• The purpose of this study is to determine if the investigational COVID-19 vaccines are safe and can stimulate and broaden the immune response against the different COVID-19 variants that cause COVID-19 when given as a single booster injection in participants who have previously been vaccinated with a full course of an authorized COVID-19 vaccine. (wikipedia.org)
  • Through the FDA's open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA. (poz.com)
  • Other experimental vaccines-including a chimpanzee adenovirus vector vaccine from AstraZeneca and the University of Oxford and a one-dose candidate from Johnson and Johnson-may also be authorized in the coming months. (poz.com)
  • The approach also has a high level of risk: Manufacturing vaccines while running trials with no guarantee of FDA approval could result in large inventories that cannot be used. (pharmacytimes.com)
  • In August 2022, the FDA authorized an update to the Moderna and the Pfizer-BioNTech COVID-19 vaccines. (mayoclinic.org)
  • According to an October piece in Nature, they've conducted trials on vaccines designed against variants such as beta, which better evades vaccine protection than others. (thebulletin.org)
  • It wasn't until December of that year when US federal regulators authorized the first shots-record speed for vaccines, which had taken years to develop and test in the past. (thebulletin.org)
  • The initial vaccines went through three stages of clinical testing on people, including large phase III trials that included tens of thousands of participants. (thebulletin.org)
  • Only after that point did US regulators authorize the vaccines. (thebulletin.org)
  • Other analyses could be used to determine whether new COVID-19 vaccines will be effective without conducting large-scale human trials. (thebulletin.org)
  • Vaccines for children under 5 years old may be authorized next. (healthychildren.org)
  • Clinical trials continue for vaccines that could be given to children as young as six months old. (healthychildren.org)
  • Find out about COVID-19 vaccines that are authorized in Canada . (canada.ca)
  • You can search the complete list of drugs and vaccines that have been authorized for treating and preventing COVID-19 . (canada.ca)
  • Clinical trials are the most appropriate way for Canadians to access experimental drugs or vaccines that could help treat or prevent COVID-19. (canada.ca)
  • To date, 12 COVID-19 vaccines have received authorization for use in at least one country, and many more vaccine candidates are undergoing clinical trials to test their safety and efficacy. (medicalnewstoday.com)
  • For most experimental COVID-19 vaccines, the primary endpoints, or the main questions that a clinical trial asks, were the prevention of COVID-19. (medicalnewstoday.com)
  • Nevertheless, in an interview for the BMJ from January 2021, Prof. Andrew Pollard, Director of the Oxford Vaccine Group and one of the leaders of the Oxford vaccine trials, explained that it would not be difficult to modify both mRNA and viral vector vaccines - of which the Oxford-AstraZeneca vaccine is one - to match emerging variants. (medicalnewstoday.com)
  • Authorized or approved, inactivated COVID-19 vaccines may be given more than 7 days +/- receipt of study product for all study participants. (uclahealth.org)
  • We applied the VE-GD model to predict protection mediated by existing vaccines against new genetic variants and validated the results by published real-world and clinical trial data, finding high concordance of predicted VE with observed VE. (nature.com)
  • You can get any of the COVID-19 vaccines authorized in the United States for your booster shot. (cdc.gov)
  • This made it possible to develop COVID-19 vaccines and fully evaluate them in clinical trials much faster than before. (who.int)
  • Like all vaccines, COVID-19 vaccines go through a rigorous, multi-stage testing process, including large (phase III) trials that involve tens of thousands of people. (who.int)
  • Because the clinical trials took place in the middle of the pandemic with many people getting exposed, it was easier for clinical trials to see if the vaccines worked or not. (who.int)
  • Clinical trials have indicated that mRNA vaccines provide a long-lasting immune response. (who.int)
  • Vaccines that are authorized for emergency use by WHO do so after going through an extensive review. (who.int)
  • While trials have indicated that several COVID-19 vaccines to have high levels of efficacy, like all other vaccines, COVID-19 vaccines are not 100% effective against the disease. (who.int)
  • For purposes of entry into the United States, vaccines accepted will include FDA approved or authorized and WHO Emergency Use Listing vaccines. (cdc.gov)
  • Results: In 2019, there were 15 clinical trials authorized and conducted by three research centers, including 12 vaccines and 3 drugs trials all approved by an ethics committee. (bvsalud.org)
  • The new Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations (the Regulations), published in the Canada Gazette II on March 2, 2022, came into effect on February 27, 2022, following the repeal of the Interim Order No. 2 . (canada.ca)
  • As of Nov. 30, 2022, no antibodies are FDA-authorized because none are expected to work against the particular viral strains circulating. (factcheck.org)
  • The JYNNEOS vaccine, to be administered intradermally, was authorized for emergency use on August 9, 2022. (news-medical.net)
  • Canada has become the second country to authorize the Pfizer-BioNTech COVID-19 vaccine, just days after it was first approved in the U.K. Currently, Health Canada has authorized the vaccine for individuals aged 16 and older. (nanaimobulletin.com)
  • On May 5, Canada became the first country to authorize Pfizer's COVID-19 vaccine for that age group. (sciencenews.org)
  • Ongoing monitoring for rare and common adverse events after vaccination is important for evaluating the balance between risks and benefits for each authorized COVID-19 vaccine, including the Janssen COVID-19 vaccine. (cdc.gov)
  • FDA authorized the use of the P zer-BioNTech COVID-19 Vaccine for children ages 5 through 11 years. (cdc.gov)
  • Once a clinical trial indicates that a COVID-19 vaccine is safe and effective, a series of independent reviews of the efficacy and safety evidence is required. (who.int)
  • CHICAGO , Nov. 30, 2021 /PRNewswire-PRWeb/ -- metaMe Health, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for Regulora®, the first FDA-authorized treatment of any kind specifically for abdominal pain associated with irritable bowel syndrome (IBS) in adults. (prweb.com)
  • Advanced clinical trials of the vaccine were delayed in December 2020 after it failed to produce a strong immune response in people over the age of 50, most likely due to an insufficient antigen concentration in the vaccine, delaying the launch of the vaccine to late 2021. (wikipedia.org)
  • In February 2021, Sanofi-GSK started for phase II trials with 722 participants in the United States. (wikipedia.org)
  • In September 2021, Sanofi-GSK started a booster trial in the United Kingdom. (wikipedia.org)
  • The companies claimed to be able to produce one billion doses, subject to successful trials and regulatory approval, during the first half of 2021. (wikipedia.org)
  • In September 2020, Sanofi-GSK started for phase I trials with 440 participants in the United States. (wikipedia.org)
  • On December 9, 2020, we authorized the first vaccine in Canada for the prevention of COVID-19. (canada.ca)
  • It was approved in October 2020 for hospitalized patients 12 years and older based on randomized, controlled clinical trials that found faster recovery times and statistically significant odds of improving conditions among hospitalized patients with mild to severe COVID-19 who received the drug, compared with those who got a placebo plus standard care. (factcheck.org)
  • There were no deaths in either group in the clinical trial that the researchers could attribute to COVID-19 by the time the data became publicly available in the New England Journal of Medicine on December 31, 2020. (medicalnewstoday.com)
  • Data from Pfizer's clinical trial showed its two-drug antiviral regimen was 90% effective in preventing hospitalizations and deaths in patients at high risk of severe illness. (indiatimes.com)
  • Moderna recently began a study similar to Pfizer's new trial, as both companies hunt the right dosage of each shot for each age group as they work toward eventually vaccinating babies as young as 6 months. (smh.com.au)
  • Audrey, 14, and her brother Sam, 12, took part in Pfizer's clinical trial to test its mRNA vaccine in adolescents. (sciencenews.org)
  • Meanwhile, Moderna announced in a news release May 6 that early data from its trial in adolescents ages 12 and up indicate that the vaccine has 96 percent efficacy in that age group. (sciencenews.org)
  • This approach is founded on the premise that such questions must be answered before clinical trials of efficacy can be responsibly undertaken," the study authors wrote in their report. (livescience.com)
  • A sub-group analysis of data from the Oxford-AstraZeneca vaccine trial showed that the vaccine only had an efficacy of 10.4 % against COVID-19 in people who had an infection with B.1.351. (medicalnewstoday.com)
  • A randomized controlled clinical trial is underway to assess the efficacy of tecovirimat for MPX treatment. (news-medical.net)
  • The study will evaluate the effect of ATH434 treatment on neuroimaging and protein biomarkers to demonstrate target engagement and clinical endpoints to demonstrate efficacy, in addition to assessments of safety and pharmacokinetics. (yahoo.com)
  • Moderna is waiting to hear whether FDA will authorize its vaccine for use in teens. (politico.com)
  • However, bamlanivimab injection in combination with etesevimab injection continues to be authorized under an EUA for the treatment of COVID-19. (medlineplus.gov)
  • Only limited clinical trial information is available at this time to support the use of bamlanivimab for the treatment of COVID-19. (medlineplus.gov)
  • 2. Authorized Clinical Trials In Hungary (01.01.2015- 25.09.2023. (ogyi.hu)
  • Following review of the safety data, the DSMB authorized that the clinical trial proceed with enrollment and dose escalation for the second cohort. (globalgenes.org)
  • There are many things to think about when considering enrollment in a cancer trial. (tricare.mil)
  • Additionally, such an approach requires fast clinical trial enrollment, which is a challenge unless a sense of urgency is present. (pharmacytimes.com)
  • Paxlovid was found in a randomized, double-blind, placebo-controlled clinical trial to reduce COVID-19-related hospitalization or death from any cause by 86% compared with a placebo after 28 days of follow-up. (factcheck.org)
  • It was shown in a randomized, double-blind, placebo-controlled clinical trial to reduce hospitalization or death from any cause by 30% compared with a placebo after 29 days. (factcheck.org)
  • Clinical trials may also be referred to as interventional trials. (who.int)
  • The U.S. on Wednesday authorized Pfizer Inc 's oral antiviral COVID-19 pill for at-risk people aged 12 and above, making it the first at-home treatment for the coronavirus and a potentially important tool in the fight against the fast spreading Omicron variant. (indiatimes.com)
  • RBDCOV is one of 11 selected projects that support clinical trials of the new vaccine and may reach beyond Europe's borders by creating links with other European initiatives to address the fight against the coronavirus crisis and strengthen existing research infrastructures. (hipra.com)
  • The latest results of several large , randomized controlled trials show no benefit in using the antiparasitic drug ivermectin to treat COVID-19, the disease caused by the coronavirus, or SARS-CoV-2. (factcheck.org)
  • Changes to a previously authorized CTA must be submitted to Health Canada either as a Clinical Trial Application - Amendment ( CTA-A ) or a Notification . (canada.ca)
  • TRICARE covers the costs for screening tests to determine eligibility for the clinical trial and the costs of participating in the cancer clinical trials. (tricare.mil)
  • The trial will include 592 children and adolescents between 3 and 18 years of age on a voluntary basis, with the signature of informed consent by parents or legal guardians, as well as the signature of informed assent for participants older than 12 years of age, residents in health areas of urban zones of the provinicial capital of Camagüey. (telesurenglish.net)
  • The trial, which will involve 300 participants, will be carried out in 5 hospitals in Spain. (hipra.com)
  • 1 "A clinical trial is defined by WHO as any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. (who.int)
  • The clinical study is supported by neurocognitive evaluations, biochemical assessments and MRI data generated in a 25-subject MPS III Natural History Study, also conducted at Nationwide Children's Hospital, where patients continued through one-year of follow up assessments. (globalgenes.org)
  • The CHMP's decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and early clinical studies in adults, which suggest that the vaccine triggers the production of antibodies that target SARS-CoV-2, the virus that causes COVID-19, and may help protect against the disease. (wikipedia.org)
  • this rate was better than what the clinical trial data suggested. (lifehacker.com)
  • This Funding Opportunity Announcement (FOA) encourages small business applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing clinical studies. (nih.gov)
  • Based on clinical trial data the vaccine effect was predicted for younger people. (mayoclinic.org)
  • Review of safety monitoring data found that 97% of reported reactions after vaccine receipt were nonserious, consistent with preauthorization clinical trials data. (cdc.gov)
  • Trial data posted on this search portal are not endorsed by WHO, but are provided as a service to our users. (who.int)
  • A Phase 1/2 clinical study of ABO-102 in Spain was recently approved by the Agencia Espanola de Medicamentos y Productos Sanitarios, and the Company is preparing to conduct this clinical study at Cruces University Hospital in Bilbao, Spain. (globalgenes.org)
  • Diseases chosen for study should be based on the NINDS strategic plan and clinical research interests ( www.ninds.nih.gov/funding/areas/index.htm ). (nih.gov)
  • The NeuroNEXT Clinical Coordinating Center (CCC) will work with the successful applicant to efficiently implement the proposed study. (nih.gov)
  • The aim of this clinical study was to evaluate the effectiveness of a whitening toothpaste containing 3% carbamide peroxide and lactoperoxidase. (hindawi.com)
  • The procedure was performed in a brain-dead patient who was a registered organ donor and whose family authorized the research, according to the new study, published Thursday (Jan. 20) in the American Journal of Transplantation . (livescience.com)
  • From the procurement of the pig's kidneys to the surgery itself, the study followed the exact same procedure that the team will use in a future clinical trial, Locke said. (livescience.com)
  • The nature of the investigation or investigational use for which clinical study information is being submitted. (uclahealth.org)
  • Assess the prevalence and clinical implications of positive PCR tests for SARS-CoV-2 in the current study. (cdc.gov)
  • We therefore proposed a study mary school, secondary school, college clinical research. (who.int)
  • The trials will be carried out with the participation of apparently healthy Cuban children and adolescents, who will be given two doses of the vaccine candidate Abdala with the goal of preventing COVID-19. (telesurenglish.net)
  • People who want to participate in the trial must have received two doses of Comirnaty (Pfizer) at least 6 months ago. (hipra.com)
  • During the vaccine trials, follow-up of individuals included the time during which side-effects could have occurred, with a large margin to make sure al side effects were captured. (who.int)
  • This presentation will not include any discussion of the unlabeled use of a product or a product under investigational use except parts of the presentation will focus on monoclonal antibodies that are not FDA approved but are FDA authorized under emergency use authorizations EUA. (cdc.gov)
  • The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006). (clinicaltrialsregister.eu)
  • Objective: The objective was to take stockof the regulation of clinical trials in Mali. (bvsalud.org)
  • An adaptive, randomized, double-blind, parallel-group, double-blind, Phase I/II clinical trial will be conducted to evaluate the safety and immunogenicity, beginning July 5. (telesurenglish.net)
  • Other therapies include monoclonal antibodies that target SARS-CoV-2 , which the FDA has authorized for patients with mild to moderate disease who are at high risk for developing severe COVID-19. (factcheck.org)
  • How do the risks and benefits of this trial compare with those available through standard care? (tricare.mil)
  • During a trial, companies or sponsors collect information on the risks and benefits of a drug or vaccine. (canada.ca)
  • Pfizer says the booster shot provided a "strong immune response" in children who took part in a clinical trial. (abc15.com)
  • The company is running clinical trials of booster shots for adults and initial inoculations in children. (politico.com)
  • ic" or the " Corporation") today reported that it had been approved to commence the clinical trial of its orally active anti-fibrotic lead drug candidate, PBI-4050, in patients suffering from cystic fibrosis ("CF"), following the CTA clearance by Health Canada. (newswire.ca)
  • Mr. Pierre Laurin , CEO of PLI commented: "We are very excited to commence this trial in cystic fibrosis patients who have benefited over the years from a myriad of medical interventions leading to a progressively improved life expectancy. (newswire.ca)
  • ProMetic has recently reported a statistically and clinically significant decrease in HbA1C levels that compares very favorably to drugs already approved and marketed for the treatment of diabetes as well as additional evidence of PBI-4050's pharmacological and clinical activity in humans based on the analysis of new pro-inflammatory biomarkers in blood and urine samples from these patients. (newswire.ca)
  • In view of the sustained increase in the number of pediatric patients, the Ismaelillo-Pediatrics clinical trial was authorized to begin on July 5. (telesurenglish.net)
  • A groundbreaking treatment for sickle-cell disease and transfusion-dependent β-thalassemia using the biomedical advancement of CRISPR technology has been authorized by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for patients aged 12 and over. (fdanews.com)
  • We look forward to reporting on future progress and potential for ABO-102 as we begin to enroll patients at the high dose and open additional clinical sites internationally. (globalgenes.org)
  • The agency said it authorized the oral drug for emergency use for the treatment of mild-to-moderate disease in adults and pediatric patients 12 years of age and older, who are at high risk for progression to severe COVID-19. (indiatimes.com)
  • Today, the U.S. Food and Drug Administration authorized marketing of the EndoRotor System to resect (cut out) and remove necrotic (dead) tissue for patients with walled-off pancreatic necrosis (WOPN), a potentially deadly condition which can occur several weeks after an episode of severe acute pancreatitis, often requiring tissue removal. (fda.gov)
  • British Columbia will begin a clinical trial on a COVID-19 drug therapy approved by Health Canada on an emergency basis for patients who are at risk of being hospitalized with severe illness. (peacearchnews.com)
  • The research team intends to eventually transplant pig kidneys into living patients, in formal clinical trials - but first the team wanted to address some critical safety questions. (livescience.com)
  • Randomized clinical trials have repeatedly found that ivermectin does not benefit COVID-19 patients. (factcheck.org)
  • Both drugs are authorized for patients with mild-to-moderate COVID-19 who are at high risk of severe disease. (factcheck.org)
  • Another key drug in the arsenal is the steroid dexamethasone, which was found in a large randomized controlled trial in the U.K. to provide a mortality benefit in hospitalized COVID-19 patients who were ventilated or receiving supplemental oxygen. (factcheck.org)
  • The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled investigation of ATH434 in patients with early-stage MSA. (yahoo.com)
  • A clinical trial is being conducted to see the benefit of a known lipid-lowering drug such as pitavastatin in patients with advanced prostate cancer who are being treated with the new anti-androgens. (who.int)
  • The World Health Organization, through its International Clinical Trials Registry Platform, has developed the ICTRP database to provide patients, family members and members of the public current information about clinical research studies. (who.int)
  • Cuba's CECMED authorized Thursday the Center for Genetic Engineering and Biotechnology (CIGB) to initiate pediatric clinical trials with the vaccine candidate Abdala. (telesurenglish.net)
  • The recent FDA authorization of these trials represents an exciting step forward in cell therapy pipelines, with the potential to remove the DMSO requirement from workflows. (fujifilm.com)
  • Bypassing normal clinical trial guidance, the U.S. Food and Drug Administration on Tuesday expanded the Emergency Use Authorization for the Jynneos monkeypox vaccine to allow for an alternative method of injection and for "high-risk" children under 18 to get the vaccine. (davidicke.com)
  • b) ensure that agreed upon timelines for completing the scientific review of outstanding questions are respected and that timely decisions are made on the authorization of the trial. (who.int)
  • Prior to issuing the expanded EUA, the FDA confirmed that "numerous" children were granted access to the vaccine on a "case-by-case basis" through a special permission process - even though the vaccine was not approved or authorized for emergency use in that age group - ABC News reported on Aug. 4. (davidicke.com)
  • The FDA has just authorized emergency use of the vaccine for children 12 and older. (sciencenews.org)
  • The search portal uses these Secondary IDs to group records about the same trial together in the search results. (who.int)
  • An external panel of experts convened by WHO analyzes the results from clinical trials, along with evidence on the disease, age groups affected, risk factors for disease, and other information. (who.int)
  • The FDA assessed the safety and effectiveness of the EndoRotor System in a trial with 30 subjects (23 enrolled in the U.S.) with walled-off pancreatic necrosis who were indicated to undergo a direct endoscopic necrosectomy. (fda.gov)
  • Dolsten told Stat a small trial that assesses safety and immune response could be completed in a month. (thebulletin.org)
  • The experiment was intended to assess the safety of such transplants, prior to them being tested in clinical trials. (livescience.com)
  • These trials, which include some groups at high risk for COVID-19, were specifically designed to identify any common side effects or other safety concerns. (who.int)
  • The Center for State Control of Medicines, Equipment and Medical Devices (CECMED) authorized Thursday the Center for Genetic Engineering and Biotechnology (CIGB) to start pediatric clinical trials with the Cuban vaccine candidate Abdala. (telesurenglish.net)
  • The vaccine was authorized by an interim order, which sped up the approval process. (nanaimobulletin.com)
  • They will maintain the flexibilities and pathway set out by the interim order until the framework established through the Clinical Trials Modernization Initiative is in place. (canada.ca)
  • Reports from the current outbreak suggest transmission patterns and clinical manifestations might not follow the classic presentation of monkeypox ( 5 - 10 ). (cdc.gov)
  • Abeona's ABO-102 program has been granted both Orphan Product Designation and Rare Pediatric Disease Designation in the USA and plans to open two additional clinical sites, one in Spain and one in Australia, to test ABO-102. (globalgenes.org)
  • The reporting time clock restarts when any of the sponsor's personnel receives additional clinical or medically relevant information for a previously reported serious or near serious adverse event. (tga.gov.au)
  • We have authorized certain products to treat COVID-19 and its symptoms. (canada.ca)
  • The US Food and Drug Administration (FDA) has stated that it authorized (allowed) qualified health claims for a reduced risk of recurrent UTIs in healthy women (see FDA Announces Qualified Health Claim for Certain Cranberry Products and Urinary Tract Infections ). (msdmanuals.com)
  • Approval from both Health Canada and the clinical site(s) Research Ethics Board(s) must be obtained prior to the initiation of the trial. (canada.ca)
  • All Clinical Trial Applications ( CTA s) and Clinical Trial Application Amendments ( CTA-A s) are subject to a 30-day default review period from the date of receipt of a complete application in Health Canada. (canada.ca)
  • Records must be made available to Health Canada within 2 days if there is a concern regarding the use of a clinical trial drug and/or a risk to the health of the clinical trial subject. (canada.ca)
  • Health Canada authorized its use in November. (peacearchnews.com)
  • Provincial health officer Dr. Bonnie Henry said Monday the trial on the drug bamlanivimab, which has been studied elsewhere, is expected to get underway by the beginning of March. (peacearchnews.com)
  • CDC has developed clinical considerations for prevention and treatment of monkeypox in persons with HIV infection, including pre-exposure and postexposure prophylaxis with JYNNEOS vaccine, treatment with tecovirimat, and infection control. (cdc.gov)
  • SANTA ANA, Calif. -- FUJIFILM Irvine Scientific, Inc., a world leader in the development and manufacture of serum-free and chemically defined cell culture media for bioproduction and cell therapy manufacturing, today announced that its PRIME-XV Stem FreezIS DMSO-Free* cryopreservation medium is to be used as an excipient in a FDA-authorized clinical trial conducted by Vitro Biopharma. (fujifilm.com)
  • Haupt Pharma is your reliable partner for the manufacturing of your clinical trial supplies. (pharmaceutical-business-review.com)
  • Once review is completed, the application is either authorized (a No Objection Letter is issued) or rejected (a Not Satisfactory Notice is issued). (canada.ca)
  • Following peer review, NINDS will prioritize and order trials that are given access to the NeuroNEXT infrastructure. (nih.gov)
  • Clinical trials are research studies that help find ways to prevent, diagnose or treat illnesses and improve health care. (tricare.mil)
  • The FDA authorized PCV20 based on immunobridging studies involving the shared serotypes between PCV13 and PPSV23. (ihs.gov)
  • EUAs and have been used for post-vaccine serology determinations for clinical trials and research studies, as noted in published or preprint articles. (cdc.gov)
  • When vaccine developers set out the conditions of their clinical trials, they work closely with regulatory authorities, such as the Food and Drug Administration (FDA), to ensure they answer the most important questions. (medicalnewstoday.com)
  • The legal framework for clinical trials is governed in Mali by two texts, one legislative and the other regulatory. (bvsalud.org)
  • The null hypothesis tested was that there was no difference in terms of the clinical parameters between the whitening toothpaste and the nonwhitening dentifrice. (hindawi.com)
  • ABSTRACT Factors affecting parents' decision to involve their children in clinical research have not been studied in all cultural backgrounds. (who.int)
  • We aimed to explore the attitudes and beliefs influencing parents' decision to involve their children in clinical research in Mansoura, Egypt. (who.int)
  • Only 98 (27.5%) parents consented to involve their child in clinical research. (who.int)
  • What kinds of therapies, tests or procedures will I have during the clinical trial? (tricare.mil)
  • Records of clinical trials should be maintained by the sponsor for 25 years, as required in Part C, Division 5 of the Food and Drug Regulations ( C.05.012 - Sponsor's Obligations - Records ). (canada.ca)