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International Clinical Trials
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Several aspects indicate that the time is ripe for a disruptive change
in the patient enrolment process to increase clinical trial efficiency.
The traditional system of recruitment is both time-consuming and
cost-intensive, yet ineffective. It is not as if trial sponsors and CROs
are not responding to this challenge – but their answer has been far
from ideal, as it primarily involves strategies to expand the number of
research sites across multiple geographies, which further adds to the
complexity issue and fails to pursue the original goal of optimising the
recruitment process.
Moreover, as therapies target niche
populations, regulatory agencies are introducing stringent norms for
trial sponsors to conduct larger and longer studies. The situation is
even worse for clinical trials that call for the treatment of naïve
patients, which dramatically shrinks the patient pool available for
studies. Industry experts estimate patient recruitment to account for
one third of the total time spent on clinical trials. Additionally, 37%
of research sites fail to meet their enrolment targets, and 10% of them
are unable to recruit a single patient for the study.
Data-Driven Approach
Within
the industry, there is a lively, ongoing discussion about the need for a
data-driven approach to use existing health data for clinical research
purposes, including patient recruitment. The long-term benefits of this
kind of system cannot be underestimated; however, this will be a
long-drawn out process considering the significant disparities among
countries in regulating security, privacy and interoperability, among
various other aspects.
In the EU, for instance, there are many
countries that do not have a specific law defining the use of health
data for clinical research purposes. The majority of the member states
are still in the process of establishing a national electronic health
records (EHR) scheme, and lack the legal and technical framework to
achieve interoperability standards. The EU level initiative to develop
an Electronic Health Records for Clinical Research platform to connect
EHR systems in different countries, and enable cross-border transfer of
data, is going to be a long-term solution. The real answer for the near
future lies in leveraging the internet and exploiting social media,
patient networks, patient advocacy groups and digital media to recruit
patients with previously unimaginable speed and precision.
Research Kit Platform
Apple
created a revelation in 2015 with the launch of the Research Kit, an
open source platform targeted at trial sponsors and clinical
investigators to develop apps specific to therapeutic areas and clinical
research studies. The University of California launched an application
for a cardiovascular study using the Research Kit, which received more
than 11,000 responses from patients in a single day. To date, more than
five apps have been created using the Research Kit with 100,000 patients
enrolling for clinical research studies in six months.
Moreover,
researchers are able to monitor patient adherence to activities via
smartphones, which reduces false reporting – a major issue witnessed in
conventional clinical trials. As with other methodologies, digital
recruitment comes with its own set of challenges; however, many of these
can be addressed by developing a patient-centric solution that is easy
to use and has a responsive design. A poorly created application will be
detrimental to the research process and, therefore, developers should
focus on interactive solutions with questions posed in the patient’s
language.
Online Enrolment
Recruiting patients
online should be backed by a wellthought- out approach that uses best
practices in various aspects such as marketing, communication and
patient education. The concept of eRecruitment is at its nascent stage,
but there are ample success stories that have clearly demonstrated that
with the right strategy, enrolment targets can be achieved in a
cost-effective manner.
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