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International Clinical Trials
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Mobile technology promotes a patient-centric approach to late phase
research, making the collection of accurate data in real-time a reality,
while driving cooperation between healthcare sites and patients.
With recent regulatory support firmly behind patient reported outcomes
(PRO), evident through both Food and Drug Administration (FDA) and
European Medicines Agency (EMA) guidelines, new emphasis is being placed
on its use in capturing safety and effectiveness data (1). This new
direction reflects the growing importance of patient perspective in
healthcare. However, it also poses greater challenges for sponsors,
particularly in late phase research for approved drugs, an area of
considerable growth.
It is now broadly accepted that comprehensive and accurate monitoring of
patient feedback on healthcare outcomes and behavioural change has a
beneficial effect. Treatment impact can be assessed most accurately
through the use of PRO measures, defined as any assessment resulting
from patients’ self-reports, collected through event logs, symptom
reports or longer questionnaires (completed either in clinic or at
home). Study design, nature of the intervention and the target
population are all factors which must be taken into account when
selecting the most appropriate PRO instrument.
Pre-registration studies include PRO to evaluate a drug’s safety and
efficacy in a relatively small group of patients in a controlled
environment. In contrast, late phase studies collect data from a larger
and broader patient population over longer periods of time, in a ‘real
world’ setting. This form of assessment follows patients through their
normal course of treatment, enabling improved determination of the
factors leading to treatment impact. Collection of accurate PRO in late
phase trials can therefore be a challenge, with the long duration of
trials and minimal clinical intervention often resulting in poor patient
engagement and poor adherence. This can lead to inaccurate and
incomplete data sets.
Pro Data Collection in Late Phase Research
Post-approval studies often focus on obtaining more in-depth information
about the drug’s profile in order to meet regulatory-driven safety
requirements. In addition, they aim to develop a better understanding of
the drug’s real-life impact while also investigating the cost benefits
associated with the introduction of the new drug to market. In order to
achieve these clinical and commercial goals, it is necessary to optimise
and maintain connectivity and communications with all stakeholders in
order to drive proactive engagement. In that way, it can be ensured that
both healthcare sites and patients will remain motivated and compliant
regardless of geography, demographics and the length of time between
visits and surveys.
Typically, late phase studies are characterised by lower budgets
allocated per patient, as compared to pre-registration trials. This has
resulted in low levels of technology adoption to date for the collection
of PRO data due to the associated hardware costs and complex logistics.
The broad patient diversity of late phase research also makes it
difficult for sponsors to identify and use a robust, flexible and
accessible enough PRO model.
The Power of Mobile Technology
As the clinical research industry evolves, gaining an understanding of
the ‘patient voice’ is increasingly recognised as critical to the
success of the drug development process. Not only is technology becoming
more readily accessible, but the 21st century patient has become an
empowered consumer, with increasing demands and expectations around
healthcare communications. These organic changes are driving the
automation and simplification of patient data capture through the
development of complimentary patient-centric technologies. This
transformation is particularly visible in the area of PRO, where there
has been an explosion in the variety of electronic patient reported
outcome (ePRO) tools that are available to study sponsors. In line with
this, the use of electronic means to capture PRO data is now being
recommended by the US FDA through the 2010 Draft Industry Guidance on
Electronic Source Documentation for Clinical Investigations (2).
According to this guidance, electronic methods can help ensure optimal
data quality, reliability and traceability.
While fixed-line internet data capture tools can be used
cost-effectively in late phase, such solutions are primarily aimed at
site-based assessments. Bearing in mind the need for patient-centricity,
a key method of electronic data capture is through the use of the
mobile phone – a technology globally recognised as the most ubiquitous
communication tool (3). In line with the increasingly widespread use of
mobile technology, leading patient engagement providers have focused
their efforts in developing innovative ePRO data collection solutions on
the mobile platform. In late phase research, these solutions facilitate
improved patient and site engagement, ensuring that patients remain
actively involved in long-term studies and are compliant with study
requirements.
Mobile phone-based ePRO solutions can be customised to suit the specific
requirements of each trial. For studies requiring targeted data
collection, patients can complete questionnaires via a series of text
messages sent intermittently to their own mobile phone. If a response is
not received by the patient within a certain timeframe, a text message
reminder can be automatically sent in order to prompt a response. In
that way, it is ensured that participants remain motivated and compliant
throughout the trial. Additionally, since data are collected in
realtime, investigator site staff can be immediately alerted to abnormal
patient data and react accordingly to ensure patient safety.
In cases when more complex patient data or lengthier responses are
required, eDiaries can be deployed over the mobile internet or as a
smartphone app. Questionnaires can be customised to improve ease-of-use
for the patient by including widgets such as radio buttons and check
boxes. Sponsors can view eDiary responses as they are submitted and
respond quickly to any issues. The acceptability and accessibility of
mobile technology enables a highly patient-centric approach,
facilitating data capture as close as possible to the point of
experience.
Case Studies: Pfizer REMOTE Study
The ongoing PhIV patient participatory centred (PPC) clinical trial is
being conducted by Pfizer into research on electronic monitoring of
overactive bladder (OAB) treatment experience (REMOTE). With the use of
mobile ePRO in collaboration with other technologies, patients whose
location might otherwise preclude them from site-based clinical trials,
can now participate. As a result, this home-based approach enables
sponsors to use otherwise untapped patient resources, thereby increasing
accessibility to clinical research and improving the potential overall
success and accuracy of a trial.
In the REMOTE study, patients are completing an episodic daily diary
capturing their OAB symptom data on an application installed on a mobile
phone. The ability to capture patient data in ‘real-time’ means that
investigator site staff can be alerted to abnormal patient data and
react to ensure patient safety. In addition, mobile eDiary technologies
are extremely easy to deploy and cost a fraction of traditional
device-based ePRO techniques.
The adoption of ePRO diaries has enabled Pfizer to interact directly
with potential and current participants in a personalised and
cost-effective manner. Patients are now able to actively manage their
own trial remotely and report results directly to a trial investigator.
Conclusion
As mobile technology continues to be used on a global level for an
increasing range of both commercial and personal applications in
people’s daily lives, it provides an ideal vehicle to engage with
patients and address the challenges of collecting PRO data in the real
world. With the use of mobile ePRO, late phase data can be centralised
instantaneously, allowing for real-time patient progress and adherence
monitoring, health tracking and reporting. As a result, this drives
proactive engagement between healthcare sites and patients to ensure
that all stakeholders are motivated and compliant, no matter what the
length of time between visits and surveys.
References
- Food and Drug Administration, Guidance for Industry,
Patient-Reported Outcome Measures: Use in Medical Product Development to
Support Labeling Claims, available at
www.fda.gov/ohrms/dockets/98fr/06d-0044-gdl0001.pdf
- European Medicines Agency, Reflection Paper on the Regulatory
Guidance for the Use of Health Related Quality of Life (HRQL) Measures
in the Evaluation of Medicinal Products, available at
www.ispor.org/workpaper/emea-hrqlguidance. pdf
- International Telecommunications Union (ITU), The World in 2011 – ICT Facts and Figures
- Bosworth HB, Patient treatment adherence: Concepts, Interventions and Measurement, 2005
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