COVID-19 is impacting the healthcare system in a way we’ve never seen before, and pharmaceutical manufacturers are facing new challenges at rapid speeds. To help keep you informed, we’re releasing a special Q&A series with our experts to discuss the virus’s impact on each stage of the development journey.
EVP of Specialty Commercialization
Principal at CEEK Enterprises,
a division of Two Labs
Senior Principal at CEEK Enterprises,
a division of Two Labs
How is the COVID-19 outbreak impacting clinical trials?
There’s no avoiding it – the virus will significantly disrupt the clinical trial process at every stage. Though the extent of that disruption varies by therapeutic area, trial design, and location, these are the challenges manufacturers can expect through the key stages of a clinical trial:
- Study Planning and Protocol Design: There are significant new challenges to study execution which need to be considered. The first effects will be felt early. Not only will manufacturers have to anticipate and address new COVID-19 challenges within their study design, but also in CRO and site selection to identify the partners that can best operate in this new reality.
- Study Start-up and Initiation: There will be delays throughout the process, including IRB approval and contracting, as the world adjusts to working from home and research programs are deprioritized at healthcare institutions. Site initiations are getting pushed out several months, making activation difficult if not impossible at the moment.
- Ongoing Trials: There will be disruptions and deviations from the trial protocol, which will result in data gaps, driving a downstream effect on trial outcomes and potentially throwing drug safety and efficacy data into question — all of which impacts drug approvals and ultimately, patients’ access to vital therapies. While some manufacturers have paused enrollment, others are still working with the patients that have already enrolled.
- For example, on March 23, Lilly paused enrollment for most ongoing studies, and on April 7, Bristol Myers Squibb followed suit, yet both are continuing some of the ongoing clinical trials with currently enrolled patients. Emerging manufacturers like MyoKardia are following a similar pattern. On March 26, MyoKardia temporarily suspended enrollment and delayed new trials but are continuing ongoing trials with currently enrolled patients. The industry is in the process of figuring out the best response to the outbreak – there will be a competitive advantage to those who will be able to reassess, react quickly, and effectively plan for the new future.
How should manufacturers react?
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.
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