COVID-19 is having a profound impact on the way current clinical trials are progressing and will change how they are performed in the future.
We are all witnessing the impact of COVID-19 affecting everything, including day-to-day life. In the clinical world, the impact is devastating. Ongoing trials that were in place before the pandemic have seen a huge drop in the number of new subject enrollments. In the most affected areas, some trials are experiencing a 50 to 80% reduction in new subjects.
Trials that were in an early phase of patient recruitment are going to face major disruption in the near and medium-term. Another major impact is that many clinical trial sites are now shut down for the safety of both patients and staff. Patients that already had successfully enrolled in a study are unable to get to their physical clinical site, which creates a risk to the quality of data collection and the overall integrity of the study.
Major challenges
The Dassault Systèmes MEDIDATA brand is leading the digital transformation of the Life Sciences industry and is committed to improving patient experience, ensuring effective trial management, and simplifying data complexity. To address the impact of the pandemic, MEDIDATA is publishing a biweekly updated paper entitled COVID-19 and Clinical Trials: The MEDIDATA Perspective with a focus on the most current, critical challenges facing sponsors and companies who specialize in clinical data trials.
Of immediate concern for clinicians is getting to the patient, as most clinical trials are conducted at clinics, hospitals, and doctors’ offices. If the patient is self-isolating or quarantined and can’t get in for their visit, then trial data can’t be collected. MEDIDATA is exploring alternatives including virtualization of consenting and survey taking as well as home delivery of study drugs. Another critical factor is that the clinical staff are also dealing with these issues just like the rest of us, having challenges getting into sites. Research must be done to find ways for clinicians and site staff to work remotely as well. MEDIDATA solutions can help solve some of the critical challenges impeding clinical trials during COVID-19.
Constant assessment of COVID-19 impact
One challenge for clinical study Sponsors and CROs (contract research organizations) is finding current data to clearly analyze the impact of the pandemic on their studies because things are changing so rapidly. To address this challenge, MEDIDATA has deployed a set of analytics to help customers quantify the impact of COVID-19 on their ongoing trials. The analytics create a baseline to assess alternative strategies, such as monitoring new subject enrollments, identifying new hot spots, and searching for indicators of recovery that can help predict when patients can start to get back to their clinical sites.
Innovate trial design
Another key challenge is how to help Sponsors and CROS design or adapt trials so accurate data can be captured in places other than in physical sites. “We have a number of options to virtualize trials. For example, we can enable patients to provide consent and to collect patient survey data through apps on their smart phones and tablets in their homes. We can also deploy synthetic control arms to supplement data in on-going trials.” said Fareed Melhem, senior vice president, Acorn AI by MEDIDATA. Typically, a clinical trial has two “arms:” One is usually an experimental drug, and the second is a placebo or
standard of care. MEDIDATA can offer an option to partially or fully replace the placebo or standard of care arm with a Synthetic Control Arm™. Synthetic Control Arm is constructed from the 20,000 clinical trials on MEDIDATA’s platform that meet the criteria for the new trial, providing data that allows researchers to decrease the number of patients required for the trial. This could potentially shorten the duration of the trial as well.
To learn more about the use of synthetic arms, click here to read about Celsion, an oncology drug development company that uses a MEDIDATA-supplied synthetic arm.
Ensuring drug delivery
Another critical challenge is ensuring drug supply delivery, MEDIDATA is adapting its current technology to get trial drugs to patients at home in a compliant and traceable way. Currently, the majority of patients receive their drug at clinical sites, and researchers and clinicians are working to find new ways to virtualize tests. For example, if patients can’t get to their site, there is a need to develop the protocols to safely ship the medication and ensure patients adhere to instructions. There is a huge amount of work to be done to develop a process for traceability and meet current or work to modify regulatory requirements.
Accelerating study start-up
Clinical trials can be initiated as an investigator-initiated study (IIS) or a normal, sponsor- investigated study. Each comes with different budgeting challenges that can slow the start-up process.
IIS budgets are typically built with the sites, where the trial will take place. If the sponsor isn’t indicating what the costs are, this approach causes delays as the sponsor will also need reliable data to verify that the costs are fair.
With COVID-19 investigator-initiated studies there can be budget negotiation delays due to the gap between the site and Sponsor’s individual cost benchmarks. This independent industry benchmark data doesn’t yet exist for COVID-19 trials.
To address the lack of data, MEDIDATA has developed a new vaccination study budgeting solution to help develop detailed trial budgets for patient, procedure and site costs. This solution leverages MEDIDATA’s existing deep fair market value data and clinical trial budgeting expertise, enabling IIS and COVID-19 Sponsored studies to streamline the budget build process for their sites.
Clinical trials post COVID-19
In addition to focusing on finding approaches to virtualizing existing (and future) clinical trials, MEDIDATA is actively involved in supporting the race to develop a vaccine and therapeutic trials related to COVID-19 prevention and treatment, respectively through its technology and solutions, focusing on speed to market, which is the number one issue. Sponsors and CROs need to get trials set up quickly and in ways that can succeed under pandemic conditions. Safe and effective drugs to treat the disease are urgently needed for those suffering from COVID-19 and vaccines for the healthy are required to prevent further spread of the virus and to ensure that life can return to normal. Going forward, the valuable data gathered, and lessons learned during the pandemic may serve as the foundation for a new more innovative approach to clinical trials.
“There have been lots of initiatives around the virtualization of clinical trials and analytics, and the subject has been getting increasing attention for a number of years. COVID-19 will accelerate the adoption of these tools, and the lessons we learn now about how to virtualize and simplify trials will have impact going forward,” said Melhem.