Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
Strategies and innovations related to how clinical professionals are utilizing technology internal and external to their organizations to advance clinical trials. Go→
News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
Editors’ Note: This opinion is offered in response to a recently posted peer-review article The Future of ePRO Platform
In the world of electronic patient reported outcomes (ePRO), many clinical trial sponsors are interested in the concept of Bring Your Own Device (BYOD) – allowing patients to use their own devices (smartphones, tablets, personal computers) to complete ePRO diary assessments in the field. BYOD approaches have notable strengths and will have a significant impact on the execution of trials, namely reducing the time, effort and costs associated with the current approach of supplying dedicated handheld devices. However, before implementing BYOD in pre-approval studies, there are a number of key questions that should be addressed.
The seeming ubiquity of smartphones is a big reason for the appeal of BYOD. However, although smartphone penetration is increasing, many individuals still do not own them and ownership is likely biased in ways that will impact a clinical trial (age, region, socioeconomic status). The question: How will regulators and other key stakeholders evaluate studies where patient enrollment may be biased by technology ownership?
Also, there are potential scientific and regulatory concerns with the multiple interface differences that are certain to be present in a BYOD approach (e.g., device size, method of inputting responses, other functions available to user, etc.). In essence, BYOD approaches inherently introduce mixed-modes of administration to a trial and this could introduce unanticipated response biases. The nature of the modality used by patients may not be random--it may be tied to other factors that could influence responding: For example, in web-based BYOD studies, some patients may be able to respond in any location at any time using a smartphone, while others using a desktop computer in their home may be limited in the timing and location of their entries. The question: What is the impact of mixing modes of administration in BYOD studies and will it affect responses and, ultimately, outcomes?
Increased compliance is one of the key reasons why ePRO is essential in studies implementing patient diaries. The high rates of compliance with traditional ePRO (> 90% typically) are due, in part, to the alarm functionality that is included in most dedicated eDiary devices, typically via an audible alarm that cannot be muted. In a BYOD scenario that utilizes smartphones, ePRO apps can use reminders, but this alarm functionality can be limited by user preferences or through the operating system itself. The question: Could compliance with the ePRO protocol be adversely impacted by BYOD approaches?
The FDA PRO Guidance states, “When a PRO instrument is modified, sponsors generally should provide evidence to confirm the new instrument’s adequacy.” This includes changing an instrument from a paper to electronic format. The challenge with BYOD is that there are a number of possible platforms that could be used by patients, each with different screen sizes and other interface features. It is difficult at the outset of a trial to ensure that patients will interpret the electronic administration the same way across ALL potential device options. This could lead to regulatory concerns about the integrity of the data collected through BYOD approaches. The question: How will sponsors determine if patients will interpret a PRO instrument implemented via BYOD in the same way as its initial, paper-and-pencil format?
A BYOD approach to ePRO data collection offers significant benefits in clinical research. Its use in post-approval studies--which have different logistic characteristics and scientific goals--can provide important data to sponsors in a more cost-effective manner than dedicated, handheld eDiaries.
However, additional research is needed to demonstrate that patients comply with and interpret PRO instruments in the same way across different types of personal devices. Sponsors who are exploring a BYOD approach for ePRO in Phase II-III clinical development should consider the questions presented here and discuss this option with regulators and ePRO experts before implementing to determine its appropriateness in pre-approval research.
For a complimentary white paper and more information on BYOD for ePRO research, visit www.ert.com/byod.
Chad Gwaltney, PhD, Senior Director, Consulting Services, ERT