In her analysis, Suzanne Caruso, Vice President of Clinical Solutions at WCG, notes that over 950 COVID trials were initiated in less than 5 months. According to Caruso, “The majority of trials for COVID are going from final protocols to first patient visits in four weeks. Prior to the pandemic, this process took an average of 6 months and even if we were really efficient, we could only cut it down to three.” Given that the speed of protocol design and study start up has significantly increased, so has the expectation for access to real time data and the rate at which information is processed.
In regards to study startups, Caruso anticipates a collision between types of trials and timing. As sponsors open trial activities (i.e., lift enrollment holds for ongoing studies, get delayed trials running, rollout other studies that have just finished planning), the number of active trials will increase drastically. As such, it is important that sites are ready to go when research does ramp up again.
Download: Free COVID-19 SOP Templates, Written For Your Research Site.Download PDF
According to Edward Jones, President & CEO of Houston Methodist Research, “COVID will be with us for a while, so sites should open in ways that assume there is still a high prevalence of community transmission.” As we move towards a new normal in clinical research, we will need to continue taking precautions to ensure participant safety across sites and for each study protocol.
Tom Wardle, CEO of CenExel, adds that it will be crucial for sites to demonstrate to patients how they are taking precautions to minimize their risk of exposure to COVID. To that end, he has implemented formal pandemic site operating procedures at his trial site network. The SOPs include testing patients for coronavirus, managing staff and patient schedules to reduce traffic, screening of all individuals prior to entry and allocating spaces to isolate anyone that might be symptomatic. Wardle stresses that a large portion of pandemic SOPs should be dedicated to educating participants. Some examples are early and frequent reminders about using PPE, rules for social distancing and what steps should be taken to prevent/control infection.
Sites should also consider the following as the industry starts to open:
- Remote monitoring of patients in between visits for safety purposes and to ensure they are not exhibiting any symptoms of COVID
- Continued use of remote visits where applicable so movement of participants is limited. Implementation must be appropriate for each protocol, the amount of site staff available and must be in accordance with evolving FDA and IRB guidelines.
- Is there adequate PPE for your workforce? Is there adequate PPE for people that your workforce interacts with (i.e., patients, monitors, accompanying visitors)?
- Will your employees be able to return to work? Will you need to hire additional staff?
- Discrepancies between state and federal policies
In closing, Cusaro offers advice to sponsors: “To best support research sites at this time, help the study coordinators. Think about the collision of studies that are starting. There is going to be so much that coordinators will have to do and the more we can help them, the better we will be coming out of this.”
- Edward A. Jones, President & CEO of Houston Methodist Research
- Tom Wardle, CEO of CenExel Clinical Research
- Suzanne Caruso, Vice President of Clinical Solutions at WCG
- Lindsay McNair, Chief Medical Officers at WCG