In the short term:
- Study Start-up and Activation: Consider a thoughtful pause. Assess the impact of COVID-19 to your trial, and consider the protocol, the target sites, partners (e.g. CRO), and the ability to enroll. Take advantage of the pause in clinical trials to prep for the future to position yourself for success down the road. This may avoid a short-term stall and enable a more efficient and effective trial in the new environment as we emerge from the pandemic.
- Ongoing Trials – Enrollment / Data Collection: Take action. Assess the impact of COVID-19 on your trial(s) and determine the appropriate course of action at a trial level and a site level; considering any regulatory guidance available. Some sites may be able to continue enrolling and monitoring patients, whereas others may need to put clinical trial activity on hold.
- Remote monitoring and data collection: Take action. Assess the options available to continue monitoring enrolled patients remotely and gathering necessary data. The right solution could negate the potential safety and efficacy concerns from missing data.
In the mid-term: Once the outbreak declines and we begin to revert back to normal, manufacturers will want to restart clinical trials – all at the same time. The key consideration is what the new ‘normal’ will be, and what needs to be done differently to achieve progress – including an assessment of key partners in the process (e.g. CROs) and effective planning and engagement with sites. Being prepared and differentiated will be the key to success.
In the long term: Assess and Evolve – The COVID-19 outbreak and its effects are going to fundamentally reshape the pharma industry. In the future, our industry will need to consider how to shift our approaches to enrollment and monitoring permanently based on what we’ve learned during this time. For example, are there still ways to facilitate conversations between the patient and physician while reducing risk? Can you send mobile units to collect blood or other trial data? Can adverse event assessments be completed by telemedicine? These long-term solutions must be considered now in order to avoid getting left behind when the virus subsides.