Tag: Clinical Trials

Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial – their approval does not mean that the therapy is ‘safe’ or effective, only that the trial may be conducted.

EMA Provides Recommendations on Compassionate Use of Remdesivir

EMA’s human medicines committee (CHMP) gave recommendations on how the investigational antiviral medicine remdesivir should be used for treating coronavirus disease (COVID-19) in compassionate use pro...

Novartis Announces Plan to Initiate Clinical Study of Jakavi® in COVID-19 Patients

Novartis today announced plans to initiate a Phase III clinical trial in collaboration with Incyte to evaluate the use of Jakavi® (ruxolitinib) for treatment of a type of severe immune overreaction ca...

Care Access Research to Lead Clinical Trial of Breakthrough Coronavirus Test

Care Access Research, the leader in rapid development and management of high-performing clinical research sites, announced it is leading a validation trial in conjunction with the FDA for a new at-hom...

The Medicine Against RNA-dependent Viruses has Passed the First Phase of Clinical Trials

Scientists of the Center for Pharmaceutical and Chemical Technologies of Ural Federal University together with colleagues from the Institute of Organic Synthesis named after I. Ya. Postovsky UrB RAS s...

Pre-clinical Trials of the Russian Vaccine’s Specific Activity Will Be Held before June 22

lab research
Russia will complete pre-clinical trials of the vaccines against the novel coronavirus (COVID-19) developed at the Vector State Research Center of Virology and Biotechnology in Novosibirsk before June...

Accord Donates 2M Tablets of Hydroxychloroquine to Largest COVID-19 Trial

Accord Healthcare Ltd, the principal European subsidiary of Intas Pharmaceuticals and the largest supplier by volume of generic medicines to the NHS, is collaborating on a large multi-national study i...

EMA: Chloroquine only to Be Used in Clinical Trials or Emergency Use Programmes

clinical-trials
Chloroquine and hydroxychloroquine, two medicines currently authorised for malaria and certain autoimmune diseases, are being investigated worldwide for their potential to treat coronavirus disease (C...

Phase 2/3 Trial for Kevzara® Initiated in Italy, Spain, Germany, France, Canada and Russia

The first patient outside of the U.S. has been treated as part of a global clinical program evaluating Kevzara® (sarilumab) in patients hospitalized with severe COVID-19. The global clinical program h...

Data Requirements for Phase 1 COVID-19 Vaccine Trials

Global regulators have published a report presenting the outcomes of a workshop on COVID-19 vaccine development that was convened under the umbrella of the International Coalition of Medicines Regulat...

Begin of Clinical Trial to Evaluate Sargramostim in Patients with COVID-19

clinical-trials
Partner Therapeutics, Inc. announced that Leukine® (sargramostim, rhu-GM-CSF) is being assessed in the SARPAC trial (sargramostim in patients with acute hypoxic respiratory failure due to COVID-19 – E...

FDA Approval of Clinical Trial for Actemra to Treat Patients With Severe COVID-19 Pneumonia

Genentech, a member of the Roche Group, announced the U.S. Food & Drug Administration (FDA) has approved a randomized, double-blind, placebo-controlled Phase III clinical trial in collaboration wi...

The Clinical Trials Market Is Booming in the APAC Region

clinical-trial
The Asia-Pacific (APAC) has emerged as the most prominent region for conducting clinical trials, accounting for over 40% of the annual share of globally conducted clinical trials in 2019, finds Global...

New Guidance: Clinical Trials During the COVID-19 Pandemic

clinical-trial-material
The European Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA) have published new recommendations for sponsors on how to manage the conduct of clinical tria...

FDA Issues Guidance for Conducting Clinical Trials

preclinical-research
The U.S. Food and Drug Administration issued a guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic. The FDA re...

$2 billion Required to Support the Development of a Vaccine Against COVID-19

The Coalition for Epidemic Preparedness Innovations (CEPI), the organisation set up to accelerate the development of vaccines against emerging infectious diseases, has made an urgent call for $2 billi...

The First Clinical Trial for a Vaccine to COVID-19 Began in USA

Inside the U.S., the first clinical trial for a vaccine to the novel coronavirus that causes COVID-19 began. It is mRNA-1273, developed by Moderna with the National Institute of Allergy and Infectious...