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Why Effective and Efficient Clinical Trial Operations Are More Complex and More Important than Ever in a Post-Pandemic World

Anita Nelsen, Senior Vice President of Clinical Trial Operations at Allucent, shares her insights on how to navigate the drug development landscape.

Anita Nelsen is the senior vice president of clinical trial operations at Allucent, a global CRO focused on small and mid-sized biotech companies that offers a full spectrum of integrated services to support drug R&D. In an interview, Nelsen discussed some of the challenges these smaller life science companies face in a post-Covid world – ranging from funding to supply chain complexities – and how these companies can benefit from expert guidance to see them through today’s drug development environment. 

A career in clinical development

Nelsen has a wide range of experiences to draw upon in this important role. She launched her career as a research scientist, initially focusing on academic and government work. She developed her skill set on the fundamentals of drug discovery through these positions and subsequent roles at a biotech startup, where Nelsen learned firsthand the challenges of securing early-stage funding. 

Later, Nelsen moved onto larger companies, conducting genetic research for more than 20 years at GSK, and then leveraging that experience to develop a new genomics business unit at the CRO Parexel, servicing a broad base of biotech companies and big, international pharma companies. 

Throughout this time, Nelsen’s work helped bring life-changing therapies to patients in need around the world. But, just as important as those critical successes, Nelsen says it’s vital to learn from every setback to help clients avoid the same pitfalls – whether it be a program that didn’t gain approval due to safety concerns or lack of efficacy, because their treatment was not effectively differentiated from other products during clinical studies, or because the product simply didn’t get to market fast enough. 

At Allucent, Nelsen uses her insights and expertise across a broad remit covering project management, patient engagement and recruiting, site engagement, and clinical monitoring ensuring that the clinical trial data collected is accurate and represents what’s really happening within the study. As she explains it, now perhaps more than ever, it’s critical for smaller biotech companies to get the specialized drug development support they need because many of them are working to advance novel and potentially groundbreaking approaches for patients and families who are urgently awaiting breakthroughs. 

Navigating modern drug development challenges and opportunities

Speaking specifically about some of the lasting impacts she’s observed following the Covid-19 pandemic, Nelsen points to how it helped accelerate adoption of certain kinds of technology for clinical trials, such as telehealth and e-consent, and also to new hurdles that continue to pose challenges in its wake. 

Anita Nelsen

“For years we’ve been exploring the use of e-consent for clinical trials. Some companies have embraced it. Other companies not so much, in part because of cost and in part because of the regulatory hurdles of leveraging e-consent in the global clinical trial environment. I’m not suggesting that all of those hurdles have been solved, but the pandemic brought on an urgency to start working on them more aggressively than what we may have been doing as an industry. In my view, that’s good for life sciences overall, and the patients and families we all serve.”

The pandemic also caused and exacerbated supply chain issues, some of it due to the domino effect of staff shortages and from reagent shortages and even difficulties obtaining pipette tips. These issues have forced the biopharma industry to anticipate longer lead times for certain aspects of study conduct, for example developing and validating bioanalytical assays. Companies with more resources are better positioned to weather these challenges. Still overall, and particularly for small and mid-sized players in the industry, these additional constraints require companies to plan more strategically and to have a holistic view from the outset. 

Nelsen prides Allucent on being able to provide that long-range, holistic view as well as the tailored solutions needed to meet individual client needs, based on their pipeline and what they need to do to satisfy their investors’ questions. The latter point is particularly timely because in today’s landscape, investor expectations are higher than before, and they’ve significantly pared back funding for biotech companies even with the unprecedented innovation coming from this sector of the industry. 

“Funding challenges have meant that biotechs have to be laser focused. You have to really think about every aspect of the clinical trial design. What value will it bring? What regulatory question might it help you answer? How might it help you differentiate your product? There is also an increased focus on making sure that you’re getting the best value for the money because the funding is much tighter than it was a few years ago,” Nelsen said. “We’re able to provide protocol optimization and insights that will help our clients deliver the most effective and efficient studies to develop their products.”

Allucent has its own decentralized clinical trial (DCT) program, Patient Direct Trials, that’s tailored for the distinct needs of small and mid-sized biotech companies. This service includes the voice of the patient and provides customized guidance and support to help companies plan and execute trials that meet patients where they are and fit more seamlessly into their daily lives.  Nelsen is quick to point out that the direct costs of executing decentralized trials are not necessarily less than traditional clinical trials.

“Our goal is to provide a cost effective solution for small and mid-size biotech to leverage the benefits of DCT solutions. They can help expedite recruitment and aid in retention of trial participants by making participation in clinical research more accessible to eligible patients.” 

This makes clinical development more efficient overall and is critically important because recruiting and retaining patients remains the biggest challenge in conducting clinical trials today. This approach also helps to diversify the participant pool so that trial results are more representative of the real-world effectiveness and safety of new treatments. 

“I recently supported a proposal for a client where we reached out and were able to very quickly get the perspectives of five or six patients who had the same disease and we were able to incorporate that information into our solution. We’re taking the patient’s lifestyle and the challenges associated with their condition into consideration when we’re planning the study. For example, we look at the duration of a visit and how many tests will be done per visit and how far participants have to travel and how frequently. All of those things are really important.” 

Given the groundbreaking science coming out of today’s biopharma industry, coupled with the mix of modern challenges and opportunities in clinical development, small and mid-sized companies stand to greatly benefit from knowledgeable guidance that Nelsen and her team bring. 

Photo: verbaska_studio, Getty Images