Challenges in Foreign Clinical Trial Sites - Case Study Example

December 2, 2017

Foreign Clinical Trial Sites

Challenges to be Considered when Planning a Foreign Clinical Trial

Introduction

A global approach to the implementation of clinical trials offers an opportunity for an expanded scope of the research environment with such advantages as the increased probability of obtaining the required sample size and cost advantages. Challenges, however, also exist that the organization must consider when employing foreign trials. Linguistic and cultural challenges, planning factors, and site organization are some of the challenges of foreign clinical trials that the company should consider, and are discussed.

Challenges to be considered

Ethical issues identify some of the challenges that should be considered the planning and employment of a foreign clinical trial. The scope of such trials involves experiments and the need for informed consent of participants before their roles in the trials. Many challenges, however, exist that could undermine the validity of offered consent. The use of jargon in clinical trials is one of the sources of the challenge as research participants may not be aware of the meanings of such jargons (Hanharan, Sexton, Hui, Teitcher, Sugarman, London, …, Klitzman, 2015). Members of a population of study may not understand such terms as placebo and randomization. Participants, therefore, are likely to misunderstand the offered information for the provision of informed consent and the offered consent is likely to be misinformed (Hanharan, et al., 2015). As a result, the ethical requirement for informed consent may be undermined and could invalidate the applicability of the research findings. In addition, legal issues could arise from the use of participants without their valid consent. A misconception in a community that research participants in a study on AIDS would receive HIV vaccine and later receive a drug for treating the syndrome is an example of effects of the challenge. The failure to meet the misconceived expectation and the misinformed basis for consent into the study establishes the threat of ethical and legal liabilities in the implementation foreign clinical trials in vulnerable populations (Hanharan, et al., 2015).

Low level of literacy in some countries is another factor to the ethical challenge to the implementation of foreign clinical trials (Hanharan, et al., 2015). The problem is significant in all countries but is more significant in developing countries. The inability to read among people with low literacy levels means their inability to understand the provisions of an informed consent form and the inability to offer informed consent. Lengthy informed consent forms could increase the significance of the literacy challenge in understanding the provisions of informed consent forms (Hanharan, et al., 2015). An informed consent form for a population from a developed country, such as the United States, in which people have a high level of comprehension, therefore, may not be appropriate for a population from a developed country and the gap should be considered in the planning of a foreign clinical trial.

The process of obtaining informed consent also establishes challenges to the planning and implementation of foreign clinical trials. The use of oral consent could address the challenge that language barrier presents to the need for written informed consent, but the differences in regulatory environments require an understanding of regulations in the foreign country. The use of verbal consent, as a solution to the language barrier problem, may not be acceptable in some countries, such as the United States (Hanharan, et al., 2015), and the regulatory environment of the targeted foreign country should be considered. In addition, the use of third parties may be necessary for addressing the problem of language barrier (Hanharan, et al., 2015), and the associated financial implication could be a significant challenge.

Cultural difference is another challenge to the development of foreign clinical trials. Differences in the levels of collectivism could play a role in individuals’ provision of informed consent. Communities with high levels of the collectivism trait may require informed consent beyond the consent of research a participant. Family members and community leaders may need to approve a study before a person participate, irrespective of the person’s willingness and consent (Hanharan, et al., 2015). Similarly, different cultures may require different tones and approaches to obtaining consent and a lack of understanding of the culture of a target population is likely to threaten the realization of desired sample size in a foreign clinical trial.

Gaps between communities’ needs and goals of clinical trials identify another challenge to foreign clinical trials and identify with both ethical and feasibility concerns. Kamat (2014), following a content analysis of qualitative data from different sources, noted a gap between the burden of diseases in India and the clinical trials that are conducted in the country. A participant in the study by Kamat notes that the clinical trials conducted in India “mirrors the disease profile in the West” (Kamat, 2014, p. 53) while the diseases that burden the country receive little attention for clinical research. The interest of the West, in conducting foreign clinical trials in India, therefore, undermines the ethical principle of beneficence. The perception, in a country in which a trial is to be done, that foreign clinical trials have the interest of another country, while it puts participating communities at risks of adverse effects is also likely to undermine participation in foreign clinical trials.

Planning and organizational challenges, which relate to contextual differences across countries, are other challenges to foreign clinical trials (Vischer, Pfeiffer, Limacher, & Burri, 2017). Under budgeting is one of the challenges to foreign clinical trials conducted in developing countries, especially because trials’ developers in developed countries underestimate foreign research environments. The high cost of community engagement in the Sub Saharan Africa, due to poor infrastructure, is an example of causes of budget constraint as a challenge to foreign clinical trials (Vischer, et al., 2017). Unrealistic deadlines, lack of understanding of the scope of the project that could emanate from unfamiliarity with the scope of the trial, and the inability to adopt a trial to the context in a foreign country are other challenges of foreign clinical trials. Organizational challenges such as staff turnover, employment conditions, and culture that influence people’s expectations from employment also affect the implementation of foreign clinical trials are other challenges that the organization should consider in the planning and implementation of foreign clinical trials (Vischer, et al., 2017).

Conclusions

Foreign clinical trials offer an opportunity for clinical trials, which are necessary for the approval of clinical strategies, treatments, and equipment. The trials, however, face many ethical, feasibility, and organizational challenges. Gaps in the levels of literacy, with the foreign country having a lower level of literacy, undermine the ability to obtain valid informed consent from participants. The collectivist trait of a community may also require the approval of community leaders for participants’ involvement, and this determines the role of the community in the feasibility of a trial. Gaps in the research interest and needs of the targeted foreign population also identify an ethical challenge, under the ethical principle of beneficence, and could undermine feasibility of a planned trial. Inadequate planning and organizational inefficiencies, which arise from contextual differences across countries, are other challenges.

Recommendations

Significant challenges exist to the development of foreign clinical trials. An understanding of literacy levels in the targeted foreign population, and the implementation of measures for bridging literacy gaps for obtaining informed consent is recommended. An understanding of the role of communities in individuals’ decisions and an incorporation of the need for approvals of community leaders, if necessary, is also recommended. In addition, foreign clinical trials should target populations in which the targeted problem is significant, and the contextual environment of the targeted region of study should be understood and be incorporated in the planning of a foreign clinical trial.