linical trials rely on volunteers, and it’s important that they come from diverse backgrounds. However, it’s been documented that 85% of those who participate in clinical research are Caucasian.

mmuno-oncology (I-O) therapies provide a unique alternative for treating different cancer types. By enhancing the individual’s immune system to target and fight cancerous cells, these therapies can increase the survivorship rate for many patients. But they can also lead to a wide experience of symptoms that affect treatment tolerability.

edical and research information and terminology can be challenging to understand, even at the best of times. But for patients and their loved ones, facing a difficult health situation and considering possible research options makes sifting through technical study information an even more daunting task. As an industry, we must work toward using harmonized plain language definitions to explain clinical research. The MRCT Center together with CDISC is bringing us one step closer to that goal, with the MRCT Center’s patient-centered Clinical Research Glossary becoming a global standard.

hildren and young people have been historically excluded from participating in clinical trials to protect them from any potential harm. Considering that there are many conditions that only affect the pediatric population, the only way to study them and to investigate novel potential treatments is by designing clinical trials addressed to this targeted population.

uccesses in understanding disease biology lead to the discovery and use of complex biomarkers in drug development, characterizing patient disease and making patient care more effective. High-technology methods help address the opportunities and challenges of using complex biomarkers, most often in clinical cancer research geared toward precision medicine. These technologies are less invasive and/or provide more data than standard tissue biopsy and imaging.

he ongoing war in Ukraine is teaching us invaluable lessons about the resilience of people and the impact of such events on clinical trials and research. It also reveals opportunities to improve guidance to protect people and ensure research quality during disruptions which can also include pandemics and natural disasters. One such opportunity arises from the ongoing revision of the ICH E6 Good Clinical Practice (GCP) Guideline as this document shapes clinical trial operations.

Protecting research participants and the quality of research data are fundamental to global GCP and are key priorities for regulatory authorities, including research ethics committees. The local regulatory authority in Ukraine is collaborating with regulatory and health authorities such as the European Medicines Agency and the World Health Organization to identify solutions to the challenges imposed by the war. These learnings may provide useful lessons for similar situations elsewhere and contribute to the evolution of regulatory and clinical trial practice.

aintaining quality and ensuring participant protection in clinical trials during wartime takes incredible effort and coordination. The ongoing war places unprecedented pressure on the healthcare system and clinical trials in Western Ukraine, and on patients, who need to find ways to continue treatment in their own country or find treatment in another country and then travel there. Investigators and sites coordinated activities to maintain good clinical practice (GCP) as the war in Ukraine began, ensuring continuity of research and care and providing lessons for future clinical trial and research conduct during disruptions such as war.

t is clear that good health is not possible without access to medical products, which are in this context considered to be instruments for public health, and that clinical trials are an integral and essential part of the overall product development process.

efore the war, the field of clinical trials had developed steadily in Ukraine, framed in a strict legal framework oriented to the legislation of the European Union and based on the Declaration of Helsinki, ICH GCP, and EU Directive 2001/20 (the Clinical Trials Directive). The State Expert Center regularly conducted clinical trials inspections, and its inspectors took part in EU GCP Inspectors Working Group Workshops and participated as observers in EMA, FDA, and PMDA inspections.

nsuring the safety of research participants during times of war is unique to the situation of each individual participant and must consider multiple aspects of each individual and the situation they are in.

he COVID-19 pandemic highlighted the need for new ways of thinking about delivering regulatory effectiveness and efficiency, and for flexibility from all stakeholders to ensure that therapies continued to reach patients in a timely manner.

Most countries in the Middle East already had priority or expedited pathways prior to the pandemic. These pathways delivered shorter assessment timelines and demonstrated the usefulness of regulatory reliance during the global emergency. Jordan, Saudi Arabia, Bahrain, and Egypt created guidelines for Emergency Use Authorizations (EUA) for vaccine or therapeutic product use, as well.

IA’s Study Endpoints, Statistics & Data Science, and Clinical Research Communities have formed a Meaningful Change Working Group which aims to help sponsors calculate “meaningful change thresholds” for their clinical trial endpoints, to supplement traditional statistical tests and improve the interpretability of trial data.