pharmaphorum

SEPTEMBER 27, 2021

As people have become more conscious and vocal about diversity and inclusion, Page & Page’s Lisa Lishman says pharma should reassess how it conducts clinical trials. The pharmaceutical industry is one of the most important industries in the world, providing lifesaving drugs and treatment to people who need it the most.

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Clinical Trials Clinical Trials Trials Vaccination 122

pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine.

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Clinical Trials Clinical Trials Trials Clinical Research 111

XTalks

AUGUST 4, 2022

Cardiovascular clinical trials need to have a diversity plan because there can be a difference in disease burden when comparing people of different race and ethnicity. The US Food and Drug Administration (FDA) is emphasizing the need for diversity in clinical trials. The Diversity of the US Population.

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Clinical Trials Clinical Trials Trials Clinical Research 52

XTalks

FEBRUARY 25, 2022

There has been increasing awareness around the need for improving inclusion and diversity in clinical trials. As such, there has been a growing emphasis on efforts to achieve better and more accurate representations of minority and underrepresented populations like Black people in clinical studies. Race-Based Medicine.

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Clinical Trials Clinical Trials Trials Research 52

pharmaphorum

AUGUST 6, 2020

” Finding new medicines to treat schizophrenia has proved to be a tough task for Lundbeck – its share price cratered in late 2018 after another potential drug failed in a phase 3 trial. The post Lundbeck gets cold feet, axes schizophrenia drug trial appeared first on.

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Drug Trials Trials Drugs Development 52

Scienmag

JULY 8, 2021

Researchers, including academics from the University of York, analysed systematic reviews of 1,200 Randomised Controlled Trials (RCTs) to assess whether reporting had improved over time.

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Trials Drug Trials Drugs Research 68

Pharmaceutical Technology

SEPTEMBER 7, 2022

Pharmacovigilance refers to the practice of collecting, detecting, assessing, monitoring and preventing adverse effects (AEs) caused by new drug substances. The following is adapted from a presentation given by Dave Par é and Silvio Scozzari at the DIA 2022 conference.

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Advarra

JUNE 27, 2023

Clinical trials are studies involving human volunteers to research ways to prevent, detect, and treat various medical conditions. The goal is to identify safer, more effective methods of treating illnesses using new drugs or new combinations of existing drugs.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

pharmaphorum

AUGUST 25, 2022

That is a moral failure on the part of medicine. But herein lies the dichotomy that medicine has created: By failing to regularly screen to find the early-stage disease, the number of patients who could participate in drug trials is limited. That makes recruitment of patients more challenging.

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Development Drugs Trials Medicine 98

FDA Law Blog

MAY 3, 2021

On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The ClinicalTrials.gov database is a public database of clinical studies administered by the U.S. National Library of Medicine. The notice was given to Acceleron Pharma, Inc.,

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Clinical Trials Clinical Trials Trials Regulation 52

NY Times

FEBRUARY 10, 2022

The panel debated whether overseas trials could be applied to a more diverse U.S. The decision may affect other Chinese drug trials, and spotlights the high cost of immunotherapy. population.

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Drugs Drug Trials Trials Clinical Trials 58

Advarra

AUGUST 16, 2022

Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Before 1983, only 38 orphan drugs had received U.S. Food and Drug Administration (FDA) approval.

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Clinical Trials Clinical Trials FDA Approval Drugs 52

The Pharma Data

NOVEMBER 10, 2020

Biomarkers will be critical to developing precision medicine for Alzheimer’s disease. Although a few are out there, phosphorylated tau (P-tau) may enable even earlier and more accurate detection, according to Eli Lilly-associated researchers speaking at the Clinical Trials on Alzheimer’s Disease (CTAD) virtual conference in early November.

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Clinical Trials Clinical Trials Trials Antibody 52

FDA Law Blog

MAY 3, 2021

Butler — On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The ClinicalTrials.gov database is a public database of clinical studies administered by the U.S. National Library of Medicine. 42 C.F.R. §§ 11.10, 11.44(a).

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Clinical Trials Clinical Trials Trials Regulation 40

Placebo Control

JULY 14, 2015

Adam Feuerstein points out - and expresses considerable alarm over - an overlooked clause in the 21 st Century Cures Act: Waive informed consent requirement for clinical trials?!?! Even though the patients aren’t personally identifiable, the collection of medical data qualifies this as a clinical trial.

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Trials Clinical Trials Clinical Trials Manufacturing 40

Placebo Control

DECEMBER 4, 2013

Instead of looking at registered trials and following them through to publication, this study starts with a random sample of phase 3 and 4 drug trials that already had results posted on ClinicalTrials.gov - so in one, very obvious sense, none of the trials in this study went unpublished. 1001566.

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Pharmaceutical Technology

APRIL 27, 2023

Genomic medicine development was ranked as the top industry trend for 2023 in a survey of 198 GlobalData Pharma clients and prospects conducted between October and November 2022. Excluding vaccines, there are five mRNA therapeutic products in clinical trial development as of November 2022. billion by 2028.

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