Pharmaceutical Technology

SEPTEMBER 18, 2023

Experts say a wider diverse pool of patients needs to be given a chance to participate in clinical trials to get rare disease drugs faster to market.

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Clinical Trials Clinical Trials Trials Drugs 162

Worldwide Clinical Trials

OCTOBER 26, 2022

Bringing a psychedelic into a clinical trial setting is complex and requires a thorough operational approach to ensure the study’s success. Psychedelic trials need to be done with scientific rigor. Our team published recently in The Journal of Psychedelic Psychiatry exploring how we can bring more rigor to these trials.

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Trials Clinical Trials Clinical Trials Licensing 243

Bio Pharma Dive

SEPTEMBER 12, 2023

Acelyrin’s share value collapsed Tuesday after its lead drug fell short in the company’s first big trial test since it raised $540 million in a May IPO.

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Trials Drugs 167

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 10, 2022

More evidence of the link has arrived with a phase 2, double-blind trial involving 233 participants, the largest study on this subject carried out so far in terms of sample size. For some years now, scientists have been investigating how psilocybin, the psychedelic compound in magic mushrooms, can ease the symptoms of depression.

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Clinical Trials Clinical Trials Trials Clinical Research 220

Bio Pharma Dive

JUNE 12, 2023

Decentralized clinical trials (DCTs) bring many benefits to the clinical research process, and more importantly, the patients. However, it is important to remember the risks if there is no data security process in place.

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Clinical Trials Clinical Trials Trials Clinical Research 274

Rethinking Clinical Trials

AUGUST 9, 2023

The Stepped Wedge Cluster Randomized Trial: Friend or Foe? Description Dr. Monica Taljaard and Dr. David Magnus discuss the pros and cons of the stepped wedge cluster randomized trial. appeared first on Rethinking Clinical Trials.

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Trials Clinical Trials Clinical Trials Medicine 130

Rethinking Clinical Trials

AUGUST 4, 2023

Swimming with the Sharks: Translation of Pragmatic Trial Results Description Dr. Greg Simon discussing translating pragmatic clinical trial results. The post Swimming with the Sharks: Translation of Pragmatic Trial Results appeared first on Rethinking Clinical Trials.

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Trials Clinical Trials Clinical Trials Research 130

Rethinking Clinical Trials

AUGUST 9, 2023

Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Trials Description Dr. Emily Largent discusses ethical considerations when vulnerable populations are subjects in pragmatic trials. Biography Emily A.

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Trials Clinical Trials Clinical Trials Medicine 130

Pharmaceutical Technology

JUNE 16, 2023

The Phase IIa trial (NCT05734040) in Australia will see a potential 500 volunteers given OVX836 in combination with quadrivalent influenza vaccines (QIVs). The developer has tested OVX836 in four completed clinical trials. The aim of the latest ongoing trial is to evaluate the vaccine in a larger and more diverse population.

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Vaccination Vaccine Trials Clinical Trials 246

Pharmaceutical Technology

JUNE 15, 2023

Eloxx has revealed its lead candidate ELX-02 improved predicted forced expiratory volume (ppFEV1) in patients with Class 1 cystic fibrosis (CF) in a new analysis of a Phase II trial that missed its efficacy endpoints. The regimen in the trial was a one-week monotherapy period (1.5

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XTalks

AUGUST 22, 2023

Recruiting participants is perhaps the most challenging aspect of any clinical trial, regardless of the therapeutic area. Yet this one piece is also the most vital, with a trial’s ability to enroll and retain participants being a key predictor of a study’s future success. What is Clinical Trials For All?

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Clinical Trials Clinical Trials Trials Clinical Research 97

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 17, 2023

American pharmaceutical company Eli Lilly announced last week that it had seen encouraging clinical trial results of its new Alzheimer’s medication. According to the company, their experimental drug, donanemab, was shown in a late-stage trial to slow cognitive decline by 35 percent.

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Trials Clinical Trials Clinical Trials Drugs 184

Rethinking Clinical Trials

JULY 31, 2023

The NIH this month published notice of a funding opportunity to support the next round of pragmatic clinical trials within the NIH-DoD-VA Pain Management Collaboratory (PMC). The PMC was established in 2017 with an initial cohort of 11 pragmatic trials. Read the full notice of funding opportunity (RFA-AT-24-004).

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Trials Clinical Trials Clinical Trials Nurses 130

Rethinking Clinical Trials

JULY 17, 2023

Kaitlyn McLeod The NIH Pragmatic Trials Collaboratory is welcoming its first class of fellows in a new program for early-career investigators from underrepresented or minoritized groups with a scholarly interest in pragmatic clinical trials. Dr. Stephanie Ibemere is an assistant professor in the Duke University School of Nursing.

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Trials Clinical Trials Clinical Trials Nurses 130

Bio Pharma Dive

AUGUST 7, 2023

Fortunately, technology has created opportunities to innovate in clinical trials for rare diseases. The need for more research into rare diseases is clear, but researchers face significant challenges.

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Clinical Trials Clinical Trials Trials Research 244

Pharmaceutical Technology

FEBRUARY 17, 2023

The agency proposes that pharma move away from the common maximum tolerated dose (MTD) to trial designs that prioritise drug dosage optimisation at different stages. In clinical trials, dose-ranging is testing different drug doses against each other to establish which works best. However, in some cases, fewer patients could be needed.

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Clinical Trials Clinical Trials Drugs Trials 289

Pharmaceutical Technology

MAY 18, 2023

For clinical trial participants, dropping out of trials is often due to the distances from their homes to the trial sites, combined with unexpected costs and number of visits needed. Add in complex trial protocols, and many participants have reported feeling a lack of patient engagement and support [i].

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Clinical Trials Clinical Trials Trials Clinical Research 130

Pharmaceutical Technology

SEPTEMBER 19, 2023

The company plans to refile the IND after assessing the feasibility of US FDA-suggested trial modifications.

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Trials 130

Pharmaceutical Technology

AUGUST 23, 2023

Celcuity has entered a partnership to use Bayer’s Nubeqa in an upcoming Phase Ib/II prostate cancer trial investigating gedatolisib.

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Trials 195

ACRP blog

SEPTEMBER 13, 2023

With observations of National Hispanic Heritage Month kicking off on September 15, this year’s events will have special resonance for a team of Oregon Health & Science University (OHSU) researchers who are working to bring the benefits of clinical trials to more persons in underserved communities.

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Clinical Trials Clinical Trials Trials Clinical Research 128

pharmaphorum

SEPTEMBER 18, 2023

US researchers start trials of universal flu vaccine Phil.Taylor Mon, 18/09/2023 - 09:20 Bookmark this

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Vaccination Vaccine Trials Research 110

Drug Discovery World

SEPTEMBER 19, 2023

The University of Oxford has revealed that researchers are currently in the advanced stages of preparing for a clinical trial of a Nipah vaccine using the ChAdOx1 vector. The post UK scientists prepare for Nipah virus clinical trial appeared first on Drug Discovery World (DDW).

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Clinical Trials Clinical Trials Scientist Trials 64

Antidote

SEPTEMBER 13, 2023

Globally, there are thousands of research studies and clinical trials conducted each year, all with the shared goal of bringing new treatment options and medical devices to the market. However, approximately 80% of clinical trials are delayed or closed because of problems with recruitment.

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Clinical Trials Clinical Trials Trials Research 98

Antidote

JULY 14, 2023

For medical research to advance, the participation of individuals in a clinical trial is essential. However, accessing trial sites can present an undue burden. A survey about barriers to clinical trial participation found that the primary reason patients declined to enroll in a study was due to the inconvenience associated with travel.

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Clinical Trials Clinical Trials Trials Research 98

ProRelix Research

SEPTEMBER 17, 2023

Since […] The post Ophthalmology disorders and current developments of novel treatments under clinical trials appeared first on ProRelix Research.

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Clinical Trials Clinical Trials Trials Development 89

Outsourcing Pharma

SEPTEMBER 18, 2023

company Novadiscovery has hailed a âwatershed moment for clinical trial designâ as its trial simulation tool successfully predicted the outcome of a phase 3 oncology trial run by AstraZeneca. The French-U.S.

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Trials Clinical Trials Clinical Trials Clinical Development 65

XTalks

MAY 24, 2023

Leading health solutions company CVS Health recently disclosed that its clinical trial business will shut down just two years after its initiation in May 2021. The company will gradually wind down its CVS Health Clinical Trial Services unit with full exit by December 31, 2024.

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Clinical Trials Clinical Trials Trials Pharmacy 97

Fierce Pharma

SEPTEMBER 19, 2023

Gaining FDA approval last month for its geographic atro | Astellas reported results of a phase 3 trial that assessed Izervay’s effectiveness and safety over a 24-month period.

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FDA Approval Trials Drugs 115

Cloudbyz

MARCH 19, 2023

Decentralized Clinical Trial Management is a new approach to conducting clinical trials that leverages decentralized technologies such as blockchain, smart contracts, and distributed computing to streamline the clinical trial process. Additionally, all data is encrypted, making it secure from cyber threats.

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Clinical Trials Clinical Trials Trials Compliance 86

ProRelix Research

MAY 31, 2023

Introduction: Clinical trials are a crucial component of the pharmaceutical and medical research industry, aimed at evaluating the safety and effectiveness of new drugs, treatments, or medical devices before they […] The post Successful Clinical Trial With ProRelix Research: Phase 1, 2, 3 & 4 Clinical Trial Services at … appeared (..)

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Clinical Trials Clinical Trials Trials Research 90

Imperical Blog

SEPTEMBER 7, 2023

Avoiding “Customs Chaos” in Clinical Trials Means Working Closely with Your Importer of Record Many global clinical trial shipments get muddled regarding the critical role and responsibilities of the importer of record (IOR) for clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Research 52

XTalks

SEPTEMBER 21, 2023

announced that the first participant has been dosed in a new Phase I trial for an innovative HIV vaccine candidate, VIR-1388. The trial’s primary objective is to assess the safety of VIR-1388 and its capacity to stimulate a specific immune response against HIV in study participants. Vir Biotechnology, Inc.,

Vaccination 52

Vaccination Vaccine Trials Clinical Trials 52

Imperical Blog

SEPTEMBER 7, 2023

Avoiding “Customs Chaos” in Clinical Trials Means Working Closely with Your Importer of Record Many global clinical trial shipments get muddled regarding the critical role and responsibilities of the importer of record (IOR) for clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Research 52

pharmaphorum

SEPTEMBER 19, 2023

Older UK people back auto-enrolment in clinical trials Phil.Taylor Tue, 19/09/2023 - 08:55 Bookmark this

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Clinical Trials Clinical Trials Trials 96