Empowering the Patient Journey in Clinical Trials
With cross-industry technological advances supporting consumer engagement, there is a wealth of new data becoming available that can provide direct insights into the patient’s journey from sickness to health. Combined with the life sciences and health care industry’s embrace of digital transformation, it is becoming increasingly possible to gain an in-depth understanding of both disease progression at the individual patient level and the patient’s journey through the life sciences and health care process ecosystems. From the International Data Corporation (IDC) perspective, digital transformation is defined as the development of integrated platforms infused with data with a focus on delivering actionable insights.
Within the life sciences, two key areas highlight the role of patients and digital transformation in advancing new therapeutics to market in the industry today. These areas are:
- Participation in clinical trials.
- Contribution of real-world evidence data (e.g., electronic medical records) to support population health-based approvals and commercialization of safer and more effective drugs and treatments.
Clinical trial hurdles
One of the largest hurdles that must be overcome in the development of a new therapeutic is the recruitment and retention of patients for clinical trials. Failure to recruit enough patients to conduct a trial stops a trial in its tracks and prevents key data collection required for regulatory approval. Historically, patients have been undervalued for their role in clinical trials, disrespected for their contributions, and neglected once their contributions to the trial have ended. It is not surprising that patient recruitment for trials remains a primary hurdle, an issue further exacerbated by the continued segmentation of diseases that further shrinks the pools of patients available to participate.
Patient engagement has become a major focus for leading innovators in the life sciences industry. From a data perspective, life sciences companies are finding several opportunities to improve, including:
- More timely and effective identification and recruitment of prospective clinical trial participants.
- Improved real-time monitoring of trial participants to minimize dropout.
- More targeted and effective trial and drug messaging for maximum impact.
- Identification of biomarkers to better characterize patients likely to benefit from treatments while simultaneously avoiding patients likely to experience adverse events.
- Collecting population-based insights in support of drug dossiers supporting formulary access.
Expanding clinical trials
In the short term, digital technology has the potential to transform the clinical trials process. Digital patient registries and electronic medical records are simplifying the identification and recruitment of patients eligible for trials. Using electronic communications, smartphones, local doctors, local labs and remote sensors, virtual clinical trials are becoming reality. That inevitably expands the number of patients eligible to participate in trials. Wearables and other remote sensor technologies are expanding the potential data that can be collected from patients as part of clinical trials. And finally, available patient data can be mined in real time during the trial to more efficiently determine trial performance, enhance patient impacts and ensure regulatory compliance.
Infosys sees a greater number of organizations using digital tools to enhance the patient journey and understand treatment patterns across therapeutic areas. Real-world evidence and data are gained by analyzing line of progression, treatment and timeline to identify intervention points and enhance efficacy and patient experience.
In the long term, digital transformation promises to significantly improve the patient journey from both the patient and the trial sponsor perspectives. With some pilots in place already, patients should be able to personally monitor their own progress in trials and directly communicate with trial sponsors (and vice versa).
Advances in the internet of things and remote sensor technologies will enable new patient-generated insights above and beyond data currently being collected. And, of course, ongoing growth of knowledge of human and disease biology promises to enable and empower personalized medicine through practical understanding of diseases at a molecular level.