Clinical Research 2020: A Trial Interactive Reflection on Resilience and Community
After a very challenging year, let’s celebrate adaptation and resilience. Here are a few observations on how study teams pivoted and innovated to remain in control in spite of a global pandemic.
To put it mildly, 2020 has been a time of adjustment. We were taken out of our comfort zones, professionally and personally, and we had to find productive ways to live in the COVID-19 pandemic present. In short, this crisis changed all of our plans, putting many trials on hold or delay and bringing new treatments quickly into testing in a rapid and dramatic way. With so much disruption, individuals and companies came face to face with both their own strengths and weaknesses.
As a technology and services provider, the Trial Interactive team has been navigating these same realities while assisting study teams as they find their way. From this vantage point, we have seen amazing things from amazing people. In honor of this adaptation and resilience, here are some of our observations:
We helped each other.
We all offered each other solutions and flexibility wherever possible. Vendors and CROs provided critical offerings for free or at substantial discounts. Executives took stock of their operations and offered remote work options and operational changes wherever possible to keep people safe.
Managers helped teams continue to work effectively and explored new ways of engaging team members without being able to see them in person. The health of individuals became the number one focus.
Meanwhile, everyone demonstrated patience and acceptance for babies crying, dogs barking, lawn mowers running, and other loud noises present on conference calls. In a world that can often feel very polarized, people were very much aligned in working together to keep each other sane and effective, in spite of it all.
Companies who trusted in and implemented available technology for conducting more remote clinical development experienced less pain. Companies who already had their eClinical infrastructures in place, and who already had remote employees, faced even less pain.
Companies who read the tea leaves and adopted simple solutions like remote monitoring, learning management, and eTMF were able to avoid delays and even hasten study startup timelines and approvals.
Such was the case for Orphan Reach, who received 48-hour approval after protocol submission to launch COVID-19-related research, or Fibrogen, who managed an expedited drug approval. We tip our hats to any and all companies who were able to not only adapt but thrive.
Teams normalized virtual water cooler chats.
One of the most painful aspects of this whole year has been simply not being able to see loved ones, friends, and colleagues in person. The emotional impact cannot be understated.
It is easy to succumb to the frustrations this disconnection creates, but teams used Slack, Skype, WebEx, Zoom, and a host of other communication tools to stay in touch and spend time together for more than just work. Virtual happy hours have been pretty thematic across many companies.
Virtual game nights and movie nights (think Tiger King on Netflix back in April) have also been popular. Companies are still working out the increase in meetings created by less in-person dialog, but the important thing is that everyone is spending time with each other in new and creative ways.
Remote inspections became the default.
In the time before COVID-19, remote inspections were not preferred, and definitely not imminently anticipated in a regulatory submission. The technology has existed to conduct them for some time, but the industry hadn’t arrived at remote inspection as a standard.
Now, study teams have to assume a remote inspection is likely, regardless of the region of the filing. This change means teams have had to think about where documentation and data lives and how they will provide access to inspectors if requested. It has now become part of the TMF planning process and a major consideration when implementing eTMF and other eClinical solutions.
We established future-focused strategies.
Nerves about regulatory considerations, risk mitigation, and change management burdens have historically led to shuffling feet. The trouble with the future is that it usually arrives before we're ready for it. This year we saw a shift toward rapid adoption of investigator site collaboration and remote monitoring solutions.
Much of this adoption was for active studies, but then we saw a greater shift where teams recognized the importance of having these solutions ready for upcoming studies. This change in perspective happened much faster than the snail-paced evolution of paper to electronic TMF. That speed is a reflection of a new outlook on planning, one that factors in the almost unimaginable. Which leads us right to the next observation…
We acknowledged unpredictability.
The world has seen a pandemic before, but not when global economies and communication networks were so connected.
The unpredictability of life is something we all experience individually, but a global, collective realization and understanding deserves a moment of recognition. This realization is being met with creativity. Team communication, patient engagement, and investigator collaboration are all experiencing innovations in approach—as are processes like site visits and investigator meetings and how they are conducted.
We watched teams quickly pivot and buck traditions for new frontiers in their approach to operations in response to the uncontrollable, thus enabling them to take back control.
The industry prevailed.
This may seem a bit premature, but when has the life sciences industry ever overseen the creation of a vaccine based on a novel virus so quickly? In 1967, the mumps vaccine took four years to develop, which until this year was the undisputed world record. Most have taken 10 years or more.
There are now hundreds of COVID-19 trials in progress, with 110 candidates, and eight have already gone through phase I trials. Most amazingly, four vaccine candidates have now completed phase III, and half of those are reporting greater than 90 percent effectiveness.
We are now hearing that billions of doses will be manufactured in 2021. Should this happen, it will be an absolute triumph of science, manufacturing prowess, and, yes, clinical trial management.
While we have not yet put 2020’s challenges behind us, we have a lot to celebrate when it comes to resilience. We are grateful for all of the sponsors, sites, and CROs who have done everything in their power to ensure critical research was able to continue.
Through those efforts the world benefits, not only from advancements in the research itself but advancements in ensuring research operations continuity without sacrificing quality, compliance, or safety—all the while, gaining speed and efficiency.
For information on how to become more flexible with site collaboration, remote monitoring, eTMF, TMF services, document management, LMS, and CTMS solutions, contact us at firstname.lastname@example.org.
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