Guidelines For Clinical Trials Research Articles

Efficacy of Eating Disorder Focused Family Therapy for Adolescents With Anorexia Nervosa: A Systematic Review and Meta-Analysis.

To systematically review and evaluate the efficacy of eating disorder focused family therapy (FT-ED) in comparison to all other forms of psychotherapy for children and adolescents with anorexia nervosa. A secondary aim is to assess the relative efficacy of different variations of FT-ED (e.g., shorter vs. longer dose, parent-focused). A search with relevant terms was systematically conducted on four databases. Twenty-three publications across 18 randomized controlled trials met inclusion criteria. Outcomes of interest included variables related to weight, eating psychopathology, and remission status. Study quality was assessed, and data were extracted by two independent researchers. Adolescents receiving FT-ED gained significantly more weight by the end of treatment in comparison to those receiving individual psychotherapy. FT-ED that was delivered just to parents or to parents and child separately offered preferable weight outcomes and rates of recovery at the end of treatment in comparison to conjoint FT-ED. No other outcomes tested in the meta-analysis were statistically significant at the end of treatment or follow-up. Currently available data suggest the use of FT-ED in its conjoint or separated/parent focused format is the best outpatient treatment option for adolescents with anorexia nervosa when immediate weight gain is paramount. The variability of outcome measurement, including the tools used and timepoints chosen, limit comparison among no more than a handful of studies. The field would benefit from the standardization of measurement and reporting guidelines for future clinical trials. PROSPERO number: CRD42023396263.

Determining the extent and frequency of on-site monitoring: a bayesian risk-based approach

BackgroundOn-site monitoring is a crucial component of quality control in clinical trials. However, many cast doubt on its cost-effectiveness due to various issues, such as a lack of monitoring focus that could assist in prioritizing limited resources during a site visit. Consequently, an increasing number of trial sponsors are implementing a hybrid monitoring strategy that combines on-site monitoring with centralised monitoring. One of the primary objectives of centralised monitoring, as stated in the clinical trial guidelines, is to guide and adjust the extent and frequency of on-site monitoring. Quality tolerance limits (QTLs) introduced in ICH E6(R2) and thresholds proposed by TransCelerate Biopharma are two existing approaches for achieving this objective at the trial- and site-levels, respectively. The funnel plot, as another threshold-based site-level method, overcomes the limitation of TransCelerate’s method by adjusting thresholds flexibly based on site sizes. Nonetheless, both methods do not transparently explain the reason for choosing the thresholds that they used or whether their choices are optimal in any certain sense. Additionally, related Bayesian monitoring methods are also lacking.MethodsWe propose a simple, transparent, and user-friendly Bayesian-based risk boundary for determining the extent and frequency of on-site monitoring both at the trial- and site-levels. We developed a four-step approach, including: 1) establishing risk levels for key risk indicators (KRIs) along with their corresponding monitoring actions and estimates; 2) calculating the optimal risk boundaries; 3) comparing the outcomes of KRIs against the optimal risk boundaries; and 4) providing recommendations based on the comparison results. Our method can be used to identify the optimal risk boundaries within an established risk level range and is applicable to continuous, discrete, and time-to-event endpoints.ResultsWe evaluate the performance of the proposed risk boundaries via simulations that mimic various realistic clinical trial scenarios. The performance of the proposed risk boundaries is compared against the funnel plot using real clinical trial data. The results demonstrate the applicability and flexibility of the proposed method for clinical trial monitoring. Moreover, we identify key factors that affect the optimality and performance of the proposed risk boundaries, respectively.ConclusionGiven the aforementioned advantages of the proposed risk boundaries, we expect that they will benefit the clinical trial community at large, in particular in the realm of risk-based monitoring.

A cross-sectional analysis of reporting guideline and clinical trial registration policies in nephrology journals.

To determine the extent to which nephrology journals recommend and require reporting guideline adherence and clinical trial registration. Despite a rising disease burden, research published on chronic kidney disease (CKD) and the field of nephrology has failed to keep pace and is limited. To improve the quality of research in the field of nephrology, reporting guidelines have been developed to minimize such deficits in research quality. However, the extent to which nephrology journals require and use reporting guidelines in addition to clinical trial registration is unknown. Sixty-two Nephrology journals were selected through the 2021 Scopus CiteScore tool. Each journal's Instructions for Authors was assessed to determine endorsement of study design-specific reporting guidelines or clinical trial registration. Researchers used R (version 4.2.1) and RStudio to create data summaries of descriptive statistics for nephrology journal reporting guidelines. Clinical trial registration was required by 52% (32/62) of nephrology journals within our sample. The reporting guideline for clinical trials, CONSORT, was required by 17.74% (11/62) of journals. The EQUATOR Network was mentioned by 46.77% (29/62) of journals, while 9.67% (6/62) failed to mention the ICMJE. The reporting guideline for systematic review, PRISMA, was only required by 12.90% (8/62) of journals. When contacting journal editors, 9.67% (6/62) responded and 4.83% (3/62) provided clarifying information. Reporting guidelines and clinical trial registration are suboptimally required and recommended by nephrology journals. Their adoption may decrease bias and increase research quality. Thus, nephrology journals should consider a more complete endorsement of these safeguards.

Investigation of acute, sub-chronic toxicity, effects of mangiferin and mangiferin solid dispersion (HPTR) on Triton WR1339-induced hyperlipidemia on Swiss albino mice

Mangiferin is a xanthonoid found in Mango leaves in abundance with many effects as a hypoglycemic, antioxidant, and anti-inflammatory agent, plant metabolite, and so on. However, nowadays, mango leaves are merely a waste product in Vietnam. To take advantage of this valuable medicinal resource, extraction conditions of mangiferin using classical and ultrasound methods were researched, and mangiferin was purified from Cat Chu mango leaves (Mangifera indica L., Anacardiaceae) collected in Dong Thap. Ultrasound-assisted extraction method was conducted with the following conditions and mangiferin was extracted at a percentage of 6.728% with a purity of 91.11%. Purified mangiferin was evaluated using molecular absorption spectroscopy UV-Vis, scanning electron microscopy (SEM), X-ray diffraction (XRD) spectroscopy, simultaneous thermal analysis (STA: TGA/DSC), and dissolution measurement method. To optimize the solubility and permeability of mangiferin, the solid dispersion system (HPTR) was made by the combination of HPMC 6M:mangiferin at the ratio of 1:5. To investigate the acute, sub-chronic toxicity and hypolipidemia effect of HPTR as compared to purified mangiferin, we followed guidelines for preclinical and clinical trials of Traditional Medicine and Herbal Medicines by the Vietnam Ministry of Health and OECD, and used tyloxapol (Triton WR1339, 400 mg/kg, i.p.) to induce hyperlipidemia. Our results indicated that purified mangiferin and HPTR extract showed no acute toxicity and sub-chronic toxicity and has potential as an antihyperlipidemic agent. The HPTR brought about a significant decrease in total cholesterol, triglycerides and LDL-c when compared to mangiferin, however there was no significance between them.

Similarities and Differences Between Pragmatic Trials and Hybrid Effectiveness-Implementation Trials.

Pragmatism in clinical trials is focused on increasing the generalizability of research findings for routine clinical care settings. Hybridism in clinical trials (i.e., assessing both clinical effectiveness and implementation success) is focused on speeding up the process by which evidence-based practices are developed and adopted into routine clinical care. Even though pragmatic trial methodologies and implementation science evolved from very different disciplines, Pragmatic Trials and Hybrid Effectiveness-Implementation Trials share many similar design features. In fact, these types of trials can easily be conflated, creating the potential for investigators to mislabel their trial type or mistakenly use the wrong trial type to answer their research question. Blurred boundaries between trial types can hamper the evaluation of grant applications, the scientific interpretation of findings, and policy-making. Acknowledging that most trials are not pure Pragmatic Trials nor pure Hybrid Effectiveness-Implementation Trials, there are key differences in these trial types and they answer very different research questions. The purpose of this paper is to clarify the similarities and differences of these trial types for funders, researchers, and policy-makers. In addition, recommendations are offered to help investigators choose, label, and operationalize the most appropriate trial type to answer their research question. These recommendations complement existing reporting guidelines for clinical effectiveness trials (TIDieR) and implementation trials (StaRI).

Recommendations for the Clinical Development of Medicinal Products for Non-specific Influenza Chemoprophylaxis

INTRODUCTION. The evolution of the influenza virus has led to a gradual decrease in the effectiveness of current antivirals. Better methods of prevention, detection, control, and treatment of influenza are needed, including more effective vaccines and antivirals. At the moment, the Russian Federation and the Eurasian Economic Union lack documents regulating the conduct of clinical trials of medicinal products for influenza prevention and require that guidelines should be developed for the matter.AIM. The authors aimed to analyse the main regulatory approaches to preclinical and clinical development programmes for medicinal products for influenza prevention in the Russian Federation, the Eurasian Economic Union (EAEU), the European Union, and the United States of America.DISCUSSION. This review substantiates the importance of non-specific influenza chemoprophylaxis in reducing the risk of adverse outcomes of the disease. The authors analysed the main stages of preclinical development of medicinal products for influenza prevention and the potential contribution of preclinical studies to the planning of clinical trials. When developing preclinical and clinical programmes for medicinal products for influenza prevention, it is necessary, first of all, to take into account the requirements of the national good clinical practice guidelines and the EAEU guidelines for clinical trials in general. This article pays particular attention to the clinical trial designs used internationally, the possible options for their implementation, the characteristics of study populations, the formation of study groups, and the selection of primary and secondary endpoints.CONCLUSIONS. The article proposes approaches to planning and conducting clinical trials of medicinal products for the prevention of influenza, taking into account the specifics of legal norms and clinical traditions of Russian practice. These recommendations will ensure high-quality data on the effectiveness and safety of investigational medicinal products and accelerate the introduction of new effective medicinal products for influenza prevention into medical practice.

Mendelian randomization in eye disorders (review)

Background: Mendelian randomization (MR) is an analytic approach in genetic epidemiology which uses the results of genome-wide association studies (GWAS) to assess causal relationships between various risk factors and phenotypes of interest (or diseases) in ophthalmology. The aim of the study: To describe the current opportunities for the use of MR in ophthalmic research. Materials and methods: We searched Scopus, Medline and Web of Science journals up to August 2022 using the PRISMA protocol “Preferred Reporting Items for Systematic Review and Meta-Analysis”. The following information was extracted: identified risk factor(s) and disease(s), design of Mendelian randomization study, sensitivity analysis(es) performed if any, genetic instrument(s) used, and also whether the causal relationship between risk and outcome was confirmed by the results of the study. Results: The current review included a total of 37 publications that tested 211 associations of a risk factor with an ophthalmic disease. The articles included were published in peer-reviewed journals up to August 2022 with 25 of them (67,5%) published in 2020 or later. The MR method indicated the causal role of blood serum lipids, C-reactive protein, free thyroxine, smoking and alcohol intake in the development of age-related macular degeneration. For glaucoma, type 2 diabetes, serum glucose, refractive abnormalities, and elevated intraocular pressure have been shown to be significant. MR analysis revealed the role of elevated intraocular pressure, level of education, body weight at birth in the development of refractive errors. The role of type 2 diabetes, hypertension and smoking in the development of cataracts was determined using the MR method. Conclusion: The results of 97 MR analyses in ophthalmology have revealed a significant role of a number of risk factors in the development of eye diseases, which will serve as a guideline for clinical trials and drug development.

Assessment of Rehabilitation Journal Requirements for the Use of Reporting Guidelines and Clinical Trial Registration

ObjectiveTo assess reporting guideline and clinical trial registration requirements in rehabilitation journals. DesignWe examined rehabilitation journals with 5-year impact factors exceeding 1.00 from the 2021 Scopus CiteScore tool, alongside the 28 journals included in the 2014 rehabilitation and disability quality improvement initiative. Journals outside the traditional rehabilitation scope were excluded. SettingA publicly-funded academic health center in the United States. Participants and InterventionsN/A. Main Outcome Measure(s)The proportion of journals requiring/recommending reporting guideline use and clinical trial registration. ResultsOver 90% (57/63) of journals required/recommended clinical trial reporting guidelines, while 68% (39/57) specified guideline requirements for systematic review/meta-analysis protocols. The 2014 collaborative initiative journals demonstrated higher rates of requiring/recommending reporting guidelines for clinical trials (24/26; 92.3%), systematic reviews/meta-analyses (23/26; 88.5%), observational studies in epidemiology (22/25; 88%), and diagnostic accuracy studies (20/24; 83.3%). Conversely, the 2021 Scopus CiteScore journals displayed higher rates for the remaining study designs. Overall, 52/63 (82.5%) journals required/recommended trial registration. Trial registration policies were comparable, with a slight advantage favoring the 2021 Scopus CiteScore journals. ConclusionRehabilitation journals variably promoted reporting guideline use and clinical trial registration. Common study designs like clinical trials, observational studies in epidemiology, and diagnostic accuracy studies demonstrated robust requirement/recommendation rates, while less common designs like economic evaluations and animal research had suboptimal rates. Journals can enhance reporting guideline use and trial registration by directing authors to the EQUATOR Network, requiring adherence to registration and reporting standards, and clarifying language in author instructions.

Commentary on 2022 guidelines on clinical trial design in cluster headache and further suggestions

BackgroundNew guidelines for cluster headache clinical trials were recently published. We welcome these new guidelines and raise additional considerations in trial methodologies.Main bodyWe present non-inferiority trials to overcome ethical issues with placebo use, and additionally discuss issues with trial recruitment.ConclusionsWe highlight some possible issues and solutions to be considered with the recently published cluster headache trial guidelines.

A Practical Guide to Understanding and Treating Peripheral Artery Disease.

Peripheral arterial disease (PAD) is the third leading cause of atherosclerotic morbidity after coronary heart disease and stroke yet is widely underdiagnosed and undertreated. Treatment of risk factors such as diabetes and cigarette smoking can benefit patients with PAD. Patients should have adequate blood pressure and lipid control to decrease clinical manifestations and symptoms of PAD. Use of antithrombotic medications should be individualized to the patient depending on the presence of symptoms, revascularization, and comorbidities. All patient care providers, including physicians, pharmacists, nurse practitioners, and physician assistants, should incorporate PAD screening in their at-risk patients to improve access for appropriate earlier diagnosis, initiation of guideline directed therapy, and risk factor modification to reduce both major adverse CV and limb outcomes. The purpose of this narrative review is to provide an overview of PAD and summarize clinical trial evidence and guideline recommendations for screening and treatment to increase awareness among health care providers to ultimately have a positive impact on patient care.

임상시험연구 교과기반 학습성과 평가

Objectives The purpose of this study is to evaluate the awareness of ethical perspective and clinical research coordinator's roles in an entry-level clinical trial research course based on the course-embedded assessment tied with the program learning outcomes of the bachelor's degree among nursing students.
 Methods Three professional clinical coordinators affiliated with Korea National Enterprise for Clinical Trials (KoNECT) and two nursing professors developed the course based on Good Clinical Practice guidelines in clinical trials. Eighty-three nursing students enrolled and completed this course. Three evaluation criteria were rated in the course-embedded assessment: Completion of the course by getting certificate from the KoNECT(70%), attendance (10%), reflection journal report (20%). Additionally, learners responded two surveys on the satisfaction with education and awareness of ethical roles in clinical trial research. Data were analyzed using the SPSS 23.0 program. The difference in ethical awareness of clinical trial research according to general characteristics was analyzed using t-test and ANOVA with Scheffé's multiple comparison. Importance-Performance analysis(IPA) and thematic analysis were used for ethical perspective and the clinical research coordinator's roles.
 Results All students completed the clinical trial research course by getting the KoNECT certificates, and 94% of students reported that they were satisfied with the course. IPA analysis showed that nursing students recognized all the ethical roles of clinical trial research nurses as more important and more performing. Thematic analysis exhibited that the roles of CRC had four main themes: expertise and responsibility as clinical trial specialists, decision-making based on ethical principles, sufficient education and explanation for the voluntary participation of subjects, and the convergent capability underlying clinical trial research.
 Conclusions Based on these findings, the entry-level clinical trial research course was useful for developing awareness of ethical roles and CRC's roles, and provided a new opportunity to map out nursing students' career path.

Investigation of acute and sub-chronic oral toxicity and effects of Allium ascalonicum L. extract on Triton WR1339-induced hyperlipidemia on Swiss albino mice

IntroductionMetabolic disorders are increasingly rapidly becoming a burden on global healthcare systems. Among these, hyperlipidemia frequently leads to cardiovascular diseases such as myocardial infarction and cerebral stroke, posing significant life-threatening risks. The pharmacological drugs, which are often costly and may cause a range of adverse side effects detrimental to health. Allium ascalonicum L., a member of the Alliaceae family, a widely used species of the Allium genus, is commonly employed as a spice and food ingredient in Asia. Allium ascalonicum (AS) is rich in triterpenoids, phenolic acids, flavonoids, thiosulfates, and anthocyanins, whose therapeutic effects have been documented. In Chinese, Allium ascalonicum L. is known as 葱 (Cōng), which is used for various types of onions and similar plants in Chinese, including shallots. Ancient Chinese medicine documented that AS has a sweet and mildly spicy taste with a slight astringency and is warm in nature. In traditional Chinese medicine, AS is prepared as infusions, juices, and poultices to harness their health benefits, and commonly used in cooking for their nutritional and medicinal purposes. Modern medicine has discovered that this type of bulb possesses antibacterial and anti-inflammatory properties, acts as a diuretic, treats diarrhea, reduces blood sugar levels, lowers blood pressure, reduces cholesterol, and among its other roles. Currently, there is a lack of in vivo study on the cholesterol-regulating potential of AS. MethodsFor our experiments, 24 and 32 Swiss albino mice were employed to investigate the acute and sub-chronic oral toxicity according to the Guidelines for preclinical and clinical trials of Traditional Medicine and Herbal Medicines by the Vietnam Ministry of Health and OECD. To investigate the effects on hyperlipidemia, 40 mice of both sexes were divided into five groups (n = 6–8 each). Tyloxapol (Triton WR1339, 400 mg/kg, i.p.) was used to induce hyperlipidemia. Atorvastatin (60 mg/kg, p.o.) was used as the standard, and AS extract was conducted at the doses of 500 mg/kg and 1000 mg/kg. Hyperlipidemic activity was assessed using a variety of parameters. ResultsAllium ascalonicum (AS) extract showed no acute toxicity and sub-chronic toxicity. The AS showed a significant decrease in total cholesterol, triglycerides and LDL-c but showed no changes in HDL-c. ConclusionOur results indicated that AS is safe to use for a longtime and has a potential as an antihyperlipidemic agent, possibly due to its ability to inhibit the elevation of total cholesterol, triglycerides and LDL-c. The AS is rich in phytochemicals like triterpenoids, flavonoids and saponins, which may contribute to its hypolipidemic effect.

The effectiveness of customised 3D-printed insoles on perceived pain, comfort, and completion time among frequent Park Runners: Study protocol for a pragmatic randomised controlled trial (The ZOLES RCT)

BackgroundRunning, a popular recreational activity, often leads to the experience of pain and discomfort among participants impacting performance and participation longevity. The ZOLES trial evaluates customised 3D-printed insoles for reducing pain in frequent parkrunners aged 35 and over. An innovative process of foot-scanning and responses to questions relating to size, pain, discomfort, and previous medical conditions are combined leading to the production of personalised 3D-printed orthotics. MethodsThe ZOLES trial is a pragmatic, outcome assessor blinded, randomised, controlled, superiority trial involving 200 recreational runners, randomised to receive either customised 3D-printed insoles (ZOLES) or to a "do-as-usual" control group. The study follows a robust protocol, ensuring adherence to established guidelines for clinical trials, and is based at St Mary's University, Twickenham, London. The primary outcome is change in running-related pain over a 10-week period, assessed using an 11-point Numeric Rating Scale. Secondary outcomes include overall pain and discomfort, running-related comfort, 5k-completion time, time-loss due to injuries, running exposure, and adherence to the intervention. A balanced-block randomisation process is stratified by sex and parkrun location, and an intention-to-treat analyses will be employed on all outcomes in the primary trial report. The trial includes a 52-week post-market surveillance to assess long-term effects of the customised insoles. DiscussionThe ZOLES trial aims to provide insights into real-world applicability and effectiveness of customised 3D-printed insoles in reducing running-related pain and enhancing overall running experience. Despite the limitation of a subjective primary outcome measure without participant blinding, the methodological rigor, including external outcome assessment and data handling, we anticipate results that are academically credible and applicable in real-world settings The results of this trial may have important implications for runners, clinicians, and the sports footwear industry, as evidence for the use of individualised insoles to improve running experience and prevention of pain may become evident. Trial registrationThe trial was pre-registered at ClinicalTrials.gov with the trial identifier NCT06034210 on September 4, 2023, and publicly posted on September 13, 2023 (https://clinicaltrials.gov/study/NCT06034210). Protocol versionVersion 1, September 27, 2023.

Ab. No. 90 Design and Validation of Tool to Assess Application of Good Clinical Practice (GCP) in Physiotherapy Academicians Using Modified E-Delphi Method: A Pilot Study

Introduction: Student’s involvement in research activity is mandatory for physiotherapy undergraduate, postgraduate and PhD courses. Due to current advancement in science and technology, research has increased manifold in physiotherapy profession which strongly manifests the need of adapting GCP guidelines to develop and publish good quality research which can significantly contribute towards social needs. Various tools are available in research community to assess application of GCP guidelines in clinical and drug trials but there is no specific tool available to assess use of GCP guidelines in physiotherapy field. In physiotherapy institutes, academicians are pillars of research that will identify thrust areas of research. One of the major roles of academicians is to sensitize their students, the future researcher community about predatory journals, unethical research and publishing practices. As a physiotherapist, all of us have knowledge of research ethics and practices but sometimes we fail to apply it in real research scenario. Thus there is a need to design and develop a tool to assess application of GCP guidelines in practical situation and not merely testing theoretical knowledge. Methods: Cross sectional study carried out on physiotherapy academicians all over India included through snow ball sampling method. A questionnaire based on 4 basic ethical principles of research on human participants (ICMR 2017) was formulated. Validation was carried out by Delphi panel members like content experts, journal editor, researcher, epidemiologist, physiotherapist and experts from various fields. Controlled feedback provided to all panel members till consensus is achieved. The validated questionnaire was distributed to physiotherapy academicians via Google form. Each item will be analyzed using factor analysis to reach an agreement level. Results: Awaited. Conclusion: Awaited. Implications: This assessment tool will help to create awareness about practical ethics over theoretical knowledge in physiotherapy research and practice.

Improved clinical trial race/ethnicity reporting and updated inclusion profile, 2017–2022: A New Jersey snapshot

BackgroundDiverse representation in clinical trials is an important goal in the testing of a medical, diagnostic, or therapeutic intervention. To date, the desired level of trial equity and inclusivity has been unevenly achieved. MethodsEmploying the US National Library of Medicine's Clinicaltrials.gov registry, we examined 481 clinical trials conducted - at least in part - in the state of New Jersey. These trials were initiated after the FDA-mandated Common Rule changes, i.e., between January 2017 and October 2022, were enacted, and had their results posted. We analyzed sex/race/ethnicity reporting as well as applicable enrollment. Using meta-analysis, we estimated group participation proportions of a subset of the 481 identified trials; specifically, the 229 studies that were conducted solely within the US (i.e., without international sites) and compared them to US census data. FindingsWithin the 481 clinical trials analyzed, over 97% reported on the race and/or ethnicity of their enrollees; all included information on sex. Reporting was not affected by funding source or therapeutic area. Based on the 229 solely US-based studies, the participants overall were 76.7% White; 14.1% Black; 2.7% Asian; and 15% Hispanic. Inclusion of Black participants did not differ from the 2020 US census data; in contrast, the levels of Asian and Hispanic participation were below the corresponding census percentages. InterpretationThe past five years have seen an overall uptick in the equity of race/ethnicity reporting and inclusivity of clinical trials, as compared to previously reported data, presaging the potential acquisition of ever more powerful and meaningful results of such interventional studies going forward. FundingSupport for this study comes from the Hackensack Meridian Health Research Institute and the Hackensack Meridian School of Medicine. Research in contextEvidence before this studyClinical trials are a critical part of determining whether or not a medical (drug/device/biologic) or socio-behavioral intervention is safe and truly effective. Through their use, scientific understanding is advanced and, ideally, human health is improved. To gain the most impactful information from a clinical trial, it should be sufficiently representative, that is, should enroll an adequate number of participants, and include a diverse population. Without such inclusion, the study is of only limited generalizability. Efforts are underway by funders, sites, and other stakeholders, to enhance reporting and promote inclusive enrollment. The extent to which such attempts are yielding results - at least for clinical trials in the state of New Jersey - is the focus of this data-driven analysis. The ClinicalTrials.gov registry database was carefully mined for the information contained in this report.Added value of this studyOur analysis of clinical trials initiated in the state of New Jersey and conducted there or elsewhere in the US reveals several positive trends. Our 5-year snapshot reveals that a very large percentage of trials report on race/ethnicity - and inclusivity is improving. While there is still some way to go to have the demographic numbers in these trials match US census values, our results suggest that recent efforts are having an effect.Implications of all the available evidenceFor myriad reasons, clinical trials have not enjoyed the public's universal trust over the years. In many ways, medicine moves at the speed of trust - without it, the promise of modern healthcare is brought into question. Clinical trials must include a commitment to diverse enrollment pools and equitable reporting under the law. Creating a legacy of trust - through greater inclusivity in clinical trials and more transparent reporting of results - will begin to heal the divide and engender faith in modern medicine and today's healthcare system. It would also allow for the desired far-reaching generalizability of results across patient populations. To better appreciate what needs to be done going forward, we must truly understand the state of clinical trials reporting and demographic inclusion. This report initiates such an analysis, by carefully documenting how New Jersey's clinical trials are performing. By virtue of its location (e.g., proximity to the cities of New York and Philadelphia) the state is part of a large biopharma cluster and healthcare nexus; it is critical that it performs well with respect to adopting/adhering to updated clinical trial guideline mandates. This report provides a glimpse - an important first look - into the state of clinical trials in New Jersey - from 2017 through 2022.

A Review on CDSCO: Central Drug Standard Control Organisation

India has been a hub for managing various multi centre trials the central drug standard control organisation (CDSCO), headed by the drug controller general of India (DCGI), drowsing the regulation for the manage of clinical trials in India the conduct of trails, regulations in India and quality of data generated may be the source for this evolution it is crucial that now all clinical trials conducted in India should as per the international conference of harmonization good clinical practice guidelines ( ICH- GCP) for clinical trials and follow the newly amended schedule Y of the drugs and cosmetic Act.

Using multiple outcomes in intervention studies: improving power while controlling type I errors

Background The CONSORT guidelines for clinical trials recommend use of a single primary outcome, to guard against the raised risk of false positive findings when multiple measures are considered. It is, however, possible to include a suite of multiple outcomes in an intervention study, while controlling the familywise error rate, if the criterion for rejecting the null hypothesis specifies that N or more of the outcomes reach an agreed level of statistical significance, where N depends on the total number of outcome measures included in the study, and the correlation between them. Methods Simulations were run, using a conventional null-hypothesis significance testing approach with alpha set at .05, to explore the case when between 2 and 12 outcome measures are included to compare two groups, with average correlation between measures ranging from zero to .8, and true effect size ranging from 0 to .7. In step 1, a table is created giving the minimum N significant outcomes (MinNSig) that is required for a given set of outcome measures to control the familywise error rate at 5%. In step 2, data are simulated using MinNSig values for each set of correlated outcomes and the resulting proportion of significant results is computed for different sample sizes,correlations, and effect sizes. Results The Adjust NVar approach can achieve a more efficient trade-off between power and type I error rate than use of a single outcome when there are three or more moderately intercorrelated outcome variables. Conclusions Where it is feasible to have a suite of moderately correlated outcome measures, then this might be a more efficient approach than reliance on a single primary outcome measure in an intervention study. In effect, it builds in an internal replication to the study. This approach can also be used to evaluate published intervention studies.

Preparation and Characterization Evaluation of Poly(L-Glutamic Acid)-g-Methoxy Poly(Ethylene Glycol)/Combretastatin A4/BLZ945 Nanoparticles for Cervical Cancer Therapy.

Cervical cancer (CC) is a highly vascularized tumor with abundant abnormal blood vessel, which could be targeted by therapeutic strategies. Poly(L-glutamic acid)-g-methoxy poly(ethylene glycol)/combretastatin A4 (CA4)/BLZ945 nanoparticles (CB-NPs) have shown great potential as nano vascular disrupting agents (VDAs) in the realm of synergistic cancer therapy. In this study, we investigated the nanocharacteristics of CB-NPs, focusing on active pharmaceutical ingredients (API), as well as lyophilized samples combining API with protective agents (PAs). The in vivo efficacy of final sample (API + PAs) was evaluated. The assembled sphere of API with complex core and thin-shell structure was confirmed. PAs were found to significantly influence in vivo efficacy. Collaborative efforts between API and PAs, namely mannitol and lactose, resulted in the most promising lyophilized sample, ie, the final sample (FS2) for CC therapy. Impressively, FS2 demonstrated an exceptional 100% cure rate on the CC U14-bearing mice model. FS2 has provided significant insights for cervical cancer therapy. It is also crucial to develop a comprehensive evaluation strategy for the formulation of nanomedicine, which has the potential to serve as a guideline for future clinical trials.

RETRACTED ARTICLE: Efficacy and safety of arthroscopy in femoroacetabular impingement syndrome: a systematic review and meta-analysis of randomized clinical trials

This study aimed to compare the efficacy and safety of arthroscopy with physiotherapy or joint lavage in patients with femoroacetabular impingement (FAI). A meta-analysis using PubMed, Embase, Scopus, and the Cochrane Collaboration Library databases was performed in September 2022. We included studies focusing on patients with FAI who underwent arthroscopic surgery versus those who underwent physiotherapy or arthroscopic lavage. The outcomes were functional scores (iHOT-33 and HOS ADL) and adverse events. Randomized clinical trials were included in the study. The risk of bias in each study was assessed according to Cochrane guidelines for clinical trials. The data were combined using Review Manager version 5.4. (PROSPERO CRD42022375273). Six RCTs were included, from a pool of 839 patients (407 females). The iHOT-33 and HOS ADL scales showed significant differences at 12 months in favor of the arthroscopy group (MD, 10.65; 95% CI 6.54–4.76) and (MD, 8.09; 95% CI 3.11–13.07). MCID was not achieved through arthroscopy in functional variables. The rates of osteoarthritis (OR, 6.18; 95% CI 1.06–36.00) and numbness (OR, 73.73; 95% CI 10.00–43.92) were significantly higher in the arthroscopy group. Arthroscopic surgery showed statistical superiority over the control group without exceeding the MCID in most studies; however, the results might have been influenced by secondary variables. Finally, arthroscopic surgery results in a high rate of conversion to osteoarthritis.

International responses addressing the under-representation of older people in clinical research.

Older people (aged 65 years +) are under-represented in clinical research across many disease areas. Such exclusions limit the generalisability of trial results and can lead to a gap in critical knowledge regarding the efficacy and safety of interventions in older age groups. International bodies and regulators have addressed this issue to varying degrees. The USA's Food and Drug Administration (FDA) has produced regular non-binding guidance about the inclusion of older trial participants, while the National Institutes of Health's (NIH) binding regulations mean that those seeking research funding must include participants of all ages unless there are scientific or ethical reasons to exclude them. European regulations governing clinical trials of new medications require that participants represent the population groups that are likely to use the product being tested, while Britain highlights the need to improve trial participation of under-served groups, which include older people. Australian clinical trial guidelines point to the potential problem of excluding some groups from research but do not specifically address older participants. While current international approaches may provide some improvements in trial representation, additional strategies are required to promote clinical research that better reflects populations seen in clinical practice. Australia could benefit from clinical trial guidance that highlights the specific issue of the under-representation of older participants and outlines strategies to facilitate greater inclusion. This article provides an overview and critique of the current approaches to the inclusion of older people in clinical research and highlights policy gaps and limitations of current strategies.