The Future of ePRO
Electronic patient diaries are much more than digitized paper, and enable new types of research not previously possible. As sponsors become more familiar with ePRO, cutting-edge capabilities and innovative use cases in diverse areas of clinical research continue to emerge.
Adaptive Trial Designs
PHT's ePRO systems enable sponsors to better leverage the benefits of adaptive trial designs. The LogPad System can be designed to automatically move patients to different arms of the trial in accordance with the protocol rules. The reduced data variance and smaller standard deviations often seen in ePRO trials as compared to paper increase the value of a pre-scheduled interim analysis. This enables biostaticians to adjust estimates on how many subjects will be needed to prove efficacy, based on the actual variance of data received. This type of trial design is especially effective when performed on up-to-the-minute results, and often results in smaller sample sizes, yielding significant savings in money and time.
Wirelessly Integrated Sensors
PHT's eSense Sensors remove the uncertainty of self-reported physiological data collected from measurement devices such as Peak Expiratory Flow (PEF) meters, glucometers and activity monitors. By wirelessly integrating devices with the LogPad scientific researchers are able to ask new questions examining the link, for example, between pain and activity level.
Cognitive Assessments
PHT's systems support the use of interactive cognitive assessments in order to provide a more complete picture of how subjects feel during the trial. Assessments can measure recognition capabilities, reaction times and more as subjects respond to the treatment.
Email Alerts
PHT StudyWorks can be configured to send automatic email alerts based on study-specific calculations, patient scores or other criteria.
Disease Management and Medication Compliance
The LogPad has been used in more clinical studies than any other ePRO system in the world - but it can also help with other healthcare and clinical initiatives. Temple University used the LogPad in a COPD disease management study investigating whether an eDiary could reduce hospitalizations and deaths due to exacerbations.
Next Generation ePRO Devices: Cell Phones
PHT has partnered with VOCEL to create an ePRO solution deployed on readily available java-enabled cellular phones, which can save hardware costs while simultaneously ensuring reliable wireless transmissions. Because the ePRO device is mobile, inexpensive and so commonly used, it maximizes subject convenience and provides sponsors with high-quality patient data at a lower price point.
Connect to Patients via the Web
As internet access becomes more prevalent throughout the world, it's possible for patients to enter their daily diaries or questionnaires via the internet. PHT's secure StudyWorks portal can be used by patients to enter high-quality, timestamped symptom data with edit checks, logic checks and email alerts functioning as alarms. Patients could also see real-time reports showing their compliance and progress, enabling them to better monitor their own safety and health throughout the trial. Web-based collection of ePRO data is an attractive alternative for large Phase IV trials as costs per patient is reduced due to a lack of hardware and telecommunications expenses.
Learn More about ePRO Futures
Are these solutions being used in clinical trials today? I have an idea for a product innovation - will PHT customize a solution for me? What else will ePRO be able to accomplish by 2010? Contact PHT for answers to these questions or any others you may have.
