Guest post by Safeer Khan, Lecturer at Department of Pharmaceutical Sciences, Government College University, Lahore, Pakistan
As we move toward 2025, clinical trial regulations are undergoing significant transformation. This shift is being fueled by technological advancements, changing healthcare needs, and an increasing emphasis on transparency and patient safety. In this post, we will explore the key clinical trial regulations shaping the clinical trial landscape, the challenges professionals face, and the strategies they must adopt to navigate this ever-evolving environment.
Decentralized clinical trials (DCTs) are quickly becoming an integral part of the clinical trial landscape. DCTs provide a flexible model that allows patients to participate from the comfort of their homes, increasing accessibility, especially for those in remote or underserved areas [1]. However, navigating the legal and operational frameworks for DCTs comes with its own set of challenges, such as ensuring compliance with local regulations and protecting patient data privacy [2].
Regulatory bodies like the FDA and EMA have updated their guidelines to accommodate this shift. In the U.S., the FDA has issued specific guidance on Conducting Clinical Trials With Decentralized Elements. This guidance offers recommendations for sponsors, investigators, and other stakeholders on integrating decentralized features into clinical trials. Similarly, the EMA has also published guidelines for Facilitating Decentralised Clinical Trials in the EU. These recommendations provide an overview of national regulations for various decentralized trial components.
In response to the growing demand for quicker access to new therapies, regulatory agencies around the world are making efforts to streamline the approval processes for clinical trials. These regulatory efforts help pharmaceutical companies reduce research and development costs while ensuring that patients gain faster access to life-saving therapies.
The UK Government has unveiled its 10-Year Health Plan aimed at expediting clinical trials. This plan includes a faster trial setup process, targeting a reduction in the commercial trial setup time to 150 days or fewer by March 2026. Similarly, in the U.S., the process of FDA’s Breakthrough Therapy Designation continues to be one of the most effective methods for speeding up the approval process for critical treatments. This designation is designed to fast-track the development and review of drugs intended for serious conditions, particularly when preliminary evidence suggests the drug could provide significant improvements over existing therapies on important clinical outcomes.
In recent years, there has been increasing awareness of the importance of diversity in clinical trials [3]. Clinical trials have historically faced criticism for failing to adequately represent minority populations, resulting in therapies that may be less effective or even harmful to these groups [4].
As we approach 2025, regulators are placing a stronger emphasis on ensuring that clinical trials are more inclusive, with a focus on gender, race, ethnicity, and age. The FDA has introduced initiatives to encourage researchers to diversify patient populations, particularly for diseases that disproportionately impact minority groups. The FDA’s Diversity in Clinical Trials initiative promotes the inclusion of underrepresented communities by urging sponsors to implement more inclusive recruitment practices [5]. This also involves addressing the social and economic barriers that prevent certain groups from participating in clinical trials.
Real-world evidence (RWE) is becoming an increasingly important resource for regulatory decision-making [6]. A study published in the Journal of Clinical Pharmacology highlighted that between fiscal years 2020 and 2022, the FDA approved five drugs and biologics based, in part, on RWE to demonstrate their effectiveness [7].
By 2025, RWE is expected to play an even more significant role in clinical trials, contributing to the development of more adaptive trial designs that incorporate data from broader and more diverse patient populations. The FDA is advancing this shift through its Advancing Real-World Evidence (RWE) Program, aimed at improving the quality and acceptance of RWE-based approaches. Similarly, the European Medicines Agency (EMA) is increasingly leveraging RWE to support drug approvals. By integrating data from real-world sources, such as patient records and registries, RWE complements traditional clinical trial data, enabling the EMA to evaluate medicines more efficiently while maintaining stringent safety and efficacy standards [8].
One of the biggest challenges for clinical trial professionals is keeping up with the fast-changing regulatory environment. With guidelines frequently being updated, the pressure to remain compliant can be overwhelming, particularly for smaller research organizations that may have limited resources.
The integration of new technologies into clinical trials holds great promise but also demands careful navigation within current regulatory frameworks. Innovations such as artificial intelligence (AI), machine learning, and blockchain have the potential to transform clinical trials by enhancing efficiency and data security. Read more about: AI in Clinical Trials in 2025. However, these technologies must be implemented in ways that comply with established regulations to ensure safety and integrity.
As each country has its own set of regulatory requirements, and therefore conducting clinical trials across multiple countries introduces additional regulatory challenges. These discrepancies can lead to delays, higher costs, and difficulties in data collection, making multinational trials more complex to manage.
Given that each country has its own regulatory requirements, conducting clinical trials across multiple nations introduces additional challenges. These discrepancies can result in delays, increased costs, and complications in data collection, making multinational trials more difficult to manage.
Regular training and continuing education programs are crucial to ensure that research teams are equipped to handle the complexities of new regulations. As such, it is essential for clinical trial professionals to stay updated with the latest regulatory developments
Regulatory affairs specialists are experts who provide crucial insights into how new guidelines may impact trial designs and assist with interpreting complex regulations. Therefore, collaborating with these experts ensures compliance, helps address potential challenges early, and facilitates the smooth execution of clinical trials.
Investing in compliance management systems helps streamline adherence to regulations. These systems should include features such as automated reporting, document tracking, and data validation to ensure ongoing compliance with evolving guidelines.
Adaptive trial designs, including Bayesian models and platform trials, offer flexibility to adjust based on emerging data [9]. This adaptability is especially valuable in the face of evolving regulations, allowing trials to conform to new guidelines without beginning from scratch. Read more about: What is Adaptive Clinical Study Design.
Engaging stakeholders early in the trial planning process helps identify potential regulatory challenges ahead of time. Maintaining open communication with regulatory agencies, ethics committees, and other key stakeholders ensures that trials proceed smoothly and efficiently.
As clinical trial regulations evolve in 2025, professionals in the field will encounter both challenges and opportunities. Staying informed, adapting to these changes, and implementing effective strategies will be crucial for the successful execution of trials. Despite the challenges, the continuous evolution of regulations promises to foster more innovative, efficient, and patient-centric clinical trials, ultimately speeding up the development of life-saving therapies and improving global healthcare outcomes.
Underhill, C., et al., Decentralized Clinical Trials as a New Paradigm of Trial Delivery to Improve Equity of Access. Jama Oncology, 2024. 10(4): p. 526.
Apostolaros, M., et al., Legal, regulatory, and practical issues to consider when adopting decentralized clinical trials: recommendations from the clinical trials transformation initiative. Therapeutic innovation & regulatory science, 2020. 54: p. 779-787.
Mohan, S.V. and J. Freedman, A review of the evolving landscape of inclusive research and improved clinical trial access. Clinical Pharmacology & Therapeutics, 2023. 113(3): p. 518-527.
National Academies of Sciences, E. and Medicine, Improving representation in clinical trials and research: building research equity for women and underrepresented groups. 2022.
Adashi, E.Y. and I.G. Cohen, The FDA initiative to assure racial and ethnic diversity in clinical trials. The Journal of the American Board of Family Medicine, 2023. 36(2): p. 366-368.
Dang, A., _Real-world evidence: a primer. Pharmaceutical medicine, 2023. 37(1): p. 25-36.
Innes, G.K., et al., Real‐World Evidence in New Drug and Biologics License Application Approvals During Fiscal Years 2020–2022. Clinical Pharmacology & Therapeutics, 2025. 118(1): p. 85-89.
Bakker, E., et al., Contribution of real‐world evidence in European medicines Agency’s regulatory decision making. Clinical Pharmacology & Therapeutics, 2023. 113(1): p. 135-151.
Kaizer, A.M., et al., _Recent innovations in adaptive trial designs: a review of design opportunities in translational research. Journal of Clinical and Translational Science, 2023. 7(1): p. e125.
Thomas Wood has recently joined the Clinical Trial Files podcast with Karin Avila and Taymeyah Al-Toubah, discussing the inception of the Clinical Trial Risk Tool, what impact AI can make in clinical trials, and what Alan Turing would make of it all. This is an episode dedicated to Alan Turing’s 113th birthday on 23 June 2025. You can find the episode on Spotify Apple Podcasts Amazon Music Podcast Index Fountain Podcast Addict Podverse.
Guest post by Youssef Soliman, medical student at Assiut University and biostatistician Before launching a clinical study, even the most promising idea must be vetted for feasibility. In other words, can this trial be executed successfully in the real world? Feasibility assessments examine practical factors like available patients, site capabilities, timelines, and budget. This step is crucial. A majority of trials encounter delays or enrollment shortfalls (by some estimates, 70–80% of trials) [1], driving up costs and risking failure.
Risk assessment is a critical process in clinical trials that involves thorough and systematic evaluation of potential risks to the study volunteers, biases affecting the results and data integrity/protection. The process requires the use of risk assessment forms to identify, evaluate, and mitigate risks and ensure patient safety and data integrity.[1] The scope of this article is to discuss whether the utilization of clinical trial assessment templates is worth the time of the study sponsors/investigators.
