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Young adults (19–24 years) commonly experience elevated rates of sleep disturbance, anxiety, and cognitive stress yet often underutilise formal mental-health services. Music therapy, binaural beats, and related auditory entrainment techniques offer accessible, non-pharmacological approaches that may enhance emotional regulation, cognition, and physiological stability.
Objective:
To systematically review interventional clinical trials published over the past decade evaluating music- and rhythm-based auditory interventions for mental-health and cognitive outcomes in young adults.
Methods:
A systematic search of PubMed/MEDLINE and PsycINFO (01 January 2015 – 01 January 2025) was conducted using the terms (music therapy OR binaural beats OR auditory entrainment) AND (mental health OR neurorehabilitation OR cognition OR anxiety OR depression). After screening 122 abstracts, 10 trials met inclusion criteria. Effect sizes (Cohen’s d) and 95% confidence intervals were extracted or estimated. Risk of bias was assessed using the Cochrane RoB-2 tool. The review protocol was registered in PROSPERO (CRD420251178490).
Results:
Interventions included bedtime music therapy, audiovisual stimulation, and binaural-beat exposure across laboratory, clinical, and rehabilitation settings. Most studies demonstrated significant or moderate improvements in at least one domain: anxiety reduction, stress physiology, mood regulation, sleep quality or cognitive performance (standardised mean differences 0.3–0.6).
Conclusions:
Evidence suggests that music-based and binaural-beat interventions can beneficially modulate sleep, anxiety, and cognitive processes in young adults. However, heterogeneity in design and small sample sizes limit the certainty of findings. Future adequately powered randomised controlled trials should address transdiagnostic mechanisms and long-term efficacy.
Opportunities for face-to-face interaction between sponsor-side clinical research associates (CRAs) and site-side clinical research coordinators (CRCs) have decreased with remote and risk-based monitoring, potentially impeding communication and mutual understanding – key determinants of team functioning. Accordingly, we implemented a reciprocal on-site training to enhance CRA-CRC mutual understanding and evaluated its impact.
Methods:
Seventeen sponsor staff, including 11 CRAs, joined an 8-hour hospital tour with CRC-guided process simulations and discussion; conversely, 14 hospital staff, including 11 CRCs, attended a 4-hour sponsor-office visit with system demonstrations and discussion. Self-assessed understanding of counterpart workflows and impressions of the counterpart group were rated pre- and post-training on 5-point Likert scales. Free-text feedback underwent text-mining analysis. Behavioral change was surveyed 6 months later.
Results:
CRAs improved on all 9 understanding items (e.g. “flow of daily medical practice:” median score 2.0 vs. 4.0, pre- and post-training, respectively, p < 0.0001); CRCs improved on 4 of 5. Positive impressions increased and negative impressions decreased in both groups (e.g. “bright atmosphere:” median 3.0 vs. 5.0 for CRAs, p = 0.0002; 3.0 vs. 5.0 for CRCs, p = 0.0044). Text-mining revealed the specific content participants learned, which included keywords reflecting this training’s objective of enhancing mutual understanding. At 6 months, 70% of CRAs and 88% of CRCs reported changes in their work behavior.
Conclusions:
A brief, reciprocal, on-site training improved CRA–CRC mutual understanding and perceptions, with sustained self-reported behavioral changes in work practices. From a team science perspective, such practical training may strengthen sponsor-site communication and collaboration.
Pre-approval access rights to potentially life-preserving experimental treatment is the focus of Chapter 7. The chapter considers whether people with life-threatening conditions should have a right to access possibly life-saving experimental treatments, as embodied in right to try laws. It argues that, despite their significant shortcomings, right to try laws bolster disability rights by seeking to advance the right to life and survival of people with life-threatening conditions beyond medically assisted dying.
Recruitment and retention of populations with limited prior participation in clinical trials remains a challenge. Thus, an increased understanding of the complex factors that impede or facilitate recruitment and retention is needed. Adapting the Systems Engineering Initiative for Patient Safety (SEIPS), we developed the Systems Engineering Initiative for Participant-Centric Research (SEIPR) framework that researchers can use to develop, implement, and evaluate interventions to increase trial participation.
Methods:
We performed a non-systematic literature review using the digital databases PubMed and Google Scholar to determine factors facilitating and impeding involvement of populations with limited prior participation in clinical trials. From this literature, we developed the SEIPR framework by applying it to the context of recruitment and retention.
Results:
We organized key obstacles and evidence-based solutions into five framework components: Person, Tasks and Tools, Technology, Physical Environment, and Organizational Conditions. Common obstacles included lack of awareness of active trials by participants and healthcare providers, patient’s distance from trial centers, lack of access to traditional advertising technology, and mistrust towards investigators, among others. Solutions included promotional strategies appropriate to the regional or social context, decentralizing trials, providing communication technology to participants, partnering with trusted members from the participant’s community and primary care team, using local connections and community centers, financial incentives, and transportation solutions.
Discussion:
The SEIPR framework presents a promising tool for investigators interested in increasing participant breadth in clinical trials. Future research is needed to explore real-world applications and assess its effectiveness in recruiting and retaining broad populations.
The emerging evidence for cannabis in the management of tics in Tourette syndrome has come almost exclusively from studies in adult patients. We now have two published feasibility studies of cannabis for adolescents with Tourette syndrome. Although both readily recruited adolescent participants, there was no explicit requirement for prior trials with standard evidence-based treatments. This is of concern given the known harms of regular cannabis use in adolescents, especially the association with psychosis. Investigating cannabis as an option for tics in adolescents with Tourette syndrome is worthwhile, but a high degree of caution is warranted.
Against a backdrop of rapidly expanding health artificial intelligence (AI) development, this paper examines how the European Union’s (EU) stringent digital regulations may incentivise the outsourcing of personal health data collection to low- and middle-income countries (LMICs), fuelling a new form of AI ethics dumping. Drawing on parallels with the historical offshoring of clinical trials, we argue that current EU instruments, such as the General Data Protection Regulation (GDPR), Artificial Intelligence Act (AI Act) and Medical Devices Regulation, impose robust internal safeguards but do not prevent the use of health data collected unethically beyond EU borders. This regulatory gap enables data colonialism, whereby commercial actors exploit weaker legal environments abroad without equitable benefit-sharing. Building on earlier EU responses to ethics dumping in clinical trials, we propose legal and policy pathways to prevent similar harms in the context of AI.
Leishmaniasis is a neglected parasitic disease responsible for significant morbidity and mortality. Currently, there is no vaccine approved for clinical use. Therefore, controlling infections in infected individuals depends on interventions to prevent infected female sand flies from biting humans, treatment of clinical infections or alternative treatment methods. This review focuses on the types of vaccine developed to control leishmaniasis and which vaccines have made it through to clinical trials. It also discusses the role CRISPR technology may play in improving vaccine candidates design.
Chronic pain research studies are important for both finding new treatments and improving existing treatments for individuals with chronic pain. For clinical trials to be effective, participants need to be engaged and willing to participate in treatment groups. Our research applies the theory of planned behavior (TPB) to understand how attitudes, perceived social norms, and perceived control over intervention engagement are associated with willingness to participate in interventions for chronic low back pain (CLBP).
Methods:
Adult Michigan Medicine patients were identified using electronic medical records and emailed a link to an online, cross-sectional survey. Participants who self-reported CLBP, ability to read and write in English, and consented to participate were able to complete the survey (N = 405).
Results:
The results showed more positive attitudes, positive social norms, and higher perceived behavioral control related to specific chronic low back pain interventions are associated with greater willingness to participate after controlling for demographic and pain-related characteristics.
Conclusion:
The findings suggest that TPB constructs may be useful in guiding recruitment efforts for chronic pain intervention trials.
Interest in psilocybin as a treatment for depression has risen over the past decade, fuelled by promising clinical trials and a rapidly evolving regulatory landscape. Media coverage plays a critical role in shaping public perceptions, yet little is known about how psilocybin is portrayed in global anglophone online news for the treatment of depression.
Methods:
This study examines the comprehensiveness and sentiment of English-language online news articles (n = 125) discussing psilocybin as a treatment for depression from January 2000 to May 2024. Articles were sourced from the top 30 global anglophone news outlets, assessed using a 13-item instrument for comprehensiveness, and analysed for sentiment across five thematic categories. A separate sub-analysis was completed for Irish media.
Results:
Findings indicate a significant increase in coverage over time, with 43.2% of articles published between 2022 and 2024, predominantly from the USA (68%). While 90.4% of articles cited researchers, fewer addressed risks (47.2%), long-term evidence (46.4%), or patient perspectives (25%). Sentiment analysis revealed a very positive sentiment across articles which was 2.27 on a scale from −5 (most negative) to + 5 (most positive) (SD 1.33), with no significant changes over the time period. Reporting on psilocybin’s onset and duration of effects increased significantly, reflecting growing clinical evidence. However, coverage remains concentrated in prominent outlets, with limited attention to patient experiences and long-term safety.
Conclusions:
These findings highlight the media’s role in shaping discourse on emerging treatments and suggest a need for more balanced reporting to align public understanding with scientific evidence. This study provides a foundation for future research on media portrayals of psilocybin and implications for public perception and policy.
There are currently no disease-modifying therapies for the frontotemporal dementias (FTD), but there are ways to enhance the lives of patients and their families by targeting the symptoms and stressors that arise. Accurate diagnosis and education are important for patients and families, and safety measures are necessary to prevent harm. Advanced care planning and caregiver support are critical for a chronic disease. Non-pharmacological treatments, such as behavioral management and a multidisciplinary approach, are recommended. The pharmacotherapy options include antidepressants, antipsychotics, and other medications, but there is limited evidence to support their use. This chapter provides information on clinical trials in FTD, including patient selection and enrollment, trial design, and potential disease-modifying treatments being explored. Further research is needed to develop effective treatments for FTD.
The National Institute for Health and Care Research has enabled the integration of world-leading science with clinical practice in the UK’s National Health Service, and has saved lives and improved lives as a result. However, this integration has not extended to mental health services. The case is made for a National Institute for Mental Health Research (NIMHR) to address this inequity.
Trust in biomedical research is essential, multidimensional, and shaped by individual experiences, culture, and communication. Participants’ trust relies on researchers’ commitment to ethical practices. As public trust in science declines due to misinformation and disinformation campaigns, biomedical researchers (BmRs) must ensure trust and cultivate trustworthiness. This study explores BmR’s perspectives on trust and trustworthiness.
Methods:
We employed a qualitative, phenomenological approach to explore the experiences of BmRs. Through purposive sampling via the Indiana Clinical and Translational Sciences Institute, we invited BmRs to participate in semi-structured interviews. We employed rapid qualitative analysis (RQA) to identify key themes from interviews with BmRs. This action-oriented approach enables a research team to efficiently summarize experiences and perspectives, using structured templates and matrixes for systematic analysis and interpretation.
Results:
Fourteen BmRs were interviewed. Volunteer demographics were collected for race/ethnicity, gender, faculty rank, and investigator experience level. The following domains were identified: individual trust and trustworthiness, institutional trustworthiness, and trust and equity as a crucial part of structural and social drivers of health.
Conclusion:
We recognize that BmRs are dedicated to health equity and addressing disparities. However, in addition to committing to “best practices,” BmRs should prioritize actions that foster genuine trust from the communities they serve. More development opportunities are needed for reflection of what it means to be trusted by research volunteers and communities. Furthermore, intentions alone aren’t sufficient; earned trust and trustworthiness are vital.
The ctrdata package has been created to boost the use of data available in public registers of clinical trials. It enables user-friendly, reproducible workflows to identify trials of interest, download protocol- and results-related data, and conduct sophisticated analyses, across multiple registers and trials. ctrdata works in the widely used R environment, and its databases can be used with other tools. The package is open source with a permissive licence, to facilitate collaboration.
This report provides an overview of ctrdata, including its implementation, cases of interest to researchers in public health, medicines, and regulatory science, as well as potential limitations and further developments. At this time, ctrdata works with the European Union (EU) Clinical Trials Information System (CTIS), the EU Clinical Trials Register (EUCTR), the US Clinicaltrials.Gov (CTGOV), and the ISRCTN—the UK’s Clinical Study Registry. The registers are complementary in scope and scientific value, yet differences in data models, variable definitions, search parametrisations, and retrieval options hamper efficient scientific workflows, calling for a scientific-technical, programmatic solution and driving the development of ctrdata.
By employing ctrdata to comprehensively use and easily leverage trial register data, researchers can effectively address a variety of questions, gain useful insights into evolving policies and practices of drug development, and inform further clinical research. Patients and their organisations, developers, policymakers, and other interested parties can build on ctrdata to create solutions for their use cases.
Recently, there has been growing awareness of the so-called ‘reproducibility crisis’ which refers to the failure to replicate the findings of many scientific studies. This may arise from the employment of questionable research practices, such as ‘p-hacking’ (conducting many statistical tests, and only reporting significant results), HARKING (hypothesising after the results are known), and outcome switching (promoting secondary outcomes to primary outcomes to fit unexpected results). Open Science practices, which encourage open methodology (including pre-registration of hypotheses and outcomes), open data (in a publicly accessible repository), and open access to publication (including pre-prints), are vital to combatting these. This chapter sets out how Open Science practices can be applied to psychiatric research, including consideration of challenges which can arise, such as how to share data safely and appropriately. The chapter includes an explanation of key principles and constructs, and explains how Open Science practises can be embedded throughout the life-cycle of a project, with practical how-to guides and sign-posting to further resources.
Despite representing 18% of the world’s population and 20% of the disease burden, only an estimated 2% of global clinical trials include at least one study site in Africa. This underscores the critical need for continued research on how to overcome clinical trial challenges on the continent. In countries with established reputations for clinical trials, Contract Research Organizations (CROs) play a vital role, accounting for half of the research workforce and effectively managing clinical trials for pharmaceutical, biotechnology, and medical device companies. In contrast, the potential of CROs in Africa’s clinical trials ecosystem remains largely unexplored. This narrative review discusses the challenges, opportunities, best practices, emerging trends, and prospects of clinical trials in Africa. Major challenges in clinical trial implementation in Africa stem from gaps in financial and human resources, infrastructure, and regulatory systems, while opportunities are linked to Africa’s large population, genetic diversity, disease burden, lower operating costs, positive economic outlook, and growing interest from global health and research players. Emerging trends, such as the decentralization of clinical trials and conducting trials during public health emergencies, offer promising avenues for maintaining research continuity. Ultimately, the paper proposes a context-specific framework, aimed at maximizing the effectiveness of CROs in the continent’s clinical trials ecosystem.
Underrepresentation of people of color in clinical trials limits equity in research and treatment outcomes. This study evaluated the impact of a brief, community-focused educational intervention on perceptions and willingness to participate. Participants attended 30-minute sessions (9 virtual, 2 in-person). Identical pre- and post-surveys were analyzed using paired t-tests with Bonferroni correction. Eighty-three participants (90.5% Black, 88.4% female; mean age 46.3) showed significant improvements in comfort with participation, randomization, belief in protections, willingness to participate, and comfort in skin-related trials (all p < 0.05). Brief education may improve understanding and participation attitudes in underrepresented groups.
Historically US-based academic organizations dedicated limited resources, including policies, personnel to ensuring compliance with clinical trials registration and results reporting requirements. A recent follow-up survey finds that 6-years after an initial survey, there is increased attention and dedication of resources to improve compliance rates for clinical trials registration and results reporting.
Methods:
Internet-based online survey using Qualtrics between 20 April 2023 and 30 September 2023 distributed to Protocol Registration and Results Reporting (PRS) Administrators at US-based academic organizations with ClinicalTrials.gov organizational accounts. The survey focused on the 249 respondents of the original 2016–2017 survey published in 2018. The overall response rate was 162/249 (65.06%) with 100% participation from National Cancer Center (NCI) Designated Cancer Centers and hubs of the Clinical and Translational Science Awards (CTSA).
Results:
Results indicated a marked increase of academic organizations with policies in place for registration (43 to 74%) and results reporting (35 to 68%). The median number of Full-time Equivalent (FTE) staff at responding academic organizations increased (from 0.08 to 0.5) with statistically significant difference between the number of organizational records and FTEs supporting registration and results reporting. Larger gains are seen with NCI-Designated Cancer Centers and/or CTSA hubs.
Conclusions:
It appears academic organizations are more equipped to comply with requirements, and demonstrate a trend towards appropriate staffing. In the 6 years since the original survey, US-based academic organizations have significantly increased attention to compliance with clinical trials registration and results reporting requirements, indicated by an increase in institutional policies and dedicated personnel.
Chapter 3, “Experiments in Risk: Women and Clinical Trials,” follows feminist advocates as they set out to use the law to mandate the inclusion of women in clinical trials. With the advent of HIV treatment, people with HIV began to survive longer. A new problem emerged: Women were being excluded from clinical trials due to a 1977 Food and Drug Administration (FDA) guideline concerned about the impact of experimental drugs on women’s reproduction and the fetus. Not only did this mean that women could not access experimental treatments, it also resulted in confusion around how to treat women with HIV. Feminists began to advocate for a change in the FDA guidance which was excluding women from clinical trials. In keeping with the broader demands in the feminist movement at the time, feminists asserted that women should be able to choose to enroll in trials despite potential exposure to risks. Buoyed by ideas of choice and bodily autonomy, feminist AIDS activists were able to undo the FDA’s reticence to enroll women in clinical trials altering scientific research in HIV and beyond.