By Judith Teall
In line with recent FDA and EMA guidelines, greater emphasis is being placed on patient reported outcomes (PRO) as a key source of safety and effectiveness data.
This emphasis is of particular relevance to late-phase (post-approval) research in which safety evaluation of new products, in addition to the assessment of real-world effectiveness, are two key focuses. Accurate and consistent PRO data is a fundamental part of determining product safety, minimizing risk, and further establishing the clinical and commercial benefit of a treatment. Study design, nature of the intervention, and the target population are all aspects which must be considered when selecting the most appropriate and effective PRO instrument.
The long duration and episodic nature of late-phase studies often results in poor levels of patient engagement and compliance, which can have a negative impact on the accuracy and completeness of PRO data. The smaller budgets associated with late-phase trials, combined with their large scale and long time frame can pose a significant challenge. As a result of this, adoption of technology for the collection of electronic patient reported outcomes (ePRO) data in late-phase research has typically been minimal due to the hardware costs and associated logistics. Additionally, the large population size and resulting patient diversity of late-phase studies means it can be problematic for sponsors to find a PRO model that is flexible and accessible enough to blend unobtrusively into the ‘real life’ setting of individual participants’ lives.
Mobile ePRO Solutions
Technology providers are increasingly recognizing the mobile/cell phone as a simple and effective interface for PRO collection with global reach. The accessible and easy-to-use nature of mobile technology offers a patient-centric approach that is ideal for late-phase studies, enabling patient data capture as close as possible to the point of experience. Cell phone-based ePRO also minimizes many of the logistical problems and cost implications associated with the use of standard ePRO technology for clinical trials, such as the distribution, training, maintenance, and recovery of devices, providing a cost-effective solution to smaller late-phase budgets.
The simplicity and intuitive design of mobile technology removes the problem of patient reporting being too time-consuming or onerous, therefore enhancing compliance rates, regardless of age and demographics. Where specific and targeted data collection is required, patients can complete questionnaires via a series of text messages sent intermittently to their own cell phone. If a response by the patient is not received within a certain time frame, a text message reminder can be automatically sent in order to prompt a response. This is extremely valuable for late-phase trials running over long time frames, ensuring that participants remain motivated and compliant no matter what the length of time between visits or surveys. In addition, the ability to capture patient data in “real-time” means that investigator site staff can be alerted to abnormal patient data and react accordingly to ensure patient safety.
Where more complex patient data or lengthier responses are required, eDiaries can be deployed. Patients receive a simple text message with an embedded link to a secure mobile Internet site that contains the eDiary. On connecting to the mobile internet URL, the patient enters their unique PIN number to access the ePRO questionnaire. This type of technology enables a wide range of questions to be presented and viewed on most cell phones.
As mobile technology continues to be used on a global level for an increasing range of commercial and personal applications, it provides an ideal vehicle to engage with patients and collect real-time and accurate data. Offering a cost-effective technology solution for late-phase studies, mobile ePRO can facilitate enhanced compliance rates, real-time patient progress and compliance monitoring, health tracking, and reporting. In addition to accurate PRO data, the accessibility of mobile technology means that it can be deployed for prospective patient recruitment, observational studies and registries, risk management strategies, disease management, and patient retention programs.
Judith Teall joined Exco InTouch in 2010 as director of patient recruitment. Prior to this appointment she headed patient recruitment for GlaxoSmithKline across Europe, Asia Pacific, and Africa. She has more than 20 years of experience in the pharmaceutical clinical research area.