Barriers and opportunities for clinical trials in Bahrain: a qualitative study of key opinion leaders

Abstract

Background and objectives

Clinical trials are essential for advancing scientific knowledge and improving patient outcomes. In the last decade, Bahrain has made notable progress in healthcare. However, clinical trial participation from the region remains modest. Thus, our study aimed to explore the perspectives of key opinion leaders on the challenges and potential solutions to conducting clinical trials in Bahrain.

Design

We conducted an exploratory qualitative study with key opinion leaders involved in clinical trials in Bahrain. Data were analysed using Braun and Clarke’s six-step thematic analysis framework. Key opinion leaders were selected using purposive sampling.

Setting

Academic institutions, governmental hospitals and research institutes in Bahrain.

Participants

11 key opinion leaders involved in the planning, oversight, regulation or conduct of clinical trials in Bahrain.

Methods

We conducted semistructured interviews in English, audio-recorded them and transcribed them verbatim. Data were analysed manually using Braun and Clarke’s six-step thematic analysis framework.

Results

Five interconnected themes were identified: (1) regulatory and operational barriers, (2) resource and capacity limitations, (3) public engagement and cultural factors, (4) strategic collaboration and systemic improvement and (5) specific research conduct challenges. Key opinion leaders discussed practical context-specific solutions to strengthen the trial ecosystem in Bahrain.

Conclusion

Bahrain has a strong national policy and a supportive regulatory framework for clinical research. Despite this, clinical trial output remains modest. Key opinion leaders perceived that persistent structural, operational and cultural challenges continue to limit clinical trial activity in Bahrain. Addressing these challenges through coordinated governance, capacity building, stakeholder collaboration and public engagement may help sustain clinical trials and inform clinical research in similar settings.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• This study explores challenges and opportunities related to clinical trials in Bahrain.

• It provides governance-level insights from key opinion leaders.

• The qualitative design enabled exploration of operational, regulatory and sociocultural barriers.

• The findings offer relevant insights for strengthening emerging clinical research systems within the Gulf region.

• As a context-specific qualitative study, the findings may be transferable to similar emerging clinical research settings.

Introduction

Clinical trials (CTs) are key to evidence-based medicine and are conducted using scientifically robust protocols and under strict ethical oversight.¹ Evidence generated from CTs informs clinical decisions and national health policies.² Moreover, locally conducted CTs are especially important as they provide context-specific evidence that supports equitable, safe and cost-effective healthcare delivery.^{3 4} This is especially relevant as Bahrain seeks to strengthen its healthcare sector through research and innovation. Bahrain’s national health strategy focuses on patient-centred care, enhanced medical research and improved management of chronic illnesses.⁵ CTs can support these healthcare goals by improving patient access to new and advanced treatments.

Despite their importance, global clinical trial (CT) activity remains highly concentrated in a small number of high-income countries, with substantial geographic and income-based disparities in trial participation and research capacity.⁶ Recent evidence suggests that factors such as research infrastructure, governance systems and institutional capacity strongly influence participation in CTs worldwide.⁶ Governance challenges, including fragmented regulatory and ethics review processes, variable implementation of international standards and limited local capacity, further hinder trial initiation and conduct globally. In response, the WHO’s Global Action Plan for Clinical Trial Ecosystem Strengthening (GAP-CTS) further emphasises the importance of coordinated national leadership, equitable participation and sustainable clinical research capacity to support more effective and inclusive trial ecosystems globally.⁷

Bahrain’s CT ecosystem includes governmental hospitals, academic institutions, industry partners and the National Health Regulatory Authority. The National Health Regulatory Authority provides regulatory oversight over all CTs conducted in Bahrain under a comprehensive framework aligned with international guidelines.⁸ Close cooperation and coordination among stakeholders across this integrated ecosystem were particularly evident during the COVID-19 pandemic. Bahrain was among the few countries in the region to participate in Phase III trials and real-world evaluations of the Sinopharm vaccine.^{9 10} These initiatives required effective intersectoral collaboration, governmental support and public trust, which together supported the timely approval and early rollout of the vaccine.⁹,¹¹ This experience demonstrated Bahrain’s capacity to conduct complex CTs and identified the need for context-specific research.

Furthermore, Bahrain has a unique demographic profile. The population includes Bahraini nationals along with a large expatriate community from diverse backgrounds.¹² Therefore, evidence generated primarily from Western or more homogeneous populations may not always be applicable in this setting. The differences in genetic background, disease patterns, comorbidities and treatment responses strengthen the need for generating population-relevant evidence to inform healthcare decisions. However, despite the presence of an integrated stakeholder ecosystem, established regulation and a diverse population, CT activity in the kingdom remains modest.

Within the Gulf Cooperation Council (GCC), Saudi Arabia accounts for approximately 66.6% of all CTs, while Bahrain contributes only 2.5%.¹³ This gap is notable, given Bahrain’s demonstrated regulatory readiness and experience during the pandemic.

Most existing research from the region has examined CTs from the perspectives of patients, clinicians or principal investigators.¹³,¹⁶ While these studies provide insight into barriers in participant recruitment and other study-level challenges, they offer a limited understanding of broader governance and institutional procedures that shape the CT environment. In this context, key opinion leaders play a central role in resource allocation, setting strategic priorities, shaping regulatory pathways and affecting research culture within institutions. Despite this, their perspectives on the challenges and opportunities related to CTs remain underexplored. To address this gap, we conducted a qualitative study to explore key opinion leaders’ perspectives on the challenges, opportunities and potential strategies for strengthening CTs in Bahrain.

Methods

We conducted an exploratory qualitative study using semistructured interviews with key opinion leaders involved in CTs in Bahrain. Data were analysed using Braun and Clarke’s six-step thematic analysis framework.¹⁷ This approach enabled an in-depth exploration of interconnected regulatory, operational and sociocultural factors influencing the conduct of CTs within Bahrain’s healthcare and research environment.

Sampling and participant selection

We defined key opinion leaders as policymakers, senior clinicians, CT regulators, institutional leaders and research administrators with substantial involvement in the planning, oversight, regulation or conduct of CTs in Bahrain.¹⁸ Using purposive sampling, we recruited eligible participants through professional networks and institutional affiliations. In Bahrain, the CT ecosystem remains relatively small, with limited designated full-time clinical research roles. Individuals involved in CTs often serve in multiple capacities, including as practising consultants, researchers, institutional leaders or members of research ethics and regulatory committees alongside their routine clinical responsibilities. Therefore, participants were selected based on their direct involvement in CT governance, oversight, regulation, implementation or institutional decision-making. 14 key opinion leaders were approached via formal email invitations. Three declined to participate due to time constraints or unwillingness to be audio recorded. We finally interviewed 11 participants who provided sufficient depth and diversity of perspectives to address the study aims. The professional roles, institutional affiliations and clinical research experience of the interviewed key opinion leaders are summarised in table 1. Given the relatively small CT ecosystem in Bahrain and the specialised roles of the participants, recruitment was discontinued after 11 interviews, as no substantially new concepts or perspectives emerged in subsequent interviews.

Table 1. Professional characteristics of key opinion leaders participating in the study (n=11).

Participant ID	Professional background	Sector	Years of clinical experience	Research area of interest
Participant 01	Clinician-researcher	Academic/Government	10–15 years	Patient-centred clinical research
Participant 02	Clinician-researcher	Government	>20 years	Clinical research and healthcare delivery
Participant 03	Clinical leadership	Government/Academic	10–15 years	Rehabilitation and clinical research
Participant 04	Research personnel	Hospital/Research	10–15 years	Chronic disease research
Participant 05	Medical clinician-researcher	Private healthcare	10–15 years	Clinical trials
Participant 06	Senior researcher	Academic/Research	15–20 years	Translational and clinical research
Participant 07	Pharmacist/researcher	Academic/Research	10–15 years	Pharmaceutical research
Participant 08	Clinical researcher	Government	>20 years	Healthcare research
Participant 09	Healthcare administrator	Government	>25 years	Public health and research systems
Participant 10	Research governance stakeholder	Academic/Government	>25 years	Research ethics and governance
Participant 11	Clinician-researcher	Government healthcare	10–15 years	Clinical research

Interview guide development and data collection

We developed a semistructured interview guide after an extensive review of the literature on CTs, research governance and barriers to trial implementation in the Gulf regional context (online supplemental file 2). The interview questions and their alignment with the final study themes are summarised in table 2. The guide included open-ended questions and was reviewed by two clinical research experts and a qualitative research expert. Interviews were conducted between May 2024 and March 2025. They were administered in English, the shared professional language of all participants.

Table 2. In-depth interview (IDI) questions and their alignment with final study themes.

IDI question	How the question contributes to the theme	Primary theme(s) addressed
Can you share your experience and involvement in clinical research initiatives in Bahrain?	Provides background context.	N/A
What motivates you to contribute to clinical research in Bahrain?	Elicits motivation, providing context.	N/A
In your opinion, what are the main regulatory or policy-related challenges that hinder conducting clinical research in Bahrain?	Investigates regulatory/policy obstacles.	Regulatory and operational barriers
Do you see any challenges related to access to funding or resources for clinical research endeavours?	Explores funding/resource limitations.	Resource and capacity limitations
What infrastructural gaps, do you feel, exist in institutions conducting clinical research in Bahrain?	Uncovers infrastructural deficiencies.	Resource and capacity limitations
Are there challenges with obtaining necessary ethical approvals?	Focuses on ethical approval challenges.	Regulatory and operational barriers
Do you think there is a sufficient pool of qualified researchers in Bahrain with the specific skills needed to conduct high-quality clinical research?	Assesses researcher skills/availability.	Resource and capacity limitations
From your experience, are there challenges in recruiting and retaining research staff?	Examines staff recruitment/retention.	Resource and capacity limitations
Do you believe cultural beliefs or perceptions about clinical research might influence public participation and trust?	Addresses cultural/public engagement.	Public engagement and cultural factors
What are the top priorities for improving the clinical research landscape in Bahrain?	Identifies improvement priorities.	Strategic collaboration and systemic improvement
From your perspective, what solutions or strategies could address the challenges mentioned earlier?	Seeks solutions/strategies.	Strategic collaboration and systemic improvement

Interviews were conducted face-to-face or via Zoom video calls, depending on participant preference, by an experienced researcher familiar with the local research context and trained under the supervision of a qualitative research expert. Written or electronic informed consent was obtained prior to participation. Participants were informed about the interviewer’s role, institutional affiliation and the purpose of the study before the interviews commenced. Interviews lasted 30–45 min, were audio-recorded, transcribed verbatim, anonymised using participant codes and conducted in private. No repeat interviews were required.

Data analysis

Data analysis was conducted in Microsoft Word using the six-step thematic analysis framework. One researcher undertook the coding and theme development, beginning with repeated reading of transcripts to achieve data familiarisation, followed by open coding of meaningful text segments and iterative refinement of an evolving codebook. Codes were documented using structured tables in Word and organised into subthemes and overarching themes.

Data analysis was conducted using Microsoft Word rather than dedicated qualitative data analysis software. To enhance methodological rigour, analytic decisions and theme development were discussed with co-investigators, including an experienced qualitative research expert, as part of an ongoing peer-debriefing process. Member checking was conducted at the interpretive stage by sharing preliminary thematic findings with a subset of participants, and reflexivity was maintained throughout the analysis through reflection on assumptions and documentation of key analytic decisions. An audit trail documenting coding decisions and theme development was maintained to support transparency, and the analytic process is summarised in table 2 and online supplemental table 1.

Patient and public involvement

Patients and the public were not involved in the design, conduct, reporting or dissemination plans of this research.

Results

Our analysis identified five overarching but interconnected themes along with their subthemes: regulatory and operational barriers, resource and capacity limitations, public engagement and cultural factors, strategic collaboration and systemic improvement and specific research conduct challenges (figure 1 and online supplemental table 1). In addition to identifying barriers, participants described several opportunities and proposed system-level solutions to strengthen the conduct of CTs in Bahrain, which are presented within the relevant themes.

Figure 1. Key challenges and proposed solutions identified by key opinion leaders for the conduct of CTs in Bahrain. CTs, clinical trials.

Theme 1: regulatory and operational barriers

Key opinion leaders consistently identified regulatory and operational factors as significant barriers. Although the regulatory framework was viewed as evolving, participants discussed persistent inefficiencies that delayed study initiation.

Regulatory processes and compliance

Participants reported that prolonged approval timelines discouraged researchers and sponsors, particularly for time-sensitive or early-phase studies.

One of the most important regulatory issues is the need for faster processes in obtaining approvals, which sometimes may hinder the start of a project. (Participant 10)

Delay in the approval processes, can sometimes delay the start of a project. (Participant 11)

Several key opinion leaders advocated for a centralised or unified ethics review process, particularly for non-interventional studies, to streamline approvals and reduce duplication.

One unification, one ethical approval… central solution in National Health Regulatory Authority . (Participant 01)

The suggestion is for a centralized ethics review process, particularly for non-interventional studies. (Participant 07)

The alignment of local regulations to international standards remains an area that needs to be addressed. (Participant 10)

Infrastructure and technology

Infrastructural limitations were perceived as another significant barrier. Key opinion leaders identified gaps in specialised laboratory spaces, data management systems and Phase-I trial facilities. The participants discussed that these gaps impeded trial execution and affected research quality.

One of the primary infrastructure gaps is the lack of trained personnel and the absence of Phase 1 clinical trial facilities in Bahrain. (Participant 04)

Do hospitals have the required space or materials, or logistics labs to be able to import/export the lab samples? (Participant 09)

CT design and execution

Key opinion leaders described several challenges within the clinical research landscape, including poor communication with pharmaceutical companies, fragmented trial structures, a lack of centralised CT registries and staffing shortages. To address these gaps, participants suggested establishing a centralised database to improve coordination and information access.

The top priorities are to enhance the communication with pharma to attract clinical Trials. (Participant 11)

Something that must be taken into account is the creation of a centralized database of clinical trials in Bahrain that will facilitate easier access to information and coordination between researchers. (Participant 10)

Theme 2: resource and capacity limitations

Resource and capacity constraints were identified as limiting factors in the conduct and sustainability of CTs in Bahrain.

Funding and investment

Key opinion leaders perceived that limited funding constrained both the scope and quality of research, as researchers may be forced to compromise on methodologies or materials.

The healthcare system struggles with limited funding and underdeveloped infrastructure. (Participant 07)

We do have a challenge… funding from governmental or local resources is limited, and without pharma sponsorship… (Participant 06)

Key opinion leaders suggested that attracting pharmaceutical companies and international organisations could supplement existing funding for clinical research.

Attracting pharmaceutical companies and international organizations to invest in clinical research in Bahrain could provide the necessary funding and resources. (Participant 11)

Researcher training and development

Key opinion leaders identified gaps in training, including trial design, methodology, regulatory submissions and medical writing. They emphasised that continuous, standardised training is essential to equip researchers with the skills required for high-quality output. Participants perceived gaps in training as contributing to variability in research practices and raised concerns about data quality and trial integrity.

Not many healthcare professionals are trained in clinical research. (Participant 01)

Absence of junior research staff like research fellows, residents, or research assistants. The majority are basic scientists, without enough knowledge of medical research. (Participant 02)

Do we make it easy for them to find out about what research opportunities there are? I don’t think we necessarily do… (Participant 06)

Staffing and recruitment

Recruitment and retention of qualified research staff remain significant hurdles due to the competitive employment market and lack of structured career pathways. Participants reported that staffing shortages limited trial capacity and continuity.

There is no career pathway… which makes them leave. (Participant 02)

Recruiting and retaining research staff can be challenging, especially in a competitive job market. (Participant 11)

Participants suggested that strategic human resource management, including competitive salaries, professional development and a supportive work environment, is essential to attracting talent and sustaining clinical research.

Theme 3: public engagement and cultural factors

Key opinion leaders discussed that the sociocultural landscape significantly impacts the recruitment and retention of participants.

Public perception and participation

Participants described limited public understanding of clinical research and expressed perceptions of cultural distrust toward medical research, particularly when it involves novel interventions or experimental treatments.

The culture of clinical trials is not well established among the public in the GCC, and there is limited knowledge about the importance of clinical research. (Participant 08)

Several key opinion leaders also noted that stigma associated with certain conditions affected willingness to participate and limited access to specific populations.

Difficulty in reaching or studying high-risk populations due to societal factors or systemic barriers.

The lack of sufficient data regarding HIV research in the region. (Participant 08)

In contrast, diseases with strong patient advocacy networks, such as sickle cell disease (SCD), demonstrated higher recruitment success.

And here I should mention the role of the SCD patients’ association, they helped us reach patients, especially in the early stages. It was easy to recruit participants for studies on Sickle Cell Disease, as the disease has no cure, and patients were eager to participate in research that could potentially improve their condition. (Participant 11)

Participants suggested public education and awareness campaigns and noted the need for transparent communication about the research process and its potential benefits to improve trust and engagement. Key opinion leaders further highlighted the importance of informed consent, showing the need to ensure that potential participants clearly understand the study and its future implications.

You have to make sure that the participant understands what he is getting into… the consent form should have a big section about explanation. (Participant 09)

There is a need to engage communities through education and transparency about the benefits of research. (Participant 10)

By campaigns, by education… also to tell about how we can develop, we can innovate, how we can help protect the community. (Participant 01)

Theme 4: strategic collaboration and systemic improvement

Key opinion leaders highlighted collaboration as a key enabler for strengthening Bahrain’s clinical research ecosystem.

Inter-institutional collaboration

Key opinion leaders viewed collaboration among universities, hospitals, regulatory authorities and industry partners as essential for resource sharing and capacity building. The establishment of international research networks and partnerships with pharmaceutical companies was also highlighted as a crucial strategy for attracting external support and funding.

Collaboration between university hospitals, the National Health Regulatory Authority, and other governmental organizations is key to promoting and supporting clinical research. (Participant 03)

We need to foster collaboration between different sectors, including the Ministry of Health, pharmaceutical companies, and healthcare institutions to encourage clinical trials. (Participant 04)

Regulatory frameworks and governance

Robust healthcare policy and streamlined governance are essential for a supportive research ecosystem. Key opinion leaders identified the alignment of local regulatory frameworks with international standards as a primary goal.

Top on the list of priorities to improve the clinical research environment in Bahrain is the development of stronger regulatory frameworks. (Participant 10)

Allowing CROs to operate and increasing Phase I and Phase IV trials under health authority jurisdiction would help address key challenges. (Participant 08)

Research strategy and patient outcomes

Key opinion leaders identified the need for a national strategy to define research priorities and promote the impact of CT on healthcare outcomes. A recurring theme was the ethical and practical drive to improve patient care through evidence-based medicine.

My primary motivation to contribute to clinical research in Bahrain is a need to promote healthcare enhancement and to make sure that our research is ethically sound and scientifically solid. (Participant 10)

I am driven by the desire to improve patient outcomes through evidence-based medicine. (Participant 11)

Theme 5: specific research conduct challenges

Beyond systemic issues, participants identified practical challenges related to data and participant acquisition.

Data and subject acquisition

Key opinion leaders identified technical barriers to data acquisition, primarily the lack of interoperability and standardisation within existing electronic health record systems. These fragmented systems limited data access and analysis.

There are challenges related to collecting sufficient and quality data for research purposes, and there are also problems related to the limitations of electronic health records in clinical research. (Participant 08)

Incentivisation and mentorship

To bolster recruitment, participants suggested implementing structures for incentivising both investigators and participants.

Not many people want to contribute. So the problem is getting enough number of participants is the challenge basically. (Participant 09)

I believe one strategy is to incentivize consultants and clinicians to engage in research by providing bonuses or career advancement opportunities. (Participant 03)

Furthermore, key opinion leaders identified the need for targeted training and mentorship programmes to support researchers in managing subject recruitment, data collection and ethical considerations.

There is no challenge with ethical approval, just limited experience in clinical research review bodies. (Participant 08)

Together, these five themes illustrate the multifaceted challenges influencing the conduct of CTs in Bahrain. The following discussion addresses these findings and their implications for the CT ecosystem in Bahrain.

Discussion

Our findings highlight the interplay of regulatory, operational, cultural and governance-related factors influencing the CT ecosystem in Bahrain. These challenges reflect broader regional and global trends, although their impact may vary according to research infrastructure, workforce capacity, funding and regulatory maturity.

Regulatory and operational inefficiencies, particularly prolonged approval timelines and fragmented review processes, were perceived as significant barriers to timely trial initiation. These challenges echo findings from Saudi Arabia and other Middle Eastern settings, where cumbersome administrative procedures discourage both local researchers and international sponsors.¹³,^{1519 20} Participants advocated for greater centralisation of ethics review, especially for non-interventional studies and more streamlined governance aligned with international best practices. Such reforms may improve efficiency without compromising participant safety, as demonstrated in more established trial ecosystems.²¹

Resource and capacity constraints constituted another major limiting factor. Limited dedicated funding, scarcity of protected research time, inadequate training in CT methodology and difficulties in recruiting and retaining specialised research staff constrained both the quantity and quality of trials. These issues were compounded by the absence of Phase I facilities and limitations in electronic health record interoperability that hinder data access and integration. Similar workforce and infrastructure deficits have been widely documented across the GCC and broader Middle East and North Africa region.^{14 15 19}

Sociocultural factors also appeared to influence trial feasibility. Key opinion leaders described limited public awareness, cultural misconceptions about clinical research and stigma surrounding certain conditions as important barriers to participant recruitment.²² At the same time, successful engagement in SCD research through patient advocacy groups illustrated how targeted community involvement and transparent communication may help overcome these challenges.²³,²⁶

A consistent message across interviews was the critical importance of strategic collaboration and systemic improvement. Participants emphasised the need for stronger inter-institutional partnerships involving academia, government, hospitals, the National Health Regulatory Authority and industry, alongside development of a national clinical research strategy aligned with local health priorities. These recommendations are consistent with the WHO’s GAP-CTS.⁷

Compared with larger GCC neighbours such as Saudi Arabia, Bahrain’s smaller and more interconnected healthcare ecosystem presents both challenges, including limited scale and specialised workforce capacity, and potential advantages for coordinated reform. The country’s successful COVID-19 vaccine trial experience demonstrated existing capacity for rapid multi-stakeholder collaboration when political will and public trust are aligned.⁹,¹¹ The primary gap therefore appears to lie less in the existence of regulatory structures and more in their consistent operationalisation alongside sustainable investment in human capital, infrastructure and long-term research capacity development.

This study has several limitations. As a qualitative exploratory study using purposive sampling, the findings are locally relevant; however, they may be cautiously transferable to similar contexts. Participants represented individuals with substantial involvement in CT governance, oversight, regulation and implementation within Bahrain’s relatively small clinical research environment, where dedicated full-time clinical research roles remain limited. Many stakeholders involved in CTs undertake research responsibilities alongside routine clinical or administrative duties. Non-verbal cues were also not systematically recorded or analysed during interviews, which may have limited additional contextual interpretation. Data analysis was conducted using Microsoft Word rather than dedicated qualitative data analysis software; however, methodological rigour was supported through peer debriefing, reflexivity, member checking and maintenance of an audit trail.

Conclusion

Strengthening CT activity in Bahrain will require coordinated efforts across regulatory bodies, healthcare institutions, academia and industry, alongside greater emphasis on context-specific and population-relevant research. Short-term priorities include research training, stakeholder engagement, public awareness initiatives and improved operational coordination, while longer-term efforts should focus on sustainable infrastructure, workforce development, digital integration and integrated national clinical research strategies. These considerations are also relevant to similar emerging clinical research systems within the Gulf region.

Data availability statement

Data are available upon reasonable request.