Sponsors are increasingly seeking emerging areas to conduct clinical trials for new patient pools and better recruitment. However, successful implementation of these trials in areas such as South East Asia requires operational strategies that circumvents the inherent diversity of these regions. In these regions, language, culture, infrastructure and resources are very different from country to country.
George Clinical was recently contracted to perform a feasibility program for an Israeli sponsor which evaluated the possibility of conducting a clinical trial in an orphan disease. A large geographical area must often be surveyed in order to obtain reliable data for a clinical trial feasibility. This article discusses how the project team adapted to the diversity they encountered in the region.
Malaysia does not have diplomatic ties with Israel and restricts business with Israeli entities. Potential Principal Investigators (PIs) from public hospitals were also concerned that the study drug would be imported from Israel.
George Clinical worked with Clinical Research Malaysia (CRM) to facilitate the feasibility process. CRM is a government organisation that supports clinical trials at Malaysian sites by acting as a clinical research centre or site management organization. Upon advice from the CRM legal team, the jurisdiction of the contract was amended to Malaysia and the signatory party was changed to the sponsor’s US entity. The project team also sought details on the manufacture of the study drug and clarified that it was manufactured in US and Germany. These actions relieved the concerns of the PIs and as a result, many sites completed the feasibility survey. The involvement of CRM sped up the process considerably.
Similar to Malaysia, Indonesia does not have diplomatic ties with Israel as well, and the project team was able to apply the solution of using the sponsor’s US entity as the signatory party. However, unlike Malaysia and many other South East Asian countries, Indonesian PIs typically prefer face to face feasibility visits rather than phone or e-mail communication. PIs in Indonesia also require more support to be involved in research as there is less infrastructure available in Indonesia to do so. For example, Indonesia lacks clinical research centres or site management organizations that can facilitate the process at public hospitals.
The George Clinical team has an experienced Indonesian CRA that can navigate the local language and culture in Indonesia – however due to the requirement for face to face visits, this has delayed the feasibility process compared to other countries. Although Indonesia has the largest population in South East Asia, the lack of infrastructure creates an environment that does not support clinical research, hence the pool of engaged Investigators can be smaller.
The Philippines also lacks a central clinical research centre or investigator database that facilitated the identification of Investigators capable of implementing a trial in this orphan disease area. However, through George Clinical’s existing database, George Clinical was able to obtain referrals for other potential Investigators.
In general, Investigators in the Philippines are very interested to conduct clinical research, but have limited time available to fit in administration during their normal routine. The project team found that Investigators in the Philippines were happy to communicate during the weekends when they did not have clinic responsibilities, and that it was the best way to get in touch with them. George Clinical was successful in completing many feasibility forms in the Philippines for this project.
As clinical trials focus on emerging regions, project teams have to be able to navigate local culture and language, and be quickly adaptable to different levels of resources and infrastructure that may be present in each country. Having on the ground presence is key, and so is clear and continuous communication with the global team and the sponsor, in order for local country issues to be quickly resolved. Close collaboration with local stakeholders, such as CRM in Malaysia, is also important to facilitate the process.