Advancing Clinical Research in Turkey, North Africa, and the Middle East, Istanbul, Turkey, 23 -24, Sept. 2010.
This conference gathered together individuals from industry (pharmaceutical companies, contract research organizations (CROs), Ministries of Health, and members of the research staff to discuss what is needed to advance clinical trials in Turkey, North Africa, and the Middle East. Featured speakers included Tamar Hifnawy, Isabelle Nakhla, and Nihal El-Hibachi. Individuals from CROs discussed several issues that need to be addressed in order to advance the conduct of clinical trials in the region. These included Quality, Timelines, and Patients. Regarding quality, pharmaceutical companies need assurances that clinical trials will produce quality data and advance the safety of the participants. Essentially, clinical sites and its investigators and research staff need to have adequate training in Good Clinical Practice. Regarding timelines, a clinical trial needs to be up and running within six months after receiving a protocol from a CRO. Major issues that would affect this timeline would include the time it takes to obtain approval from the research ethics committee, Ministry of Health, and customs officials to received the necessary supplies to conduct the clinical trial. Finally, patients need to understand the nature of clinical trials and how they differ from medical care and they need to trust the research enterprise in order for them to feel comfortable in giving their permission to enroll in clinical trials.
Individuals from the Ministries of Health and regulatory bodies discussed the need for the training of the research ethics committees and members of the research staff. There was much discussion regarding how to offer training in Good Clinical Practice and the mechanisms of certifying individuals to conduct clinical trials. Also discussed was the nature of these courses (eg., face-to-face or online) and the existence of such courses in Arabic so that members of the research staff can take such courses.
Finally, investigators discussed their need for human resources and capital equipment to develop functioning clinical trial sites and who could help fund such sites. Individuals from CROs said they would be willing to make the investment to help develop clinical sites, but there needs to be support and committment from top officials to conduct clinical trials.
The conference was successful in gathering together important stakeholders from the different regions to discuss the above issues and also to discuss experiences of different individuals from the different regions. By the conclusion of the two-day meeting, there was a general feeling of optimism that there was much support from the regulatory bodies and enthusiasm from pharmaceutical companies, CROs, and investigators that the conduct of clinical trials can be successful in this region.