The recent geopolitical developments in Ukraine have seriously influenced the conditions and the environment for clinical trials in Ukraine and in Russia.
The recent geopolitical developments in Ukraine have seriously influenced the conditions and the environment for clinical trials in Ukraine and in Russia.
In a webinar today, Natalia Fetkovska, Senior Partner at SanaClis, a CRO providing clinical trial services for Central and Eastern Europe (CEE), highlighted the problems.
Ukraine’s proportion of CEE clinical trials has grown over the past two years and now lags only behind Poland and Russia. But on May 12, the Ukraine Minister of Health instructed that no new studies would be approved for Crimea or Sevastopol (a city on the Crimean peninsula, with separate municipal powers from Crimea) and that recruitment of new patients into current studies should also cease.
Fetkovska suggested however that while some sponsors have suspended recruitment in Eastern Ukraine, they should still consider Ukraine for their trials. She noted that the investigator and patient population was more than willing to participate in clinical trials because they are feeling the economic impact of sanctions.
To minimize risks for conducting trials in the Ukraine, Fetkovska recommended:
• Avoid Crimea for new studies.
• Avoid sites in the critical cities of Eastern Ukraine, such as Luhansk, and Donetsk.
• Check logistic partners to make sure they are not sanctioned.
• Check site payments to make sure the banks are not sanctioned.
• Check the IT reliability of local partners, cloud-based solutions could or could not be positive based on regulatory concerns.
The Weight-Loss Gold Rush: Legal and Regulatory Implications
July 11th 2024Jim Shehan, chair of the FDA Regulatory practice, Lowenstein Sandler, discusses how the FDA and other regulators likely to respond to the increased public interest and potential off-label use of GLP-1 drugs, what needs to be done for GLP-1s to be covered, advice for investors and financiers considering entering the weight-loss medication market and more.
Healthcare Marketing Strategies for Reaching Diverse Audiences
May 14th 2024Amanda Powers-Han, Chief Marketing Officer, Greater Than One, and Pharmaceutical Executive Editorial Advisory Board member, discusses how improved DE&I in healthcare marketing strategies can not only reach diverse audiences more effectively but also contribute to improved patient care outcomes, challenges faced in crafting culturally sensitive messages, and much more.