Clinical research is going global. This growth translates to sponsors no longer running separate studies in each and every country they are seeking marketing approval; instead they are opting for large, global studies that have percentages of the required subjects in each venue they desire for marketing approval. A major benefit of these global studies is streamlining the clinical part of drug development, allowing sponsors to make their breakthrough therapies available to more people around the world in a shorter period of time. However, these studies also present some challenges that sponsors are forced to address earlier in the clinical process due to the global nature of this landscape. Below are three common challenges and potential mitigation strategies that can be implemented to ensure a global study is optimized for success.
One of the most conspicuous differences from venue to venue is what languages are commonly spoken and the prevalence of a globally accepted language. Many countries have adopted English within the science and the healthcare industry, meaning doctors and medical staff will be able to operate in English; however, this is more often not the case for the study subjects. Per the ICH/GCP regulations, any documents presented to the subject must be written in a language which is understandable to the subject, starting with informed consent. Special attention should be paid to patient reported outcomes, which will also require advance translation into the common language. In addition, if the study requires use of a specific assessment as an endpoint, the challenge of whether the scale has been previously translated and validated in the required languages arises. Many sponsors choose endpoint assessments based on proof of efficacy, not based on which regulatory authorities will provide marking authorization. Therefore, translation and validation of assessments is required if not already available in the required languages. Furthermore, if addressed too late, this lack of validation can result in a major delay of study initiation or rethinking the global execution strategy to exclude the countries where a validation would be required. In order to avoid a delay in study start up, it is imperative to recognize this challenge and address it during the study design and planning period. During this period, there is ample time to determine whether translation and validation is required and begin the process well before the study is initiated, resulting in smoother global study execution.
Standard of Care
The healthcare industry is moving towards global standardization, however it is still the case that some therapies and treatment paths are not available in many countries which results in a discrepancy in the standard of medical care across the world. This holds especially true for oncology and neurology disorders, where an established cure has not been discovered and individualized treatment may be required. For a sponsor planning to run a global oncology study in a number of different venues around the world, it is of utmost importance to assess this challenge early on. They must decide if they will choose venues that meet their standard of care requirements or if they will establish the standard of care for their specific study in all venues desired. If they decide to establish the standard of care, the sponsor must provide the necessary therapies/tools needed to accomplish this.
Global vendor availability
Almost all clinical studies will utilize at least one third party vendor for services such as laboratory processing, drug packaging, distribution to sites in each venue, etc. Many times this does not present a challenge; however, with a large, multi-venue study, the logistics of utilizing certain vendors may prove more complicated than anticipated. This is commonly the case in clinical studies that require specific laboratory procedures for certain indications or large molecule and cell-based therapies that can require very specific transportation and storage equipment. In these situations, utilizing a reputable, global vendor provides the most streamlined option, however it is common that one may not be available. Again, it is integral to recognize this need early on during study planning to ensure that there is no delay in study initiation or execution. This planning may require optimization strategies such as sites storing batches of lab samples to allow for less shipments to the specific lab, special packaging and carrier services for biological therapies that must be maintained at constant lower temperatures, or providing specific equipment directly to the sites for certain preparation protocols. Strategies such as these, when implemented at the beginning of a clinical study, will facilitate smooth initiation and execution, absent of major time delays due to vendors being unable to accommodate the venues planned for the study.
The move towards global clinical research is an exciting and positive transition, however it is not without its own specific set of challenges. In all of the challenges presented above, the common recommended theme is a robust planning period where all possible risks to successful study completion are workshopped to identify specific challenges and develop strategies to overcome them. A strong project plan sets any global clinical study up for success, allowing sponsors to streamline their clinical development to bring therapies to the global market as fast as possible.