Drug Hunter

OCTOBER 5, 2023

With thousands of articles now, many of you have mentioned wanting to see more examples from previous coverage. Super Search A common complaint about this version of the site was the difficulty in searching for articles. “CYP induction”). The post Phase III is Coming! appeared first on Drug Hunter.

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Trials Drugs 247

PPD

JUNE 24, 2024

In the realm of vaccine development, mega trials — studies enrolling 5,000 subjects or more — have been instrumental in the fight against many pathogens, including influenza, rotavirus, malaria, RSV and most recently in the rapid development of vaccines against COVID-19.

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FDA Law Blog: Drug Discovery

MARCH 19, 2023

s Mark Tobolowsky co-authored the peer-reviewed article “ Microdystrophin Expression as a Surrogate Endpoint for Duchenne Muscular Dystrophy Clinical Trials ” in the recently published edition of Human Gene Therapy. Hyman, Phelps & McNamara, P.C.’s

Therapies 98

Therapies Clinical Trials Treatment Trials 98

Conversations in Drug Development Trends

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 Licensing Licensing 97

Drug Target Review

MARCH 24, 2025

Having previously drawn parallels with industry adoption of electronic lab notebooks in part 1 , this article expands on his vision for the future of the industry, sharing his forward-thinking ideas and practical recommendations. Currently, understanding these aspects requires extensive animal testing followed by human trials.

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Clinical Trials Animal Testing Drugs Pharmacokinetics 59

Drug Target Review

APRIL 7, 2025

A surrogate endpoint is a marker used in clinical trials as a substitute for a direct clinical outcome. Diagnostic biomarkers typically confirm or establish a diagnosis and are often used in selecting patient populations for clinical trials.

Clinical Development 59

Clinical Development Clinical Trials Clinical Pharmacology Trials 59

Drug Hunter

MAY 21, 2023

This “journal club” article highlights five recent articles of general interest to drug discovery scientists, including reviews on therapeutic areas of interest, principles and areas of medicinal chemistry and pharmacology, and a synthetic transformation worth keeping in mind. Get ahead now by requesting a trial. Chiodi and Y.

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Agency IQ

APRIL 19, 2024

BY LAURA DIANGELO, MPH On April 14, FDA announced that its Center for Drug Evaluation and Research (CDER) is launching a new clinical trial innovation hub, the CDER Center for Clinical Trial Innovation (C3TI). Fill out the form to read the full article.

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Clinical Trials Trials FDA Research 64

Drug Hunter

MAY 21, 2023

This article highlights six recent articles of interest in the field of targeted protein degradation including but not limited to potentially new ligases, recruiting motifs, and a discussion on the feasibility of CNS-penetrant degraders. Get ahead now by requesting a trial. already a member?

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Targeted Protein Degradation Trials Therapies Disease 131

Drug Patent Watch

DECEMBER 30, 2024

This article aims to provide a comprehensive overview of the key aspects of the regulatory framework, highlighting the requirements and challenges faced by pharmaceutical companies seeking to introduce generic drugs into the Japanese market. New Drug Application (NDA) : Needed for marketing approval of new drugs.

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Drug Development Clinical Pharmacology Clinical Trials Pharmaceutical Companies 52

Conversations in Drug Development Trends

OCTOBER 31, 2023

However, with a greater number of trials, sponsors and CROs face an increased risk of operational challenges, and sites continue to feel the widespread effects of the COVID-19 pandemic. To encourage further expansion and innovation in cancer studies, it’s critical to consider what contributes to success in an oncology trial.

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Trials Clinical Trials Clinical Development Clinical Research 75

Drug Hunter

JUNE 26, 2023

This article compiles recent high-profile clinical readouts and related news with small molecules of general interest and structures where they are available. III trial ( NCT05099640 ; n=98, 7.5-60mg/kg Get ahead now by requesting a trial. III in Phenylketonuria sepiapterin (PTC923, CNSA-001) oral BH 4 precursor 7.5-60mg/kg

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Small Molecule RNA Trials Treatment 130

Quanticate

AUGUST 2, 2024

Real-world evidence (RWE) is changing clinical drug development, bridging the gap between controlled clinical trial environments and the complexities of everyday patient experiences.

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Drug Development Clinical Trials Drugs Trials 104

Cytel

DECEMBER 29, 2022

Perspectives on Enquiry and Evidence explores a wide variety of topics within clinical trial design and data science in the form of expert articles, interviews, ebooks, and more. Here are some of our most read posts of 2022.

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Clinical Trials Trials Science Clinical Development 52

Agency IQ

APRIL 12, 2024

BY LAURA DIANGELO, MPH In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic. In this article, AgencyIQ explores the current regulatory state of decentralized trials and what’s likely coming next.

Regulations 59

Regulations Trials Clinical Trials Research 59

Quanticate

JUNE 26, 2024

There are three key CDISC standards which are vital for efficient data processing and analysis of clinical trial data known as CDASH , SDTM and ADaM. This article will focus on ADaM and provide you with everything you need to know in 2024.

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Clinical Trials Trials 98

Agency IQ

JULY 22, 2024

AgencyIQ has analyzed those approvals, revealing the extent to which FDA is approving products reliant upon just a single pivotal trial – and in some cases, trials with remarkably little racial or ethnic diversity. Fill out the form to read the full article.

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Clinical Trials Trials Drugs FDA 59

Quanticate

APRIL 12, 2024

The landscape of clinical research is undergoing major changes with virtual clinical trials driving these transformations. These innovative trials promise to revolutionise the way medical research is conducted, making it more accessible, efficient, and patient-centric than ever before.

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Clinical Trials Trials Clinical Research Disease 52

PPD

MARCH 11, 2025

Breaking through research barriers Challenge #1: Small groups of patients Rare diseases impact a small number of individuals, making it difficult to recruit enough participants for clinical trials. Moreover, in some rare disease trials, it is unethical to design a control group of patients with a placebo.

Drug Development 52

Drug Development Clinical Trials Disease Trials 52

Quanticate

SEPTEMBER 6, 2024

The integration of Artificial Intelligence (AI) and Machine Learning (ML) in clinical trial design is beginning to reshape the pharmaceutical and medical research industries.

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Clinical Trials Trials Pharmaceuticals Research 52

Agency IQ

AUGUST 18, 2023

Those protections are found at 21 CFR 50 and 56 and include concepts like informed consent, appropriate clinical trial oversight by institutional review boards (IRBs), the review of investigational research protocols by the FDA, and ensuring that test articles have been appropriately vetted prior to human use.

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FDA Clinical Trials Clinical Research Regulations 52

Agency IQ

AUGUST 23, 2024

AgencyIQ summarizes the noteworthy changes in the updates to several documents designed to help sponsors and other entities involved with clinical trials to transition to the Clinical Trials Information System (CTIS) on January 30, 2025. Fill out the form to read the full article.

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Clinical Trials Trials 52

Quanticate

DECEMBER 2, 2024

Double-blind randomised controlled trials (RCTs) are the gold standard for evaluating clinical interventions in the biomedical field. This article provides a comprehensive guide to randomisation in clinical trials, exploring its fundamental principles, various methods, and the practical challenges involved.

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Clinical Trials Trials Treatment 52

Agency IQ

JUNE 28, 2024

BY COREY JASEPH, MS, RAC New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time. Fill out the form to read the full article.

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Trials Clinical Trials Marketing 52

Quanticate

SEPTEMBER 23, 2024

Whether you’re working on clinical trials or handling complex data analyses, mastering SAS® programming techniques and managing large datasets efficiently are crucial for successful outcomes. SAS® (Statistical Analysis System) is a powerful tool widely used in clinical programming, data analysis, and reporting.

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Clinical Trials Trials 98

Quanticate

APRIL 5, 2024

Clinical trial professionals are well aware of the unique challenges presented by oncology, a therapeutic area dedicated to the prevention, diagnosis, and treatment of cancers. In this article, we delve into key CRF design considerations for oncology clinical trials.

Trials 52

Trials Clinical Trials Treatment 52

Quanticate

AUGUST 29, 2024

In clinical trials, where the accuracy and reliability of data can determine the success of a study, the database lock (DBL) process is essential. A smooth and effective database lock is not merely a procedural step, but an important milestone that ensures the integrity and quality of the trial’s data.

Clinical Trials 52

Clinical Trials Trials 52

Vial

JUNE 24, 2024

Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery. As clinical trials grow in complexity, the volume of data being gathered and utilized for these studies is expanding.

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Clinical Trials Trials Clinical Research Treatment 52

KIF1A

FEBRUARY 10, 2024

Read the Article Rare Roundup Bespoke Gene Therapy Consortium Publishes First ‘Playbook’ to Bring Rare Disease Programs to Clinic Gene-based therapy is still a new arena; even as scientists across the world work on gene therapies, a major question is how to best prepare these treatments for clinical trials and regulatory approval.

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Therapies Clinical Trials FDA Disease 111

Reprocell

AUGUST 29, 2023

Clinical trial analytics software is used by researchers to collect, store, analyze, and visualize data from clinical trials. These digital platforms can automate complicated analytical processes, improving the efficiency of clinical trials and reducing costs.

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Clinical Trials Trials Research 52

Drug Hunter

JUNE 25, 2023

This article highlights million-dollar molecules that were recently in the news with related patent applications that give clues to their structures and properties. Oral Allosteric AR Modulator s request a trial You don’t have time to read everything, but you can’t afford to fall behind. Get ahead now by requesting a trial.

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Targeted Protein Degradation Computational Chemistry Trials Licensing 130

Agency IQ

AUGUST 23, 2024

EMA issues more updates to prepare for clinical trials transition Offices throughout the EU—including those of the EMA—have slowed operations for the summer holiday, but that didn’t keep the EMA from publishing a stack of updated documents. Per the CTR, all clinical trials are to be moved over to the CTIS by January 30, 2025.

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Clinical Trials Trials Regulations Production 40

Quanticate

SEPTEMBER 13, 2023

In this article, we delve into six key clinical data management practices for the complex terrain of biotechnology trials. From setting clear study objectives to embracing risk-based quality management, these practices underscore the industry's commitment to precision, efficiency, and innovation as it propels itself into the future.

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Trials Drug Development Drugs 52

H1 Blog

JUNE 7, 2023

Clinical trial success is a key factor for pharma companies when designing and recruiting patients into trials. In a recent article in Clinical Leader , Randy Krauss, head and executive director of metrics, analytics, and performance, Merck & Co.,

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Trials Clinical Trials Pharma Companies Clinical Development 52

Agency IQ

JUNE 28, 2024

New guidance provides definition for orphan device, offers alternative trial designs New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time. Data outside the PMCF (section 9.4) These data may help detect rare complications.

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Trials Marketing Clinical Trials Disease 40

Labcorp Drug Development

APRIL 17, 2023

In a 2022 Hepatology article, researchers estimated that the one-year increase in alcohol consumption during the pandemic would result in an … The post Alcohol-related liver disease: Inherent Challenges and Strategies for Successful Clinical Trial Conduct appeared first on Insights From Our Labs to Yours.

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Clinical Trials Disease Trials Research 52

Drug Target Review

JULY 4, 2023

In this article, Petra Dieterich, Ian Glassford, and Jeff Mocny, Scientific Leaders at Abzena discuss real-world data that is challenging traditional scientific thinking on the ADC therapeutic window. 2 However, when dosed at the MTD, ADCs display improved efficacy over small molecules in oncology trials.

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