An evaluation of pharmaceutical clinical trials from Saudi Arabia registered on Clinicaltrials.gov

ABSTRACT

Objectives:

To evaluate clinical trials involving pharmaceutical agents conducted in Saudi Arabia and registered on ClinicalTrials.gov. Since the early 2000s, Saudi Arabia has expanded its involvement in clinical research. Recognizing the importance of clinical trials, we aimed to analyze the clinical trial landscape in the Kingdom to identify well-covered areas and potential gaps.

Methods:

In this descriptive cross-sectional study, ClinicalTrials.gov was used as the primary source to collect data regarding pharmacological and biological interventions conducted in Saudi Arabia between 2002 and June 2025.

Results:

A total of 474 pharmaceutical studies were included. Of these, 52.95% were completed, indicating moderate research activity but suggesting room for growth compared to global benchmarks. Among completed trials, 38.64% had their results published on ClinicalTrials.gov. Overall, 223 sponsors were identified: 23.32% were international pharmaceutical companies and 24.22% were Saudi sponsors, of which 77.78% were governmental and 22.22% private. Additionally, 239 studies were funded by international companies. Oncology (23.21%) was the most represented medical field, followed by infectious diseases (12.87%).

Conclusion:

Saudi Arabia witnessed an increase in registered clinical trials between 2002 and June 2025, with strong contributions from both international and Saudi sponsors, particularly the governmental sector. However, only one-fifth of completed trials had results published on ClinicalTrials.gov, highlighting the need for greater transparency and dissemination of findings.

Clinical trials play a vital role in advancing medical research, leading to improved patient outcomes and the development of new treatments. Over recent decades, there has been a significant increase in the number of clinical trials conducted worldwide, with a total of 1,166,737 trials registered in the World Health Organization between 2000 and 2024.¹ Saudi Arabia has also witnessed significant growth in its contribution to clinical research over recent years.² The Kingdom has experienced a steady rise in the number of registered clinical trials, reflecting a growing interest in research activities. This trend may be attributed to several factors, including Saudi Arabia’s substantial healthcare market, 5.7% of the gross domestic product, as well as the government’s efforts to enhance the healthcare sector through increased funding, private sector involvement, and public-private partnerships.³

Saudi Arabia’s “Vision 2030” initiative aims to increase the private sector’s contribution to healthcare from 40% to 65% by 2030. This involves privatizing hospitals and primary health centers and forming health clusters to promote integrated care, enhance accessibility, and drive digital innovation.⁴ Alongside its strong healthcare infrastructure, the Kingdom increasingly prioritizes research by collaborating with private institutions to establish specialized research centers. These centers aim to advance critical medical fields, empower healthcare professionals with innovative tools, and reduce reliance on outbound medical tourism.^3,5,6

Saudi Arabia has established a robust framework for conducting clinical trials to ensure patient safety and promote healthcare innovations. The Saudi Food and Drug Authority (SFDA) is the regulatory authority responsible for overseeing and approving clinical trials in the nation. All clinical trials conducted in Saudi Arabia are registered in the Saudi Clinical Trials Registry, which serves as the country’s formal record for clinical trial data.

The ClinicalTrials.gov website, which acts as a global database for registered clinical trials, was launched by the United States’ National Institutes of Health in response to a mandate from the country’s Food and Drug Administration.⁷ ClinicalTrials.gov provides valuable information about the registered studies, including their designs, sponsor names, inclusion and exclusion criteria, key points, and initiation and completion dates. On January 23, 2024, ClinicalTrials.gov listed 479,859 studies from 223 countries.⁸ Registering clinical trials is essential for enhancing transparency and mitigating selective reporting. Authoritative bodies such as the International Committee of Medical Journal Editors advocate for the registration of all clinical trials. This practice serves to improve transparency in clinical research and discourage the withholding of trial outcomes.

Little is known regarding the specific trends, characteristics, and outcomes of clinical trials conducted in Saudi Arabia, particularly those involving pharmaceutical and biological interventions. To address this gap, the objective of this study was to systematically analyze the characteristics, reporting practices, sponsorship patterns, and therapeutic focus of these trials, and to evaluate their alignment with national healthcare goals such as Vision 2030. Although the number of clinical trials registered in publicly accessible databases has increased in recent years, their characteristics—including completion rates, approaches to reporting results, sponsors, and therapeutic priorities—are under-reported for many registered studies.⁹ Such studies often draw on external resources without evaluating the strengths and gaps in local clinical research capacity and whether there is an alignment with national healthcare goals such as Vision 2030. Using a data-driven approach, we derived recommendations to strengthen policy, partnerships, and local clinical research infrastructure.

We comprehensively evaluated the clinical trials registered in ClinicalTrials.gov conducted in Saudi Arabia, shedding light on the country’s research efforts and their impact on healthcare advancements.

Methods

Data source

In this descriptive cross-sectional study, the ClinicalTrials.gov website was used as a primary source to gather data concerning clinical trials conducted in Saudi Arabia over the study period.

Inclusion and exclusion criteria

We included only studies concerning pharmacological or biological medications conducted in Saudi Arabia between January 2002 and June 2025. Studies involving procedures, medical devices with or without medications, diagnostic tests, dietary patterns, radiation therapy, behavioral therapy without drug components, or studies conducted outside Saudi Arabia were excluded.

Data extraction

The essential information extracted from the database included:

• Title

• Targeted conditions

• Interventions

• Clinical trial phase

• Each trial’s NCT number (unique identifier)

• Results (availability of trial results)

• Size (number of participants)

• Start date

• Sponsor

• Location within Saudi Arabia

Ethical approval of the study’s protocol was obtained from the institutional review board of King Saud University Medical City on May 4, 2023 (Approval no: E-23-7753).

Study status identification

The studies’ statuses were categorized as completed, recruiting, unknown, active but not recruiting, terminated, not yet recruiting, suspended, enrolling by invitation, withdrawn, approved for marketing, or available, as was reported on ClinicalTrials.gov. More information regarding the definition of each category is available on the website.¹⁰

Phases, participant numbers, and dates

Based on the information provided on ClinicalTrials.gov, the studies were classified into phase I, II, III, and IV. Some were labeled “not available” if the phase was not specified. Given the information provided on each study’s page, it was categorized as either interventional or observational.

The number of participants enrolled in each study and its dates were recorded and analyzed to determine the research trends in Saudi Arabia.

Locations and sponsors

The raw location data provided in the studies was categorized as 2 variables: the name of the research institution, and administrative region within Saudi Arabia, from the options: Riyadh, Makkah, Madinah, Eastern Province, Al-Qassim, Hail, Tabuk, Al-Jawf, Najran, Jizan, Asir, Baha, and Northern Borders. All the studies were assigned to specific sponsors. To establish consistency, the sponsors’ names were revised in the formal form, using their official names from their respective platforms. This step aimed to minimize any variations in sponsor names as reported on the ClinicalTrials.gov website.

Conditions and therapeutic categories

To ensure consistency and avoid duplication, the conditions in the study’s titles or descriptions were standardized and renamed. Two of the authors (KG and IS) reviewed the selected studies and assigned formal condition names based on the type of condition or study title. Any cases of disagreement were resolved by the primary investigator. The formal condition names were further classified using the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification (ICD-10-AM) guidelines to identify the most researched conditions in Saudi Arabia.¹¹ Conflicts were resolved through consensus discussions among the investigators, with final classifications determined after reviewing all available evidence and reaching mutual agreement.

The pharmacological and biological interventions identified in the studies were similarly classified into therapeutic categories. This classification was performed using the DrugBank database¹² and discussions among the investigators in ambiguous cases.

Statistical analysis

Descriptive statistical analyses were used to report the study findings. Categorical variables are presented as frequencies and percentages, while continuous ones are presented as means and associated standard deviations or medians (interquartile ranges), based on the data distribution. All statistical analyses were conducted using STATA 17 software.¹³

Results

A total of 1055 studies conducted in Saudi Arabia were retrieved from ClinicalTrials.gov between 2002 and June 2025. Based on inclusion and exclusion criteria, 474 studies were included, while 581 studies were excluded. Figure 1 presents the breakdown of the excluded studies.

Figure 1.

- Excluded studies and the reasons for their exclusion. Studies excluded from the analysis are outlined, with detailed reasons for their exclusion to ensure transparency and validity in the research process

Of the studies included, only 97 (20.46%) had their results published on ClinicalTrials.gov, highlighting a major transparency gap. The remaining 377 studies (79.54%) had no accessible results posted. The included studies comprised 251 (52.95%) that had been completed, 86 (18.14%) that were recruiting, 42 (8.86%) that were active but not recruiting, 18 (3.80%) that had been terminated, 10 (2.11%) that had not yet begun recruiting, 5 (1.05%) that had been suspended, 4 (0.84%) that were enrolling subjects by invitation only, 4 (0.84%) that had been withdrawn, 1 (0.22%) that had been approved for marketing, and 1 (0.21%) with a status of “available.” The website had missing data regarding the statuses of 54 of the studies (11.39%).

Most of the medication-related studies were phase III trials (184, 38.82%), followed by phases IV (76, 16.03%), II (70, 14.77%), and I (20, 4.22%). The remaining 124 studies were classified as observational (68, 14.35%) and interventional (56, 11.81%).

Figure 2 shows the number of clinical trials conducted in Saudi Arabia annually over the study period. An overall increasing trend was observed; however, a notable decrease occurred since 2021, with only 56 trials registered.

Figure 2.

- Number of clinical trials performed in Saudi Arabia from 2002 to 2025. A chronological overview of the number of clinical trials conducted in Saudi Arabia over a 20-year period is presented, illustrating trends and growth in research activities

Locations and sponsors

A total of 223 sponsors were identified, of whom 52 (23.32%) were international pharmaceutical companies, either independently or in collaboration with other sponsors. A total of 239 studies (36.5%) were funded by international pharmaceutical companies. The top 5 pharmaceutical sponsors, including Novartis (36 trials, 5.5%), Bayer (25 trials, 3.82%), Roche (23 trials, 3.51%), Pfizer (20, 3.05%) and Novo Nordisk (16, 2.44%) emerged as the leading contributors (Figure 3). The complete list of sponsors is provided in Appendix A (Supplementary Table S1)

Figure 3.

- Top 60% of sponsors with the highest contributions to the clinical trials landscape of Saudi Arabia. The leading sponsors responsible for the majority of clinical trials in Saudi Arabia are identified, showcasing their significant contributions to the research landscape.

Supplementary Table 1.

- A list of all sponsors contributing to clinical research in Saudi Arabia according to the ClinicalTrials.gov database between 2002 and 2025.

Ranks	Sponsors	Number of Clinical trials	Percentage	Cumulative Percentage
1	King Faisal Specialist Hospital & Research Center	43	6.56	6.56
2	Novartis	36	5.5	12.06
3	Bayer	25	3.82	15.88
4	King Saud University	25	3.82	19.69
5	Hoffmann-La Roche	23	3.51	23.21
6	Pfizer	20	3.05	26.26
7	Novo Nordisk	16	2.44	28.7
8	AstraZeneca	15	2.29	30.99
9	King Abdullah International Medical Research Center	15	2.29	33.28
10	National Cancer Institute (NCI)	15	2.29	35.57
11	King Abdulaziz University	14	2.14	37.71
12	Imam Abdulrahman Bin Faisal University	12	1.83	39.54
13	Sanofi	12	1.83	41.37
14	Eli Lilly Company	10	1.53	42.9
15	National Guard Health Affairs	9	1.37	44.27
16	Ministry of Health, Saudi Arabia	8	1.22	45.5
17	King Abdul Aziz Specialist Hospital	7	1.07	46.56
18	Al-Azhar University	6	0.92	47.48
19	King Abdulaziz Medical City	6	0.92	48.4
20	King Khaled Eye Specialist Hospital	6	0.92	49.31
21	King Saud Medical City	6	0.92	50.23
22	Amgen	5	0.76	50.99
23	Biogen	5	0.76	51.76
24	Janssen Research & Development, LLC	5	0.76	52.52
25	King Fahad Medical City	5	0.76	53.28
26	McMaster University	5	0.76	54.05
27	Riyadh Colleges of Dentistry and Pharmacy	5	0.76	54.81
28	Riyadh Elm University	5	0.76	55.57
29	Tanta University	5	0.76	56.34
30	Australian and New Zealand Intensive Care Society Clinical Trials Group	4	0.61	56.95
31	Canadian Institutes of Health Research (CIHR)	4	0.61	57.56
32	Daiichi Sankyo, Inc.	4	0.61	58.17
33	GlaxoSmithKline	4	0.61	58.78
34	Kafrelsheikh University	4	0.61	59.39
35	King Faisal University	4	0.61	60
36	Princess Nourah Bint Abdulrahman University	4	0.61	60.61
37	Taibah University	4	0.61	61.22
38	Actelion	3	0.46	61.68
39	Ain Shams University	3	0.46	62.14
40	Al Hayat National Hospital	3	0.46	62.6
41	Beni-Suef University	3	0.46	63.05
42	Canadian Critical Care Trials Group	3	0.46	63.51
43	Celgene	3	0.46	63.97
44	King Abdullah Medical City	3	0.46	64.43
45	King Khalid University Hospital	3	0.46	64.89
46	Maternity and Children Hospital, Makkah	3	0.46	65.34
47	Menoufia University	3	0.46	65.8
48	NRG Oncology	3	0.46	66.26
49	National Health and Medical Research Council, Australia	3	0.46	66.72
50	Regeneron Pharmaceuticals	3	0.46	67.18
51	Security Forces Hospital	3	0.46	67.63
52	University of Arizona	3	0.46	68.09
53	Zagazig University	3	0.46	68.55
54	AbbVie	2	0.31	68.85
55	Abbott	2	0.31	69.16
56	Albireo	2	0.31	69.47
57	Alfarabi Colleges	2	0.31	69.77
58	ApoPharma	2	0.31	70.08
59	Armed Forces Hospitals, Southern Region, Saudi Arabia	2	0.31	70.38
60	Astellas Pharma Inc	2	0.31	70.69
61	Australian and New Zealand Intensive Care Research Centre	2	0.31	70.99
62	BioMarin Pharmaceutical	2	0.31	71.3
63	Cairo University	2	0.31	71.6
64	Children’s Oncology Group	2	0.31	71.91
65	Eagle Pharmaceuticals, Inc.	2	0.31	72.21
66	European Society for Blood and Marrow Transplantation	2	0.31	72.52
67	Hikma Pharmaceuticals LLC	2	0.31	72.82
68	International Cancer Research Group, United Arab Emirates	2	0.31	73.13
69	Janssen-Cilag International NV	2	0.31	73.44
70	King AbdulAziz City for Science and Technology	2	0.31	73.74
71	King Fahad Specialist Hospital Dammam	2	0.31	74.05
72	Mansoura University	2	0.31	74.35
73	McGill University	2	0.31	74.66
74	Merck KGaA, Darmstadt, Germany	2	0.31	74.96
75	Merck Sharp & Dohme LLC	2	0.31	75.27
76	National Cancer Centre, Singapore	2	0.31	75.57
77	Prince Sultan Cardiac Center, Adult Cardiology Department.	2	0.31	75.88
78	Procare Riaya Hospital	2	0.31	76.18
79	Radiation Therapy Oncology Group	2	0.31	76.49
80	Saud Al Babtain Cardiac Center	2	0.31	76.79
81	Saudi German Hospital - Madinah	2	0.31	77.1
82	Sulaiman Al Habib Medical Group	2	0.31	77.4
83	Swedish Orphan Biovitrum	2	0.31	77.71
84	The Eye Center and The Eye Foundation for Research in Ophthalmology	2	0.31	78.02
85	The George Institute	2	0.31	78.32
86	The University of Queensland	2	0.31	78.63
87	Universiti Sains Malaysia	2	0.31	78.93
88	University Vita-Salute San Raffaele	2	0.31	79.24
89	University of Oxford	2	0.31	79.54
90	ALL SCTped Forum	1	0.15	79.69
91	ALL-BFM Study Group	1	0.15	79.85
92	Acerta Pharma BV	1	0.15	80
93	Al Hada Military Hospital	1	0.15	80.15
94	Al Mashfa Medical Center	1	0.15	80.31
95	Alexion Pharmaceuticals	1	0.15	80.46
96	Amryt Pharma	1	0.15	80.61
97	Aravind Eye Hospitals, India	1	0.15	80.76
98	Asociacion Para Evitar La Ceguera En México	1	0.15	80.92
99	Assistance Publique – Hôpitaux de Paris	1	0.15	81.07
100	Assiut University	1	0.15	81.22
101	Australasian Gastro-Intestinal Trials Group	1	0.15	81.37
102	Australasian Society for Infectious Diseases	1	0.15	81.53
103	Australian & New Zealand Children’s Haematology/Oncology Group	1	0.15	81.68
104	Australian Society for Antimicrobials	1	0.15	81.83
105	Bellicum Pharmaceuticals	1	0.15	81.98
106	Berry Consultants	1	0.15	82.14
107	Boehringer Ingelheim	1	0.15	82.29
108	Bristol-Myers Squibb	1	0.15	82.44
109	Buraidah Central Hospital	1	0.15	82.6
110	Cancer International Research Group (CIRG)	1	0.15	82.75
111	Cardialysis B.V.	1	0.15	82.9
112	Centre de recherche du Centre hospitalier universitaire de Sherbrooke	1	0.15	83.05
113	Chiesi Canada Corp	1	0.15	83.21
114	Children’s Hospital of Eastern Ontario	1	0.15	83.36
115	Children’s Hospital of Philadelphia	1	0.15	83.51
116	Chugai Pharmaceutical	1	0.15	83.66
117	Clinical Urology and Epidemiology Working Group	1	0.15	83.82
118	Cyberjaya University College of Medical Sciences	1	0.15	83.97
119	Cyclo Therapeutics, Inc.	1	0.15	84.12
120	Dallah hospital	1	0.15	84.27
121	Dammam Central Hospital	1	0.15	84.43
122	Dr Cipto Mangunkusumo General Hospital	1	0.15	84.58
123	Dr. Soliman Fakeeh Hospital	1	0.15	84.73
124	Duke University	1	0.15	84.89
125	Dutch Childhood Oncology Group	1	0.15	85.04
126	ECRI bv	1	0.15	85.19
127	EMD Serono Research & Development Institute, Inc.	1	0.15	85.34
128	Egyptian Biomedical Research Network	1	0.15	85.5
129	Elan Pharmaceuticals	1	0.15	85.65
130	Ergomed	1	0.15	85.8
131	EsPhALL	1	0.15	85.95
132	ennedy Shriver National Institute of Child Health and Human Development (NICHD)	1	0.15	86.11
133	European Cardiovascular Research Center	1	0.15	86.26
134	European Organisation for Research and Treatment of Cancer - EORTC	1	0.15	86.41
135	Exelixis	1	0.15	86.56
136	Fondazione Angelo Bianchi Bonomi	1	0.15	86.72
137	Infectious Disease Institute of Translational Medicine, Jilin University China	1	0.15	86.87
138	Fovea	1	0.15	87.02
139	Gambro Renal Products, Inc.	1	0.15	87.18
140	Genomic Health®, Inc.	1	0.15	87.33
141	Global Blood Therapeutics	1	0.15	87.48
142	Global Coalition for Adaptive Research	1	0.15	87.63
143	Hamad Medical Corporation	1	0.15	87.79
144	Hamilton Academic Health Sciences Organization	1	0.15	87.94
145	HemoShear Therapeutics	1	0.15	88.09
146	Hospital Center Regional And University De Nancy Hospital Central	1	0.15	88.24
147	Hospital Sao Luiz	1	0.15	88.4
148	INDOX Cancer Research Network	1	0.15	88.55
149	Incyte Corporation	1	0.15	88.7
150	Innogene Kalbiotech Pte. Ltd	1	0.15	88.85
151	Innovative Therapies For Children with Cancer Consortium	1	0.15	89.01
152	Intensive Care National Audit & Research Centre	1	0.15	89.16
153	International Society of Chemotherapy	1	0.15	89.31
154	Janssen Pharmaceutica N.V., Belgium	1	0.15	89.47
155	Janssen-Cilag Ltd.	1	0.15	89.62
156	Jerry Zimmerman	1	0.15	89.77
157	John Hopkins Aramco Healthcare	1	0.15	89.92
158	g Abdallah University for Science and Technology (KAUST), Thuwal, Saudi Arabia.	1	0.15	90.08
159	King Fahad Armed Forces Hospital	1	0.15	90.23
160	King Fahad Military Medical Complex	1	0.15	90.38
161	King Fahad University Hospital	1	0.15	90.53
162	King Fahd Medical Research Centre	1	0.15	90.69
163	LogicBio Therapeutics, Inc.	1	0.15	90.84
164	Majmaah University	1	0.15	90.99
165	Max-Planck-Institut of Quantum Optics (MPQ)	1	0.15	91.15
166	Medical Research Council	1	0.15	91.3
167	Medical Research Institute of New Zealand	1	0.15	91.45
168	Medtronic	1	0.15	91.6
169	Merck Serono Middle East FZ LLC	1	0.15	91.76
170	Meshalkin Research Institute of Pathology of Circulation	1	0.15	91.91
171	Modus Therapeutics AB	1	0.15	92.06
172	Monash University	1	0.15	92.21
173	nd Albert Einstein College of Medicine, Newyork, United States of America (USA)	1	0.15	92.37
174	NSABP Foundation Inc	1	0.15	92.52
175	National Eye Institute (NEI)	1	0.15	92.67
176	National Institute of Allergy and Infectious Diseases (NIAID)	1	0.15	92.82
177	National Intensive Care Surveillance MORU	1	0.15	92.98
178	North West Armed Forces Hospital	1	0.15	93.13
179	Northwestern University	1	0.15	93.28
180	OMER B ABDELBASIT	1	0.15	93.44
181	Octapharma	1	0.15	93.59
182	Oregon Health and Science University	1	0.15	93.74
183	Pan American Collaborative Retina Study Group	1	0.15	93.89
184	Prince Sultan Military College of Health Sciences	1	0.15	94.05
185	Princess Al-Johara Al-Ibrahim Cancer Research Center	1	0.15	94.2
186	Qassim Health Cluster	1	0.15	94.35
187	Qassim University	1	0.15	94.5
188	Qatif Central Hospital	1	0.15	94.66
189	Queensland Clinical Trials & Biostatistics Centre	1	0.15	94.81
190	Quintiles, Inc.	1	0.15	94.96
191	Rezolute	1	0.15	95.11
192	Riyadh Military Hospital	1	0.15	95.27
193	Royal Alexandra Hospital	1	0.15	95.42
194	Royal Victoria Eye and Ear Hospital	1	0.15	95.57
195	Saudi National Comprehensive Plan for Science & Technology	1	0.15	95.73
196	Saudi Society of Dermatology and Dermatologic surgery	1	0.15	95.88
197	Sintesi Research Srl	1	0.15	96.03
198	Society of Critical Care Medicine	1	0.15	96.18
199	St. Anna Kinderkrebsforschung	1	0.15	96.34
200	St. Joseph’s Healthcare Hamilton	1	0.15	96.49
201	St. Marianna University School of Medicine	1	0.15	96.64
202	St. Petersburg State Pavlov Medical University	1	0.15	96.79
203	Suez Canal University	1	0.15	96.95
204	Swiss Pediatric Oncology Group	1	0.15	97.1
205	Tabriz University of Medical Sciences	1	0.15	97.25
206	Takeda	1	0.15	97.4
207	Tallaght University Hospital	1	0.15	97.56
208	Terumo Medical Corporation	1	0.15	97.71
209	The Physicians’ Services Incorporated Foundation	1	0.15	97.86
210	Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL)	1	0.15	98.02
211	UMC Utrecht	1	0.15	98.17
212	Ultragenyx Pharmaceutical Inc	1	0.15	98.32
213	Unity Health	1	0.15	98.47
214	University Hospital, Basel, Switzerland	1	0.15	98.63
215	University of Alberta	1	0.15	98.78
216	University of Bern	1	0.15	98.93
217	University of California, San Francisco	1	0.15	99.08
218	University of Helsinki	1	0.15	99.24
219	University of Jazan	1	0.15	99.39
220	University of Pittsburgh Medical Center	1	0.15	99.54
221	University of Western Ontario, Canada	1	0.15	99.69
222	argenx	1	0.15	99.85
223	peter metrakos	1	0.15	100

Saudi Sponsors

Among the funding bodies for the clinical trials, 54 (24.22%) were Saudi, compared to 169 non-Saudi or international sponsors (75.78%). Of the 54 Saudi sponsors, 42 (77.78%) were governmental institutions, with only 12 (22.22%) being from the private sector. King Faisal Specialist Hospital and Research Center provided the most significant contribution, supporting a total of 43 studies (6.56%), followed by King Saud University with 25 studies (3.8%).

The top 25% of sponsors contributed approximately 70% of the funding, with the remaining 75% being responsible for a combined total of approximately 30%. A total of 114 studies (24.05%) were conducted across multiple centers, with the remainder being single-center studies. Over half of the studies were conducted in Riyadh (56.80%), followed by Makkah (21.17%) and the Eastern Province (13.28%), suggesting potential geographic centralization and disparities in regional research capacity. Other regions included Qassim, Madinah, Aseer, Najran, Tabuk, and Jizan (Table 1).

Table 1.

- Number of studies conducted per administrative region in Saudi Arabia.

Region	Number of studies (n)	Percentage (%)
Riyadh	389	(56.79)
Makkah	145	(21.17)
Eastern province	91	(13.28)
Qassim	20	(2.91)
Madinah	16	(2.34)
Aseer region	13	(1.90)
Najran region	5	(0.73)
Tabuk region	3	(0.44)
Jizan region	3	(0.44)

Conditions and therapeutic categories

The fields of medicine explored by the trials comprised 22 distinct ICD-AM-10 codes. Oncology (23.21%) was the most investigated medical field, followed by infectious diseases (12.87%) and endocrine and metabolic disorders (11.18%). Other fields included neurology (8.65%), cardiovascular disease (7.38%), and hematology (7.38%) (Table 2).

Table 2.

- Medical conditions and therapeutic categories of the included trials.

Condition Category	Number of studies (n)	Percentage (%)
Oncology	110	(23.21)
Infectious diseases	61	(12.87)
Endocrine and metabolic disorders	53	(11.18)
Neurology	41	(8.65)
CVD and related risk factors	35	(7.38)
Hematology	35	(7.38)
Dental care using pharmacological agents	25	(5.27)
Inflammatory and autoimmune diseases	22	(4.64)
Supportive care	18	(3.80)
Respiratory and respiratory diseases	17	(3.59)
Diseases of the eye and adnexa	10	(2.11)
Pregnancy, delivery, and newborn-related disease	7	(1.48)
Pharmacokinetics and pharmacodynamics study	6	(1.27)
Disease of the GIT	6	(1.27)
Liver and liver-related diseases	5	(1.05)
Bone and related conditions	4	(0.84)
Renal and renal-related diseases	4	(0.84)
Skin and related disease	4	(0.84)
Others	2	(0.42)

CVD, cardiovascular disease; GIT, gastrointestinal tract, Others: include Diagnostic studies using pharmacological agents, Dyslipidemia, Erectile dysfunction, Heat stroke, and Musculoskeletal diseases.

Discussion

This study evaluated the status of clinical trials conducted in Saudi Arabia that were registered on ClinicalTrials.gov between 2002 and June 2025. We assessed characteristics such as study designs, completion statuses, therapeutic areas, and sponsors. Our analysis revealed 474 studies investigating pharmacological or biological interventions, of which over half (52.95%) had been completed. Phase III trials (38.82%) were the most prevalent, followed by phase IV (16.03%). Almost 36.5% of the trials were funded by international pharmaceutical companies. Among the funding bodies sponsoring the trials, 54 (24.22%) were Saudi, with 77.78% of these being governmental institutions. Most of the studies were conducted across multiple centers, with Riyadh accounting for 56.79%, followed by Makkah (21.17%) and the Eastern Province (13.28%). Oncology (23.21%) was the most investigated medical field, followed by infectious diseases (12.87%) and endocrine and metabolic disorders (11.18%).

Despite the noticeable increase in the number of clinical trials conducted annually in Saudi Arabia, it remains significantly lower than might be expected given the country’s population of 35 million.¹⁴ Currently, 16.8 trials are conducted per million people in Saudi Arabia, compared to 341 trials per million in the US.¹⁵ Although there is no universally recommended number of clinical trials per million, this disparity highlights the excellent potential for growth in clinical research in Saudi Arabia. Nevertheless, Saudi Arabia’s significant contribution to the clinical trials landscape in the GCC area merits acknowledgment. A retrospective bibliometric analysis of interventional clinical trials conducted in the GCC region between January 2000 and October 2019 revealed that Saudi Arabia had the highest share, accounting for 66.6% of the clinical studies in the region.¹⁵ After the number of trials published for each nation was adjusted for population size to prevent bias, Saudi Arabia was ranked third after Qatar and Kuwait, with 16,846 trials per million population. The GCC region contribution, however, only represented 0.37% of the clinical trials conducted globally.¹⁵

In 2017, a previous retrospective study similarly evaluated the number of clinical trials conducted in Saudi Arabia that were registered on Clinicaltrials.gov, for the period spanning November 1999 to February 2016. That study reported a total of 405 trials in the region since the registry’s inception.¹⁶ By contrast, our study comprehensively evaluated the registry and identified 1055 total studies, of which we analyzed only those concerning pharmacological or biological agents. Our data showed that nearly 624 studies were added and included between the ten-year period spanning February 2016 to June 2025. Data from our previous study, published in 2021, described and evaluated all the studies that were submitted to the SFDA between 2009 and 2020, totaling 352.9 The higher number of studies included in our current study may be attributable to both its longer duration and the Kingdom of Saudi Arabia’s growing interest in clinical research.

In our study, over half of the trials conducted were phase III and IV studies. Phase III studies accounted for 38.82%, whereas phase IV studies accounted for 16.03%. Previous investigations have demonstrated that sponsors generally show higher levels of interest in phase III and IV studies than in phase I or II studies,⁹ implying a predominant focus on establishing safety and efficacy, as opposed to earlier-phase trials that tend to focus primarily on safety alone.

A significant proportion of the studies we analyzed (36.5%) were supported by international pharmaceutical companies, which aligns with the findings of similar previous studies.^9,16 A previous study of ours demonstrated that over two-thirds of the clinical trials we analyzed were sponsored by pharmaceutical companies and private hospitals.⁹ Ali et al¹⁶ reported that King Faisal Specialist Hospital and Research Centre, along with Bayer Pharmaceutical funded the most trials in the Kingdom. These findings suggest that there is a dependency on external funding sources over domestic ones for clinical trials in the country. The alignment between our present findings and those of previous similar studies indicates a long-standing reliance on the private sector to push clinical research. Furthermore, the fact that international pharmaceutical companies fund a significant proportion of medical research may prompt researchers in Saudi Arabia to focus more on commercial interests rather than locally defined public health priorities or diseases with less market value. However, this reality may also compromise a research system’s approach to health and raise ethical issues, with local research becoming at risk of losing independence by relying on external partners. Although this type of collaboration might not serve national health priorities, it can also encourage accountability if designed within a patient-centered model of care that includes capacity building and improvements to infrastructure. While these international advantages are crucial, domestic funding should also be strengthened to ensure the preservation of independent research, as well as initiatives with higher local relevance.

Approximately one-quarter of the sponsors identified in this study were Saudi-based, contributing a total of 35.88% of the research funding. Although this represents a meaningful contribution, it also reveals a significant disparity, with 75% of sponsorship stemming from non-Saudi entities. This imbalance suggests that domestic investment in clinical research remains limited, which highlights an opportunity to increase this percentage to ensure the long-term sustainability and independence of the research ecosystem in the kingdom. Notably, there was no presence of national pharmaceutical companies as sponsors for clinical trials included on ClinicalTrials.gov. This may suggest the lack of interest among national pharmaceutical companies regarding listing their clinical trials on the ClinicalTrials.gov site as such act is not mandatory by the SFDA. However, our previous study revealed that national pharmaceutical companies sponsored a total of 13 (3.9%) of all studies submitted to the SFDA, indicating a very low contribution to clinical research in the kingdom.⁹ A recent study collected multiple challenges, including a fragmented regulatory landscape, the scarcity of clinical coordinators, the absence of a data sharing culture, and payment challenges.¹⁷ We found that a total of 114 studies had more than one sponsor, reflecting the collective efforts being made in recent years to advance clinical research and improve patient care.

Compared to that in our previous study,⁹ the percentage of clinical trials that were conducted in Saudi Arabia’s capital city, Riyadh, increased from 51.76% to 56.79%, while the percentage conducted in the Makkah region decreased from 29.73% to 21.17% and that in the Eastern province remaining relatively constant at 13%. Therefore, the distribution of clinical studies appears to be geographically concentrated, in Riyadh, Makkah, and Eastern Province which may reflect a general imbalance in regional research capabilities in Saudi Arabia. Several studies have found that these areas are the main destinations for healthcare professionals. For example, studies of the dental manpower situation in the Kingdom of Saudi Arabia showed that more than 80% of Saudi dentists work in these areas and that many specialties, such as periodontology and orthopedics, have a similar regional distribution.^18-20 Furthermore, as was observed, such centralization of specialized healthcare services, including cancer centers, amplifies the disparity, which impedes research and access to care in outlying areas.²¹ These findings highlight the importance of specific interventions to improve the condition of medical research infrastructure and capabilities outside these cities.

This study demonstrated an upward trend in the number of clinical trials conducted annually in Saudi Arabia from 2002 to 2020. There was a notable decrease detected in 2021, with only 35 trials performed compared to the 53 done in 2020.²² This decline is likely attributable to the impact of the COVID-19 pandemic and the emerging shift of research toward observational studies, narrative reviews, and opinions concerning the clinicopathological aspects of the disease, as well as strategies for controlling and preventing the spread of its causative virus.²² Furthermore, the decline continued in subsequent years, which may reflect a reduction in the need to register the studies on the website in the presence of the SFDA’s Saudi Clinical Trials Registry.

This study was constrained by certain limitations that were inherent to its sole reliance on the ClinicalTrials.gov database. These limitations include inconsistencies in the reporting of study phases, current statuses, and the availability of results for completed trials, which may have hindered a fully comprehensive exploration of the scope of clinical trials being conducted in Saudi Arabia. The absence of specified locations for certain studies also impacted comprehensive data analysis and interpretation.

To mitigate these limitations, we recommend enhancements to the ClinicalTrials.gov platform to ensure the consistent reporting of location data. Future research might build on this work by comparing the GCC to the Middle East and Northern Africa regions, providing a broader assessment of their contributions to the global medical knowledge base. Nonetheless, this study was able to shed some light on the clinical research currently being conducted in Saudi Arabia, identify the key partners involved or sponsoring these initiatives, and inform decision makers concerning future resource allocations and directions related to the current research gaps.

In conclusion, Saudi Arabia needs to establish health priorities to enhance its clinical trial ecosystem, such as enhanced result reporting requirements, incentives for early-phase studies, and guidance that motivates domestic pharmaceutical companies to engage in clinical research. While a positive momentum is clear through the increasing number of studies over the past years, challenges remain, particularly with insufficient representation of local sponsors and early phases of clinical trials.

To maintain growth and drive healthcare advancements, Saudi Arabia may need to consider policies that include incentives for domestic pharmaceutical research and development, simplified and accelerated approval processes for domestic trials, and performance-based funding of priority health research in public institutions. Additionally, credibility and inclusivity throughout the research landscape can be enhanced by increasing transparency through compulsory result disclosure and fostering a decentralized research infrastructure.

Ultimately, the alignment of national clinical research agenda with ‘Vision 2030’ needs to be targeted at two levels: strengthening the local research capacity while promoting strategic global alliances anchored on public health relevance and ethical stewardship. This approach will help ensure a resilient, transparent, and impactful clinical research environment in the Kingdom.