Several factors affect clinical trial success, such as patient recruitment and retention, protocol design and compliance, study duration, and high-quality partnerships between sponsors and non-industry collaborators1. But success can also rely on other circumstances like political decisions, technological advances and financial uncertainties. So far this year, we have witnessed several announcements that could have a major impact on the clinical trials market and our global health overall. Kate Shaw, Innovative Trials’ CEO, sets out her thoughts on the opportunities and challenges of the year ahead and how Innovative Trials will navigate this landscape to continue supporting its clients. The process of bringing a new therapeutic to market is never easy. A recent study calculated the median cost of successful drug development to be USD$879.3 million2. The COVID-19 pandemic and its lingering after-effects of weaker drug development pipelines, delays between trial phases and ongoing clinical trial patient recruitment challenges have only added to the financial burden. As the sector continues to recover from the pandemic, change is also in the air. From new governments and their vision for clinical research to new technologies and initiatives to make clinical trials more streamlined and inclusive. We know it is likely to be an uncertain time for the pharmaceutical industry now and for several years to come as we grapple with all these factors, but this uncertainty also presents opportunities to build trust with the public, and streamline the drug development process to give more patients faster access to new therapeutics.

The global political landscape and its implications for clinical trials

President’s Trump inauguration at the beginning of the year has brought with it uncertainties in healthcare and potentially for clinical research too. The president’s decision to remove the US from the World Health Organization (WHO), for example, may have the unintended consequence of making global collaboration in clinical research more difficult. We will need to see how this plays out, especially as the US isn’t due to officially leave until 2026, but it will mean that the US is no longer part of an international network with the potential to work together to discover new treatments more quickly. Domestically, President Trump’s federal funding freeze could have a significant impact on cancer research, as well as other sectors. This action, currently under review by the US judicial system3, could be potentially devastating for patients, especially if it becomes a long-term measure. As the new administration seeks to ‘Make America Healthy Again’, we will be watching closely for any new developments that may affect the clinical trials market. It is also widely recognized that US Health Secretary Robert F Kennedy Jr. has been a vocal critic of vaccines, particularly those developed for COVID-19. He has even repeated the dangerous myth that they cause autism as recently as 20234. This highlights the importance of robust science – something Kennedy says he supports – and the need to tackle misinformation and disinformation. Meanwhile, the UK is taking action to realize its vision of leading the world in clinical trials. This was kickstarted by the previous Conservative government, which commissioned an independent review led by Lord O’Shaughnessy into commercial clinical trials.

The current Labour government has taken up the mantle and, just before Christmas, proposed amendments to the Medicines for Human Use (Clinical Trials) Regulations 2004 were laid before Parliament5. These updated regulations will likely come into force next year, 2026, and aim to create a more flexible, transparent and streamlined approach to clinical trials that should accelerate patient access to innovative new treatments.

At Innovative Trials, we are particularly pleased to see a commitment to:

  • ensuring clinical trials are designed around the needs of patients
  • moving away from a one-size-fits-all mindset, to enable and respond to greater innovation 
  • introducing a more streamlined approach to accelerate clinical trial applications without compromising on safety
  • increasing public transparency, which should boost trust in science and the clinical trial process. 

Increasing diversity in clinical trials

In the US, it looks likely that the FDA’s Diversity Action Plans should be finalized this year with final guidance expected in the summer. Once published, these plans will reinforce the need for pharmaceutical companies to ensure underrepresented patient populations are included in clinical trials. Historically, women, older people, those who are disabled and people from ethnic minority communities have been neglected when recruiting for clinical trials. We hope the introduction of these Diversity Action Plans will ensure all relevant patient populations are meaningfully included. Diversity and inclusion in clinical trials are issues that we at Innovative Trials have been passionate about since day one. Ensuring equitable access to new treatments for all eligible patients will improve data collection, inform dosage recommendations, and ultimately decide if the drug is worthy of a marketing authorization. To this end, we work closely with our clients in a variety of ways at all stages of clinical trial design and implementation to improve patient diversity in clinical trials. 

Find out how we boosted patient recruitment for a Phase III study by targeting diverse communities.

Artificial intelligence (AI) in clinical trials

AI is making strides in streamlining and accelerating drug development and clinical trial patient recruitment and retention. Algorithms facilitate faster data analyses and patient identification, technology automation can help ease the typically heavy workload of research staff, and the use of AI-powered chatbots has the potential to engage with both potential and enrolled clinical trial participants. The speed at which AI is progressing has necessitated a need for regulation. The European Union’s AI Act6, which came into force in 2024 and will be fully applicable for most AI providers and deployers by August 2026, provides a legal framework that we hope will promote the ethical development and use of AI globally. Despite the excitement and promise of AI-driven solutions, it is crucial to remember that AI cannot replace the human element, particularly when it comes to patient-facing services. At Innovative Trials, we know that patient trust and engagement are built on meaningful human interactions, and this is the ethos behind our Patient Support Center.  Sometimes, clinical trial patients and/or their families or caregivers may have questions or need support in a way that AI-powered chatbots are not able to handle effectively. Through our Patient Support Centre, which is staffed by a team of real, in-country people, we offer direct and compassionate communication, ensuring those we speak to feel valued and supported throughout their clinical trial journey. Through this personalized approach, our clients have benefitted from accelerated prescreening, increased patient and caregiver engagement and improved patient retention. Find out how we can do the same for your clinical studies.

How we’re helping clients navigate the clinical research landscape

In today’s complex global environment, Innovative Trials prides itself on remaining agile, proactive and confident in the work we do to support our clients in accelerating patient access to new and innovative treatments. Our comprehensive suite of services, including global 1:1 In-country Recruitment Coaching  & Site Support, and patient-centric engagement strategies like the Patient Support Center and Retention Patch Program, ensures studies meet enrollment targets and retain clinical trial patients for the duration of the study, no matter what. Now, more than ever, securing the right expertise in clinical trial patient recruitment and retention is essential to success. If your organization is looking to optimize clinical trial patient recruitment, ensure diverse patient representation in your trials and boost patient retention, contact us today.

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