Dr Gen Li returns to the theme of how the war in Ukraine has impacted global clinical development and the further lessons that have been learned.
Prior to Russia’s invasion of Ukraine, the region was a major hub for clinical trials. And although the war has been isolated to a single region, the effect on clinical development was significant. Global data analysis from Phesi found that Ukraine’s share of global recruiting investigator sites decreased by almost two thirds in the first year after the invasion, from 1,769 in September 2021 to 670 in March 2023. Similarly, the share of investigator sites in Russia – previously one of the top 10 countries for clinical development – fell by almost two thirds, from 3,329 in September 2021 to 1,239 in March 2023.
Trends in the region meant that some diseases under investigation have been impacted more heavily. In early 2022, more than a quarter (26%) of schizophrenia trials took place in Ukraine and Russia, as well as a high proportion of gastrointestinal disease studies – including ulcerative colitis (14%) and Crohn’s Disease (10%). These disease indications have been disproportionately affected in related development programmes.
Given the ethical issues of completely stopping treatment for patients, clinicians initially directed patients to neighbouring countries, including Poland, where investigator sites increased by 10% in 2022. However, reallocation puts additional burden on patients, requiring them to travel further and resulting in a decline in recruitment.
Now is a good time to reflect on what the clinical development industry has learned during this time and where there is still room for improvement
Reallocation also poses questions around data integrity and continuity as data is transferred between sites and clinicians. As ever, protecting the wellbeing of patients in such extreme circumstances should be at the centre of all actions.
With Q1 2024 marking two years since the war started, now is a good time to reflect on what the clinical development industry has learned during this time and where there is still room for improvement.
Sponsors and trial planners must prepare for conflict, assess potential risk, and develop risk mitigation plans. This means using data from previous clinical trials to generate deeper insights into trial protocol design, target patient populations and to eliminate unnecessary practices such as placebo arms. By moving from a perception-led to a data-driven approach, sponsors can be flexible when the unexpected happens, minimising the impact of external events on patients and investigator sites.
Recent innovations in data and AI technologies can be applied to simulate trials and predict outcomes, bolstering protocols against disruption. With insights from existing data and scenario modelling, sponsors can supplement disrupted studied and close knowledge gaps to get trials over the finish line. For many trials in the later stages, there may already be enough data available to create digital twins and Digital Patient Profiles, helping get urgently needed treatments to patients faster. Finally, the most successful trial protocols will deliver a mix of in-person, decentralised and even digital trial arms, depending on the indication under study – for the best chance of success.
- Dr Gen Li is president and founder of clinical trials database leader, Phesi
