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Clinical Pharmacology Modeling Simulation6 Study Adaptations to Keep Studies Moving Despite COVID-19 Pandemic
The COVID-19 Pandemic continues to evolve and fluctuate across the globe – but not evenly or predictably. Some countries have recovered to a large or small degree of normalcy, while others are still in the midst of their battle with COVID-19 and seeing increasing infection rates. Simultaneously, most are preparing for a 2nd wave of COVID-19 to hit.
What we have found over the past few months of the COVID-19 pandemic is that you must adapt your study for the unique challenges of your individual sites and especially that of your individual patients. This adds an additional layer of complexity and management to clinical trials running today.
As you might suspect, there has been a range of responses from the governmental levels of country leadership/regulatory authorities globally, and we see a spectrum of different impacts at the clinical research level, impacting individual sites and patients.
Recently, we held a fireside chat with our project managers and clinical trial leaders to learn how they are adapting their studies during the COVID-19 Pandemic. Here, we discuss six commonly seen adaptations to allow their studies to push through the impediments and challenges of COVID-19.
1. Tracking COVID Impact at Site & Patient-Level
First and foremost, more trackers are essential to keep up with this new level of complexity. One of the most significant changes is the need to track and monitor rules and requirements that may be unique to each site location, even within the same country.
“We have to reassess what we do every day. We use trackers to assess regional and site risks. Some sites are resuming normal activity while others have reduced functionality or capability to support our studies,” says Jennifer Jarrell Parisette, Senior Clinical Trial Leader, Project Management. “We have to be able to quickly pivot because once you have a good grasp on the situation, it all changes, and thus the trackers are essential to keep pace.”
This is also the case for tracking patients at the individual level. Is the pandemic worsening in their locality, or do they need other options and tools to continue their participation? Are they even willing to continue to participate, or have they fallen ill to COVID-19?
In summary – common tracker adaptations are:
- Country-level COVID-19 regulations guidance tracker
- Site-level COVID-19 status and challenges tracker
- Patient-level COVID-19 needs and challenge status tracker
These efforts help synchronize the entire study team and help preserve and protect patient safety while furthering research.
2. Patient-Level Adaptations - Supporting Their Needs
The COVID-19 Pandemic has caused many issues with patients being enrolled or retained (patient retention). Depending on their location and the prevalence of COVID-19, many of our studies are having to deploy strategies focused on the individual patient – either already enrolled or to enroll new patients in the study. A few examples are:
- Shipment of study drug to patients so they can continue dosing, where possible, within protocol guidelines. Now, this is entirely dependent on the study drug or IP and the countries involved.
- Utilize a company to handle shipments from sites to patient homes (e.g., yourway).
- Setting up alternative sites for patient or lab visits. This, too, is entirely dependent on your study setting. Still, we have set-up alternative labs and investigative sites to retain patients on the study and allow for continued treatment and analysis.
- Home monitoring, in-home visits, or using third-party vendors to provided certified nurses can help in certain situations, but not all depending on your type of study design and disease.
- Telehealth visits where sites are capable of providing and where this works with study design and complies with the protocol
These adaptions ramp up internal communication on the CRO side as well as that of the Sponsor.
“We have more calls with CRAs to make sure they are collaborating with sites to find solutions at the patient-level, such as local lab sampling and home blood pressure monitoring for patients who could not travel to sites for study visits. We have to look at all options to keep patient enrollment and patient retention moving in a positive direction,” explains Catalina Teodor, Clinical Trial Leader, Project Management.
3. Deploying Remote Monitoring Solutions
Where possible, dependent upon your countries involved, changing your onsite strategy to Remote Monitoring is essential to continue operations.
Allucent has successfully changed a majority of its investigative sites to Remote Monitoring. As you likely already know, not allocations within a country can support Remote Monitoring, and some countries even prohibit it from occurring. Therefore, again, we have to deploy site-specific strategies to continue to monitor sites. If sites cannot support remote monitoring due to country or site limitations, often sponsor and CRO must discuss alternatives that could entail stopping/pausing enrollment at the site, replacing the site, etc., depending on your situation/study.
“Remote monitoring is a site-to-site issue, even for locations where the contract included a statement about remote monitoring and their ability to support it. What we are seeing is some sites simply cannot support it either because of reduced capability and hours of operation or because of other internal challenges on their side,” said Jennifer Jarrell Parisette.
4. Revising ICF Language to Support COVID-19 Strategies
To support some of your study’s COVID-19 urgent safety measures, you need to update your Informed Consent Form (ICF) or create a secondary ICF specifically to address your modifications. This allows you to achieve appropriate consent of the patient to support various strategies such as:
- Drug supply shipment to the patient’s home
- In-home nursing or doctor visits
- Telehealth visits for sites capable of performing
5. Protocol Amendments – Compensating for Urgent Safety Measures
Several of the strategies mentioned above will require Regulatory or Ethics notification at a minimum, and likely a protocol amendment and approval. Most of our sponsors are pursuing the protocol amendment route either proactively or reactively due to COVID-19. Many are doing this as a proactive step in front of the expected 2nd wave of COVID-19 anticipated to arrive later in 2020.
6. Considering Countries Least Impacted by COVID-19
As you start new studies or continue to pursue patient enrollment in your ongoing study, being mindful of current COVID-19 status in a given country is critical.
As mentioned at the beginning of this article, several countries are in a better place or nearing some normalcy, whereas others are still struggling. Not to forget there could be a 2nd wave on the horizon, potentially. In the countries that have returned to a reasonable “normal,” site operations have also returned to normal. This means they are likely to enroll better and should likely be considered for inclusion in your study, pending disease prevalence. Sponsors and CROs may activate new countries and sites to alleviate current country or site limitations where COVID-19 is still highly prevalent.
Adapting to Research During COVID
Clinical teams everywhere have had to make a variety of adaptions to keep studies running during COVID. They have scrambled to monitor the pandemic and its impact on country and local regulations, as well as its influence on patients and their safety. Being supportive of your sites and especially your patients is critical to achieving study progress.
Authors:
Carrie Doub, Clinical Trial Leader, Project Management
Jennifer Jarrell Parisette, Senior Clinical Trial Leader, Project Management
Catalina Teodor, Clinical Trial Leader.Project Management
John Colby, Exec. Director, Global Marketing & Communications
Renee Breiten, Marketing Content Manager