According to the August issue of The Centerwatch Monthly, the number of investigators in Central and Eastern Europe who filed Form FDA 1572s last year was close to 3,000, which means investigator participation in global clinical trials conducted in the region was up 25% over the prior year’s. Sponsors and global project managers from Western countries are managing teams and investigators from this region, and it is important for them to understand the specifics of this process.
As the CEO of Eastern Europe-based contract research organization OCT, Dmitry Shaikin recommends taking into account the following practical considerations to run a successful investigator meeting in Eastern Europe.
Being an Eastern European CRO that often liaises between Western managers and Eastern European investigators, helping them communicate, we have developed an understanding of the potential bottlenecks caused by the different approaches to the same situation by people in the West and the East. We have learned to streamline communication to maximize the efficiency, shorten the timelines, and reduce the risk of mistakes.
In this article, I bring up some examples of the issues that require some additional attention based on the company’s experience in setting up investigator meetings with Eastern European investigators, and describe how we at OCT work with management teams from the West to avoid potential setbacks.
The logistical aspect for the global project manager to keep in mind is that some of the Eastern European countries are not EU or Schengen members and require visas, so the investigator meeting location should be chosen very carefully, and time for the visa arrangement should be added to the overall preparation timelines.
That said, I would still encourage those who decide on the meeting location to hold global meetings somewhere outside of Eastern Europe if the budget allows. The investigators from Eastern Europe like to travel and the chances of having a significant number of principal investigators attend is higher if the meeting is held in a “nice” location.
It is also advised that the investigators be given at least several hours of free time to do some sightseeing. Sometimes the investigators have to change two of three flights travelling to and from the meetings, so they have bitter feelings when all they do is just sit within the four walls of the meeting hall and then have to return home.
Some of the site personnel who attend the meetings travel infrequently (nurses, pharmacists, etc). They may be lost in the chaos of the airport and may not find their way to the driver who was sent to pick them up and take them to the hotel. The local hospitality teams should be picked very carefully during preparation so that all investigators arrive on time for the meeting. We also advise preparing greeting signs in the languages of the investigators. They may find the hospitality team more easily in this case. Clinical research associates may help you with the translations of the greetings.
Communicating with the investigators during the meeting
Investigators from Eastern Europe generally show good comprehension of English, but if you want to train them fully, we suggest that interpreting services be provided at the meeting and that slides be translated into their local languages, if the budget permits. The best way would be to arrange simultaneous interpreting, but meeting organizers should ask the clinical research associates to ensure that the translation is adequate. Our experience shows that the investigators learn more during the meeting this way and the meeting becomes more of a learning experience for them.
Some sponsors are also often worried when the investigators don’t ask questions during the meeting. This can be explained by the fact that the culture in Eastern European countries does not always allow people to speak up in public and most of the investigators are embarrassed to do that. To overcome this problem, I suggest that the meeting organizers encourage the investigators to ask these questions through the clinical research associates from their respective countries, who can also help with the translation if this is required.
We have highlighted some aspects of the investigator meeting arrangements that need to be taken into consideration when organizing the meeting for investigators in Eastern Europe. The trick is to pull in local teams during the planning phase of the meeting preparation to ensure that the meeting goes smoothly. The management teams from the West should keep their ears open for the advice that the local experts may give. Eastern Europe has already proved to be a good source of patients and quality data, and it still has potential. To take full advantage of it, consider getting the local experts’ advice.