Ethical Cultures to Maintain High Quality in Clinical Trials in CEE

The biopharmaceutical industry is becoming increasingly globalized and facing heightened demand for new treatments of diseases. Eastern European countries provide higher patient recruitment opportunities, higher incidence of certain diseases, and a greater number of treatment naïve patients according to Outsourcing-Pharma (2006). Slower patient enrollment and start-up times are challenging U.S.-based pharma companies to globalize and complete more trials overseas, especially in emerging markets such as Central Eastern Europe (CEE). Some of the challenges facing CROs today are not much different than they were 20 years ago, however; it is important to establish a value-based, ethical culture to maintain high quality in clinical trials in CEE.

In 1992, Eastern Europe countries had no consistent guidelines, and some countries even had no ethical committees or standards to speak of, but investigators were eager to participate in international research projects and capacity was not an issue. However, investigators in Germany were well educated and experienced but no longer interested in participating in clinical trials. This was due to a variety of reasons; most were overworked and frustrated at the increasing misconduct and decreasing quality in clinical trials. The industry was also frustrated and pushing to find new markets. The environment in CEE countries was not yet developed for clinical trials; there were only some local CROs, but some of them were known to work without legal licenses and bribed authorities to look the other way. Investigators often were not paid; staff was hired for a project, not trained, and then fired after the project was finished.

It became very clear that CEE countries would need to implement ethical principles in order to guarantee legal, fair, sustainable, and high-quality business practices. German practices would need to be implemented in these countries. A stable work environment needed to be created for employees and investigators, so ultimately clients would feel safe doing business in these countries.

The first step to creating ethical principles is to hire only local people who are established in the area in order to reduce employee turnover. It is good to chose individuals that are not in the industry and haven’t been corrupted in any way from working at other institutions. Employees that are untouched can be trained how to conduct trials ethically from the start. It also helps to hire only fixed employees that aren’t allowed to work for other companies. In times of less work, workload can be reduced for all but no employees are terminated so employees feel safe within the company.

One of the first trials was in Romania at the University Hospital in the city of Brasov, Transsylvania. The investigator fee of $100.000 USD was paid to the hospital, and the following year the hospital proudly showed how they had invested the money: they had renovated a part of the hospital and equipped it with new diagnostic devices. This was something unheard of prior since before that investigator fees, if paid at all, went directly into private pockets. It showed that Western principles worked and were accepted and that the business brought into the country was of benefit to the entire country, not just some individuals.

From a business perspective, it is important to show clients that promises are kept, so they establish trust in the company and in the country. A company should always take the time to focus on quality, not profits, and establish repeat business relationships whenever possible with clients as well as with investigators. A company should remain financially conservative and only spend what is earned, not overstretching precious resources.

Intensive oversight is necessary to ensure principles are followed. It is important for key management to visit offices regularly, and attend all investigator meetings. Key staff should be intensively trained, and educated about Western values and best practices, while being respectful of the Eastern culture.

Any pharmaceutical company that wishes to initiate a trial in Eastern European countries must be aware of both the challenges and the methods that create success, and be prepared to put in the time and oversight needed to implement ethical standards.