Clinical trials are instrumental in advancing medical research and improving patient care, while also being crucial in guiding future drug development initiatives. Because they are so important, it is essential that clinical trial processes are dynamic and adaptable — allowing them to keep up with the fast-paced pharmaceutical industry.
In recent years, advancements in technology, regulatory shifts and a growing focus on the needs and experiences of patients have been the main driving forces behind the changes to clinical trials that are currently being observed. The COVID-19 pandemic has also significantly accelerated these trends, while simultaneously demonstrating the remarkable potential of the industry to get drugs to market rapidly.
While these changes have reshaped the conduct, regulation and perception of clinical trials, the industry must remain aware of the challenges associated with them. It also must endeavour to build on the successes achieved during the COVID-19 pandemic; these advancements have the potential tp set the stage for significant advancements in the future.
To explore the world of clinical trials further, Dr Danial Arkwell, Head of Global Key Accounts, Pharma and Diane Onken, the Head of Sales in the Americas for Envirotainer, explore the current trends shaping today’s clinical trials, as well as delving into their future.
Data collated from health records, insurance claims and wearable devices offer valuable insights into how patients respond to treatments
Current trends in clinical trials
There have been a number of recent developments in the clinical trial space, including:
- Real-world evidence: Data collated from health records, insurance claims and wearable devices can allow those in charge of clinical trials valuable insights into how patients respond to treatments, as well as a therapeutic’s efficacy and safety in this setting.
- Decentralised/remote trials: Virtual or at-home trials can allow participants to contribute to studies from the comfort of their own home, which eliminates the need for travel and its associated costs. It also has the ability to increase patient participation and study effectiveness.
- Patient-centricity: Regulatory agencies and sponsors now actively involve patients in the trial design process to align research with their needs and preferences. This enhances the relevance of trials and improve patient recruitment and retention.
Regulatory updates globally
The regulatory aspect of clinical trials is continually evolving, and countries around the world are adapting their rules regularly. In India, the Ministry of Health and Family Welfare updated the New Drugs and Clinical Trials Rules back in 2019 — which set new time limits for responses to clinical trial applications, making the regulatory process simpler and more efficient.
More recently, in the US, the FDA released a ‘Good Clinical Practise’ draft guidance in June 2023, which encourages innovation and quality in clinical trials, while supporting the use of digital health technologies like wearable sensors to improve the efficiency of data collection.
Meanwhile, the European Union implemented its new Clinical Trials Regulation in early 2023. This initiative simplifies the approval processes, harmonises trial designs and establishes a single portal for trial submissions across member states. These changes Ian to reduce the burdens on administrative staff and increase the competitiveness of EU clinical research.
Regulatory changes ... worldwide reflect a global effort to make clinical trials more efficient and patient-focused
The UK has also introduced new measures. In October 2023, the Medicines and Healthcare Products Regulatory Agency announced a more streamlined and flexible framework for the approval of clinical trials. This latest update to the UK regulations supports diverse trial designs, including decentralised models, and aims to accelerate the approval process without compromising on safety.
The regulatory changes that can be observed worldwide reflect a global effort to make clinical trials more efficient and patient-focused. Moving forward, we can expect regulatory agencies to collaborate with the pharmaceutical industry even more closely to
adopt more flexible approaches. This will improve the clinical trial landscape and enable faster responses to emerging health crises.
For example, during a sudden outbreak of a new disease, regulatory bodies can expedite the trial approval process for promising treatments; this would allow for faster deployment of essential medications while still maintaining health and safety standards.
What the future holds
As the clinical trial landscape continues to grow and change, several key trends will likely shape the industry’s future. One major advancement will be the integration of optimised technologies for data analysis. Artificial intelligence (AI) and machine learning are both already used in clinical trial data handling, though future developments in this technology will advance this even further.
Predictive modelling, data mining and real-time monitoring are enabling researchers to develop more efficient trial designs, select suitable patients better and identify safety concerns early. These techniques can analyse patient data and use it to predict which individuals are most likely to benefit from a treatment, allowing trials to target specific, relevant patient populations. Technologies such as AI can also reduce the costs associated with data administration, as well as accelerate the time to market for new drugs.
Clinical trials from a logistics perspective
The rise of decentralised and remote trials will encourage more patients to enrol in clinical trials, but to keep up with the demand for medications at home, the industry must have reliable cold chain logistics backing it. With the support of this service, virtual check-ins with healthcare providers and clear regulations, more people will be able to access pivotal studies, leading to better overall outcomes.
Clinical trials will also have to be adapted to consider individual genetic profiles and treatment responses. This will mostly be driven by advancements in the field of genomics and biomarker discovery, which is paving the way for targeted therapies. For instance, a trial looking into the efficacy and safety of a cancer treatment may stratify participants based on their genetic mutations and test the new therapy on the most relevant patient groups. 
A new era for clinical trials
The world of clinical trials is hardly recognisable from what it was a decade ago. There is now a strong focus on real-world evidence, patient-centric approaches and streamlined regulatory processes. These changes have made clinical trials more efficient, user-friendly and more globally connected. The future looks even more promising with advancements in data analytics, decentralised trials, global harmonisation and the rise of personalised medicine.
With this advancement comes increasing pressure on the cold chain industry to respond to the demand for safe, secure and swift transport of medicines and clinical samples. Packaging suppliers will need to develop materials and containers that maintain the integrity and efficacy of medications during transport to patient homes and remote locations. This includes meeting stricter temperature requirements and regulations for new drugs and ensuring secure transportation systems.
This progress will result in safer and more effective treatments, reducing the time spent in the trial phase and significantly benefiting those in need. The evolution of clinical trials will not only impact pharmaceutical companies and patients, but also drive innovation across the supply chain, including packaging and logistics providers who will be continually challenged to handle increased volumes more rapidly and with reduced risk.
