Globalized Trials

Global clinical research provides large economic and research-based benefits.

Global clinical research refers to the practice of engaging in drug development in multiple countries. This type of research is often descriptive of research in developing countries. The practice of clinical research in this manner has created profound benefits for the companies that engage in it as well as for the countries who participate. Along with these benefits, there are also significant challenges to this form of research.

There are a number of advantages and challenges with conducting global clinical research. One of the most significant benefits for this research is the enrollment. The large sphere of enrollment allows for researchers to include populations which are often under-represented, such as developing nations (Siribaddana, 2012). This provides a large pool of applicants as well as in many cases providing aid for individuals in these countries who could otherwise not afford or obtain access to treatment (Siribaddana, 2012).

Another large benefit stemming from global research is the patient compliance. The participants in many countries that need particular medications tend to have higher compliance rates and less issues with participation (Siribaddana, 2012). This is likely due to the fact that these individuals have less access than participants in developed countries.

One of the largest benefits to global clinical research is cost. Research in developed countries faces increasingly more complex regulation and cost. Global research does not have this burden and developing countries provide a large incentive for research that would otherwise be too expensive in the developed world (Siribaddana, 2012). This benefit, is however partially to blame for some of the challenges facing global clinical research.

While global clinical research can be conducted with less regulation, it is also prone to ethical issues as well as harmonization issues. One significant problem is informed consent. In the developed world, patients who have not provided the proper information and lack informed consent are protected by the law. In Section 4.8 of the International Congress of Harmonization (ICH) Guideline for Good Clinical Practice E6(R1); informed consent is a requirement (Department of Health and Human Services, 2011). The ICH also requires that prior to a trial, the investigator must receive written approval that shows informed consent (Department of Health and Human Services, 2011).

Informed consent is also not always defined in these countries which can present ethical problems. In the US, informed consent is defined as the patient being made aware of:

· The diagnosis, if known
· The nature and purpose of a proposed treatment or procedure
· The risks and benefits of proposed treatment or procedures
· Alternatives (regardless of costs or extent covered by insurance)
· The risks and benefits of alternatives
· The risks and benefits of not receiving treatments or undergoing procedures (Temple Health, 2014).

Informed consent is not always easily obtained in this manner due to language issues as well as the fact that in some instances, the country has not adopted the ICH standards.

There is also the issue of data security. Depending on where a trial is held, may significantly impact the security of the data collected. In developing countries there are generally less laws that protect the collection and dissemination of data (Siribaddana, 2012). These laws are not always present or have the same strength as those laws in the developed world.

Conclusions

Global clinical research is emerging as a more effective method of research due to its larger and more compliant participant pools. The reduced regulation and cost also presents significant incentive for companies to develop abroad. However, as globalization continues to connect countries and cultures, these incentives may be less enticing in the future. Already the ICH is expanding into more territories and this means that regulation and practices will likely follow this trend. While cost may be lower for trials now this may change as countries develop and establish more comprehensive standards. For now, global clinical research continues to be more effective and less costly approach to drug development.

References

Department of Health and Human Services (2011) Good Clinical Practice Resource Guide Retrieved from http://www.niaid.nih.gov/labsandresources/resources/dmidclinrsrch/documents/handbook.pdf

Lang T, Siribaddana S (2012) Clinical Trials Have Gone Global: Is This a Good Thing? PLoS Med 9(6)

Temple Health (2014) A Practical Guide to Informed Consent Background: Requirements for Informed Consent Retrieved from http://www.templehealth.org/ICTOOLKIT/html/ictoolkitpage5.h