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CRO Supplement 2015

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Page 23 of 51

LIFESCIENCELEADER.COM 24 THE CRO LEADERSHIP AWARDS 2015 By E. Miseta THE CHALLENGES OF PERFORMING GLOBAL TRIALS How many years' experience do you have performing trials in Eastern Europe (including Belarus, Bulgaria, Croatia, Hungary, Poland, Russia, Serbia, Ukraine)? I performed trials in this region for two years, from mid-2012 to mid-2014. Are there specific challenges to performing trials there that are due to the current political climate? Fortunately, the political climate in Eastern Europe did not have a noticeable impact on the trials that I was involved with. Minor protests and uprisings did not prevent site and CRO staff from per- forming their duties. Even during the first few months of the Crimean Crisis, patient visits, monitoring visits, and sup- ply shipments continued as scheduled. Our trials completed shortly thereafter. There is no doubt that the potential for political instability carries some risk, and that must be weighed against the potential benefits. In our case, this region was able to recruit patients very quickly. I have heard of other clinical trials in which some Ukrainian sites had to be closed due to the conflict. This risk was mitigated by the involvement of other, less volatile, regions. Getting needed medicines to patients can always be a challenge, but even more so when performing trials in different parts of the world. Were there any supply chain issues you had to deal with? Supply distribution is complex in many regions, maybe a little more so in Eastern Europe. It was helpful that our clini- cal supply production site and central warehouse was in a European Union (EU) country. This made the move- ment of material to sites in the Eastern EU countries, i.e., Bulgaria, Croatia, Hungary, and Poland, fairly easy. It was more challenging in non-EU countries of Russia, Ukraine, Belarus, and Serbia, with requirements for import licenses and permits. Each of these countries has different requirements and timelines for approving the importation of clinical supplies. After approval, the time needed to schedule and transport the supplies, as well as the courier cost, can also be significant. It was, therefore, essential that depot warehouses be established in those non-EU countries so that supplies were in country well before supplies needed to be shipped to the study sites. Employing a CRO with local regulatory expertise and a CMO with local logistics expertise was critical to our successful supply distribution. Patient recruitment and retention is a hot topic in pharma today. Was this a challenge you faced and how were you able to overcome it? Currently, there is less competition from sponsor companies for investigators and patients in these emerging mar- kets, compared to the more traditional clinical trial locations. This, combined with the large pool of treatment-naive patients, good access to healthcare infrastructure, and highly motivated investigators, made the patient recruit- ment process quite rapid. In fact, the rate of patient recruitment sometimes threatened to exceed the available drug supply, and investigators had to delay enrolling new patients into the study. This was an unexpected situation, quite opposite of my usual experience in which recruitment lags behind projection. So, the challenges were to accelerate the delivery of drug supplies and to maintain a good relationship with the investiga- tors during the delay. Patient retention and compliance was also quite good in this region. This may have been due to the indication being studied and limited access to alterna- tive treatments. Even though many patients had to travel a great distance for scheduled visits, very low dropout rates were observed. It was important to have an adequate visit window and to dispense enough extra study medication to continue treatment when visits were delayed due to weather and other travel obstacles. Were there any specific regulatory issues you had to deal with that made the conduct of trials particularly challenging in this region? The regulatory requirements for the Eastern European countries that are part of the EU are well-established and easier to navigate, although the timelines for approval of the Clinical Trial Application (CTA) can vary between member states. In some of the other countries, specifi- cally Russia, Ukraine, and Belarus, there have been recent changes in regulatory guidelines and processes. Reorganization of the Ministry of Health in Russia and changes to the ethics approval process in Ukraine initially produced some unexpected delays. But now things have adjusted, and the process is improved compared to the time before the changes were implemented. Overall, there has been an effort to decrease the difficulty of getting trials launched in this part of the world while at the same time ensur- ing the protection of human subjects and setting standards for investigational site qualification. Any thoughts on what the future of clinical trials might look like in this region? I expect the clinical trial activity in Eastern Europe will continue to increase. These countries are interested in the revenue and access to new medicines that clinical trials bring. Recent changes to the regulatory processes have made it more feasible, and often quicker, to initiate trials in this region. As spon- sor companies gain experience in these countries, realizing the benefits of a large, diverse population and becoming comfortable with the quality of investi- gational sites and clinical data, it is likely that more global trials will include this region. L ROUNDTABLE leaders

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