Clinical research at the dawn of the new decade: what’s next?
December 31, 2019
New York, NY (USA)
Author: Dr. Monica Tocchi, Founder and Chief Medical Officer of Meditrial
Clinical trials, the way ahead
Emerging disruptive innovations such as digital health, virtual trials and electronic data capture have immense potential to benefit healthcare and society in the next decade.
Will this affect you, and in what way?
“Given the massive costs and escalating regulatory challenges associated with medical innovation, preparing for the new clinical trials environment is imperative both for the pharmaceutical and medical device industry to achieve scientific acceleration through digital technology and intelligent automation“.
NEW AVENUES AND OPPORTUNITIES – A QUICK LOOK
Impact on Patients and Society
Digital health (1) refers to the use of information technology and electronic communication tools that provide digital and objective data to make them accessible to both caregivers and patients. This sharing of clinical data affects the doctor-patient relationship because it allows patient participation in decision-making and the democratization of care (2). In the next decade, software and technologies that assist in diagnosis, treatment options, storing and sharing health records, will empower patients to make informed decisions about their own health. These advancements will also provide new options for facilitating prevention, early diagnosis of life-threatening diseases, and management of chronic conditions.
Thanks to digital innovation in clinical research, patients will be at the forefront of healthcare evolution. Online channels, public platforms and social media will empower the research community to reach and engage the right candidates. Multi media and online education will be applied to patients and physicians alike. This represents a radical change from the traditional concept of research “subjects” who are recruited from local clinics and hospitals, to be treated and tested at a single research institution. Mobile health tools (3), decentralized trials (4) and electronic consent (5) will allow enlarging the geographical outreach of research, as more patients from areas remote from the study centers will be able to participate (3). The rising number of innovative low cost, portable and wearable monitoring sensors for use in-pharmacies, in-home, on-body, and eventually implantables will complement this decentralized ecosystem with devices, apps, and supporting services which are ideally suitable for integration into the clinical trials process.
Impact on Pharma and Medtech Industry
The next decade offers a prodigious opportunity for both startups and established companies to build value by leveraging new technologies and approaches in support of clinical validation on new products. Fully mobile workflows for data capture and integrations with Electronic Medical Records (EMRs) will be developed (6). By helping standardize their data using machine learning, researchers will create a massive, diverse and distributed medical research dataset, allowing the medical community to discover potential cures for diseases much faster. Life sciences companies need to embrace this emerging value network. These new approaches for running trials have the potential to dramatically lower drug and device development costs, reduce time to market, mitigate risk, and increase the probability of trial success. The next decade will surpass the “reluctance to adopt innovative approached among sponsors and clinical research organizations” recently emphasized by FDA Commissioner Scott Gottlieb (4). In spite of scientific and technical complexity, industry and academia need to leverage these approaches and develop new incentives that reward collaboration and data sharing across the clinical research enterprise. Process change is complex, but embracing these new realities is essential to remaining competitive over the longer term.
Impact on Clinical Research Industry
The job of clinical research organizations and regulatory professionals is to help life sciences companies obtain approval for their new therapies. This includes designing trials, recruiting and enrolling the right patients, delivering therapies to patients, monitoring patient progress, ensuring compliance to the plan, analyzing the results, and submitting them to regulators for approval.
The CRO of the next decade will evolve to provide integrated and affordable digital tools suitable for not only for large enterprises, but also for smaller companies with more limited financial resources. In today’s competitive world, CROs need to invest in a modern IT infrastructure and dedicated solutions to best support customers succeed in their endeavors. Disruption in healthcare is moving in the direction of offering more affordable access in home and on mobile devices and CROs need to be prepared for what’s next not only from a clinical and regulatory viewpoint, but also from a technological perspective (7).
In this framework, a modern CRO needs to provide more than what was expected in the past.
In my personal experience, customers of Meditrial CRO demand not only the key strategic guidance for their new technologies, but also an ability of their CRO partner to confront their evolving business needs through collaboration with regulators, leading physicians, researchers, academia, entrepreneurs and investors. New skills and resources are required to CROs in order to claim “full-service offering” in today’s healthcare ecosystem.
In addition to the rapid implementation of modern electronic tools for running trials, the CRO of the future will adopt a digital enterprise management model for greater speed, higher quality and overhead control. Advancements in clinical software will enable online management of clinical trial operations with automated key performance indicators to monitor the trial progression itself; best-in-class CROs will embrace these tools and bolster a digital revolution in the research process. Clinical and regulatory leaders will be engaged in the development of new continuing education models designed for researchers and clinical professionals that will bloom in the next decade, due to the need to remain abreast of fast regulatory changes that follow the innovation process.
A look at the future of evidence-based medicine
In a decade, technology and partnerships between healthcare organizations, academia, lifescience and consumers industry will transform medical science and change our thinking about innovation. This progressive mutation began in the last decade and will mature tomorrow to open new pathways for truly global access to large patient and data pools, enhancing the quality of clinical evidence and reducing time and cost of running trials, which is key to healthcare and society.
5 TIPS TO GET READY FOR 2020
- Gain a clear understanding of Digital Health and what it means for your business.
- Carefully plan how to Virtualize your Trials to save time and money.
- Embrace electronic Clinical Outcomes Assessment (eCOA) to capture real-world data from patients and physicians.
- Adopt Artificial Intelligence, CTMS and automated algorithms to streamline the entire trial process from trial design to data lock and publication.
- Choose partners that offer the right Digital Solutions for your needs.
Dr. Monica Tocchi
Dr. Monica Tocchi is a physician with a specialization in cardiology and PhD in cardiovascular pathophysiology, author of multiple groundbreaking research publications.
As advisor of multiple companies, she understands the needs and challenges of innovators.
Dr. Tocchi is an expert on European and U.S. regulations and works with the ISO (lnternational Standardization Organization) and AAMI (Association for the Advancement of Medical Instrumentation) committees to develop new regulations on clinical trials (ISO 14155) cardiac valves (ISO 5840, ISO 5910) and other medical device standards.
- Digital health. US Food and Drug Administration. 19 July 2019
- Bertalan Meskó, et al. Digital health is a cultural transformation of traditional healthcare. mHealth. 2017;3:38
- Sanjeev P. Bhavnani, et al. Mobile technology and the digitization of healthcare Eur Heart J. 2016 May 7; 37(18): 1428–1438
- Statement by FDA Commissioner Scott Gottlieb, M.D., on new strategies to modernize clinical trials to advance precision medicine, patient protections and more efficient product development
- Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers
- Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry
- Innovations trends impacting global health care in 2019 Royth von Hahn, VP Medical and Health Services, TUV SUD Product Service Division