Vol 63, No Supplement 1 (2025): Transforming the Clinical Trials Ecosystem in Ethiopia

Background: Medical products are regulated from premarket clinical trials (Phase I, II and III) to post marketing surveillance (phase IV clinical trials). Product development and research organizations have responsibilities to conduct clinical trials subject to ethical approval and clinical trial authorization prior to releasing products to the market. Harmonized approaches for ethical and regulatory approvals of clinical trials are practiced globally including in East African countries through regional economic communities. The aim of this study was to explore opportunities and challenges in the implementation of a harmonized ethical and regulatory review system for clinical trial protocols in East African Countries.  

Methods: A qualitative study was conducted in five selected East African countries focusing on regional economic communities (RECs). Purposive sampling method was applied to select key informants from national health research ethics review committees, national medicine regulatory authorities, development partners, sponsors and research institutions. Data were collected through self-administered structured questionnaires shared through email. The data were analyzed using a thematic approach using QDA Miner Lite qualitative data analysis software.

Results: A total of 24 key informants (eight females) from five east African countries (Ethiopia, Kenya, Sudan, Uganda and Tanzania) were involved in this exploratory study. Strong desire to have strong ethics and regulatory review system, availability of established platforms and enabling opportunities were identified as opportunities for the implementation of a harmonized ethical review and trial authorization system in the region. On the other hand, weak capacity, lack of framework to support harmonization, difference in organizational structure and regulatory requirement, lack of procedural clarity, long incubation to establish harmonized system and lack of political commitment were some of the identified challenges.

Conclusion: The study highlights both the opportunities and challenges of implementing harmonized ethical review and regulatory authorization system for clinical trial protocols in East African countries. Given the importance of harmonized ethical review and regulatory authorization system in the region, actions need to be taken by all stakeholders of clinical trials to identify strategies in order to maximize the available opportunities and tackle the challenges in a sustainable way. 

Background: Ethiopia's participation in clinical trials remains low. This study aimed to investigate the challenges and opportunities associated with conducting clinical trials in Ethiopia.
Method: This study employed a qualitative, exploratory design. Seventeen purposively selected clinical trial
stakeholders participated: clinical trial investigators (n = 6), ethics review board members (n = 8), regulatory
authority officials (n = 2), and an insurance company officer. Data were collected through in-depth interviews,
which were audio recorded, transcribed, and analyzed thematically.
Results: Four themes were identified: (1) system of protocol approval, (2) investigator motivation, strengths, and
opportunities, (3) challenges, and (4) recommendations on improving the clinical trial system. The potential impact and opportunities of clinical trials were the main motivating factors for investigators to engage in clinical
trials. The availability of trial sites, patient recruitment potential, and recent interest of insurance companies were
mentioned as the main opportunities. There was a bigger preoccupation with the challenges, and five groups of key
challenges for conducting clinical trials were identified. These included the limited financial, infrastructural, and
human resources, leading to a slow trial approval process. Investigator-related factors, including incomplete submissions, low protocol quality, delays in responding to reviewers’ comments, and engagement in high-risk trials,
were also identified.
Conclusion: Ethiopia offers promising foundations and opportunities for conducting clinical trials. However,
many challenges prevail at every level. To harness the opportunities, stakeholders need to address the main challenges, namely addressing structural issues (resources, infrastructure, and harmonization) at both national and
institutional levels, speeding up the approval process, and building broader clinical trials capacity

Introduction: The number of clinical trials conducted globally is increasing over the past decade. However, engagement of low- and middle-income countries (LMICs) in clinical trials remains disproportionately low. This study aims to assess trends in clinical trials registered from Ethiopia in international trial registry platforms.

Methods: A systematic search was conducted across three major international clinical trial registries, i.e., International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov, and the Pan-African Clinical Trials Registry (PACTR), to identify registered trials from Ethiopia. The search results were exported in XML format and analysed using STATA version 14.2.

Results: A total of 489 studies were identified across the three trial registry platforms. Over 80% of these trials were registered on ClinicalTrials.gov and the Pan-African Clinical Trials Registry. The predominant focus of the trials was on Infectious diseases, particularly NTDs, TB, HIV and malaria, which accounted for 54.4% of the total.  Trials comprising behavioural interventions constituted about 40% of the total. Most of the registered clinical trials were sponsored by local academic institutions, and early-phase clinical trials constituted just 9.8% of the total registered studies. The first clinical trial was registered in 1999. However, 85.0% of the trials were registered just in the past decade, since 2015, a year marking the celebration of the first International Clinical Trials Day.

Conclusion: Ethiopia has made significant strides in conducting clinical trials, especially in the past decade, reflecting a growing commitment to contributing to global clinical research. However, considerable work is still needed to enhance the role of clinical trials in therapeutic advancement. To sustain and accelerate the current momentum of clinical trials, ethics committees and regulatory authorities as well as academic and research institutes have to increase their effort in partnership with relevant national and international stakeholders, particularly the industry.

Background: Physicians have a vital role in the design and conduct of clinical trials. Their involvement promotes evidence-based practice, and improves patient care. However, the degree of their engagement varies across
regions and countries. This study aimed to assess the engagement and experience of physicians in the design or
conduct of clinical trials in Ethiopia.
Methods: A cross-sectional study was conducted in three teaching hospitals where clinical trials are frequently
conducted in Ethiopia: Tikur Anbassa Specialized Hospital, University of Gondar Specialized Hospital, and Jimma
University Medical Center. The experience of the physicians from the three hospitals was assessed using a selfadministered questionnaire. The data were analyzed descriptively.
Results: A total of 213 physicians were involved in this study, of whom 40 (19%) reported current or previous
engagement in the plan and conduct of clinical trials. Among those who were engaged in clinical trials, 57.5% (23
out of 40) had been involved only in one clinical trial. Of those who were engaged in clinical trials, 80% reported
that the clinical trials they were engaged in were registered in clinical trial registry platforms although only half
had been an author of any trial-related publications. The physicians noted that obtaining ethics and regulatory
approval took too long. While nearly all physicians who participated in the study (98%) expressed an interest in
getting involved in future clinical trials, only17% were aware of any ongoing clinical trials within their institutions.
Conclusion: The engagement of physicians in clinical trials is low and most appear to have minimal awareness.
However, many would like to get more involved. There is fertile ground to engage physicians in clinical trials,
though this may necessitate training in clinical trial management and design and greater awareness of clinical
research careers.

Background: Most clinical trials have been conducted in developed countries, and out of the total 343, 835 trials conducted worldwide only 157, i.e., 0.047% have been conducted in Ethiopia as of 26 June 2020. Ethics and regulatory review systems have been stated as the second most common barrier to trial development in Africa. All clinical trials to be conducted in Ethiopia have to get authorization from the Ethiopian Food and Drug Authority (EFDA). However,  no study has been done to investigate the effects of clinical trial regulation on clinical trial development in Ethiopia. In this study, we sought to study the enablers and barriers of the regulatory system for the conduct of clinical trials in Ethiopia.

Method: A descriptive qualitative study was done. Thirteen clinical trial investigators and 2 staff working in the clinical trial team of EFDA were interviewed. The data were analyzed in a thematic way of analysis.

Results: the establishment of a team in EFDA with a guideline and committed staff responsible for clinical trials regulation were opportunities; while inadequate staff, financial constraints, space shortage, lack of trial site follow-up inspection, absence of timely feedback to reports, and lengthy approval process were identified as barriers for the development of clinical trials in Ethiopia.

Conclusion: In Ethiopia, clinical trial researchers face substantial ups and downs starting from clinical trial authorization to completion. Though the regulatory body is trying to facilitate clinical trial authorization and regulation, the system needs improvement by building and/or strengthening regulatory capacity to encourage investigators to conduct clinical trials in Ethiopia.