clinical trials
Envirotainer
Clinical trial transformation Recent changes and future predictions iStock.com/metamorworks
Clinical trials play a pivotal role in advancing medical research and improving patient care, and are an essential part of new drug development. In recent years, clinical trials have undergone significant changes driven by technological advancements, regulatory shifts and a growing emphasis on patient-centricity.
A
ccelerated by the COVID-19
pandemic, we have seen a shift in clinical trials, with changes to the way they are conducted, regulated and perceived. In this article, we will explore the recent transformations in the world of clinical trials and offer insights into their potential future direction.
Recent changes in clinical trials One of the most prominent recent developments in clinical trials is the increasing use of realworld evidence (RWE). RWE uses data from a variety of sources, including electronic health records, insurance claims and wearable devices. This allows researchers to gather data beyond
also known as virtual, at-home or site-less trials.
focuses on quality, and establishes proportionate
With the implementation of telemedicine and
and risk-based approaches for conducting
home-based monitoring, patients can take part in
clinical trials, while minimizing unnecessary
trials from the comfort of their homes, eliminating
complexities”. New recommendations include
the need to travel to specific sites. This approach
encouraging the use of innovative digital health
has shown increased patient participation and
technologies (DHTs), such as wearable sensors,
increased study effectiveness, and will ultimately
to increase the efficiency of data collection.
help to get drugs to market faster.
European Union: The EU has implemented
There has also been a growing emphasis on
a new Clinical Trials Regulation (CTR) to
patient-centricity in more recent clinical trials.
create a more unified and efficient framework
Regulatory agencies and sponsors are actively
for clinical trials across member states.
involving patients in the trial design process to
The CTR, fully implemented in early 2023,
ensure that the research is aligned with patients’
simplifies the approval process, harmonises
needs and preferences. This approach not only
trial designs and establishes a single portal for
enhances the relevance of the trials but also
trial submissions. These changes are expected
increases patient recruitment and retention rates.
to reduce administrative burdens and enhance
Several countries have undergone significant changes in their clinical trial regulations to adapt to the changing landscape:
the competitiveness of EU clinical research. India: In 2019, the Ministry of Health and Family Welfare (MoHFW), Government of India
traditional clinical trial settings, providing
United States: In June 2023, the FDA
released updated New Drugs and Clinical Trials
a more comprehensive view of a treatment’s
announced the availability of a new draft
Rules, designed to help streamline regulations and
effectiveness and safety.
guidance, ‘E6(R3) Good clinical Practice (GCP)’.
guide clinical trial conduct in India. These updated
The COVID-19 pandemic accelerated the
The latest draft guidance includes updated
rules include new time limits for responses to
adoption of remote and decentralised clinical trials,
recommendations and “encourages innovation,
submissions for application for clinical trials.
This issue is sponsored by | AMS Instrumentation & Calibration Solutions | www.ams-ic.com.au 21