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The Evolving Landscape of Clinical Trials

During Covid-19, the ability to safely and quickly test vaccines and drug therapies could be lifesaving for millions. It’s critical that other important therapy groups for a range of conditions continue to be tested, produced and regulated. So how can clinical trials at Life Sciences organizations continue to move forward?

June 2020

The Evolving Landscape of Clinical Trials

By Emily Beebe, Team Lead, Clinical Project Management - USA

 

As we are quickly realizing, clinical trials have never played more pivotal roles than they do now. During Covid-19, the ability to safely and quickly test vaccines and drug therapies could be lifesaving for millions. It’s critical that other important therapy groups for a range of conditions continue to be tested, produced and regulated. So how can clinical trials at Life Sciences organizations continue to move forward? 

 

Remote Clinical Trials Transform the Life Sciences Industry

Beginning in early March, industry reports advocated an increased number of remote clinical trials. The ability to monitor and interact with patients has been transformed by innovations in telehealth and wearable technology. That being said, the Covid-19 crisis has accelerated the adoption of these technological advancements within a sector that is typically unreceptive to change. The current crisis required clinical trials at Life Science organizations to quickly deploy new processes or develop existing procedures that were in line with new social distancing guidelines. However, virtual trials don’t simply rely on technology for their success. One must also consider the logistics of ensuring that medical supplies, drugs, and devices are all getting to where they need to be, as well as call center communication and maintenance to ensure that patients have access to any information that they need. Remote clinical trials are just as multifaceted as any other clinical trial and organizations through the industry must ensure that they have access to the expertise that they require to put them into practice. 

 

Outsourcing is Growing

Clinical Research Organizations (CROs) have typically been the “go-to” for large Life Sciences organizations and this has increased significantly in the past few years. We have seen a growing demand for more flexible and collaborative functional service recently meaning that pharmaceutical companies are not always partnering with the global players as was often the case. Small and medium CROs are often able to be more agile and offer specialty services. However, it is worth noting that pharma companies now prefer long-term partnerships with a fewer vendors, so as long as these smaller CROs are able to offer an end to end service, they are likely to be more successful.

 

Shifting Regulatory Timescales

It used to take years to bring drugs to the market, but Covid-19 has thrown these timescales into flux. Under emergency measures, regulators all over the world are providing support on vastly condensed timescales. The FDA, EMA and CDE have all deployed emergency clinical approval processes and some products have already moved significantly down the pipeline. The timescales that have seen a reduction are positive for those in the race to produce vaccines and treatments in specific therapy areas. This however has ramped up the pressure for regulators to work quickly. Scientists, regulatory experts, clinical experts, and healthcare professionals now face several hurdles, such as international travel restrictions, social distancing measures, and shifting stay-at-home guidelines. The deployment of virtual solutions, remote patient monitoring, and robust safety management systems are all facilitating those working within clinical research to get their job done safely. 

All industries have been impacted by the pandemic and the future remains uncertain for a lot of organizations. No one knows what the future holds in the coming days, weeks or even months, but rigorous clinical trials seem to be a critical part of the industry’s response to Covid-19. Organizations who operate within the clinical sphere must review their current strategy, including within talent acquisition, to ensure that they have the agility, flexibility and methodology to access the best professionals when they need them most. It is critical for companies throughout the industry to be prepared for what’s next – not only to ensure business continuity for the now, but to secure future success in clinical trials in the face of unprecedented challenges posed by the pandemic. 

 

Emily partners with pharmaceutical, biotechnology and clinical research organizations to find the very best talent within clinical operations and project management. She is always interested in increasing her network – if you are interested in speaking with her about talent acquisition strategy within this space, do reach out – ebeebe@i-pharmconsulting.com