Fitting Your Needs: Pandemic-Proofing Protocols

With more than half of 2020 underway, it’s safe to say the year is not looking like anyone thought it would, not only in our personal lives but in the world of clinical research too. In March, everything was paused in an effort to flatten the curve, and only recently have sites begun to open back up. Sites had to quickly pivot and adjust protocols amid the chaos.

Although the pandemic forced an era in clinical research with no set guidelines on seamlessly adjusting, many sites have been able to set themselves up for success, continuing research on essential protocols. Now that sites have begun to open back up and are starting to return to a semblance of normalcy, it’s important to remember we are not out of the woods yet from COVID-19, and the possibility of a second wave is still looming.

Additionally, throughout the COVID-19 pandemic, many amendments and adjustments have shown the research community that it’s possible to conduct high-quality research with streamlined processes, increased patient-centricity, and the ability to use remote or virtual technologies. These practices and procedures don’t need to go away once the COVID-19 hype dies down; in fact, this can be looked at as a time to innovate and create procedures that aren’t looked at as temporary – rather, procedures that can be looked at as research moves forward.

Take an Inventory

While sites are starting to open back up, this is the time to take an inventory of processes and procedures, inspecting them with a fine-tooth comb. Consider various aspects of a study, including:

• Recruitment, screening, consenting
• Visit conduct
• Monitoring and auditing
• Regulatory inspections
• Protocol amendments

Of these aspects, what needs to be updated or modified? Are new procedures needed? How can processes be done more efficiently or streamlined? Research staff can ask questions such as these to fully critique what’s working and what is not, with the end goal to be developing and implementing new workflows to create a better research experience for the participant and research staff.

Communicate Regularly

As with any change, communication is key. Especially with a change as complex as restructuring protocols, it’s better to overcommunicate than under communicate, and to do so often. Gathering the necessary stakeholders together on a regular basis so everyone’s in the know and understands what’s going on will go a long way. If a site is implementing changes in a phased approach, it will be helpful to keep everyone informed during each phase, and what to expect from the next phase.

Additionally, communicating with the key players will ensure information is spread quickly and accurately to all stakeholders in the organization. The more staff feels included, and in the know during the process, the higher their confidence will be to continue doing research as needed during times of external strain.

Prioritization as a Project

Due to the nature of this project, a project manager will need to be allocated to keep everything on track. Since these considerations will most likely be institution-wide, it’s helpful to appoint a person with a holistic perspective. They can look at the bigger picture and greater good of the organization. Determine key decision makers to work closely with the project manager to organize and lead these changes. Again, people may need to be added in as an institution moves further down the list of innovations, or if anything new is thought up during the project. Obtaining stakeholder input will also be helpful – having staff to give feedback and guide decision-making will help keep the project moving.

A Time for Disruptive Innovation

While this may be a long and complicated project for a team to take on, the benefits far outweigh the heavy lift. This is a time to improve the participant experience and make studies more patient-centric. Becoming more participant-centric may look like recruiting participants from remote areas, rather than requiring them to physically come into a clinic to receive care. Or perhaps streamlining the time it takes to move a protocol through the phases and to market, ultimately helping even more patients.

To learn more about pandemic-proofing your protocol, watch Advarra’s webinar, The New Normal: Considerations for Restarting Research.

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