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The Revolution & Evolution
Of Clinical Trials

By Jan Filakovsky, CEO of Biomapas

Clinical trials transformed from the 1980s CRO boom to present-day personalized medicine and adaptive designs. As a leader in clinical development in the Baltics and CEE region, Biomapas is keen to explore these evolutions and share insights, especially for Nordic companies looking to expand their operations in our region.

 

Janos Filakovsky

The Accelerated Pacesetters:
COVID-19 and Technology

The urgency ushered in by the COVID-19 pandemic fast-tracked the adoption of decentralized trials. A notable instance is the REMAP-CAP trial, a global network of hospitals aiming to accelerate the treatment of severe pneumonia. This not only sped up patient recruitment but also diversified patient populations, enhancing the generalizability of the results.

From Oncology to Diversity

A decade ago, oncology studies were the focus of clinical research. Today, data from the WHO shows a far more diversified landscape. Diversity manifests not only in the therapeutic areas but also in the demographic composition of the trials. For instance, 75% of the participants in FDA-approved trials for 53 novel drugs in 2020 were Caucasian, indicating a clear gap we have to bridge as an industry.

What’s Shaping the Future?

As we look to the horizon, several trends stand out in their potential to further redefine how we conduct clinical trials. Among these, decentralized trials and Advanced Therapy Medicinal Products (ATMPs) are causing us to rethink traditional methods.

Decentralized trials leverage remote monitoring and telehealth, breaking geographical barriers and democratizing patient access to cutting-edge treatments. ATMPs, including gene and cell therapies, are pushing the boundaries of what’s medically feasible, offering potentially curative treatments for previously untreatable conditions.

Then there’s the FDA’s “Breakthrough Therapy” designation, exemplified by the rapid approval of innovative gene therapies like Zolgensma, drastically accelerating the pace at which life-saving treatments reach those who need them. 

The Digital Frontier in Clinical Trials

The digital landscape is unprecedentedly revolutionizing the world of clinical trials, leading to enhanced efficiency, inclusivity, and comprehensive research. Take, for instance, the “Digital Twin” concept—a unique digital identity that holds all pertinent information about a physical item, whether a medical device, a pharmaceutical product, or a laboratory sample. Adopting this technology vastly improves the traceability and reliability of data, thus elevating the overall integrity of clinical studies.

Similarly, IBM Watson has emerged as an AI powerhouse in the medical field. By analyzing vast volumes of medical literature, patient records, and treatment guidelines, Watson can generate personalized treatment recommendations for cancer patients, thereby driving the effectiveness of clinical trials while tailoring solutions unique to individual needs.

Artificial Intelligence is also playing a critical role, with tools like Google’s DeepMind and Genentech’s AI analyzing complex patient data to make early interventions. This not only improves patient care but also boosts the efficiency and success rates of clinical trials.

Reality Behind the Utopia

As much as we’d like to believe that we’ve entered a utopia of possibilities in clinical trials, it’s essential to acknowledge that this landscape is not without its challenges. The saying, “You can’t have a rainbow without a little rain,” rings particularly true here. One of the most significant hurdles is ethical considerations concerning data privacy. As clinical trials become increasingly digital and global, safeguarding patients’ sensitive health data becomes a growing concern. Initiatives like the “All of Us” research program by the National Institutes of Health (NIH) are helping to address this issue. The program anonymizes and securely manages patients’ health data, setting a precedent for handling ethical considerations in this new digital age of medicine.

But the ethical dilemma is just one part of the puzzle. The biotech industry also faces tangible challenges related to funding. With advancements in medical science growing exponentially, the financial backing needed to support such endeavors is also ballooning. And it’s not just the amount of funding but also its source and the accompanying risks that are evolving. Following the new regulatory landscape under the Clinical Trials Regulation (CTR), we see new trials moving out of Europe, influencing the pace and direction of clinical research.

In essence, while the future of clinical trials is teeming with promise thanks to groundbreaking technological advancements and innovative approaches, there are critical challenges that we must navigate carefully. Whether it’s ethical dilemmas or financial constraints, these challenges are crucial reminders that our journey toward revolutionizing medicine is complex, requiring collaborative and multi-dimensional solutions.

Our Commitment to Collaboration

The merits of co-development and outsourcing cannot be overstated in an ecosystem that thrives on change. They streamline the trial process and enable us to identify and terminate less promising drug developments early, living by the adage “Failing Fast Together.”

Despite the advancements in adaptive design and technology, clinical trials still face delays due to two primary factors: administrative burdens during startup, such as site contracting, the Clinical Trials Regulations (CTR), and challenges in patient recruitment. Leveraging our expertise as a Contract Research Organization, we partner with our customers to navigate and overcome these critical challenges, ensuring a smoother and more efficient trial process.

Clinical trials have evolved from focusing on single sectors like oncology to embracing a diversified approach in therapeutic areas and participant demographics. As pioneers in the clinical research sector in the Baltics and CEE region, Biomapas is committed to navigating these evolving trends and challenges. We offer a wealth of expertise and a commitment to innovation and ethical practices for Nordic companies seeking expansion into our region. Together, we can shape the future of medicine.

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