Global Market Outlook on Digital Trials
Digitalization delivers enhanced efficiency, better insights, and improved patient outcomes in clinical trials. Early adopters will lead the industry in the near future.
- The global Digital Clinical Trials market is estimated to reach 7.61 Billion by 2022, at a CAGR of 12.4% during the forecast period (2017-2022).
- EDC contributes to a major share of clinical trial technologies market, followed by CTMS
- Increasing demand to collect patient self-reports through mobile and digital technologies makes eCOA/ePROs to grow at a faster pace than other technologies
- Cloud-based delivery model is expected grow faster until 2020 than web hosted delivery mode or licensing delivery mode, due to the ease of integration and maintenance through SaaS mode than web hosted or licensing mode
- Integrated eClinical approach: Data from multiple sources is integrated in a hub arrangement
- Increase in penetration of cloud architecture
- Access of trial software, using wide range of channels and devices by patients, site staff,and trial managers
- Pharma sponsors will take an increasingly holistic view, enmeshing their information strategies with wider organizational goals
- There is a movement to a system that is more flexible and easily accessible by the consumers
- Moving to an open-source license is trending high in the industry. This license has the flexibility, which provides accessibility to anyone who needs the data of the clinical trial
Opportunities and Challenges
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
- Greater Accuracy
- Richer data sets
- Improved protocol Compliance
- Greater flexibility with user inputs
- Real-time study tracking
- Patient and caregiver engagement
- Simple, virtual, visit-less trials
- Shorter development times
- Identify new disease Phenotypes
- Personalized treatment and enhanced safety
- Remote and continuous monitoring
- Faster enrollments
Factors Slowing the Digital revolution
- Lack of long term user engagement
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.
- Psychological resistance to technology
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.
Benefits of site-less clinical trials
- Patient centricity is a main concern for all sponsors. Virtual trial model is able to accomplish this with greater efficiency
- Virtual trials will enable effectiveness and timelessness to a greater extent, which is Industry’s on-going emphasis
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