Category Intelligence on Digital Trials covers the following
Digitalization delivers enhanced efficiency, better insights, and improved patient outcomes in clinical trials. Early adopters will lead the industry in the near future.
Stakeholders are looking for better ways to conduct clinical trials. Implementing Electronic Clinical Outcome Assessments (eCOA) for example, can improve data, reduce costs, and increase participation rates. Similarly, the adoption of digital health on an IoMT (internet of Medical Things) platform can creates limitless opportunities for the clinical trial enhancement
Opportunities created for clinical trials by adoption of digital health on an IoMT platform
Factors Slowing the Digital revolution
Smart devices and wearable technology managed within a digital health platform can significantly increase patient retention by fully engaging with them throughout the trial. However, the very fact that patient retention is at an average of just 50% after 14 months of a study, shows the engagement isn't there yet.
If a change project involving new technology is not carefully managed, the resulting change may be of such magnitude that the organization cannot cope. As a natural safeguard, stakeholders tend to resist change that can be perceived as a great leap, preferring small steps where uncertainty of the outcome is at a minimum.
‘Pilot-itis' is the inability to break out of pilot stage. Successful pilots of mHealth, wearable technology and biosensors are in abundance. However, even with promising results, most clinical trials have been slow to reach scale. The solution is to build for scale and sustainability from the start. To plan for scalability and universal access from the start, prioritize the integration of content and services.
Improved Recruitment and Patient Convenience
By utilizing electronic medical records, Bigger pools of potential participants to studies can be availed. By breaking the conventional geographic frame of trials, patients need not spend multiple days for site visit. The site-less clinical trial will democratize involvement in the assessment of the most capable medicines available.
The shift of investment to wearables, smart phones, remote devices and electronic patient diaries, has enabled the patients to use devices that they already are comfortable using. Patients will comfortable report their true condition to their smart phone instead of putting on a brave face to a doctor or nurse for fear of judgement.
Improved Engagement and Compliance
It is a stress to travel or fill out cumbersome consents and paper surveys or even just to the regional clinic site when you are sick. Attrition decreases by making the participation simple , that can be availed from home , that has smart phone compliance and intuitive questionnaires. However, it is imperative to note that the virtual trial model is not suitable for all therapeutic area that demands more physician oversight , such as oncology.
When patients are submitting data electronically, the clinical outcome assessment happens in real-time, that allows researchers to make faster protocol adjustments and decrease the risk to participants.
FDA openly encourages solutions that provide larger data sets and greater number of patient reported outcomes specially that involves wearable data