By: Harsha K. Rajasimha, MS, PhD & Sharlene Brown, PhD
Clinical trials are the regulatory mechanisms agencies like the Food and Drug Administration (FDA) use to evaluate and review evidence of safety and efficacy of investigational medicines in humans. With the cost of discovery and development of one novel therapy exceeding $2.5 billion over a duration of 10-15 years, according to a 2018 PhRMA report, initiating, conducting, and successfully completing a clinical trial of any kind is one of the most complex endeavors. A major driver of both time and cost is the challenge of patient enrollment. Most trial participants are required to visit trial sites in person which creates significant travel/logistical burdens such as:
● Time off work
● Lost income
● Distance to site
About 97% of eligible patients choose not to enroll at all and about 1 in 4 (25%) mentioned travel burden as being the primary reason for not enrolling in a clinical trial. About 85% of clinical trials experience patient drop-out, with an average dropout rate of 30%.
The biopharmaceutical industry has experimented with the use of mobile technologies and internet-based tools in proof-of-concept clinical trials for various diseases. Jeeva interviewed thousands of stakeholders in 2019-2021 including key decision-makers, influencers, regulators, patients, and end-users, which included:
● Directors of clinical operations
● Clinical investigators
● Site coordinators
● Patient advocacy groups
● Regulators from FDA
● Clinical research associates from contract research organizations (CROs)
● Vendors of validated software such as electronic data capture (EDC) and potential competitors
Gaps in industry solutions
Despite major advances in Digital Health in general, customers noted study startup and patient recruitment as the strongest bottlenecks in the therapy development process. The following limitations in the current commercial clinical trial software solutions were highlighted:
1. Time, effort, and attrition involved in patient recruitment, particularly related to travel/logistics.
Each clinical trial site staff is expected to pick up a clinical protocol from a sponsor or contract research organization (CRO) that is often designed without seeking inputs from site staff or patients. With many Biotech sponsors now employing an internal patient advocacy team, this issue is being alleviated by better protocol designs that are patient-centric accounting for the travel and logistical burden involved. Part of this is minimizing travel burden by employing decentralized and hybrid study designs with remote screening of participants for eligibility, electronic informed consent, bi-directional communication between study staff and participants.
2. Accelerating trial timelines was noted as a critical goal, yet with the current solutions, it takes about 90 days to configure/start a study.
Sponsors, CROs, and sites have the burden of selecting validated and secure software systems of high quality for various aspects of executing the study. Because each study has its own unique protocol and study schedule requirements, multiple software tools have to be employed in the process. Ensuring consistency across all trial sites is an important consideration requiring that all study staff be trained in the selected software systems and configure the study in all of them accurately and ensure they work in a coordinated manner.
3. Study teams are frustrated with the overall experience of trial operations citing repetitive manual configurations, the burden of training users on multiple tools, and validating the integrated solution among other roadblocks.
Of the 1000+ stakeholders we interviewed, not a single person said s/he had a good experience conducting or participating in a clinical trial. Study staff quoted “Every clinical trial feels like the first-ever trial undertaken by mankind.” We often find ourselves scrambling for solutions for the same set of repeating challenges trial after trial after trial.
4. Instead of using real-time monitoring dashboards to identify and fix issues early and often during the study startup and patient recruitment phases, there is a 30–90-day lag.
Most clinical trials involve clinical research associates traveling to trial sites on a monthly or quarterly basis for data quality verification and central aggregation for further analysis. If data can be gathered in near real-time at the individual sites and centrally aggregated at the study level, corrective action and preventive action can be taken much sooner before it’s too late.
Visit Jeevatrials.com for more ways to accelerate your clinical trials. In honor of #clinicaltrialsday on May 20, 2021, Jeeva Clinical Trials Inc. CEO Harsha Rajasimha will present at the 12th Annual Clinical Trials Summit 2021 in India. Be sure to check out his virtual session on conducting digital trials will provide insights into achieving trial success in today’s changing world.
Harsha K. Rajasimha, MS, PhD is a precision medicine data scientist and entrepreneur on a mission to accelerate human-centric clinical research through technology innovation and global advocacy.
Sharlene Brown, PhD is a cure-focused molecular neurobiologist and opportunity builder committed to helping patients of rare, genetic, and chronic diseases one preclinical discovery, publication, and partnership at a time.