In the News

Kathleen Mandziuk, Vice President of eClinical Development & Delivery, offers insights on the persistent challenges of patient recruitment, the revolutionary role of AI and digital tools, and the critical importance of diversity and inclusion.

Clinical trial protocols are becoming increasingly complex, with more endpoints and procedures across trial phases and therapeutic areas. ICON experts discuss how protocol optimisation can simplify trial design, accelerate study timelines and drive better outcomes.

In today's healthcare landscape, data is a powerful tool for driving informed decisions, enhancing patient care, and shaping strategic business outcomes. However, the real value of healthcare data lies not just in its availability but in its transparency, understanding its origins, methodologies and context. Without clarity, decision-makers risk relying on incomplete or misleading information.

In the February edition of TOPRA's Regulatory Rapporteur, ICON summarises the European legislation related to Regulation (EC) 1901/2006 and how it incorporates PIPs but omits the unborn foetus. We also review the guidelines and other application precedents while providing insight into distinctions that may be made by the agency in this matter, as well as highlighting relevant precedents which were identified during this peer reviewed article.

Rare disease N of 1 studies offer patients the hope of finding a personalised, effective treatment. ICON experts discuss the challenges, solutions and promise of these unique trials in this PharmaTimes article.

For sponsors considering how to most efficiently and effectively allocate resources, innovative trial designs offer advantages. In early phase trials—specifically, phase I and II trials involving safety, dosing, and proof of concept—innovative designs offer potential for improvements in efficiency and decision-making, as well as lowering costs. Innovative trial designs, such as adaptive trials, Bayesian methodologies and master protocols, can be utilised to add value when used in early phases.

It would seem intuitive that in order to pass a clinical trial and be compliant with EU MDR/IVDR, the trial data would need to conform to the processes and rules set out by the Notified Bodies. Surprisingly, in practice this is not always the case. Learn more about potential pitfalls and how to mitigate against them.

Medical interventions increasingly involve the use of technology and devices. New treatments may involve a medical device, combination product or in vitro diagnostic device. For sponsors this means their studies have additional regulatory requirements to meet, each on very distinct submission pathways. Read the full article.

As the cost of developing new therapies continues to rise, pharma executives must turn to technologies that drive better insights into de-risked investments and produce operational efficiencies. AI-powered digital measures are being developed and validated to better define disease, patients, and drug efficacy.

At first glance, translating clinical outcome assessments (COAs) from their original language to other languages appears to be no more complicated than other trial planning elements. However, as scientific instruments, the process is much more complex. COA translation needs to consider conceptual equivalency and cultural relevance.