In recent years, sponsors have turned to emerging markets to include in their clinical trials. Attractions are numerous. Many of these countries have well-developed healthcare systems with reasonable facilities. For sponsors, there is a large potential patient pool because clinical research is relatively new to many of the patient populations in those countries. This is an attractive solution to the saturation that has been observed in developed markets. Lastly, but just as important in a world ruled by economics, the fact that it is much cheaper to conduct clinical trials in developing countries is a strong argument to bring trials to those regions.
However, these opportunities are not without challenges. What do sponsors and researchers unfamiliar with the region need to know?
The most significant lesson is that there are differences between doing research in the MENA countries compared to the more traditional markets in Western countries. In fact, this sets the scene for all that is to follow. Having said that, it is also important to be aware of the huge diversity among these countries, so what applies in one country will not necessarily be applicable in another.
The first hurdle is obtaining approval for the research, namely Ethics approval and Regulatory approval. Timelines need to be established for each. If it is a multicenter study, does one Ethics Committee cover all the included sites or should there be multiple applications to different Ethics Committees? Should applications to Ethics Committees and regulatory authorities be made in parallel or in succession? What documents are required for each?
Translations of documents, such as participant information sheets, informed consent forms and questionnaires are often another holdup. In some cases, the need for translations is overlooked altogether. Despite the knowledge that many of the participants will likely be non-English speakers, it is not uncommon for applications to be made for review with English-only versions. In many other cases, the sponsor does go to the trouble of having the documents translated by a legal translator or by some other means. Nevertheless, the translated documents are often full off complicated words or awkward phrases that are difficult to understand, don’t flow or even make sense.
It is therefore prudent for the investigator to thoroughly review translated documents. If he is not familiar with the language, he needs to work with someone reliable who is. Submissions for approvals should only be allowed to proceed once he is confident that the translated document complies with guidelines and actually fulfills its purpose.
Do you want to improve research productivity? Have you been struggling to fulfill your research goals? Understand what the 7 main challenges are and how you can overcome them.