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BACKGROUND: Tryptase, a mast cell protease, has been identified as a potential therapeutic target in managing patients with refractory asthma. We assessed the efficacy, safety, pharmacokinetics, and pharmacodynamics of MTPS9579A, an anti-tryptase antibody, in a phase 2a randomized trial for patients with uncontrolled asthma and a phase 1c trial to understand activity within the lower respiratory tract. METHODS: Phase 2a patients (n = 134) received 1800 mg MTPS9579A or placebo intravenously every 4 weeks for 48 weeks. The primary endpoint was time to the first composite exacerbation event. Phase 1c patients (n = 27) received one intravenous dose of 300 or 1800 mg MTPS9579A or placebo. Both trials measured MTPS9579A concentrations and effects on tryptase in serum and nasal lining fluid; phase 1c also analyzed bronchial lining fluid. RESULTS: MTPS9579A did not meet the primary endpoint (hazard ratio = 0.90; 95% CI: 0.55-1.47; p = 0.6835); exacerbation rates in the placebo group were low. Serum and nasal MTPS9579A pharmacokinetics and tryptase levels were consistent with data from healthy volunteers. However, in phase 1c patients, compared to nasal levels, MTPS9579A bronchial concentrations were 6.8-fold lower, and bronchial active and total tryptase levels were higher (119-fold and 30-fold, respectively). Pharmacokinetic/pharmacodynamic modeling predicted intravenous doses of 3800 mg every 4 weeks would be necessary to achieve 95% active tryptase inhibition from baseline. CONCLUSIONS: The MTPS9579A dose tested in the phase 2a study was insufficient to inhibit tryptase in bronchial lining fluid, likely contributing to the observed lack of efficacy.

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Proper and timely characterization of the safety profile of a pharmaceutical product under development is imperative for assessing the overall benefit-risk relationship of the product and for making key development decisions. For ongoing clinical development, a comprehensive and robust safety monitoring and safety signal detection program which is based upon quantitative statistical reasoning is critical. Methods presented here can be applied to safety signal detection and periodic safety monitoring. Various statistical properties, distributions, and models, all utilizing a Bayesian framework are considered and further examined in order to identify robust methods applicable to a broad set of scenarios and situations. Methods developed for incidence counts (including those with under-dispersed distributions) with variable time-at-risk and with underlying constant or non-constant hazard rates, are proposed and compared to traditional methods designed to assess adverse event incidence rates or binomial incidence proportions (which assume an underlying constant hazard rate and subsequent Poisson distribution for modeling event counts).

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Anti-obesity medications (AOMs) have emerged as one element of comprehensive obesity clinical care intended to improve long-term health outcomes for children and adolescents. The number of pediatric AOM clinical trials has burgeoned in recent years as new pharmacotherapeutics have been developed. Factors related to growth and development in children and adolescents can present unique challenges in terms of designing and conducting clinical trials investigating the safety and efficacy of AOMs. These barriers can delay the AOM development and evaluation process, increase the cost of performing trials, create challenges in the interpretation of results, influence the generalizability of the findings and present ethical dilemmas. In an effort to address these issues and provide guidance to streamline the process of designing and conducting pediatric AOM clinical trials, relevant key stakeholders convened a series of roundtable meetings to discuss, debate and achieve harmonization on design features. Stakeholder participants included a multidisciplinary group of international pediatric obesity experts, patient (parent) representatives and representatives from academic medicine, key regulatory agencies and industry. Topics of discussion included primary efficacy end-points, secondary end-points, eligibility criteria, trial run-in and follow-up phases, use of active comparators and guidelines for down-titration and/or stopping rules for excessive weight reduction. Consensus recommendations were agreed upon. Regarding end-points, emphasis was placed on moving away from BMI z-score as a primary outcome, incorporating multiple alternative BMI-related outcomes and measuring adiposity/body fat as a prominent secondary end-point. Trial eligibility criteria were carefully considered to maximize generalizability while maintaining safety. The limited value of trial run-in phases was discussed. It was also underscored that designing trials with extended follow-up periods after AOM withdrawal should be avoided owing to ethical issues (including possible psychological harm) related to weight regain without providing the opportunity to access other treatments. The panel emphasized the value of the randomized, placebo-controlled trial but recommended the thoughtful consideration of the use of active comparators in addition to, or instead of, placebo to achieve clinical equipoise when appropriate. Finally, the panel recommended that clinical trial protocols should include clear guidance regarding AOM down-titration to avoid excessive weight reduction when applicable.

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Ophthalmic diseases include a wide array of conditions, each requiring individualized treatment approaches. In ophthalmic research and as therapeutics against potential pharmacological indications, several subtypes of exosomes (EVs) have been reconnoitered, mainly for their regenerative, neuroprotective, and anti-inflammatory characteristics. EVs are recently gaining wider attention as promising vehicles for therapies because of their natural participation in communication between cells and targeted delivery. These small vesicles, derived from cells, transport numerous molecules between cells, thus contributing advantages like low immunogenicity, stability, and the ability to target cells specifically. These inherent advantages of carrying the therapeutic cargo and enabling intercellular signaling make them a captivating avenue for progressing ophthalmic disease treatment options. While research is ongoing, and clinical applications are still emerging, several EV subtypes have shown promise for possible applications in addressing several ophthalmic diseases, such as glaucoma, age-related macular degenerative disorders, retinal degenerative disorders, and ocular inflammatory conditions.

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INTRODUCTION: This review addresses the prevalence of hypersexual behavior in Parkinson's patients and the underlying neurobiological mechanisms, identifying risk and protective factors, comparing incidence among different treatments, and proposing recommendations for management and prevention. OBJECTIVE: To conduct a review on the relationship between Parkinson's disease and hypersexual behavior as a result of pharmacological treatment. METHODOLOGY: The search strategy, guided by PRISMA and PICOS criteria, focuses on the correlation between Parkinson's disease and hypersexual behavior due to pharmacological treatment. Utilizing databases like PubMed and Proquest, studies from the last 10 years in English or Spanish were selected, emphasizing clinical trials with Parkinson's patients under treatment. Inaccessible, irrelevant, or mixed-sample studies were excluded. The Cochrane Scale assessed the risk of bias. RESULTS: Out of 122 records, 103 remained after eliminating duplicates; 48 were reviewed, and ultimately, 6 studies met the inclusion criteria for analysis. CONCLUSIONS: Synthesizing the risk and protective factors linked to hypersexual behavior in Parkinson's patients receiving pharmacological treatment underscores the critical need for early detection and incorporation of these factors into clinical care. The suggested guidelines for managing and preventing hypersexual behavior in these patients carry substantial practical implications.

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BACKGROUND: Tobacco use (smoking) causes adverse clinical outcomes among patients with cancer, including increased cancer-related mortality. In participants in cancer clinical trials, the prevalence of tobacco use and the factors associated with tobacco use are not well described. METHODS: Data were examined from participants enrolled in SWOG cancer clinical treatment trials between 2016 and 2022 who reported their smoking status at trial enrollment. Baseline variables (smoking status, insurance type, zip code, and demographic factors) were obtained from patient registration forms. Bivariate and multivariable associations were examined via logistic regression. RESULTS: Among 4326 patients enrolled in 29 trials, 48.1% reported currently/previously smoking, including 12.4% currently, 4.9% recently, and 30.7% formerly. Ever smoking was more commonly reported in males, patients aged ≥65 years, patients with Medicaid or no insurance, patients from areas of high socioeconomic deprivation, and rural patients. Patients of Hispanic ethnicity and Asian and Pacific Islander patients were less likely to have ever smoked. In multivariable regression, patients with lung cancer were most likely to report ever smoking compared to patients with breast cancer (odds ratio, 4.98; p < .001). CONCLUSIONS: In the first comprehensive evaluation of smoking status among trial participants enrolled in National Cancer Institute network group treatment trials, nearly half reported ever smoking and one in six reported current or recent smoking. Smoking was more common among vulnerable population patients defined by demographic and socioeconomic factors. Tobacco use should be routinely assessed and reported in clinical trials to help reduce the negative cancer and overall health effects of persistent tobacco use and to address disparities among patients with cancer.

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WHAT IS THIS SUMMARY ABOUT?: This is a summary of the article discussing the results of the CAPItello-291 study. In the study, participants had advanced breast cancer that could not be completely removed with surgery, and that was diagnosed as a type of breast cancer where tumor cells had hormone receptors (HR-positive) but did not have HER2 receptors (HER2-negative). All participants were also required to have previously received treatment with a type of therapy called an aromatase inhibitor (with or without a CDK4/6 inhibitor), but over time their cancer cells had still grown or spread. The CAPItello-291 study researchers wanted to find out if a treatment combination of the medications capivasertib plus fulvestrant worked better than placebo plus fulvestrant. Capivasertib is a drug that blocks the activity of a protein called AKT, which is found inside breast cancer cells. WHAT ARE THE KEY TAKEAWAYS?: The main finding was that participants who took capivasertib plus fulvestrant lived longer without their disease getting worse (progressing) compared with those treated with placebo plus fulvestrant. This is called progression-free survival. This result was seen across all participants (median progression-free survival of 7.2 months with capivasertib plus fulvestrant vs 3.6 months with placebo plus fulvestrant). It was also seen in participants whose tumors had detectable genetic alterations in genes called PIK3CA, AKT1, and/ or PTEN (median progression-free survival of 7.3 months with capivasertib plus fulvestrant vs 3.1 months with placebo plus fulvestrant). The most common side effects experienced by participants included diarrhea and different types of rash. These were as expected (given how capivasertib works). The CAPItello-291 study is still ongoing, and more results are expected to be released in the future. WHAT WERE THE MAIN CONCLUSIONS REPORTED BY THE RESEARCHERS?: Results from the CAPItello-291 study showed that capivasertib plus fulvestrant compared with placebo plus fulvestrant improved progression-free survival in participants with HR-positive/ HER2-negative advanced breast cancer whose cancer had grown or spread despite hormone therapy (with/without a CDK4/6 inhibitor).Clinical Trial Registration: NCT04305496 (CAPItello-291) (ClinicalTrials.gov).

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BACKGROUNDFrailty significantly affects morbidity and mortality rates in the older population (age >65 years). Age-related degenerative diseases are influenced by the intestinal microbiota. However, limited research exists on alterations in the intestinal microbiota in frail older individuals, and the effectiveness of prebiotic intervention for treating frailty remains uncertain.OBJECTIVEWe sought to examine the biological characteristics of the intestinal microbiome in frail older individuals and assess changes in both frailty status and gut microbiota following intervention with a prebiotic blend consisting of inulin and oligofructose.METHODSThe study consisted of 3 components: an observational analysis with a sample size of 1,693, a cross-sectional analysis (n = 300), and a multicenter double-blind, randomized, placebo-controlled trial (n = 200). Body composition, commonly used scales, biochemical markers, intestinal microbiota, and metabolites were examined in 3 groups of older individuals (nonfrail, prefrail, and frail). Subsequently, changes in these indicators were reevaluated after a 3-month intervention using the prebiotic mixture for the prefrail and frail groups.RESULTSThe intervention utilizing a combination of prebiotics significantly improved frailty and renal function among the older population, leading to notable increases in protein levels, body fat percentage, walking speed, and grip strength. Additionally, it stimulated an elevation in gut probiotic count and induced alterations in microbial metabolite expression levels as well as corresponding metabolic pathways.CONCLUSIONSThe findings suggest a potential link between changes in the gut microbiota and frailty in older adults. Prebiotics have the potential to modify the gut microbiota and metabolome, resulting in improved frailty status and prevention of its occurrence.TRIAL REGISTRATIONClinicalTrials.gov NCT03995342.

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OBJECTIVE: To evaluate the effect of rapid palatal expansion (RPE) using Haas-type expanders on children's oral health-related quality of life (OHRQOL) and compare said effect with that previously reported for the use of Hyrax-type expanders. MATERIALS AND METHODS: Forty participants aged 8-10 years with transverse maxillary deficiency were treated using Haas appliances. OHRQOL was measured using the CPQ8 - 10 before RPE, during RPE (T1), at the end of RPE (T2), and 1 month after appliance removal (T3). Generalized mixed models were fitted to assess the effect of the Haas-type expander compared to previously collected data (a nontreated and a Hyrax-type expander-treated group). RESULTS: RPE with Haas-type appliances had a negative impact on overall OHRQOL at T1 and T2 (P = 0.001), and a positive impact at T3 (P = 0.001). The Haas-type expander had a significantly greater negative impact on OHRQOL than the Hyrax-type appliance during RPE. At T1, overall scores using the Haas-type expander were 1.08 times the scores using the Hyrax-type expander (i.e., 8% increase; 95% CI, 1.01-1.17; P = 0.033). Patients using the Haas appliance had 1.24 times the scores of those using Hyrax-type devices for the oral symptoms domain at T1 (i.e., 24% increase; 95% CI, 1.06-1.46; P = 0.009). CONCLUSIONS: Correction of the transverse maxillary deficiency by RPE using the Haas appliance in children 8-10 years improves OHRQOL. The Haas- and Hyrax-type devices temporarily worsen OHRQOL during treatment, however, the negative impact is less with the Hyrax-type expander than with the Haas-type expander, because it causes fewer negative oral symptoms. CLINICAL RELEVANCE: From a patient-centered perspective, the use of the Hyrax over the Haas appliance may be suggested as it causes less negative oral symptoms during use.

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The proven efficacy of immunotherapy in fighting tumors has been firmly established, heralding a new era in harnessing both the innate and adaptive immune systems for cancer treatment. Despite its promise, challenges such as inefficient delivery, insufficient tumor penetration, and considerable potential toxicity of immunomodulatory agents have impeded the advancement of immunotherapies. Recent endeavors in the realm of tumor prophylaxis and management have highlighted the use of living biological entities, including bacteria, oncolytic viruses, and immune cells, as a vanguard for an innovative class of live biotherapeutic products (LBPs). These LBPs are gaining recognition for their inherent ability to target tumors. However, these LBPs must contend with significant barriers, including robust immune clearance mechanisms, cytotoxicity and other in vivo adverse effects. Priority must be placed on enhancing their safety and therapeutic indices. This review consolidates the latest preclinical research and clinical progress pertaining to the exploitation of engineered biologics, spanning bacteria, oncolytic viruses, immune cells, and summarizes their integration with combination therapies aimed at circumventing current clinical impasses. Additionally, the prospective utilities and inherent challenges of the biotherapeutics are deliberated, with the objective of accelerating their clinical application in the foreseeable future.

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Gastric cancer (GC) poses a significant global health challenge, ranking fifth in incidence and third in mortality among all malignancies worldwide. Its insidious onset, aggressive growth, proclivity for metastasis, and limited treatment options have contributed to its high fatality rate. Traditional approaches for GC treatment primarily involve surgery and chemotherapy. However, there is growing interest in targeted therapies and immunotherapies. This comprehensive review highlights recent advancements in GC targeted therapy and immunotherapy. It delves into the mechanisms of various strategies, underscoring their potential in GC treatment. Additionally, the review evaluates the efficacy and safety of relevant clinical trials. Despite the benefits observed in numerous advanced GC patients with targeted therapies and immunotherapies, challenges persist. We discuss pertinent strategies to overcome these challenges, thereby providing a solid foundation for enhancing the clinical effectiveness of targeted therapies and immunotherapies.

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This review delves into the generation and therapeutic applications of mesenchymal stem cell-derived neural progenitors (MSC-NPs) in Multiple Sclerosis (MS), a chronic autoimmune disease characterized by demyelination, neuroinflammation, and progressive neurological dysfunction. Most current treatment paradigms primarily aimed at regulating the immune response show little success against the neurodegenerative aspect of MS. This calls for new therapies that would play a role in neurodegeneration and functional recovery of the central nervous system (CNS). While utilizing MSC was found to be a promising approach in MS therapy, the initiation of MSC-NPs therapy is an innovation that introduces a new perspective, a dual-action plan, that targets both the immune and neurodegenerative mechanisms of MS. The first preclinical studies using animal models of the disease showed that MSC-NPs could migrate to damaged sites, support remyelination, and possess immunomodulatory properties, thus, providing a solid basis for their human application. Based on pilot feasibility studies and phase I clinical trials, this review covers the transition from preclinical to clinical phases, where intrathecally administered autologous MSC-NPs has shown great hope in treating patients with progressive MS by providing safety, tolerability, and preliminary efficacy. This review, after addressing the role of MSCs in MS and its animal model of experimental autoimmune encephalomyelitis (EAE), highlights the significance of the MSC-NP therapy by organizing its advancement processes from experimental models to clinical translation in MS treatment. It points out the continuing obstacles, which require more studies to improve therapeutic protocols, uncovers the mechanisms of action, and establishes long-term efficacy and safety in larger controlled trials.

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Hydrogels are biomolecules made of artificial and natural polymers. Their quasi-three-dimensional structure has created unique features. They are very hydrophilic, and in addition to the high inflation rate, they also have excellent water maintenance capacity, biodegradability, biocompatibility, and strong mechanical properties. These properties are used in many tissue engineering applications. All these features have made these scaffolds widely used as attractive structures in the world of tissue engineering and regeneration medicine. In addition to research, scaffolds entered the field of medicine and are expected to play a significant role in the repair of many tissues in the future. This study aims to review the various polymers involved in hydrogel fabrication and their application in the repair of diverse tissues and clinical trials.

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The CIOMS book "International Ethical Guidelines for Health-related Research Involving Humans", published in 2016 (IEG2016), provides information to assist research ethics committee members and research practitioners with pragmatically implementing ethical considerations while planning and conducting their research. To identify which aspects of research IEG2016 has had the greatest impact since its publication, we analyzed metadata from 942 papers that cited IEG2016 (English language title only) from Web of Science (WoS, Clarivate). Using VOSviewer, we mapped the co-occurrence of keywords to derive the network of all keywords that co-occurred at least five times in the set of citing papers. We found that the keywords ethics, research ethics, informed consent, and clinical trials had high co-occurrence scores in this set of publications. Strong links were also observed between ethics, research ethics, and informed consent. We identified fifteen human-related (HR) keyword nodes in this keyword network. Analysis of the subset of 273 IEG2016-citing articles containing these fifteen HR keywords showed later-date publications were focused on the youngest humans (children, adolescents, young people, minors) and the humans typically responsible for those youngest humans, namely women and parents. Seventy-nine of the 110 networked countries/regions associated with IEG2016-citing articles were home to HR keyword articles. We conclude that IEG2016 has had significant impact in health and medical science literature and has served as a foundation for health-related research around the world in the areas of ethics, informed consent, and research ethics and the linkage of these topics to under-represented populations in such research.

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Clinical evidence generation from and for representative populations can be improved through increased research access and ease of trial participation. To improve access and participation, a modern trial infrastructure is needed that broadens research into more routine practice. This commentary highlights current barriers, areas of advancement, and actions needed to enable continued transformation toward a modern trial infrastructure for an improved evidence generation system. The focus of this commentary is on the development of medical products (e.g., drugs, devices, biologics) and infrastructure issues within the United States, with the aim to have broader, multi-national applicability.

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Gene therapy as a disease-modifying therapeutic approach for neurodegenerative diseases, such as Alzheimer's disease (AD) and Parkinson's disease (PD), is a promising avenue. Promising results in the preclinical studies involving rodents and nonhuman primates utilizing gene therapy have led to multiple clinical trials evaluating various genes of interest for AD and PD. In AD, clinical trials are assessing gene therapy involving brain-derived neurotrophic factor (BDNF) and other targets such as apolipoprotein E2 (APOE2) and human telomerase reverse transcriptase (hTERT). In PD, clinical trials are evaluating gene therapy delivering neurotrophic factors, such as glial cell line-derived neurotrophic factor (GDNF). Additionally, gene therapy delivering enzymes aromatic L-amino acid decarboxylase (AADC) and glutamic acid decarboxylase (GAD) are also being evaluated for PD. All these trials primarily utilized adeno-associated virus (AAV) to deliver the above transgene of interest. This review summarizes the current clinical trials involving gene therapy for AD and PD. It also discusses the challenges and opportunities associated with the gene therapy approach in AD and PD and ongoing developments related to increasing the safety and efficacy of the gene therapy for long-term outcomes, which include evaluation of various serotypes and administration routes. This comprehensive review emphasizes translating preclinical findings into clinical trials, further directions, and the potential for this promising therapeutic approach to alleviate neurodegenerative disease.

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Background: Hereditary transthyretin (ATTRv) amyloidosis, a multifaceted disorder affecting multiple systems, substantially diminishes patients' physical capabilities and overall quality of life. Patisiran and Vutrisiran, two Ribonucleic acid (RNA) interference therapies, target reducing both pathogenic and wild-type transthyretin (TTR) protein levels. This systematic review assesses the effectiveness and safety of these treatments in managing ATTRv. Methods: A comprehensive, thorough literature search across databases including Embase, PubMed, Web of Science, Cochrane Central, and Google Scholar yielded 858 studies. Following removing duplicate and irrelevant articles, 676 distinct studies underwent review. These studies, conducted on a global scale, encompassed a range of methodologies, including clinical trials and indirect treatment comparisons. Results: Ten studies, spanning a total population of 756 patients, were selected for in-depth analysis. Patisiran and Vutrisiran consistently demonstrated significant improvements in primary and secondary endpoints related to neuropathy, quality of life, and cardiac function. Both medications were well-tolerated, with primarily mild to moderate adverse events. Indirect treatment comparison studies indicated Vutrisiran's superiority over Tafamidis in treating ATTRv amyloidosis. Conclusion: This systematic review recommends using Patisiran and Vutrisiran to treat ATTRv amyloidosis. The findings suggest that these RNA interference therapies improve neuropathy, quality of life, and cardiac symptoms. The results indicate sustained benefits over prolonged treatment, with satisfactory safety profiles. However, potential biases, conflicts of interest in the studies, and limited follow-up periods in some trials necessitate cautious interpretation. Future research should address these limitations and provide more robust evidence for the long-term efficacy and safety of Patisiran and Vutrisiran in ATTRv treatment.

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In this Personal View, we address the latest advancements in automatic text analysis with artificial intelligence (AI) in medicine, with a focus on its implications in aiding treatment decisions in medical oncology. Acknowledging that a majority of hospital medical content is embedded in narrative format, natural language processing has become one of the most dynamic research fields for developing clinical decision support tools. In addition, large language models have recently reached unprecedented performance, notably when answering medical questions. Emerging applications include prognosis estimation, treatment recommendations, multidisciplinary tumor board recommendations and matching patients to recruiting clinical trials. Altogether, we advocate for a forward-looking approach in which the community efficiently initiates global prospective clinical evaluations of promising AI-based decision support systems. Such assessments will be essential to validate and evaluate potential biases, ensuring these innovations can be effectively and safely translated into practical tools for oncological practice. We are at a pivotal moment, where continued advancements in patient care must be pursued with scientific rigor.

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The recent pandemic ushered in a marked surge in the adoption of digital health technologies (DHTs), necessitating remote approaches aiming to safeguard both patient and healthcare provider well-being. These technologies encompass an array of terms, including e-health, m-health, telemedicine, wearables, sensors, smartphone apps, digital therapeutics, virtual and augmented reality, and artificial intelligence (AI). Notably, some DHTs employed in critical healthcare decisions may transition into the realm of medical devices, subjecting them to more stringent regulatory scrutiny. Consequently, it is imperative to understand the validation processes of these technologies within clinical studies. Our study summarizes an extensive examination of clinical trials focusing on cardiovascular (CV) diseases and digital health (DH) interventions, with particular attention to those incorporating elements of AI. A dataset comprising 107 eligible trials, registered on clinicaltrials.gov and International Clinical Trials Registry Platform (ICTRP) databases until 19 June 2023, forms the basis of our investigation. We focused on clinical trials employing DHTs in the European context, revealing a diverse landscape of interventions. Devices constitute the predominant category (45.8%), followed by behavioral interventions (17.8%). Within the CV domain, trials predominantly span pivotal or confirmatory phases, with a notable presence of smaller feasibility and exploratory studies. Notably, a majority of trials exhibit randomized, parallel assignment designs. When analyzing the multifaceted landscape of trial outcomes, we identified various categories such as physiological and functional measures, diagnostic accuracy, CV events and mortality, patient outcomes, quality of life, treatment adherence and effectiveness, quality of hospital processes, and usability/feasibility measures. Furthermore, we delve into a subset of 15 studies employing AI and machine learning, describing various study design features, intended purposes and the validation strategies employed. In summary, we aimed to elucidate the diverse applications, study design features, and objectives of the evolving CV-related DHT clinical trials field.

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Background: The methodologies for clinical research trials are evolving to greater usage of social media platforms, providing opportunities to incorporate smart technologies in their delivery. Research Nurses should consider how they can utilise platforms for public engagement in trials. Aim: To explore the experiences of social media platforms and clinical research trials in a healthy population group, to gain insight into how clinical researchers can utilise these platforms professionally and ethically. Methods: Using a critical realist qualitative focus group design with template analysis, we recruited 16 healthy members of the public aged 18-75 years. The data expands upon their thoughts and behaviours regarding social media platforms with their understanding of clinical research. Results: Three main themes along with their specific subthemes (1) Design: Patient and Public Involvement (Subtheme: Understanding of clinical research, Diversity of social media users), (2) Implementation: Recruitment to active studies, (Subtheme: Motivators for volunteering, Trustworthy), (3) Dissemination: Impact and Awareness of Results, (Subtheme: Information overload, Motivations for users to share information). Conclusions: This study has highlighted the need to consider the way different population groups use social media platforms and the information they share when looking to engage them in clinical research trials.