Do’s and Don’ts for Organising Clinical Trials in Russia and the Ukraine

In this interview Annegret Van der Aa, Clinical Trial Manager, Galapagos NV, shares her experience's of working in emerging markets; the main challenges that arise and approaches to overcoming them.

Pharma IQ: Changes to market conditions mean that the pharmaceutical industry is turning to Russia, what do you see as the potential challenges for the clinical trials market? 

Annegret Van der Aa: Recruitment issues in W-EU and NA due to more treatment options over the last 10 years, and patients (and Investigators) not always willing anymore to step into early phase (short term) clinical studies. Emerging markets have the benefit for the industry that treatment options there are often much more limited, despite the fact that for clinical supply import and export the processes are sometimes more complicated logistically.

Pharma IQ: What are would you say are the benefits for conducting clinical trials in Russia and Eastern European countries?

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Annegret Van der Aa: Impressive recruitment rates, dedicated clinical research personnel and very motivated patients to generate high-quality data 

Pharma IQ: What would be your do’s and don’t for organising clinical trials in Russia and the Ukraine?

Annegret Van der Aa: Based on latest info locally, Ukraine is much more recommended for fast start up iso Russia due to extended regulatory approval timelines. Make sure that all logistic partners in study can also cover more ‘remote’ areas where sites are located. Make sure that all involved study personnel is properly trained in the study. Guarantee to have local experts involved knowing all the ins and outs and recent evolutions in the field at all levels of your study. Have a study team with experience in the field as much as possible to interact with parties locally.
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Pharma IQ: What would be your top 5 tips for ensuring clinical trial supplies success in emerging markets?

Annegret Van der Aa:

• Make sure all docs contain exactly all info needed, and make sure that info is consistent throughout documents
• Work with local experts in order to have most up to date info on/insights in requirements
• Sufficient time for preparation, identifying best partners to work with
• Establishing good communication with all parties involved in supply chain
• Calculate some buffer time for obtaining regulatory approvals/IL in case of delays 

Pharma IQ: What are most looking forward to about the Clinical Trial Supply Europe event in February? 

Hear about experience of colleagues in the field, and learn from that for our own projects!

Interview conducted by Andrea Charles.
 

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