To Care is To Cure – We’re Back!
I’m excited to announce the return of To Care is To Cure after a long hiatus. When I last published in 2021, the world was grappling with the COVID-19 pandemic, and our discussions revolved around how clinical trials were evolving in response to the crisis. From decentralised trials to diversity in study populations, we explored important topics that were shaping the future of clinical research.
Fast forward to 2024, and the world of clinical development has continued to evolve in fascinating ways. Today, I’m back to share fresh insights on the trends driving innovation in the industry. Over the next few months, I’ll be publishing a new 5-part series that explores some of the most significant advancements in clinical research and development since the pandemic.
During the height of the pandemic, we were focused on adapting to a rapidly changing world. We looked at decentralised clinical trials (DCTs), diversity in trials, and the personalisation of healthcare as crucial areas to address. In many ways, these trends have matured and paved the way for further advancements in the clinical development field that I’m excited to explore in this revived blog.
As I prepared for this series, I reflected on the many trends that have shaped the clinical development landscape in recent years. So much has changed, and when you're immersed in the field, it can be difficult to step back and truly assess the bigger picture. After careful consideration, I’ve narrowed it down to five key trends that I believe are essential to discuss. These trends are not only transforming how clinical trials are conducted but are also reshaping the very frameworks that govern clinical research:
1. Decentralised Clinical Trials (DCTs): Lessons Learned and the Future
Although decentralised and hybrid trials weren't brand new when the pandemic struck, their rapid adoption was largely fuelled by the urgent need to keep trials running and ensure drug development could proceed despite restrictions on in-person interactions and the challenges of patients attending clinical trial sites in the traditional way. What began as a crisis response has since evolved into a more permanent shift in how we think about the conduct of clinical trials. I’ll explore how DCTs have evolved, lessons learned from this transition, and where we might be heading in the future.
2. Artificial Intelligence and Machine Learning in Clinical Research
Clinical development has made significant strides in harnessing technology and data science, especially through the growing use of artificial intelligence (AI) and machine learning (ML). These approaches are no longer just experimental; they have become scalable, essential and integral to critical areas such as clinical trial design, site selection, patient recruitment, predicting patient outcomes, enhancing patient monitoring through digital tools, automating trial management tasks, data analysis and reporting processes. With these advancements, the future of clinical trials is being reshaped, and I’m particularly excited to share insights into how AI and ML are revolutionising this space.
3. The Rise of Digital Biomarkers
The integration of wearables and mobile health technologies has opened new doors in patient monitoring and data collection. In this post, I’ll explore the increasing use of digital biomarkers in clinical trials, why they matter, and what they mean for the future of personalised medicine.
4. Regulatory Innovations and Flexibility
The rapid regulatory changes seen during the pandemic have led to more flexibility in how clinical trials are conducted. I’ll examine the latest guidance from regulatory bodies, such as the FDA and EMA, and discuss how adaptive trial designs and real-world evidence (RWE) are becoming more central to the approval process.
5. Sustainability and ESG (Environmental, Social, Governance) in R&D
Beyond innovation, the clinical development industry is starting to consider its broader impact on society and the environment. This post will focus on the growing emphasis on sustainability and ESG practices in R&D, from greener operations to ethical considerations in clinical trials.
I’m excited to dive back into writing and explore a range of important topics once again. The upcoming series will be filled with insights and reflections on the trends shaping our industry. Whether you’re a professional in the field or simply interested in how clinical research is evolving, I hope these posts will inspire meaningful discussions. Don't forget to subscribe and follow along as we explore these exciting developments. Thank you for your continued support - I’m eager to reconnect with this wonderful community!
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