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Mobile strategies bring near-endless possibilities to engage with patients in clinical trials.
A review of over 10,000 clinical study protocols by Kenneth Getz found strong evidence of increasing study complexity (significantly greater numbers of unique procedures, as well as increased procedural frequency, longer trial durations, more data collected in the Case Report Form (CRF), and increased site ‘work burden’). This is likely due to the desire to capture direct evidence from patients, in conjunction with the growing specialism and demand for Phase IIIb and IV clinical studies.
This emerging new trend changes the overall balance of study data to a dataset that is increasingly patient self-reported, often lengthy, as it includes large volumes of participants, and one which carries an enhanced risk of response or completion issues, and potential data entry-related errors. It is in this arena that mobile eCOA comes into its own right.
Overcoming practical challenges
Electronic data collection has been used with increasing frequency in Clinical Outcome Assessments (COA) over the past 10 years, including outcomes attained directly from the patient (Patient Reported Outcomes or PRO). The proliferation of mobile technology on a global scale has provided a new means of access to patients and created an ideal platform for the capture of ePRO assessments to replace the outdated, traditional pencil and paper-based data collection methods.
Incorporating mobile eCOA into clinical studies has a myriad of benefits. Native apps facilitate the collection of objective data from medical devices (e.g. spirometers and glucometers) and wearable technology such as activity trackers alongside patient diaries. Data from these devices can be transmitted directly into an app via Bluetooth, removing the requirement for transcribing results manually. Furthermore, date and time stamps for each data point can be captured from patient source through to EDC database, and fraud can be eliminated by introducing two-factor authentication.
Mobile technologies can also play a role in enhancing clinical data cybersecurity and protecting confidentiality in ePRO. Firstly, unique PINs are created by users to ensure control over who is entering the data within the mobile device. Not only is this reducing the risk of fraudulent data entry, but the restricted access also prevents others from seeing the record, and therefore, it enhances data confidentiality. One of the most fundamental methods of data protection is data encryption. With mobile data capture, both the transmission of information and the offline storage of resting data can be readily secured via this methodology. Furthermore, any ‘sensitive’ data such as Personally Identifiable Information (PII), or indeed the actual content of the completed questionnaire/diary (Protected Health Information or PHI) are encrypted to ensure data protection.
Mobile eCOA has another practical advantage, which is providing more efficient patient engagement. A patient who has missed diary completions can be reminded of the importance of taking part in the study, and should this not improve future ePRO compliance rates, sites can follow up immediately. Site staff can discuss any difficulties or misunderstandings with patients and provide additional timely education and support to enable continuation in the study before they are lost.
Since 1980, in global terms, the over-60 demographic has more than doubled, rising from a figure of less than 400 million to over 800 million. By 2050 the figure is expected to exceed two billion.
It has been suggested that the prevalence of particular medical conditions among the elderly could hinder their ability to complete surveys using these mobile technologies. However, mobile devices are now very familiar technologies to most people and are not viewed as ‘study specific’ hardware additions. Therefore they can be integrated into elderly patients’ lives more seamlessly. The sophistication of the technology is such that age (or impairment) is not a barrier to the successful capturing of data.
Professor Nicholas Bellamy of the University of Queensland, an authority in validated clinical assessments who has developed and globalized the WOMAC and AUSCAN Indices for the evaluation of patients with Osteoarthritis, comments that "[although] it might be assumed that cognitive and dexterity problems in elderly patients would preclude their use of mobile ePRO,” elderly populations are “using technology regularly,” particularly mobile phones. “So long as the interface is designed appropriately and is user friendly,” Bellamy suggests, “then it should be implementable across a broad range of age groups, including the elderly.” The use of mobile technology allows assessments to be tailored to specific devices and the individual requirements of each patient. For example, larger fonts and buttons on tablets may be used to aid the visually impaired.
Generally, successful application of mobile eCOA in clinical research lies in careful evaluation of the target population to identify the optimum solution prior to the solution design phase, and it should consider the locality and the prevalence of technology in each geographical location, general characteristics of the patients to determine the modality and specification of provisioned devices and the optimum communication strategy (SMS, e-mail, in-app messaging), as well as data capture requirements of the protocol (e.g. criteria and frequency of assessments, device specification required to ensure psychometric equivalence of validated assessments, use of monitoring devices and the minimum data transfer proprieties).
The increasing prevalence of digital technology means that it is no longer necessary to conduct trials by pushing specific technological solutions on to trial participants; instead, the best solution can be applied to suit the patients and their needs.
Introducing mobile eCOA into a study
Knowing how and when to introduce mobile eCOA into a study design is crucial. Different approaches can be taken by clinical trial sponsors depending on the objective behind the data collection. Possible scenarios that should be considered include site vs patient data capture (Clinical Reported Outcome (ClinRO) vs PRO, as mobile eCOA can help obtain high quality self-reported patient submission data through implementing diaries to collect momentary assessments at pre-defined time points between visits, as well as enabling the inclusion of validated instruments. Mobile eCOA can also expand options for real-time oversight by medical device integration alongside a daily diary to supplement subjective data from patients with objective data direct from Bluetooth-paired devices, which can be used by patients at home. Finally, the use of patients’ own devices through the BYOD (Bring Your Own Device) approach in Phase IV event driven studies can provide a cost-effective way to incorporate mobile eCOA and collect event-driven data recorded by patients at home in order to obtain Health Economics evidence and to keep the patients engaged in the study over extended periods of time.
The future today
Mobile PRO has introduced a multitude of benefits into clinical trials - from patients to sites and sponsors. As well as creating a truly scalable platform to support patients during clinical trials, it has simplified the process of capturing their data, and significantly reduced the risk of it being inaccurate or incomplete.
Using this mobile strategy, sponsors and sites can implement study communication plans that dovetail with the everyday life of patients, resulting in better data quality, better medication adherence, and, ultimately, better health outcomes.
Mobile strategies bring near-endless possibilities to engage with patient, be it through the use of games consoles, internet TVs, or other as-yet-unknown technology. In terms of the knowledge, the capability is already there. However, for this dream to become an everyday reality the healthcare needs to escalate the adoption of existing mobile PRO so that it becomes the accepted approach to self-reported clinical data.
Chris Watson is Product Manager for Exco InTouch
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