drive the Decentralized Clinical Trials Market
Major regulatory authorities such as FDA, the European
Medicines Agency (EMA), the UK’s Medicines and Healthcare Products Regulatory
Agency (MHRA), Singapore’s Health Science Authority (HSA), and China’s Center
for Drug Evaluation (CDE) recognize the growing importance of digital future of
clinical trials and hence are quickly evolving and adapting to the new digital
world. All these agencies are issuing an increasing number of digital
initiatives, guidelines, and regulations for the safe and compliant conduct of
DCTs. The guidance documents issued by these agencies highlight how new
processes and methods can be implemented to protect patients and facilitate
continued trial execution while maintaining good clinical practice (GCP)
standards.
The decentralized clinical trials 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: Decentralized Clinical
Trials Market
The 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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Associate, Medi-Tech Insights
+32 498 86 80 79
info@meditechinsights.com
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