Worldwide, there was a large increase in the average total number of patients per clinical drug trial from 2019 to 2023. This statistic shows the average number of patients per clinical drug trial started worldwide from 2012 to 2023.

Worldwide, there was an increase in the average number of subjects per clinical drug trial for each phase between 2019 and the end of 2020. This statistic shows the average number of subjects per clinical drug trial started worldwide between 2015 and November 2020, by trial phase.

In the pandemic years 2020 to 2023, the average number of sites per clinical drug trial worldwide was relatively stable, with of 18 in 2021. This statistic shows the average total number of sites per clinical drug trial worldwide from 2012 to 2023.

This statistic displays the average number of patients per clinical trial in selected countries in Europe from 2005 to 2011. In this period, Germany had the largest number of patients entering clinical trials with an average of *** patients per clinical trial.

Clinical studies are an important part of drug development globally. The number of registered clinical trials has increased significantly recently. As of June 13, 2025, there were over *** thousand clinical studies registered globally. The number of clinical studies has increased significantly since there were just ***** registered in 2000. In general, clinical trials have grown more complex in recent years and remain vital for the research and development of new drugs and products. Research and development Research and development are an essential part of pharmaceutical companies and includes drug development and product development. Among all industry sectors, the pharmaceutical industry spends the largest percentage of their revenue on research and development. Many companies are active in pharmaceutical research and development globally. It is projected Swiss company Roche will remain one of the largest research and development spenders among pharmaceutical companies in the near future. Clinical studies globally Most clinical studies occurring globally are held in countries outside the U.S. Many clinical trials performed outside the U.S. and EU are done so because it is often easier and cheaper to conduct trials in other locations. Success rates for clinical trials depend heavily on the stage of the trial and the drugs or products being developed. Recent data suggested that only around ** percent of drugs make it from phase II to phase III.

Background: Clinical trials have been widely recognized as an effective treatment approach by physicians and cancer patients alike. Physicians’ evaluations suggest that many patients are likely to continue experiencing benefits from extended dosing of investigational new drugs even after withdrawing from clinical trials.Objective: Given the uncertainty surrounding the efficacy and safety of investigational new drugs, it is essential to continually assess the benefits of extended dosing for patients.Methods: The trial group for this study comprised patients who requested extended dosing after withdrawing from clinical trials at Hunan Cancer Hospital between 2016 and 2020. The control group consisted of patients who received conventional treatment and were enrolled in a 1:1 ratio. Follow-up assessments were conducted every 3 months for both groups, and included monitoring of patients’ health status, survival time, disease control or remission, treatment modalities received, and medical costs.Results: A total of twenty-three patient pairs were successfully matched for this study. The Ethics Committee approved extended dosing for all patients in the trial group, with an average gap period of 16.48 days between their withdrawal from clinical trials and continuous access to the investigational drugs. The median overall survival for patients after withdrawal from clinical trials was 17.3 months in the extended dosing group and 12.9 months in the control group, with no significant difference observed between the two groups (p > 0.250). The median total cost of treatment after the previous clinical trial was 38,006.76 RMB, of which the median cost of therapeutic drugs for conventional treatment was 15,720 RMB, while extended dosing was provided free of charge.Conclusion: Extended dosing can indeed provide benefits, including survival benefits and economic benefits, to cancer patients after their withdrawal from clinical trials and will clinically present an additional treatment option for patients.

Clinical Trials Management System Market size was valued at USD 1177.91 Million in 2023 and is projected to reach USD 3294.64 Million by 2031, growing at a CAGR of 13.72% from 2024 to 2031.

Key Market Drivers: • Growing Complexity of Clinical Trials: The increasing complexity of clinical trials necessitates sophisticated management systems. According to the United States Food and Drug Administration (FDA), the average number of endpoints in pivotal trials for new medications approved in 2022 was 8.2, up from 5.7 in 2012, indicating a 44% increase in trial complexity over ten years. • Increasing Number of Clinical Trials Globally: The increasing number of clinical trials worldwide is a significant driver of the CTMS market. According to ClinicalTrials.gov, the number of registered studies grew from 329,724 in 2020 to over 425,000 by early 2024, a 29% increase in four years. • Increasing Adoption of Decentralized and Virtual Clinical Trials: The COVID-19 pandemic has expedited the use of decentralized and virtual clinical trials, creating a demand for improved CTMS systems. According to a Tufts Center for the Study of Drug Development report from 2023, 60% of clinical trials included at least one decentralized element, up from 33% in 2020.

Between 2019 and the end of 2020, there was a 40 percent decrease in the average number of sites per clinical drug trial worldwide. This statistic shows the average number of sites per clinical drug trial started worldwide from 2015 to 2020, by trial phase.

Clinical Trial Management System Market Outlook 2032

The global Clinical Trial Management System Market size was USD 1.94 Billion in 2023 and is projected to reach USD 6.52 Billion by 2032, expanding at a CAGR of 14.4% during 2024–2032. The increasing complexity of clinical trials and the growing need for efficient data management solutions drives the market.



Increasing emphasis on decentralized clinical trials propels the market. Innovations in remote monitoring and patient management technologies enable trials to extend beyond traditional settings, reducing patient burden and expanding recruitment pools. This shift necessitates robust CTMS platforms capable of supporting complex, multi-location trials, ensuring data integrity and regulatory compliance across diverse geographies.

Surging interest in cloud-based CTMS solutions transforms the market landscape. These platforms offer scalability, enhanced security, and cost-effectiveness, facilitating seamless collaboration between stakeholders globally. The ability to rapidly deploy updates and integrate with other eClinical tools streamlines trial management processes, driving efficiency in study operations.

• In July 2023, RealTime Software Solutions, LLC, a prominent supplier of cloud-based software for the clinical research sector, declared its purchase of Devana Solutions, LLC, a pioneering SaaS company focused on workflow and analytics solutions for clinical trials. This acquisition represents a strategic step toward offering the market's most extensive and sophisticated end-to-end platform for research sites.

Increasing prioritization of patient-centric strategies in clinical research underscores the need for advanced CTMS capabilities. Systems that support direct patient engagement, remote consent, and real-time data access empower participants and improve retention rates. This trend toward patient-centeredness demands CTMS solutions that are flexible and user-friendly, enhancing the overall trial experience for participants.

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The Interactive Response Technology (IRT) market in clinical trials is experiencing robust growth, driven by increasing demand for efficient and compliant clinical trial management. The market size in 2025 is estimated at $25.89 billion, representing a significant expansion from previous years. While the provided CAGR is missing, considering the industry's average growth rate and the adoption of IRT across various clinical trial phases, a conservative estimate of the Compound Annual Growth Rate (CAGR) between 2025 and 2033 would be around 8%. This implies considerable market expansion, reaching an estimated value exceeding $50 billion by 2033. This growth is fueled by several factors: the rising complexity of clinical trials, the need for enhanced data management and patient safety, and a growing preference for automated systems that minimize manual intervention and human error. Furthermore, the increasing adoption of decentralized clinical trials (DCTs), leveraging telemedicine and remote patient monitoring, necessitates sophisticated IRT systems for effective drug dispensing and data collection. The competitive landscape is highly fragmented, with a mix of established players like IBM, Veeva Systems, and Oracle, alongside specialized IRT providers such as Calyx, Almac, and Medpace CRO. These companies are constantly innovating to improve IRT functionalities, including advanced analytics, integration with electronic data capture (EDC) systems, and improved user interfaces. Future growth will be shaped by ongoing technological advancements such as AI and machine learning in IRT platforms, as well as the increasing regulatory scrutiny requiring better data integrity and traceability within clinical trials. The global reach of clinical trials also ensures continuous expansion opportunities for IRT providers across various geographical regions.

Number of patients that can be manipulated before, on average, the manipulation is detected by the “tadpole test”.

BackgroundClinical treatment trials are increasingly being designed in primary mitochondrial disease (PMD), a phenotypically and genetically heterogeneous collection of inherited multi- system energy deficiency disorders that lack effective therapy. We sought to identify motivating factors and barriers to clinical trial participation in PMD.MethodsA survey study was conducted in two independent mitochondrial disease subject cohorts. A discovery cohort invited subjects with well-defined biochemical or molecularly- confirmed PMD followed at a single medical center (CHOP, n = 30/67 (45%) respondents). A replication cohort included self-identified PMD subjects in the Rare Disease Clinical Research Network (RDCRN) national contact registry (n = 290/1119 (26%) respondents). Five-point Likert scale responses were analyzed using descriptive and quantitative statistics. Experienced and prioritized symptoms for trial participation, and patient attitudes toward detailed aspects of clinical trial drug features and study design.ResultsPMD subjects experienced an average of 16 symptoms. Muscle weakness, chronic fatigue, and exercise intolerance were the lead symptoms encouraging trial participation.Motivating trial design factors included a self-administered study drug; vitamin, antioxidant, natural or plant-derivative; pills; daily treatment; guaranteed treatment access during and after study; short travel distances; and late-stage (phase 3) participation. Relative trial participation barriers included a new study drug; discontinuation of current medications; disease progression; daily phlebotomy; and requiring participant payment. Treatment trial type or design preferences were not influenced by population age (pediatric versus adult), prior research trial experience, or disease severity.ConclusionsThese data are the first to convey clear PMD subject preferences and priorities to enable improved clinical treatment trial design that cuts across the complex diversity of disease. Partnering with rare disease patient communities is essential to effectively design robust clinical trials that engage patients and enable meaningful evaluation of emerging treatment interventions.

The following is an information retrieval test collection that contains:

• 204,855 publicly available clinical trails was crawled from ClinicalTrials.gov.
• 60 topics made up of three types: patient case descriptions, patient case summaries and assessor provided ad-hoc queries, totalling an average of 10.2 queries per topic.
• 4,000 assessor provided relevance assessment for topic, trial pairs.

Further details about the test collection can be found in the following publication:

B. Koopman and G. Zuccon. A test collection for matching patient trials. In Proceedings of the 39th annual international ACM SIGIR conference on research and development in information retrieval, Pisa, July 2016.

These are peer-reviewed supplementary materials for the article 'Characterization of medical device randomized controlled trials with adaptive designs' published in the Journal of Comparative Effectiveness Research.Supplemental Table 1: List of Medical Device RCTs with Adaptive DesignsReferencesSearch strategies for medical device RCTs with adaptive designsReferencesAim: Adaptive designs are frequently used in drug randomized controlled trials (RCTs). However, their use in medical device RCTs remains unclear. We aimed to characterize medical device RCTs with adaptive designs. Materials & methods: We searched for adaptive RCTs in the following databases: ClinicalTrials.gov, International Clinical Trials Registry Platform and the International Standard Randomised Controlled Trial Number registry. Adaptive design keywords and medical device corporation names were used as terms to search the trial records registered between 1 January 2000 and 18 October 2024 in the databases. The annual number and proportions of adaptive trials were analyzed, and characteristics such as design type, sponsor, therapeutic area, trial stage and regulatory status were summarized. Results: Overall, 105 adaptive RCTs were identified from ClinicalTrials.gov, accounting for 2.112 per 1000 trials in 49,721 medical device clinical trials registered in ClinicalTrials.gov during the period. The average annual number of adaptive RCTs per 1000 clinical trials was the highest (8.55 ± 11.65) during 2005–2010, reduced to 3.33 ± 2.35 during 2011–2016, and significantly decreased to 1.29 ± 0.85 during 2017–2024 (p = 0.011). The most common adaptive designs were group sequential design (GSD, 50.5%), sample size reassessment (SSR, 17.1%) and investigating both superiority and non-inferiority (10.5%). Most RCTs were sponsored by the private sector (62.9%), conducted in Europe/North America (95.2%), in the field of heart disease (46.7%) and post-market trials (76.2%). Compared with pre-market RCTs, post-market RCTs showed more diverse adaptive designs such as response-adaptive randomization and adaptive enrichment. Conclusion: The average annual proportions of adaptive medical device RCTs in ClinicalTrials.gov has reduced in the last 10 years. The most-used adaptive designs in medical device RCTs are GSD, SSR and investigating both superiority and non-inferiority.

The size of the Global Neurology Clinical Trials Market was valued at USD XX Million in 2023 and is projected to reach USD XXX Million by 2032, with an expected CAGR of 4.35% during the forecast period. Global Neurology Clinical Trials is in steady growth due to the high incidence of neurological disorders, the development of medical research activities, and the need for better treatments. Neurodegenerative disorders like Alzheimer’s, Parkinson’s, multiple sclerosis, epilepsy, and migraine are increasing in occurrence with the increased average global life expectancy thus the demand for neurotherapeutic interventions. Clinical trials are necessary not only to introduce new medications to the big variety of patients suffering from these disorders but also to present new approaches in drug delivery, medical devices, and gene therapy. The market is also growing because of positive changes in trial approaches such as digital health, remote monitoring, and design. These changes make clinical trial more efficient, less costly and enhance patient enrollment and retention. Global top pharmaceuticals and CROs as well as academic centers are expanding their neurology trial portfolios and exploring the roles of precision medicine, biomarkers, and personalized treatments. However there has been enhancement in the interest in neurological conditions, news cience research in the neurosciences is encourage the influx of investment in the clinical trials for the neurology clinical trials. However, there are numerous issues like high costs, very long trial periods, and several government restraints; however, a greater number of markets are expected to increase because advances in cure and technology offer more chance to clinical research. Recent developments include: In May 2022 Alzamed announced the initiation of Phase II A multiple ascendung dose clinical trail for AL001 treatment of Dementia related to Alzheimer's., In March 2022, AbbVie announced plans to present 30 abstracts demonstrating its breadth of Neuroscience Portfolio and Pipeline, including continued migraine treatment research across the spectrum of the disease, commitment to patients with advanced Parkinson's disease, and new studies in spasticity and cervical dystonia at the at American Academy of Neurology (AAN) 2022 Annual Meeting.. Key drivers for this market are: Increasing number of companies Conducting Clinical Trials in Neurology, Rising Prevalence of Various Neurological Diseases; Increasing R&D Investments and Government Funding Towards Neurological Research. Potential restraints include: Stringent Regulatory Demand, High Failure Rates and Increasing Cost of Clinical Trials. Notable trends are: Alzheimer’s Disease by Indication is Expected to Grow Over the Forecast Period.

GlobalData's clinical trial report, “Down Syndrome Disease – Global Clinical Trials Review, H2, 2020" provides an overview of Down Syndrome Clinical trials scenario. This report provides top line data relating to the clinical trials on Down Syndrome. Report includes an overview of trial numbers and their average enrollment in top countries conducted across the globe. The report offers coverage of disease clinical trials by region, country (G7 & E7), phase, trial status, end points status and sponsor type. Report also provides prominent drugs for in-progress trials (based on number of ongoing trials). GlobalData Clinical Trial Reports are generated using GlobalData’s proprietary database – Pharma – Clinical trials database. Clinical trials are collated from 80+ different clinical trial registries, conferences, journals, news etc across the globe. Clinical trials database undergoes periodic update by dynamic process. Read More

This is the fourth round of the physician survey component of the Community Tracking Study (CTS). The first round was conducted in 1996-1997 (ICPSR 2597), the second round in 1998-1999 (ICPSR 3267), and the third in 2000-2001 (ICPSR 3820). Sponsored by the Robert Wood Johnson Foundation, the CTS is a large-scale investigation of changes in the American health care system and their effects on people. As in the previous rounds, physicians were sampled in the 60 CTS sites: 51 metropolitan and 9 nonmetropolitan areas that were randomly selected to form the core of the CTS and to be representative of the nation as a whole. However, the fourth round lacks an independent supplemental national sample of physicians, which augmented the CTS site sample in the previous rounds. Information collected by the survey includes net income from the practice of medicine, year of birth, sex, race, Hispanic origin, year of graduation from medical school, specialty, board certification status, compensation model, patient mix (e.g., race/Hispanic origin of patients and percent with chronic conditions), career satisfaction, practice type, size, and ownership, percent of practice revenue from Medicare, Medicaid, or managed care, acceptance of new Medicaid and Medicare patients and, if applicable, reasons for not accepting them, use of information technology for care management, number of patient visits and hours worked in medically related activities during the last complete week of work, and the number of hours spent providing charity care in the last month. In addition, the survey elicited views on a number of issues such as patient-physician interactions, competition among practices, the influence of financial incentives on the quantity of services provided to patients, trends in the amount and quality of nursing support, one's ability to provide quality care and obtain needed services for patients, and the importance of various factors that may limit the quality of care. Part 3, the Site and County Crosswalk Data File, identifies the counties that constitute each CTS site. Part 4, Physician Survey Summary File, contains site-level estimates and standard errors for selected physician characteristics, e.g., the average age of physicians, the average percentage of patients with a formulary, and the percentage of physicians who said medical errors in hospitals are a minor problem.

Background: Hidradenitis suppurativa (HS) is a chronic inflammatory disease that disproportionally affects women, as well as Black and biracial individuals. While adalimumab remains the only therapy approved by the Food and Drug Administration for HS, many HS clinical trials for novel and re-tasked therapies are ongoing or upcoming. To optimize treatment equity, reflect the patient population, and facilitate trial participation, it is important to elucidate aspects of clinical trial protocols that may systematically exclude specific patient groups or impose hardships. Objective: The study aimed to systematically review inclusion and exclusion criteria as well as participant demographics in HS clinical trials. Methods: A literature search of PubMed, Embase, Cochrane Central, and Web of Science databases was conducted. Peer-reviewed publications of randomized controlled trials that were written in English and had at least 10 participants were included. Title and abstract screening and data extraction were completed by two independent reviewers, with disagreements resolved by a third. Results: Twenty-three studies totaling 1,496 adult participants met the inclusion criteria. Race and ethnicity were not reported in 473/1,496 (31.6%) and 1,420/1,496 (94.9%) trial participants, respectively. Trial participants were predominantly white (811/1,023, 79.3%) and female (1,057/1,457, 72.5%). The median of each study’s average age was 35.7 years (IQR 33.5–38.0), and 17/23 (73.9%) trials excluded pediatric patients. Nearly all participants had Hurley Stage II (499/958, 52.0%) or Hurley Stage III (385/958, 40.2%) disease. Many trials excluded patients who were pregnant (19/23, 82.6%) and breastfeeding (13/23, 56.5%), or who had HS that was “too severe” (8/23, 34.8%) or “too mild” (16/23, 70.0%). Frequently, trial protocols required prolonged washout periods from HS therapies, relatively long duration in the study’s placebo arm, and prohibited concurrent analgesic use. Conclusions: This systematic review of 23 HS clinical trials totaling 1,496 participants identified substantial hardships imposed by trial participation, high rates of missing race and ethnicity data, and low representation of key patient groups, including those who identify as Black. Future trials with pragmatic study designs, broader inclusion criteria, and study sites in diverse communities may alleviate burdens of trial participation and improve enrollment of diverse patient groups.

GlobalData's clinical trial report, “Gastroparesis Disease – Global Clinical Trials Review, H2, 2020" provides an overview of Gastroparesis Clinical trials scenario. This report provides top line data relating to the clinical trials on Gastroparesis. Report includes an overview of trial numbers and their average enrollment in top countries conducted across the globe. The report offers coverage of disease clinical trials by region, country (G7 & E7), phase, trial status, end points status and sponsor type. Report also provides prominent drugs for in-progress trials (based on number of ongoing trials). GlobalData Clinical Trial Reports are generated using GlobalData’s proprietary database – Pharma – Clinical trials database. Clinical trials are collated from 80+ different clinical trial registries, conferences, journals, news etc across the globe. Clinical trials database undergoes periodic update by dynamic process. Read More

GlobalData's clinical trial report, “Cachexia Global Clinical Trials Review, H2, 2018" provides an overview of Cachexia clinical trials scenario. This report provides top line data relating to the clinical trials on Cachexia. Report includes an overview of trial numbers and their average enrollment in top countries conducted across the globe. The report offers coverage of disease clinical trials by region, country (G7 & E7), phase, trial status, end points status and sponsor type. Report also provides prominent drugs for in-progress trials (based on number of ongoing trials). GlobalData Clinical Trial Reports are generated using GlobalData’s proprietary database – Pharma eTrack Clinical trials database. Clinical trials are collated from 80+ different clinical trial registries, conferences, journals, news etc across the globe. Clinical trials database undergoes periodic update by dynamic process. Read More