pharmaphorum

SEPTEMBER 28, 2022

The FDA has published draft guidance giving its position on the ethical reasons for including children in clinical trials, and protecting them from harm. ” The post FDA sets out its thinking on protecting children in clinical trials appeared first on.

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Clinical Trials Clinical Trials Trials Clinical Research 57

ACRP blog

JULY 5, 2023

Under-representation of diverse groups in the clinical research workforce contributes to the under-representation of diverse clinical trial participants. To grow and diversify the clinical research workforce, Merck (known outside the U.S.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

ACRP blog

JULY 5, 2023

Under-representation of diverse groups in the clinical research workforce contributes to the under-representation of diverse clinical trial participants. To grow and diversify the clinical research workforce, Merck (known outside the U.S.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

Advarra

NOVEMBER 17, 2022

Nusinersen’s approval marked the first time nonclinical data supported conducting initial clinical trials involving children. Usually, when there aren’t data to support enrolling children in clinical trials, the risk threshold requires the prospect of direct clinical benefit. Why This Guidance Now?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Research 52

Find Me Cure

APRIL 16, 2020

With 85% of patients unaware of clinical trials as an option at the time of their diagnosis, according to the NIH , it’s a shame that many parts of the application process are still needlessly complicated when a patient is aware and motivated. How to search for relevant trials.

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Clinical Trials Clinical Trials Trials Doctors 68

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 109

Worldwide Clinical Trials

NOVEMBER 10, 2023

 Instead, the medical community and regulating agencies need to balance all aspects when making decisions, working in partnership with their patients. Collaborating The Burden of Participation in Clinical Trials I was most surprised during the conference to hear that participating in a clinical trial can be rather daunting for pain patients.

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Clinical Trials Clinical Trials Trials Compliance 168

ACRP blog

NOVEMBER 8, 2023

As several retail pharmacy chains proclaim a rosy outlook for ongoing efforts to expand their services into the clinical trials arena in the wake of the pandemic, traditional study site personnel and patients interviewed on the topic offered more mixed and nuanced concerns about the prospects for near-term success for such ventures.

Pharmacy 59

Pharmacy Trials Clinical Trials Clinical Trials 59

ACRP blog

NOVEMBER 8, 2023

As several retail pharmacy chains proclaim a rosy outlook for ongoing efforts to expand their services into the clinical trials arena in the wake of the pandemic, traditional study site personnel and patients interviewed on the topic offered more mixed and nuanced concerns about the prospects for near-term success for such ventures.

Pharmacy 52

Pharmacy Trials Clinical Trials Clinical Trials 52

Worldwide Clinical Trials

FEBRUARY 22, 2023

Katie Nichols, senior project manager at Worldwide Clinical Trials, has been dedicated to rare disease research for seven years, seeing the impact firsthand that the progression of rare disease research has on rare disease communities. What will have the greatest impact on rare disease patients in 2023?

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Clinical Trials Clinical Trials Trials Research 130

ACRP blog

JANUARY 31, 2023

As Christine Senn, PhD, CCRC, CPI, ACRP-CP, FACRP, Chief Integration Officer with Centricity Research, settles into her volunteer duties as the 2023 Chair of the Association Board of Trustees (ABoT) for ACRP, she took time to answer some questions about her outlook on the current state of the Association and the clinical research enterprise.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

pharmaphorum

JANUARY 24, 2022

” Those trials also need to be large, involve a diverse range of individuals, and able to be run at reduced cost, said Landray. Protas will design and run smart clinical trials through collaborations with charities, foundations, academic research teams and industry partners, and will take on both repurposed and experimental drugs.

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Trials Drugs Clinical Trials Clinical Trials 97

STAT News

MARCH 6, 2023

Still, when doctors told her last year that the cancer was growing despite two operations, radiation therapy, and a fifth regimen of chemotherapy, the retired business-meeting facilitator decided to do something unorthodox: spend $83,000 out of pocket on an unproven experimental cancer vaccine.

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Vaccination Vaccine Drugs Clinical Trials 98

Drug Discovery World

APRIL 14, 2023

Kathryn E Wellen, PhD – Outstanding Achievement in Basic Cancer Research Wellen is an investigator at the Penn Epigenetics Institute and Vice Chair and Professor in the Department of Cancer Biology in the Perelman School of Medicine at the University of Pennsylvania. Vickers’ award lecture will be held on Sunday April 16 at 3pm ET.

Genetics 52

Genetics Research Medicine Clinical Research 52

The Pharma Data

DECEMBER 15, 2020

As the world’s first PPAR pan agonist that completed two confirmatory phase III clinical trials, Chiglitazar Sodium has shown significant and long-lasting hypoglycemic effects in a series of clinical studies, as well as other comprehensive effects including significant insulin sensitization and blood lipid regulation.

Insulin 40

Insulin Drugs Production Clinical Trials 40

WCG Clinical

SEPTEMBER 26, 2023

Listen and Subscribe: Apple PodCASTs Spotify Google PoDCASTS About this episode: Join WCG Talks Trials podcast host Kelly Fitzgerald, PhD, in a riveting dialogue with guest expert Currien MacDonald, MD, as they unravel the nuances of “Psychedelics in Research: Ethical and Medical Perspectives.” Kelly: Okay.

Research 59

Research Drugs Trials Clinical Research 59

The Pharma Data

MARCH 15, 2021

Clinical research is a key component of developing. A critical component of our medicinal product development is clinical research. This involves conducting clinical trials in humans to evaluate the safety and efficacy of new pharmaceutical products. We are committed to Good Clinical Practice.

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Clinical Trials Clinical Trials Trials Medicine 40

Pharmaceutical Technology

NOVEMBER 1, 2022

The medicines regulators in Europe have a strategy for 2025 where the second pillar is data and digitalisation, so we are trying to transform medicines regulation to be data-driven,” says Peter Arlett, Head of Data Analytics and Methods Task Force at EMA. Arlett explains that Darwin EU is playing a collaborative role in this goal.

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Big Data Regulation Medicine Research 278

pharmaphorum

MARCH 12, 2021

The pandemic has forced the industry to embrace virtual patient engagement to an extent that would have seemed unachievable little more than a year ago, but there is much more the industry needs to do to ensure that trial designs can truly meet patient needs in a post-COVID world. Listening to patients. Thanks very much’.”.

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Trials Research Pharma Companies Clinical Trials 132

pharmaphorum

MAY 25, 2021

Opportunities are growing for real-world evidence research as the technology matures and a pioneering new partnership between Savana, utilising its AI-driven clinical research methodology, and BREATHE aims to drive innovative research using this new way of working. The benefits of RWE. Patient-friendly studies.

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Big Data Clinical Research Research Trials 134

XTalks

FEBRUARY 4, 2021

Bernard, executive vice president for research and chief research officer at Vanderbilt University Medical Center, shared his experience in helping set up a DNA and clinical data resource called BioVU. Dr. Bernard’s clinical research interests are in the areas of sepsis and acute respiratory distress syndrome (ARDS).

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Research Biobanking Drugs Genome 98

The Pharma Data

NOVEMBER 10, 2020

Combined with real-world study (RWS) as well as medical theories and clinical cases, the monograph concludes, from the perspective of medical treatment, the experience of doctors in various regions of China in exploring the application of hydrogen-oxygen adjuvant therapy in mild, moderate, severe and critical patients at the baseline level.

Medicine 52

Medicine Clinical Trials Clinical Trials In-Vivo 52

pharmaphorum

MARCH 16, 2021

By extracting and reading unstructured information buried within the free text of clinical notes, Savana’s technology and clinical research methodology is enabling clinicians and health researchers around the world to analyse vast amounts of previously inaccessible clinical data. “We AI use in the pandemic.

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Doctors Doctor Life Science Clinical Research 113

XTalks

OCTOBER 1, 2020

Lin has made several transitions throughout her career, from being a clinician at an academic center, to academic research, to heading business development in industry. The drug is currently in clinical trials for alcoholic hepatitis (AH), nonalcoholic steatohepatitis (NASH), as well as in COVID-19 patients with acute liver or kidney injury.

Scientist 52

Scientist In-Vitro Research Life Science 52

XTalks

SEPTEMBER 14, 2020

By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. Sinovac Biotech is already in Phase III clinical trials testing its CoronaVac vaccine which it plans to evaluate in approximately 11,000 volunteers. The price of that prize is incalculable.

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Vaccination Vaccine Antibody Life Science 92