A Site Guide to Clinical Trials During the COVID-19 Pandemic
COVID-19 is changing the world, and the way we conduct clinical research.
The COVID-19 pandemic is spreading rapidly and impacting industries around the globe. Social distancing, travel restrictions and supply chain disruptions are creating unprecedented challenges to business operations, and clinical trials are especially feeling the effect. Sites and research organizations need to be strategic in their procedures moving forward to preserve business continuity and ensure that patients remain involved in clinical trials. With the proper technology and clear communications during this pandemic, your site can continue to function while minimizing damage and financial loss, and then be positioned for additional success and growth once the crisis is over.
The news surrounding the COVID-19 pandemic chances by the minute, and it is creating a great deal of uncertainty in the research community. Critical questions are being raised regarding the effects that COVIS-19 is having on clinical trials, including:
- How do you keep patients engaged in the trial while minimizing risk of exposure to the virus?
- How will COVID-19 impact patient recruitment?
- What protocol deviations need to be reported to the IRB?
To get answers these questions and more, it is essential for sites to have clear and consistent communication with everyone involved in their clinical trial, including sponsors, IRBs, research participants, as well as other sites. Sponsors should be communicating with their research sites about the steps they need to take in order to keep their studies ongoing. Interactive webinars between sponsors and their sites give sponsors the opportunity to address the concerns sites face and provide a platform to stay informed and ask questions. If a sponsor is not reaching out to their sites as much as they should, sites should not hesitate to contact them ASAP. Using clinical trial software like CTMS, eReg or eSource can make communicating even easier by giving your site the ability to share documents, electronically request signatures, and engage with your patients. Since patient safety is a top priority, there are even two-way patient texting tools your team can use to maintain constant contact with participants and inform them of any changes to the trial that will affect them.
One of the first aspects of running a trial that will change during the pandemic is recruitment. An increasing number of patients fear exposure to COVID-19 and are cancelling their visits. Even those wanting to show up may not have any means of transportation. Only some study visits can be conducted remotely or offsite, and sponsors/IRBs are just starting to develop policies for visit deviations that require a physical site. Finally, many research organizations use clinic visits and paper documents to keep track of source data and consent information.
Despite these challenges, there are several ways clinical research organizations can adapt and continue their recruitment efforts. For many recruiters, clinical trial management software has become an indispensable tool for keeping the recruitment workflow efficient while working remotely. A CTMS has the capability to create adaptable recruiting workflows, integrate with social media platforms and provide two-way texting communication to better communicate with potential participants.
Below are some approaches that your team can leverage for a recruiting campaign in the COVID-19 environment:
- Build an adapted call list of best candidates
- Apply multi-variable filters to your CTMS database to deprioritize prospects who are elderly or immunocompromised
- Develop a timely recruitment messaging strategy
- Reassure your potential participants with clear and concise messaging surrounding how your site is handling exposure mitigation and other important aspects of the trial
- Leverage external recruitment lists and your CTMS database to setup targeted email campaigns
- Try and personalize your emails with reassuring and clear messaging, as well as set up landing pages that route participants to pre-screening questions or a call with a recruiter
- Attract additional patients by building a social media campaign
- Create relevant human-interest posts that connect to the COVID-19 crisis and show how your study team is adjusting to work under their new, temporary “normal.” Everyone is looking for some levity so make it fun!
- Set up customized text messaging campaigns
Texting gives prospects the ability to respond when it is convenient for them and can be tracked in your CTMS for recruitment reporting. Two-way texting is also very effective for ongoing study follow-up.
Alongside ongoing recruitment efforts, clinical research organizations need to work to retain patients that are currently enrolled in trials. Below are some best practices for how to retain these patients in the midst of a medical emergency:
Determine Remote Tasks: Research organizations should have already transitioned most of their staff to remote work. Those staff members should have contact information for the Sponsors, CROs and enrolled patients, as well as any other information that they would need to conduct their job effectively. From there, those staff members can continue to schedule or reschedule necessary patient visits, as well as provide participants the information they will need for the study going forward. Tools like CTMS, and two-way texting help streamline communications and can be accessed remotely via the web.
Develop a Communication Engagement Strategy: Clinical research sites should be reaching out to their enrolled participants consistently to provide them with updates on the status of the trial. If anything changes regarding offices closures, visit changes or the implementation of telemedicine, participants need to be made aware in order to reduce the risk of additional delays or dropouts. Remote staff should reach out to currently enrolled participants through phone call, two-way text or email to arm them with the appropriate information.
Protocol Amendments and IRB Approval: Once a research organization has developed a communication strategy, the next step is to start amending protocol. All unnecessary visits must be removed from the protocol immediately in order to the reduce the risk participants face from encounters with staff and other patients. During this unprecedented time, an IRB is going to be your best source of information when it comes to submitting changes for approval. Remember, protocol deviations do not need to be reported to an IRB unless they negatively impact participants or will have negative impacts on an on-going study. For more information, be sure to read the recent FDA guidance for conducting trials during the COVID-19 pandemic.
The protocol amendments/changes that still need to be IRB approved are:
- The elimination or reduction in the number of study visits
- A shift from onsite to telemedicine or home healthcare
- The collection of labs off-site
The best source information regarding protocol amendments is a research sites IRB. Clinical research organizations must discuss their risks and options with their IRB, and don’t forget to document everything!