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219
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ShareScore release 0.9.0
Dataset results
219 results for “new drugs”
The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months
ClinicalTrials.gov study NCT00224133. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes
ClinicalTrials.gov study NCT01658826. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Data from: Quality of evidence considered by Health Canada in granting full market authorization to new drugs with a conditional approval: a retrospective cohort study
Objectives: This study examines the characteristics of studies that Health Canada uses to grant full marketing authorization for products given a conditional approval between January 1, 1998 and June 30, 2017. Design: Cohort study. Data sources: Journal articles listing drugs that fulfilled their conditions and received full marketing authorization, Notice of Compliance database, Notice of Compliance with conditions web site, Qualifying Notices listing required confirmatory studies, clinicaltrials.gov, PubMed, Embase, companies making products being analyzed, journal articles resulting from confirmatory studies. Interventions: None Primary and secondary outcome measures: Characteristics of studies - study design (randomized controlled trials, observational), primary outcome used (clinical, surrogate), blinding, number of patients in studies, patient median age, number of men and women. Results: Eleven companies confirmed 36 publications for 19 products (21 indications). Twenty-nine out of the 36 studies were randomized controlled trials (RCTs) but only 10 stated if they were blinded. Twenty used surrogate outcomes. The median age of patients was 56 (interquartile range (IQR) 44, 61). The median number of men per study/trial was 184 (IQR 58, 514) versus women - 141 (IQR 46, 263). Conclusions: Postmarket studies required by Health Canada had more rigorous methodology than those required by either the Food and Drug Administration or the European Medicines Agency. There were still deficiencies in these studies. The absence of blinding in the majority of RCTs may introduce bias in their results. The use of surrogate outcomes especially in oncology trials means that improvements in survival are not available. The relatively young age of patients, even for products for cancer, means that predicting how the elderly will respond is often unknown. The almost universal finding that men outnumbered number women may make it hard to differentiate responses by sex. These results raise potential concerns about the quality of evidence that Health Canada accepts.
Data from: How innovative are new drugs launched in the UK? A retrospective study of new drugs listed in the British National Formulary (BNF) 2001-2012
Objectives: Innovative new drugs offer potential benefits to patients, healthcare systems, governments and the pharmaceutical industry. Recent data suggest annual numbers of new drugs launched in the UK have increased in recent years, and we sought to understand whether this represents increasing numbers of highly innovative drugs being made available or the introduction of increasing numbers of drugs with limited additional therapeutic value. Design and setting: Retrospective observational study of new drug entries in the British National Formulary (BNF). Primary and secondary outcome measures: Number of new drugs launched in the UK each year (based on first appearance in the BNF) from 2001 to 2012, including new chemical entities and new biological drugs, categorised by degree of innovativeness according to published criteria that incorporate both clinical usefulness and the nature of the innovation. Results: Highly innovative, moderately innovative and slightly innovative drugs made up 26%, 18% and 56% of all newly launched drugs, respectively, for the study period (n=290). There was an upward trend in annual numbers of slightly innovative drugs from 2004 onwards (R2=0.44), which aligned closely with the recovery in total numbers of new drugs launched each year since that time. There were no discernible time trends in the highly or moderately innovative categories. New drugs for malignancy and skin disease were most likely to be characterised as highly innovative (44% and 57%, respectively). Conclusions: Highly innovative new drugs comprise only around a quarter of all new drug launches in the UK. In contrast, drugs categorised as only slightly innovative comprised well over half of all new drugs and annual numbers in this category are increasing. Current policy initiatives that seek to increase the supply of innovative new drugs have long-lead times to impact, and will need careful assessment to ensure they deliver their aims without unintended consequences.
Supplementary Material: Festivals following the easing of COVID-19 restrictions: Prevalence of new psychoactive substances and illicit drugs
<p>Supplementary Material</p>
A Study Investigating the Safety, Absorption and Elimination of GLPG3312, a New Drug in the Treatment of Inflammatory Diseases
ClinicalTrials.gov study NCT03800472. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Drug-Coated Balloon in Combination With New Generation Drug-Eluting Stent in the Treatment of Long Diffuse Coronary Artery Disease
ClinicalTrials.gov study NCT05650450. IPD Sharing: Not stated. Countries: 1. Publications: 2.
Efficacy and Safety of New Generation Drug Eluting Stents Associated With an Ultra Short Duration of Dual Antiplatelet Therapy. Design of the Short Duration of Dual antiplatElet Therapy With SyNergy I
ClinicalTrials.gov study NCT02099617. IPD Sharing: NO. Countries: 9. Publications: 1.
Impact of the New Generation Anti-diabetic Drugs on Diabetic Retinopathy
ClinicalTrials.gov study NCT07351786. IPD Sharing: YES. Countries: 1. Publications: 4.
IMPAACT P1058A: Pharmacokinetic Effects of New Antiretroviral Drugs on Children, Adolescents and Young Adults
ClinicalTrials.gov study NCT00977756. IPD Sharing: Not stated. Countries: 2. Publications: 4.
Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice
ClinicalTrials.gov study NCT01186133. IPD Sharing: UNDECIDED. Countries: 1. Publications: 8.
A New Drug Delivery System - Silk Fibroin Film Loaded or Not With Insulin on Palatal Mucosa Wound Healing
ClinicalTrials.gov study NCT05171400. IPD Sharing: YES. Countries: 1. Publications: 5.
New Tablet Containing Two FDA Approved Anti-HIV Drugs For Antiretroviral Therapy Experienced HIV-1 Infected Subjects
ClinicalTrials.gov study NCT00044577. IPD Sharing: Not stated. Countries: 9. Publications: 0.
Preferences for Certainty Versus Access When Evaluating New Cancer Drugs. A Discrete Choice Experiment.
ClinicalTrials.gov study NCT05936632. IPD Sharing: NO. Countries: 1. Publications: 1.
New Drugs in the Treatment of Mood Disorders
ClinicalTrials.gov study NCT00001482. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Ticagrelor Monotherapy in PAtients Treated With New-generation Drug-eluting Stents for Acute Coronary Syndrome; T-PASS Trial
ClinicalTrials.gov study NCT03797651. IPD Sharing: UNDECIDED. Countries: 1. Publications: 1.
Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular Lymphoma
ClinicalTrials.gov study NCT00092274. IPD Sharing: Not stated. Countries: 1. Publications: 2.
Testing the Safety and Efficacy of the Addition of a New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Cisplatin and Etoposide or Carboplatin and Paclitaxel) for Adult and Pediatric Patients
ClinicalTrials.gov study NCT05019716. IPD Sharing: YES. Countries: 1. Publications: 1.
New Approach of Assessing Drug Response for Treatment of Nasopharyngeal Cancer
ClinicalTrials.gov study NCT01365208. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Study to Determine the Dose, the Safety and Effectiveness of a New Drug, Modified Release rhTSH, in Patients With Multinodular Goiter
ClinicalTrials.gov study NCT00454220. IPD Sharing: Not stated. Countries: 8. Publications: 2.
ScienceDex guides
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These curated guides explain access requirements, typical timelines, costs, and reuse considerations for widely used research datasets.
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OpenNeuro
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