The emergence of patient-centric applications provides a great opportunity for pharmaceutical drug developers to engage patients and create a direct, relationship with them. The clinical trial space provides an excellent channel to leverage these technologies. The integration of mobile technology in new clinical trial design and business strategy development holds promise for aligning site and patient needs with faster study execution and reduced costs. The hype of leveraging mHealth in clinical trials has stirred some drastic movements within the industry. This explosive growth is being fueled by advancement of technologies and increasing demand for personalized patient care. This can be seen from the community of delegates who attended the Mobile Clinical Trial Congress 2015 (MCT Congress), held at the Edinburgh International Conference Center (EICC) this past week.
MCT-Congress aims to explore the realities of mobile technology in clinical trials, its opportunities and barriers, and how the industry can work together to face the challenges and build on the area’s potential to benefit businesses and patients. Following the inaugural 2014 MCT Congress, the 2015 event focus less on the theory and more on the practicalities of adopting mobile technology.
From an industry viewpoint, this year’s congress reinforces the slow moving of this particular industry. The adoption of technology i.e. mHealth in clinical development faces many barriers to adoption and it is repeated issues like lack of a structured policy, vague regulation, misaligned reimbursement and incentives, patient privacy, data security and legal barriers. They are all valid, up to a point, but it seems that the biggest barrier right now is the lack of communication between stakeholders, vendors and the regulators. We need to work in sync to create a more hospitability environment for the community of the industry to operate in.
Regardless of the slow industry growth, it is clear that the digital health industry is more robust in the USA then it is in UK/EU. This is probably because the USA has broad ecosystems around various health trends.
While great differences exist in the healthcare systems for both regions, major trends in digital health that have taken center stage are: wearable technologies, self-monitoring systems, patient engagement apps and electronic health record (EHR) systems. Following the early success in the USA, Europe is now reinventing and adapting local market solutions to solve daily issues in health care and possibly a pointer to how we can see repeatable success.
The issue of e-Consent was very much a topic of discussion. The effective coordination of healthcare relies on communication of confidential information about consumers between different health and community care services. And consumers must be able to give or withhold “e-Consent” to those who wish to access their electronic health information. For someone who has no other means of survival due to a chronic disease and relaying on clinical trials to receive treatment, giving consent seems to be the last thing on their minds! But for others, broadening of access to patient information comes the risks that such information is used for purposes not originally consented to by the patient. Given the complexity of clinical work and the substantial variation, we can expect in an individual’s desire to make her personal medical details available, it is unlikely a “one size fits all” approach to e-Consent will work. Consequently, with a well-chosen consent design, it should be possible to balance the specific need for privacy of some of the population against the desire by others to err on the side of clinical safety, and clinicians desire to minimize the burden that an electronic consent mechanism would impose.
For carriers and telcos, (ones present at the congress were Vodaphone and Orange), the slower yet steady growth of mHealth will offer opportunity to build secure and reliable networks and long-term strategies that can be leveraged by medical device manufacturers, healthcare organizations and mHealth app developers.
Clinical trials are still the basis for deciding how good and safe new drugs are, and that’s true even more so now than in the past. The challenges that mHealth has to overcome in the industry are primarily due to regulations, so working together with the regulatory landscape will be best to push mHealth to fully leverage mHealth. In addition, unlike other industries, the growth of the mHealth industry requires a long-term view. It also requires a geographic lens as adoption rates vary between regions and countries.
To capture mHealth’s full potential, industry stakeholders will need to act in a coordinated fashion to redesign their approach in streamlining the clinical trial process. The key to understanding health and its disease is research and data. All research wants is a measured, quantitative and objective data and the industry needs to come with a well-defined solution that address all the issues mentioned in this blog. To speed up the movement and gain traction in the industry, one cannot do it alone. Joint ventures, partnerships and working in parallel with a trusted and credible organization, like FirstApp, is crucial for success.
Other issues that contributed to the discussion in the congress incudes patient recruitment and retentions, Bring Your Own Device (BYOD) and cloud servers, which are covered in 2015 edition of Journal of Clinical Trials.