Clinical trials, the cornerstone of medical advancement, have stood largely unchanged over the past two decades.
An evolution has begun, however, indicating a future where patient-centricity and technological innovation reign supreme—which we are already beginning to see with the incorporation of artificial intelligence (AI) and machine learning in clinical trials.
Traditionally, trials have targeted broad patient populations, but a paradigm shift is underway. Study sponsors are honing in on niche groups, driven by advancements in genetics and biomarkers.
This personalised medicine approach is opening new doors, particularly in tackling rare diseases.
Navigating the regulatory landscape is another evolving challenge. Stringent rules necessitate adaptability from pharmaceutical companies, pushing them to explore innovative solutions.
Yet, the colossal costs and persistent recruitment hurdles demand a rethink. Streamlining processes and harnessing digital technologies offer a path forward. Moreover, embracing a patient-centric mindset promises greater evolution in clinical trial practices.
A Dynamic Landscape
While the pharmaceutical industry has adapted to shifts in consumer attitude around healthcare and the introduction of medical technology, clinical trials have consistently lagged behind.
Conventional methods persist, with trials primarily conducted at designated sites and endpoints remaining static. Recruitment woes persist, alongside escalating costs and high dropout rates.
However, signs of change are encouraging. Sponsors are increasingly targeting unmet needs and rare diseases, leveraging genetic screenings and biomarkers for patient selection. This shift yields more complex drugs, exemplified by DNA-based and gene therapies entering the market.
Yet, this scientific progress complicates trials with an array of endpoints, posing challenges for patient enrollment. Regulatory updates, like GDPR in Europe and updated Good Clinical Practice guidelines, add further layers of complexity.
The Covid pandemic also highlighted the necessity for increased collaboration and harmonisation between the various regulatory bodies across the globe, as standardisation offers the promise of faster trials, potentially reducing both costs and time to market.
Innovation is brewing, albeit slowly. Sustained efforts aim to streamline processes, but the call for disruptive innovation grows louder.
A recent example of this was during the Covid pandemic, with the implementation of lockdowns exponentially increasing the adoption of technology platforms enabling remote communication between healthcare professionals and patients, mitigating disruption to care pathways.
AI and machine learning are helping to reshape trial methodologies, for example aiding pre-trial planning and protocol design through predictive modelling and expediting analysis of clinical trial data and results.
Patients first
Central to future trial strategies is a patient-centric approach. Traditionally, patients tended to participate in trials close to home and depended on awareness among local HCPs, limiting the diversity of trial which is crucial when testing a drug’s effectiveness against all who are affected by the disease in question.
Casting a wider net through consumer outreach on platforms, like social media, promises a wider reach amongst both HCP and consumer audiences. Digital communications channels offer alternative distribution methods for patient engagement materials.
Changing attitudes are helping to improve inclusivity by ensuring that language, style and imagery better reflects the desired patient population.
Technological innovations, particularly genetic screening, enhance patient targeting. E-consent emerges as a tool to simplify the consent process, potentially accelerating recruitment.
Decentralised trials
Hybrid trial models, blending site-based and remote components, offer short-term solutions.
Decentralised clinical trials (DCTs), facilitated by wearable devices and digital therapeutics, continue to contribute to an increasing patient pool as it enables patients to more easily participate from the comfort of home, expanding trial reach.
Advancements like remote monitoring hold promise, particularly in fields like nephrology. Post-approval trials could transition to a virtual format, alleviating the burden on patients and healthcare infrastructure.
Challenges remain, from equipment validation to technological limitations. Yet, regulatory and technical advancements could pave the way for fully virtual trials.
Algorithms and AI may even replace human subjects in certain scenarios, offering a faster, safer, and more ethical approach to drug development.
Embracing the Future
As clinical trials move toward a more patient-centric, technologically-driven future, the potential for transformative change is profound. Collaboration among stakeholders and a willingness to innovate are key to continue driving change and innovation.
While challenges in technology and regulation persist, progress is becoming more evident,. Embracing a leaner, more cost-effective model necessitates regulatory openness to new ideas and the courage of sponsor companies to embrace unconventional approaches.
Companies must adapt to this evolving environment to stay competitive, with the potential of the clinical research organisation and functional service provider models offering flexibility and efficiency that works best in a dynamic environment.
Looking ahead, the emphasis on value and outcomes underscores the continued evolution of clinical trials towards a more dynamic and impactful future.
By embracing innovation and prioritising patient needs, the next decade holds definite promise in revolutionising clinical research.
Graham Belgrave is Senior Vice President, Global, Medical & Regulatory Affairs; Managing Director Europe, Advanced Clinical
