- November 12, 2015Read more
Compliance with the protocol is the most important requirement to be met in order to have a successful clinical trial and accurate data. Using paper based Patient Reported Outcome (PRO) measures commonly known as paper based patient diaries is often a threat to having accurate data. When the data is filled out on paper and brought to the study center for the next study visit, it is easy to fake compliance. The famous “parking lot effect” when the patients back fill their diaries right before they step into the doctor’s office is the most common deception. A study done by A. Stone and colleagues (2002) on paper vs. electronic diary compliance captures this effect along with other deceptions such as forward filling of diaries and misleading self-evaluations of diary compliance. Real compliance with paper diaries in this study turned out to be only 11%, which makes it obvious that data from paper diaries is unreliable.
Furthermore, the FDA’s PRO Guidance states: “If a patient diary or some other form of unsupervised data entry is used, we plan to review the clinical trial protocol to determine what steps are taken to ensure that patients make entries according to the clinical trial design and not, for example, just before a clinic visit when their reports will be collected’’ (U.S. department of health and human services food and drug administration, 2009). With being able to regulate patient diary time windows, and having reminders and time stamps with electronic diaries, it is easy to satisfy the FDA guideline. With paper diaries, this is practically impossible and the sponsor risks having data that does not satisfy the needs of regulatory authorities.
In addition to satisfying regulatory requirements, ePRO or electronic patient diaries can improve patient engagement and serve additional functions such as reminding the patient to take the medication and increase medication compliance, and providing feedback of the patient’s diary compliance and health state to both the investigator and the patient. We have previously introduced an algorithm to assess the submitted diary data from COPD patients, and setup automated real-time notifications to the investigator when a COPD exacerbation was anticipated. Having health monitoring in the study and timely follow up on symptom worsening improves patient engagement in the study, where the patient is more likely to be compliant with diary (ePRO) submission to receive the benefit of their disease being monitored and an additional level of care.
If you are looking to use an ePRO solution for a study, get in touch with us and discuss how to make the most out of ePRO in more detail. HealthDiary has been providing Electronic Data Capture (EDC), Patient Diaries (ePRO) and Patient Registry services to Biopharma and CRO organizations since 2003. To benefit from our experience, please contact us today.
- November 6, 2015Read more
When electronic Patient Reported Outcomes (ePRO) or electronic patient diaries became an option for clinical data collection over a decade ago, they introduced a few challenges as any novel method in a highly regulated environment such as clinical investigations. One of the most important is the equivalence in data collected on paper and electronically.
Among efforts to study equivalence, the most notable is a study done by the ISPOR Taskforce published in 2009. A recent meta analysis by Muehlhausen et al. (2015) provides additional support for ISPOR Taskforce’s conclusion that quantitative equivalence studies are not necessary for migrating questionnaires with changes classified as minor in their paper. Minor changes include placing a paper and pencil questionnaire into electronic patient diary format without significantly altering content, the response options or recall period, changing the number of questions that display on a screen, and minor wording changes such as going from “mark an option” to “select an option”. The majority of changes when switching from paper format to electronic patient diaries fall into this category.
This data is reassuring for sponsors and researchers that are utilizing ISPOR Taskforce’s best practices for questionnaire migration to electronic devices such as smartphones, tablets, computers, etc.
- September 21, 2015Read more
Mobile clinical trials clearly have indisputable advantages over paper-based trials. Why is it then, despite the long-term cost savings and convenience of real-time data that there a large percentage of trials are still being run on paper? While it dazzles many of us, the Clinical Trails Transformation Initiative (CTTI) group is actively looking for answers through their CTTI mobile technologies initiative.
Mobile technologies can be utilized in nearly all aspects of clinical research, such as patient recruitment, data collection, symptom monitoring and health management to name a few. As an Electronic Data Capture (EDC) Systems provider, we have been involved in the data collection aspect specifically, collecting the data via electronic Patient Reported Outcome (ePRO) instruments and mobile devices for over a decade now.
It has been our experience that although the technology is sound and has a proven track record, the adoption of EDC and ePRO in clinical research has been slower than anticipated for one main reason. Many organisations think they have an effective paper-based method and are passing up the benefits of real-time data and everything that comes with it, including easier patient management, faster resolution of any potential issues in the trial, increased patient safety if symptoms are monitored, and even lower cost due to reduced staff hours and no need for data transcription utilizing ePRO. The most prominent barriers to adoption of mobile technologies in clinical research nowadays seem to be that of habit, fear of the unknown and the perceived minimization of risk by utilizing an old technique.
It is unlikely that the current barriers to EDC and ePRO adoption will remain prominent for much longer, as the world-wide adoption of mobile devices is rapidly growing and our habits are changing in such a way that we are inseparable from our mobile devices. It is only a matter of time before paper becomes obsolete and data collection via mobile devices the norm.
It is our belief that the CTTI initiative will shed some light into the underlying reasons for slow mobile adoption in clinical trials, and will provide a number of regulatory, legal and technical guidelines that will standardize and facilitate mobile technology use in clinical research.
- August 28, 2015Read more
Electronic Patient Reported Outcomes (ePRO), commonly known as electronic patient diaries and Clinical Outcome Assessments (eCOA) can be delivered via a variety of methods and across a myriad of different devices including computers, tablets, smart phones, etc. The device chosen and method of delivery of the patient diaries must be compatible with the patient group being studied and the timelines specific to the study. Numerous patient factors as well as characteristics of the study itself and the instruments utilized need to be taken into consideration when deciding on the appropriate ePRO device.
Factors such as screen size, patient dexterity, and technological proficiency in terms of mobile device use, appropriate reminders and daily diary commitments greatly influence both the ability of the patient to complete the diaries effectively as well as overall patient compliance in the trial. Apart from being appropriate for the patient population, the screen size has to accommodate the instrument that is to be delivered as an electronic Patient Reported Outcome (ePRO). For example, if the instrument involves graphics and diagrams that will be too small to view on a smartphone, perhaps tablet is a better choice. Visual Analog Scales also have to be accommodated with an appropriate screen size to ensure proper visibility.
Overall device size may also be a factor, especially when the patient may need to carry the devices with them at times. Typically, smartphones are easiest. However, if the instrument or screen size required needs to be larger than a smartphone, tablets are often a viable alternative. Tablets are also the top choice for ePRO completion at research sites as they provide a good balance of portability and screen size and allow for patients to conveniently complete their ePROs in the waiting room or the doctor’s office.
- August 19, 2015Read more
Electronic Data Capture (EDC) and Electronic Patient Reported Outcomes (ePRO), commonly known as patient diaries and Clinical Outcome Assessments (eCOA) have gained traction in the clinical research industry over the past 15 years, where the adoption of technology for data capture in clinical trials has maintained an upward slope.
The growth of EDC and ePRO is driven by several factors, including ease of use, superior accuracy of data and instant access to supplied data that can drive clinical decisions and improve compliance with protocol requirements as well as standard operating procedures. A recent report by ISR entitled “EDC and eCOA/ePRO Market Dynamics and Service Provider Performance” (2015) provides a deeper insight into the increasing technological trend of EDC and ePRO/eCOA penetration into pharmaceutical markets and the driving forces behind it.
Electronic Data Capture systems have matured since their inception nearly 15 years ago, where software workflows have been polished to suit patient management, trial management as well as data collection and reporting processes. Given the usability of EDC systems, where data is easily input and can be securely accessed from anywhere, it comes as no surprise that ISR’s report found that 91% of clinical research professionals prefer EDC applications over paper.
A strong driving force behind EDC, ePRO and eCOA adoption is the superior data accuracy that these electronic technologies provide over paper. EDC and ePRO systems implement point-of-entry data validation to ensure that the data provided is within the appropriate ranges as outlined in the study protocol, as well as that data entry is complete. Ensuring data accuracy and completeness saves a tremendous amount of time typically spent throughout a paper based trial on data transcription and query resolution.
Finally, the data supplied electronically via EDC, ePRO and eCOA can be viewed instantly and accessed from anywhere. The main advantage of real-time data is that the patient condition can be monitored more closely and drive decisions pertaining to that patient’s care, as well as monitoring compliance with data input and standard operating procedures, which ensures any potential issues are spotted before they can impact study outcome.
ISR’s report indicates that the majority of clinical research professionals intend to increase their use of EDC and ePRO in the near future. Therefore, it is only a matter of time before paper-based trials become obsolete.
HealthDiary provides Electronic Data Capture (EDC), Patient Diaries (ePRO) and Patient Registry services to Biopharma and CRO organizations. To learn more about our services, please contact us today.
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