Clinical research teams are no strangers to pressure.
Even still, conducting trials and performing potentially life-saving research during a pandemic makes the work that much harder. Resources need thoughtful management, recruitment becomes more complicated and collective medical knowledge changes daily.
Below are some of the ways clinical research directors can ensure their teams have the resources they need to conduct trials effectively and safely.
First, however, it’s important to understand what challenges arise for clinical research teams who are working in the middle of a pandemic. This will inform what supportive steps can be taken next.
A Pandemic Multiplies the Challenges of Conducting Clinical Trials
The research complications that an ongoing pandemic presents are both ethical and practical. In a paper published May 2020, Francois Bompart of the Drugs for Neglected Diseases initiative in Switzerland laid out some of those complications:
- The pools of participants tend to shrink.
- Shortages of medicines and medical supplies can happen.
- Ethical review boards can be overwhelmed with work.
- Different research teams, while working concurrently, can publish findings that conflict or contradict one another, which could then impact public health decisions.
Meanwhile, there remains an intense sense of urgency because patients are awaiting treatment, and some people are dying, as has been the case with COVID-19. The due diligence that science requires can create friction with the very real, very human desire to develop treatments as soon as possible.
“It’s difficult to conduct clinical trials in the face of an epidemic, particularly during one with a newly discovered virus,” says Kathryn Edwards, a professor of pediatrics, scientific director and vice-chair for clinical research at the Vanderbilt University Medical Center. Edwards advised researchers during the West African ebola epidemics from 2014 to 2016, and she is currently advising COVID-10 researchers.
“You don’t know all about the disease at that point and you certainly don’t know how to treat it. You’re still learning. There is always a push to try and do something therapeutic: Often, there is a push to use medicines and other treatments that might be beneficial, but they haven’t yet been proven to be beneficial and they might even be harmful.”
It’s against this backdrop that trial leaders must find ways to support their teams.
High-Level Support: Coordinating With Others to Secure Resources
During the first weeks of the COVID-19 pandemic, public and private organizations came together to find ways to align their efforts so that research could proceed as quickly as possible.
Francis S. Collins and Paul Stoffels, respectively from the National Institutes of Health and Johnson & Johnson, described one such partnership in a May 2020 article in JAMA. The NIH and its partners from the private sector have created four working groups, they write. These include:
- A group to synthesize preclinical knowledge and “and accelerate testing of candidate therapies and vaccines to support entry into clinical trials.”
- A group to identify and evaluate, through clinical trial, some potential therapies for COVID-19.
- A group to optimize the existing networks of clinical trials “to increase efficiency and build capacity.”
- A group to speed up the evaluation of COVID-19 vaccine candidates.
Therefore, the playing field for clinical research has changed during the COVID-19 pandemic, and similar shifts are to be anticipated during future pandemics. Research leaders will need to be able to navigate those networks to ensure they and their teams have access to the resources they need.
Other partnerships and coalitions have emerged, too. Here are a few examples that could be useful for research directors who aren’t sure where they can turn for support:
- The COVID-19 Clinical Research Coalition is connecting members with government agencies to ensure data are standardized, research is shared quickly, and the healthcare capacities of communities — particularly those most vulnerable — are not compromised by this mobilization.
- The Clinical Research Coordination Initiative in British Columbia is supporting local researchers by helping launch a biobank, by both establishing a platform for patient recruitment and by curating available funding opportunities.
- The Stanford Center for Clinical Research in California is in the process of strengthening its partnership network. Already, that team has reported success in its trials of a compound that could help alleviate COVID-19 symptoms.
- SubjectWell is helping build a patient registry so researchers can recruit participants more easily.
Front-Line Support: Protecting Staff During Patient Interactions
Another critical aspect of supporting research teams is providing them with safe working environments.
In many fields, professionals are able to adapt to social-distancing guidelines more easily than can happen in a medical research context. Therefore, researchers need protective equipment and protocols that will allow them to feel safe while they work.
Jennifer Goldfarb, VP of IMA Clinical Research, writes how the research community in general is constantly learning better methods of keeping safe. “We have put new processes in place to protect participant safety, including screening procedures recommended by the CDC,” Goldfarb writes.
“We have adjusted participant visit schedules, in consultation with sponsors, to eliminate unnecessary in-person visits. We have accommodated remote monitoring visits, often facilitated by the use of amazing CTMS systems, including many that allow for electronic source and electronic regulatory documentation. [...] We add to this list of accommodations every day, without hesitation, and will continue to do so over the coming months, and years, as needed.”
Because there is such an informational component to researcher safety, it’s best to publish, revisit and update policies as needed. The HR team at Johns Hopkins University has a good example of up-to-date guidelines. Information regarding working environments and time-off policies are easily accessible to all employees. This level of reporting and transparency is needed so that staff feel safe at work.
Technology’s Role in Supporting Current and Future Research
As Goldfarb notes, clinical research will continue to evolve with the pandemic, and some changes will likely remain after the pandemic. Therefore, it’s worth remembering that the work done now to support research staff could have far-reaching impacts.
For example, many research organizations have explored and invested in technology that allows for the remote monitoring of patients. This can be a boon to researchers during the pandemic, but it might also change research workflows for years to come.
Organizations that have built up their digital capabilities in previous years may have an advantage during the new normal that COVID-19 creates. The South Carolina Clinical & Translational Research Institute, for example, leveraged its technology to “activate a trial of an at-home COVID-19 antibody test for health care workers in just 14 days.”
Not every organization has those capabilities, though, and some are having to play catch-up. “Many companies are looking to immediately implement remote monitoring procedures, but because such procedures have been unevenly employed in the U.S. to date, sponsors lack the infrastructure and established processes to transition quickly,” consultant Laurie Halloran writes. “The situation is worse in the EU, where GDPR requirements make remote monitoring nearly impossible.”
Still, remote monitoring is but one aspect of how technology can facilitate research during and after a pandemic. Other tools, such as clinical trial management systems and planners that can help assess a trial’s feasibility, provide research teams with crucial resources that allow them to work more effectively.
When teams have the resources they need to work effectively and safely, they can then focus on the mission at hand: Developing treatments and saving lives.