Drug Target Review

MARCH 3, 2025

“We believe this will definitely make its way into preclinical research and practice.” This approach has the potential to revolutionise clinical trial design and lead to more effective, personalised treatments. “Then, the organoid model would be tested with, say, five, six, or seven drugs available on the market.

Disease

Advarra

DECEMBER 17, 2024

For example, AI tools can pull data from protocols and automatically update clinical trial management systems (CTMS), reducing manual entry errors and increasing workflow speed. This same data could be used to auto-generate study calendars based on the schedule of assessments, streamlining trial planning.

Clinical Research

The Pharma Data

JUNE 16, 2025

The initiation of this new trial brings much-needed hope for a future in which progression might be delayed or even halted. This further strengthens the biologicial rationale for proceeding into a larger and more definitive Phase III trial. Comments from Roche’s Chief Medical Officer Levi Garraway, M.D.,

Disease

Conversations in Drug Development Trends

NOVEMBER 5, 2024

Their virtual platform is fantastic, as well as their collaboration with the European Reference Network are all things CROs should leverage to support their trials. Both approaches need experts in the drug process, and CROs can definitely make an impact. Looking ahead to 2025, what are your hopes for rare disease research?

Disease

New Drug Approvals

JULY 8, 2025

Clinical Trials: Pritelivir is currently in phase II clinical trials, with ongoing research into its effectiveness and safety. Clinical Trials: Pritelivir mesylate is currently under extensive study to evaluate its efficacy and safety profile, with promising results in early clinical trials. Johnston, C. 2016.18189.

Virus

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Here, the draft guidance states that the appropriate timing for an INTERACT meeting should be when a sponsor has identified a specific product and has conducted some preliminary proof-of-concept (POC) studies but has not yet designed and conducted definitive toxicology studies.

Therapies

BioPharma Drive: Drug Pricing

JANUARY 2, 2024

A non-addictive pain pill faces its definitive test, while study results in ALS, a rare heart disease and lung cancer could have far-reaching implications.

Clinical Trials

KIF1A

JUNE 21, 2025

SpineX Pilot Trial Results : We’re thrilled to announce that two KAND patients completing an 8-week SpineX trial will have their progress and results shared during Friday afternoon’s session. She’s definitely the Queen Bee! London was diagnosed with KIF1A in 2022.

Therapies

DrugBaron

OCTOBER 17, 2022

Examples, such as post-hoc analyses of failed trials, are today too numerous to even be notorious. And such is the complexity of drug development (and indeed biology generally) that it doesn’t take much effort for management to “spin” the available data to match the chosen narrative.

Pharma Companies

PPD

AUGUST 5, 2024

Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success. The clinical sites working on these trials are highly experienced and have a deep understanding of the complexities of successfully running PAH clinical trials.

Clinical Trials

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. Notably, this is also the first guidance to describe the possible use of a conditional Notified Body certificate.

Trials

Crucial Data Solutions

DECEMBER 19, 2023

The growth of decentralized clinical trial (DCT) strategies may be happening slower than many expected, but it is definitely happening. The post The Advantages of Decentralized Clinical Trials in Diabetes Research appeared first on Crucial Data Solutions.

Clinical Trials

FDA Law Blog: Drug Discovery

MARCH 7, 2024

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

Clinical Trials

Cytel

APRIL 22, 2024

Kyle Wathen, Vice President, Scientific Strategy & Innovation One of the pivotal metrics considered when designing a clinical trial is the study’s probability of success, which can be measured in several ways.

Clinical Trials

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.

Trials

Conversations in Drug Development Trends

MAY 1, 2024

This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinical trials. Additionally, consider the locations of your trial; if it is multiregional, you can start planning for your overall product approval strategy.

Clinical Research

Advarra

JUNE 18, 2024

Defining Feasibility Feasibility is “a process of evaluating the possibility of conducting a particular clinical program/trial in a particular geographical region with the overall objective of optimum project completion in terms of timelines, targets, and cost.” Take a clinical trial management system (CTMS) example.

Clinical Trials

The Premier Consulting Blog

OCTOBER 21, 2024

However, accelerated approval comes with a condition: sponsors must conduct confirmatory trials to verify the drug’s anticipated clinical benefits using robust outcome measures. Concerns have arisen over delays—sometimes spanning over 7–8 years—that may expose patients to risks before confirmatory trials are completed.

Trials

Vial

JUNE 12, 2024

PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated. What are PROs in clinical trials? In a study on cancer clinical trials, Pe et al. From a regulatory standpoint, agencies like the U.S.

Clinical Trials

FDA Law Blog: Biosimilars

FEBRUARY 9, 2024

Overall, the final guidance provides many editorial clarifications as well as some noteworthy updates, including discussions on DHTs that meet the definition of a device, selection of a DHT and rationale for use in a clinical investigation, retention and protection of data collected by DHTs, and DHT updates.

FDA

Advarra

JUNE 9, 2022

Optimizing clinical trial access for potential patients is a critical goal for researchers and sponsors. Decentralized clinical trials (DCTs) can meet that need, but they come with some challenges. Designing a DCT comes with certain challenges of course, particularly when proposing to utilize outside groups or locations for the trial.

Clinical Trials

The Pharma Data

AUGUST 5, 2020

Following an interim analysis of the phase 2 ELARA trial, researchers found that Kymriah met the primary endpoint of complete response rate (CRR) – a standard measure of response to therapy in FL patients. Source link.

Therapies

PPD

AUGUST 9, 2023

The increased adoption of decentralized clinical trial (DCT) designs has revolutionized how the industry approaches clinical studies. In short, for clinical trial design to truly benefit from the digital revolution, data flow, management and analysis are the next frontiers.

Clinical Trials

The Pharma Data

SEPTEMBER 23, 2020

The halting of AstraZeneca’s COVID-19 vaccine trial around the world was cause for much initial concern over the eventual safety and efficacy of the therapy. Trials have resumed in the UK, Brazil and South Africa, but US trials remain on hold. Matt Fellows. Source link.

Vaccine

Advarra

OCTOBER 4, 2022

Clinical trial site selection can make or break a trial’s success before it even begins. When you consider around 11% of sites 2 fail to even accrue one participant on a given study, cost savings become a major consideration when evaluating which sites to partner with for a trial.

Clinical Trials

Antidote

FEBRUARY 28, 2023

In the United States, a rare disease is defined as a condition that impacts less than 200,000 people — by that definition, about 1 in 10 individuals (roughly 30 million people) in America have a rare disease

Disease

Drug Target Review

OCTOBER 5, 2023

This study sought to shed light on the safety and effectiveness of aHSCT in routine healthcare settings, moving beyond the confines of clinical trials. It’s important to note that this study is observational in nature and lacks a comparative group, which limits the ability to draw definitive conclusions.

Therapies

Alta Sciences

SEPTEMBER 13, 2023

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials pmjackson Wed, 09/13/2023 - 17:01 September is pain awareness month, and the importance of pain management and continued research into effective analgesics is integral to helping patients suffering from various pain conditions. Tags Clinical Trials Weight 1

Clinical Trials

LifeSciVC

JANUARY 16, 2024

Whether trial design, execution, or otherwise, drug development even where there is precedent is a challenging road and should not be taken for granted. Additional trials (e.g., The incretins as a class also look interesting across a number of follow-on indications, as evidenced by clinical trials in these areas (below).

Small Molecule

Conversations in Drug Development Trends

FEBRUARY 28, 2023

Though cancer ran in my family, we definitely weren’t expecting this news, and the survival rates left little to be hopeful for,” says Rob. Over the next few decades, that drug made its way through clinical trials, securing approval in 2007—just 36 months before Rob was diagnosed in 2010. To say it was devastating is an understatement.

Clinical Trials

Conversations in Drug Development Trends

FEBRUARY 21, 2024

To proactively manage subject expectations, we provide participants with the following: Dry restrooms No definitive stopping date Dietary requirements 24/7 collection of urine & fecal matter Blood sample collection 2. This process involves a careful assessment of medical history and daily bowel habits.

Clinical Trials

Cytel

APRIL 25, 2023

This program includes a definition of maximum fair price, based on key elements including comparative effectiveness data and information about a drug’s impact on specific Medicare populations.

Trials

DrugBaron

JANUARY 31, 2024

Consider target selection, which is probably the most critical decision for any drug R&D project (after all, if the target is wrong, then everything that follows will by definition be wasted). Can AI help make better decisions here?

Pharma R&D

Alta Sciences

JUNE 27, 2023

Cancer Treatments, Clinical Trials, and the Motivation to Innovate nbartlett Tue, 06/27/2023 - 20:58 Getting to the Heart of Science with Michelle Newby At the heart of science are stories—stories of courage, challenges, successes, lessons, and people. A: I went with the clinical trial. A: I wouldn’t be here without clinical trials.

Clinical Trials

LifeSciVC

AUGUST 21, 2024

Clinical Trials Are your clinical trials on track? What has the impact of summer been on recruiting efforts and the ability to manage clinical trial participants? Have you identified and reached out to the PIs and potential clinical trial sites? Or maybe you are nearing the clinic. Do you have ample drug supply?

Clinical Trials

Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic.

Regulations

FDA Law Blog: Biosimilars

AUGUST 4, 2023

DASCA amended the CSA by revising and adding specified substances to the definition of “anabolic steroid,” providing for the temporary and permanent scheduling of anabolic steroids and adding labeling requirements for products containing anabolic steroids. Implementation of the Designer Anabolic Steroid Control Act of 2014 , 88 Fed.

Regulations