The COVID-19 pandemic has clinical trial professionals dealing with a whole new world, with travel restrictions, fearful patients and other factors causing concerns. Below, Jackie Kent (JK)—executive vice president and head of product at Medidata, a Dassault Systèmes company—tells Outsourcing-Pharma (OSP) about the unprecedented challenges created by the pandemic, and potential solutions for the problems.
OSP: Could you please talk about some of the ways the COVID-19 pandemic has shaken up the clinical trial industry?
JK: At the beginning of the pandemic, we were looking at monthly year-over-year changes in new patients entering trials to understand and grasp the magnitude of COVID-19, across geographies and therapeutic areas. We started to see a leveling off and in some cases a reversal of the impact in China and Italy, as examples; however, that leveling off may be reversing in some countries, particularly the United States based on the surge in the number of new COVID-19 infections, hospitalizations, and deaths.
Recently, we changed the methodology to look at month to month changes in new patients entering trials for the same regions and therapeutic categories. Globally, as of the end of June, we were seeing a ~30% drop in new subjects entering trials, using October 2019 as the pre-COVID-19 baseline. This compares to a ~70% drop globally in April 2020.
As mentioned above, there is large variability in the extent and timing of recovery within geographic regions, as COVID-19 cases continue to change in geographic regions, and policies are adapted over time.
From a therapeutic areas perspective, peak impact on new patients entering trials occurred in April. Cardiovascular and oncology trials have recovered globally, with new patients being added to study sites at a rate similar prior to the pandemic. Cardiovascular trials experienced a nearly 90% drop in April versus October levels for new subjects entering trials. Oncology trials have been impacted the least, but during the peak nonetheless saw a drop of >40% in new patients entering trials versus October. Lagging behind are CNS, Dermatology and ID/Anti-Infectives trials, even with the recent uptick in COVID-19 trials.
Furthermore, the impact of the pandemic on sites was well documented by a Medidata survey of over 1,000 clinical site personnel in late April 2020. The responses clearly indicated that most sites felt the negative impact of the pandemic on current and future trials, specifically around delays in patient enrollment and recruitment.
That said, sites have shown flexibility and ingenuity in adopting new approaches and technologies - over half of sites reported switching site patient visits to virtual ones and/or are using telemedicine to interact with patients.
OSP: What are some of the ways sites and sponsors can work to alleviate some of these challenges and obstacles?
In our white paper, COVID-19 and Clinical Trials: The Medidata Perspective, we outline four main categories of challenges facing clinical trials and some of the solutions that both minimize disruptions to current studies and advance new trials:
- Understanding the Evolving Situation
- Study/sponsor level metrics and dashboards to understand impact on enrollment, patient visits, data collection, query response rates, and additional metrics to help diagnose risk areas
- Industry-wide dashboards and analysis to understand trends globally and areas of greater or lesser disruption
- Reconsidering Trial Design to Enable Data Capture
- Shift to more virtualization – reduce patient visits; minimize site burden
- Shift site mix to lower-impacted countries / regions
- Consider synthetic controls to reduce patient enrollment needs
- Maintaining Quality and Supply
- Centralize data oversight and monitoring activities, bringing identification of patient anomalies earlier in the process and away from onsite identification
- Closely monitor patient volume and drug supply to minimize supply disruptions
- Accelerating Study Start-Up
- Sponsors focused on developing vaccines against, and treatments for COVID, must safely and effectively accelerate study start-up times through faster investigator budgeting, so cures and treatments can get to market faster
OSP: Could you please go into detail about how technology can help clinical trials streamline their imaging workflow?
JK: The use of medical imaging in clinical trials is growing rapidly. Roughly 50 percent of all clinical trials use medical imaging as an endpoint or for eligibility criteria. And in therapeutic areas like oncology, nearly all trials rely on medical imaging; to illustrate the volume of information generated by these studies, Medidata processes more than 500 million images annually.
Technology allows us to simplify image and data acquisition, reduce manual processes, streamline, automate, and optimize imaging workflow, determine patient eligibility, monitor disease progression or response, and expedite go/no go clinical decisions. All this helps to minimize the risk and complexity of medical image management in clinical trials and ensure accurate and timely completion of study goals.
OSP: How can companies like Medidata work with clinical research teams to come up with effective solutions?
JK: Medidata delivers clinical operational efficiencies around critical processes, ensuring real-time visibility and control of ongoing study activities and documents across all stakeholders.
The company has been able to offer clients the solutions they need to help address challenges from the COVID-19 pandemic. Medidata regularly shares analyses on the effect of the pandemic on patient study enrollment and the response from regulatory bodies to share with clients.
Additionally, the company created a COVID-19 task force to gather information from customers on pressing challenges they faced such as limited ability for operations at sites, supply chain disruption, challenges for patients to get to sites and data integrity. Some of these factors are captured in our white paper, COVID-19 and Clinical Trials: The Medidata Perspective.
Medidata also created a forum to share information and get feedback with sponsors on potential solutions for the many challenges created by the pandemic through a regular Office Hours series. Topics include:
- Intelligent Trials (study design, study feasibility, advanced performance analytics)
- Medidata Rave RTSM (randomization and trial supply management)
- Medidata Rave eConsent (remote consent)
- Medidata Rave eCOA (clinical outcome assessment)
- Medidata Detect (centralized statistical monitoring)
This collaborative series of virtual meetings with our customers not only provided tremendous insights into their COVID-19-related challenges but also how our current solutions could be modified or adapted to quickly help them pivot to a more virtualized clinical study model. These solutions would not only overcome obvious challenges with patient recruitment and trial participation but also assist sponsors to mitigate their risk around potential data quality issues through various forms of centralized monitoring.
OSP: Could you please explain Remote Source Review—what it is, how it works, and why it’s especially useful and important in the face of the pandemic?
JK: Medidata Remote Source Review (RSR) is a streamlined and quick-to-implement solution that helps fill the gap when studies have critical timelines and no secure option to collect, de-identify, manage, review and verify critical study documents. It has already been deployed at over 15,000 clinical sites during the COVID-19 pandemic. The good news is that this solution is so useful, safe and cost-effective that it will continue to be used and adopted by sponsors after the pandemic has waned,
RSR, in brief:
- Acquires documents, via secure browser-based uploads, routes and manages document workflows to support source document review and verification remotely
- Is a 21 CFR Part 11 compliant system that includes the ability to de-identify and redact Personally Identifiable Information (PII) and Protected Health Information (PHI)
- Mitigates risk due to site monitoring and patient visit disruption for some studies with no secure option to manage critical documents
When considering a remote monitoring solution, one of the most common concerns expressed from sites is the time and resources required to scan and redact source documents. RSR supports sites by directly connecting to EMR systems so redactions can be made directly in the application, significantly reducing time and effort.
When there are obstacles to adequately monitor active studies, sponsors should not be required to use less secure, outdated technology such as fax, email, video, and file sharing software to manage critical documents. Regulatory guidance in a number of regions around the world supports sponsors to find ways to remotely perform critical document management and source data review via a secure cloud-based viewing portal.