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International Clinical Trials

Capturing the Patient’s Voice

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.


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.


  1. Food and Drug Administration, Guidance for Industry, Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, available at
  2. 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 pdf
  3. International Telecommunications Union (ITU), The World in 2011 – ICT Facts and Figures
  4. Bosworth HB, Patient treatment adherence: Concepts, Interventions and Measurement, 2005


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Judith Teall is Director of Clinical Excellence at Exco InTouch, having joined the company in 2010 as Director of Patient Recruitment. Prior to this appointment she headed Patient Recruitment for Glaxo SmithKline across Europe, Asia Pacific and Africa. A graduate from the Sheffield School of Nursing, Judith has over 20 years of experience in pharmaceutical clinical research. 
Judith Teall
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