Clinical Industry Analytics Report 2020
“You never change things by fighting the existing reality. To change something, build a new model”
Clinical Professionals Group CEO, Yvette Cleland comments:
“Covid19 has been a global disruptor in literally every section of society. However, for the future of society clinical trials are essential for the long- term health benefits to every nation and those brave patients that enrol, do so much for the future patients. Covid19 could be used as an opportunity to establish new and efficient practices that allow us a greater agility in delivering much needed therapies to patients, often with an unmet medical need.
Astra Zeneca’s eagerly awaited COVID19 vaccine passes a large test, this gives us all a little more hope. Synairgen, a Southampton, UK based pharma company announces positive results from a clinical trial of SNG001. Despite all the bad news economically and on the back of a globally disruptive time, we see glimmers of hope and positivity. During the global pandemic we saw the clinical function within biopharma one of the hardest hits in terms of open vacancies. To context this, in 2020 to date general science vacancies were down circa 5%, yet live vacancies within clinical saw a staggering 20% drop versus the same period in 2019. As the pandemic evolves what will the reopening strategies be in trials? Business continuity may now be challenged more than at any-time in recent history but is, at galloping pace becoming increasingly important. Limiting patient attrition and protecting data is key as we work to minimise delays, and yet, things are still changing daily. With an industry that had already been advancing virtual capabilities, we now see this accelerate and the foot now seems pressed hard on the pedal of change.
So, what is Covid19 already offering us in terms of the challenges we are facing and lessons to learn? Could it be ensuring in future, biostatisticians will need greater input as failing to capture data from patients will be greatly impacted because of Covid19 and we must prepare for a 2nd wave. Sites will need deep levels of collaboration with the clinical teams and statisticians as patient safety is always paramount, assessing the size and scope of the impact will be pivotal. So, what do we do around the missing data and at-risk endpoints? When focusing on a strategy around missing data it will be essential that we collect what we can whilst sharply documenting what has happened and analyse. The innovation & growth in technology will no doubt offer different ways to retrieve data by calling patients or arranging local clinic visits. A study visit could be completed via video or phone? Safety is always the priority but having some data versus none would of course be the preferred outcome. There is an acceptance via Regulatory bodies that the current pandemic will inevitably deliver essential missing data, but patient level data omissions will still need to be clearly documented such as the missed visits or adjustment to virtual visits etc. Protocol addendums can be written to capture these changes and separately logged.
Communication is always key in times of turmoil. Internal leadership teams, external partners, vendors, sites, study participants, and regulatory agencies all need to have a clear understanding that seamlessly runs between them. Quality checklists written for the specific challenges of Covid19 and impacted areas will be key and should also focus on a post COVID19 quality plan. There will be a long tail of issues past COVID19 with continued risk that will need to be minimised. Mobilising, once travel restrictions are lifted will be a key focus whilst considering the protocols documenting actions taken during Covid19, and again looking at impact on data. How will be look at proper social distancing so patients continue to be protected?
As sites resume activities a focus for sponsors will be on monitoring strategies considering alternative methods and long-term plans and strategies around missing data plans, any changes to site or vendor audits. A full consideration of virtual trial capabilities would seem to make sense as we consider the impact of a 2nd wave of Covid19. Having already documented Covid19 deviations and impact plans will be informed from this newfound knowledge. Sites will require a full understanding of anticipated needs and Sponsors will need to step up their communication. Solid contingency plans will need full consideration to ensure operations can resume. However, there are a plethora of considerations around enrolment of patients that will need more time to review consent whilst deeply considering general patient anxiety and safety. If protocol deviation occurs, these must be patient centric. Would in some cases oral drugs being sent directly to patients lift some of the burden? Engagement with family and caregivers will be essential. All these considerations come with additional costs. Open and clear communication will be key throughout.
So yes, Covid19 has been a global disruptor in literally every section of society and new and efficient practices that allow us a greater agility in delivering much needed therapies to patients, is still key. You never change things by fighting the existing reality. To change something, build a new model. Perhaps the current dire situations we find ourselves in will lead to new and innovative ways to bring much needed therapies to the coming generations.”
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