A qualitative investigation exploring the factors that shorten medical product timelines has identified stakeholder alignment, innovative research designs, and sustained financing as the core mechanisms driving accelerated clinical development for drugs and vaccines in Europe. Published in the journal Globalization and Health, the study analyzed semi-structured interviews with twenty-five clinical development leaders and policy experts to understand how regulatory pathways, clinical trial infrastructure, and collaborative networks operated during recent health emergencies and how those practices might inform routine clinical development. The authors conducted the inquiry against the backdrop of expedited vaccine and therapeutic responses observed during the COVID-19 pandemic and earlier outbreaks of Ebola virus disease and drug-resistant tuberculosis, where clinical phases were overlapped, regulatory reviews were expedited, and manufacturing commenced prior to formal approval.
To evaluate these dynamics systematically, the researchers executed a formal power-interest stakeholder analysis to identify key groups across the European clinical trials landscape, subsequently mapping organizations into a power-interest matrix. Using purposive sampling from high-power and high-interest sectors, the research team invited 192 specialists and secured the participation of 25 experts, representing an overall participation rate of 13 percent across four primary domains. The final interview cohort comprised six professionals from large pharmaceutical corporations, three officials from the European Medicines Agency, three representatives from national competent authorities within European Union member states, and thirteen key opinion leaders, including academic researchers in global health, bioethics specialists, and representatives from non-governmental organizations. Eighty percent of the participating experts possessed more than ten years of experience in clinical trials, 64 percent held doctoral degrees, and 36 percent were women.
Data collection involved semi-structured interviews that averaged 29 minutes in duration, with 24 conducted online and one conducted in person between April and July 2023. Audio recordings were transcribed using Amberscript and manually verified against source audio by the investigative team before undergoing thematic analysis in MAXQDA software. The research team constructed an analytical code tree structured around previously documented acceleration factors, iteratively incorporating emergent inductive codes identified across interview transcripts. Disagreements in coding were addressed through iterative consensus discussions among the authors to establish a cohesive qualitative framework. Through this inductive and deductive clustering process, the authors synthesized participant accounts into three primary themes: alignment among diverse clinical trial stakeholders, implementation of innovative research designs and operational processes, and mechanisms governing research and development financing.
Within the first major theme, stakeholder alignment emerged as an essential requirement divided into coordination, cross-sector collaboration, and proactive priority setting. Informants observed that during acute crises such as the COVID-19 outbreak, alignment between academic institutions, sovereign governments, and pharmaceutical developers rapidly intensified, enabling multi-center initiatives and swift data sharing. However, multiple specialists underscored substantial limitations in how collaboration functioned in practice, noting that while public funds subsidized early scientific development, private developers frequently retained intellectual property, patents, and manufacturing technologies rather than placing them into the public domain. Participants noted that accelerating clinical trials sustainably outside crisis periods requires establishing pre-existing research agendas, standardizing endpoints and laboratory assays, and creating dedicated review mechanisms, such as European-level research ethics committees specifically tasked with handling accelerated protocol evaluations.
The study also identified significant structural barriers that impede cross-border trial coordination across the European Union. Prominent among these obstacles was persistent disharmony across member states regarding clinical trial practices, ethical governance, and regulatory requirements. Participating experts explained that differing contract standards at individual research sites and divergent expectations between national competent authorities and ethics committees frequently hinder multi-country trials, causing situations where approval in one member state contradicts recommendations from another. Additionally, investigators recorded severe consequences stemming from the fragmentation of scientific efforts during the COVID-19 pandemic, where the absence of a central research allocation body led to an uncoordinated proliferation of underpowered, duplicate studies. These redundant trials competed for the same participant pools, strained clinical center capacity, and diluted public funding resources without generating definitive scientific findings.
Priority setting operated as another crucial dimension of stakeholder alignment, with participants illustrating how political and economic motivations dictate which health conditions receive expedited attention. The research team noted that societal anxiety regarding the macroeconomic and health disruptions of pandemics generated acute urgency among high-income nations, rapidly unlocking political willpower and institutional support. Conversely, participants highlighted pervasive inequities regarding diseases that predominantly affect low- and middle-income countries, such as tuberculosis, where limited commercial return dampens private investment and institutional urgency. Experts highlighted that while commercial developers accelerate development when compounds promise substantial market advantages or longer exclusivity periods, public health imperatives determined by agencies like the World Health Organization remain critical for legitimizing priority status for neglected conditions.
The second primary theme centered on innovative trial designs and streamlined regulatory procedures capable of compressing clinical development timelines. Participating experts highlighted the utility of adaptive platform trials, which establish a shared master protocol and common comparator arm, allowing novel therapeutic candidates to enter or exit existing trial infrastructure without requiring entirely new administrative launches. Decentralized trial models, which expanded significantly during pandemic lockdowns by removing requirements for patients to physically travel to central research sites, were similarly identified as effective mechanisms for accelerating participant recruitment. However, regulators among the interviewees cautioned that highly complex adaptive frameworks must be evaluated carefully during early scientific advice consultations to ensure that compressed protocols do not pressure authorities into accepting unverified safety profiles or compromised statistical rigor.
Streamlining administrative and assessment workflows constituted an equally critical component of procedural innovation. Experts advocated for structured pre-submission consultations involving sponsors, national competent authorities, and ethics committees to resolve protocol uncertainties before formal application filings. While accelerated assessment pathways, rolling reviews, and conditional marketing authorizations were recognized as impactful tools, specialists noted that such mechanisms are labor-intensive and difficult to sustain at crisis-level intensity during routine operations. Furthermore, participants identified significant administrative friction associated with the European Union Clinical Trials Regulation and the Clinical Trials Information System portal. Although intended to harmonize submissions across member states, the information system was characterized during its initial rollout as complex, inflexible, and burdensome for academic researchers who lack the dedicated regulatory support teams maintained by major pharmaceutical companies.
The third overarching theme characterized research financing as a foundational meta-driver directly governing clinical infrastructure, operational personnel, and trial execution speed. Informants explained that sufficient financial backing allows research teams to secure experienced clinical staff, expand physical trial facilities, and assign dedicated personnel to expedite ethics and regulatory dossiers. Industry experts articulated an operational trade-off among speed, overall cost, and experimental quality, arguing that achieving rapid timelines while upholding rigorous standards requires substantial capital expenditure. While commercial developments in non-crisis settings depend heavily on private capital and first-to-market incentives, public funding was deemed indispensable for de-risking early development, empowering academic consortia, and advancing therapies targeting poverty-related conditions that lack lucrative commercial markets.
The authors contextualized these qualitative findings by outlining methodological considerations and operational constraints associated with their inquiry. A notable limitation was the absence of representatives from the European Commission, as invited officials declined to participate, alongside a slight underrepresentation of the European Medicines Agency and national competent authorities relative to academic and industry cohorts. Furthermore, the study focused predominantly on stakeholders connected to European frameworks and infectious diseases, potentially limiting direct generalizability to non-infectious conditions or regions outside high-income jurisdictions. Concluding their analysis, the researchers emphasized that systematic acceleration of clinical development requires European policymakers to address regulatory disharmony, optimize submission platforms like the Clinical Trials Information System, and establish flexible frameworks that support adaptive designs without compromising scientific integrity or patient safety.
Subject of Research: Qualitative analysis of drivers and barriers in accelerating clinical development of drugs and vaccines in Europe
Article Title: Building a case for accelerated clinical development of drugs and vaccines – what are the driving forces?
Article References: van Eck, L. C., Pallisé Perelló, C., Evans, N., van den Hoven, M. A., Grobusch, M. P., Hermans, S. M., & de Jong, H. K. (2026). Building a case for accelerated clinical development of drugs and vaccines – what are the driving forces?. Globalization and Health, 22(1), Article 46. https://doi.org/10.1186/s12992-026-01213-z
Image Credits: AI Generated
DOI: 10.1186/s12992-026-01213-z
Keywords: clinical development, accelerated clinical trials, stakeholder alignment, adaptive platform trials, European Medicines Agency, Clinical Trials Information System, vaccine development, drug development, regulatory harmonisation, research and development financing, decentralised clinical trials, emerging infectious diseases, national competent authorities, research ethics committees, priority setting, global health policy
News Source: Courtney Benton. (November 13, 2026). Stakeholder Alignment, Adaptive Designs, and Dedicated Funding Drive Accelerated Clinical Development. Scienmag.
