Obstacles to Running Clinical Trials in Developing Nations

Clinical trials are necessary to find efficient and effective new diagnostic and treatment modalities to address the disproportionate burden of infectious and non-communicable diseases in underdeveloped nations (such as HIV/AIDS, TB, and malaria). However, their gross under-representation in global clinical trial platforms contributes to sustained health inequity. This study aims to recognize the constraints and opportunities for conducting locally-led trials in low- and middle-income (LMIC) nations. Three case studies were conducted in Ethiopia, Cameroon and Sri Lanka.

Lack of Expertise

Researchers in developing countries must be able to perform clinical trials and other health research. Performing these jobs in low-resource settings can be challenging because they require various talents. It is especially true for complex clinical trials that require a high level of expertise. Consequently, the number of clinical researchers in developing countries is low. Respondents in all three case studies reported that few local clinicians could conduct a clinical trial. Competing demands (such as patient care) often make it difficult for physicians to participate in clinical research. They also face ethical challenges posed by the requirement to provide effective treatments to study participants after the end of a trial.

Those capable of conducting clinical trials and studies report that better networking is needed to facilitate collaboration. It could include developing national researcher registries and holding networking events. It would also be helpful to focus research on diseases people in developing countries suffer from rather than testing new drugs for conditions primarily affecting rich countries. It will help reduce the endemic practice of “parachute research,” whereby teams from Western high-income countries or major CROs visit a country, conduct their trials and leave, bypassing local institutions.

Lack of Infrastructure

Research with human subjects has expanded rapidly worldwide but without corresponding growth in the infrastructure necessary to protect participants. The disproportionate burden of communicable (e.g., HIV, tuberculosis) and non-communicable diseases (e.g., cardiovascular disease, diabetes) in developing countries necessitates trials to identify cost-effective new diagnostic and treatment modalities. However, many barriers inhibit local involvement in clinical trial conduct. The study employed a prospective multiple case-study design with 34 interviews, 13 focus groups and ten process mapping exercises to explore barriers and enablers to locally-led trial conduct at the macro, institutional and individual levels.

There need to be more resources and operational barriers in all three countries, reduced motivation to conduct clinical trials, prejudiced grant applications and international collaboration opportunities. It limited the uptake of trial results by researchers and decision-makers. In addition, a lack of staff with the knowledge and skills to conduct trials and support their implementation was widely acknowledged as a critical barrier. Consequently, there was widespread consensus that funding and training curricula should focus more on clinical research.

Lack of Financial Resources

A key barrier to clinical trials in developing countries is more financial resources. In addition to the costs associated with implementing and reporting on a trial, other expenses include equipment, travel, and staff salaries. It can make conducting tests in developing countries unfeasible for many researchers. One way to address this issue is to promote local investigator-driven research, which can be more responsive to a country’s needs and help build a research culture. In addition, it is essential to improve funding for low- and middle-income countries.

There is a need for better incentives to get more researchers to perform clinical trials in their nations. It can include financial rewards, opportunities for career progression and international recognition. Furthermore, developing training curricula focusing on clinical research in developing countries is necessary. These elements will contribute to increased clinical trials in developing nations, ultimately improving health outcomes for individuals worldwide.

Lack of Awareness

The healthcare systems of developing countries need new and effective diagnostic and treatment modalities. They bear a disproportionately high burden of communicable and non-communicable diseases. However, they need to be more represented in global clinical trial platforms. It contributes to sustained health inequity in the region. Respondents across all case studies identified various barriers to local clinical research. These included concerns about ethical pitfalls, lack of ownership of priorities and processes, and the unequal relationship between participants and researchers.

Many respondents stated that the need to balance clinical practice and research impeded their involvement in trials. Others felt that limited funding, negative attitudes towards clinical research and inadequate incentives deterred them from undertaking clinical trials. However, some respondents cited that opportunities for professional development, peer recognition and career progression were sufficient motivation to undertake research. The moral principle of justice as reciprocity requires that benefits accruing to participants should also be returned to them. It is particularly important in cases where trials are based on the principle of beneficence. Given the challenges experienced by participants in underdeveloped nations, it might be unfair to guarantee a future benefit that is not currently accessible.

Lack of Human Resources

Researchers in LMICs face an ethical trade-off between strict protection of research participants and exploiting the potential of local populations for global medical progress. Achieving a sustainable balance between the two requires many tertiary-qualified research workers and an environment conducive to attracting and retaining them. Across all three case studies, participants cited a lack of suitably skilled staff as one of the biggest barriers to conducting trials. They also reported a need for more training curricula focused on clinical trial research and a lack of funding to support the conduct of clinical trials.

In addition, there is a widespread perception that the research and pharmaceutical industry rewards those who contribute to their profits rather than investing in building scientific capacity in LMICs. The development of research and clinical trial capacities in LMICs must be a priority, including promoting investigator-driven trials that are demand-led and locally responsive. These are more likely to lead to translating research into action that addresses the needs of a local population. They should be carried out under regulatory and ethical oversight.