Advarra

AUGUST 8, 2024

The EU AI Act’s implications extend into clinical research, where AI is increasingly utilized for tasks like medical image analysis, natural language process for endpoint analysis, and generating/analyzing data for synthetic control arms. Here are some key requirements for “high risk” AI systems as they relate to clinical trials.

Clinical Research 98

Clinical Research Research Clinical Trials Compliance 98

Advarra

NOVEMBER 14, 2024

In an era where clinical trials are increasingly global, it’s more imperative than ever to leverage international expertise. Data and safety monitoring boards (DSMBs), also known as data monitoring committees (DMCs), play a critical role in overseeing a clinical trial’s safety and efficacy.

Clinical Trials 97

Clinical Trials Trials International Clinical Research 97

Conversations in Drug Development Trends

JANUARY 24, 2024

Written By: Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Disease Given that 80% of rare diseases have a genetic etiology, genetic implications should be addressed at the onset of a clinical program to support trial enrollment.

Trials 75

Trials Disease Clinical Trials Clinical Research 75

FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

Clinical Development 69

Clinical Development Production Clinical Trials Treatment 69

Conversations in Drug Development Trends

JANUARY 6, 2025

In contrast, an adaptive trial design allows for modifications to an ongoing trial and its analyses under a pre-specified framework, which is outlined in the FDAs Adaptive Designs for Clinical Trials for Drugs and Biologics Guidance for Industry, published in 2019.

Trials 75

Trials Clinical Trials Treatment Disease 75

Conversations in Drug Development Trends

NOVEMBER 5, 2024

In preparation for World Orphan Drug Congress Europe, we interviewed Nathan Chadwick, Senior Director, Therapeutic Strategy Lead, Rare Disease, and Derek Ansel, MS, LCGC, Vice President, Therapeutic Strategy Lead, Rare Disease, to hear their insights into the current progress in rare disease research and their hopes for 2025.

Disease 52

Disease Clinical Trials Therapies Clinical Research 52

PPD

JANUARY 2, 2025

Its ability to maneuver persistent drug development challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success. clinical operations, pharmacovigilance, regulatory) across various medicinal products, a portfolio of studies or the entire company.

Clinical Development 98

Clinical Development Clinical Trials Trials Regulations 98

Drug Target Review

APRIL 7, 2025

As our understanding of the underlying biology of disease grows more sophisticated, emerging therapies operate on increasingly complex biopathological systems and mechanisms. A surrogate endpoint is a marker used in clinical trials as a substitute for a direct clinical outcome.

Clinical Development 69

Clinical Development Clinical Trials Clinical Pharmacology Trials 69

PPD

MARCH 11, 2025

While individual rare diseases affect populations that are small in numbers, collectively they impact millions globally, posing significant health and research challenges. Real-world data (RWD) and real-world evidence (RWE) have emerged as transformational tools in addressing these hurdles, advancing rare disease drug development.

Drug Development 52

Drug Development Clinical Trials Disease Trials 52

PPD

AUGUST 5, 2024

Pulmonary arterial hypertension (PAH) is a progressive and fatal lung disease that is caused or influenced by multiple factors. Composite endpoints might include factors such as hospitalization, transplantation and worsening of clinical outcomes. Historically, the available drugs and U.S. None offers a cure for PAH.

Clinical Trials 98

Clinical Trials Trials Clinical Research Disease 98

Olympian Clinical Research

AUGUST 5, 2020

Hidradenitis Suppurativa is a skin condition, not an infectious disease. . Researchers are working every day to develop a cure for HS, and they’re making great strides when it comes to treatments. The post A Closer Look At Hidradenitis Suppurativa: Disease, Causes, & Treatment appeared first on Olympian Clinical Research.

Treatment 98

Treatment Disease Clinical Trials Clinical Research 98

PPD

JUNE 7, 2023

Adults aren’t the only patients affected by the increasing prevalence of liver disease. The number of pediatric patients diagnosed with nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) is on the rise, yet there are currently no approved therapies to treat NAFLD and NASH in adult or pediatric populations.

Trials 98

Trials Clinical Trials Clinical Research Disease 98

PPD

AUGUST 16, 2023

The COVID-19 pandemic rapidly accelerated the adoption of hybrid and decentralized clinical trial (DCT) models. At the end of 2022, the PPD clinical research business of Thermo Fisher Scientific surveyed key leadership and staff on the frontline of clinical trial execution across the industry.

Clinical Trials 98

Clinical Trials Trials Clinical Research FDA 98

PPD

MAY 18, 2023

For neurodegenerative disease research, the care partner, or caregiver, is equally important as the person with dementia. Even with stronger awareness of studies, drug developers must contend with the inherent lack of trust between the dementia community and clinical trials. There’s little time to lose.

Clinical Trials 86

Clinical Trials Trials Clinical Research Doctors 86

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.

Vaccine 97

Vaccine Trials Clinical Trials Laboratories 97

PPD

OCTOBER 31, 2024

From adapting to complex new trial designs to embracing cutting-edge technologies, staying ahead requires a deep understanding of the current landscape. Drug development The rising cost of clinical trials is the top challenge this year, due to increasingly complex protocol designs and difficult patient recruitment.

Drug Development 52

Drug Development Clinical Trials Trials Drugs 52

Drug Target Review

JULY 3, 2025

It is becoming increasingly evident that generative artificial intelligence (GenAI) is a resourceful tool for helping pharmaceutical companies reduce manual tasks required by clinical trials. This is especially relevant with today’s heavier focus on enhancing personalised medicine via broader emerging scientific findings.

Drug Development 65

Drug Development Drugs Animal Testing Engineering 65

PPD

JUNE 20, 2025

Patients diagnosed with idiopathic pulmonary fibrosis (IPF) — a progressive, rare lung disease marked by scarring and worsening lung function — often face a poor prognosis. While two approved treatments, pirfenidone and nintedanib, slow disease progression, there currently is no treatment that reverses the effects or offers a cure for IPF.

Clinical Development 52

Clinical Development Treatment Clinical Trials Trials 52

Cytel

MAY 14, 2024

Written by Angela Vinken and Patti Arsenault Key Opinion Leaders (KOLs) — i.e., trusted, well-respected experts — are crucial in clinical research, especially in rare diseases. The challenge, however, is how to use KOLs wisely — they are often clinicians first and researchers second, and their time is in high demand.

Clinical Trials 59

Clinical Trials Disease Trials Clinical Research 59

Conversations in Drug Development Trends

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.

FDA 96

FDA Trials Clinical Trials Disease 96

PPD

OCTOBER 9, 2023

“Patient-centric” is used frequently to describe today’s clinical trial and health care landscape. The industry applauds that point of view and strives to include a patient-centric approach in all aspects of clinical trial designs. Education on the disease state and regular reinforcement.

Clinical Trials 98

Clinical Trials Trials Compliance International 98

Conversations in Drug Development Trends

OCTOBER 14, 2024

Autoimmune diseases and bone health conditions are not just medical challenges – they’re personal battles that millions of people fight every day. Fortunately, advances in clinical research are providing hope for better treatments and outcomes.

Research 52

Research Clinical Trials Therapies Immune Response 52

Labcorp Drug Development

MARCH 7, 2023

The field of nephrology clinical research has been steadily adding new interventional trials over the last five years at an average pace of 176 trials per year. This activity reflects the … The post Enabling better access to kidney disease trials appeared first on Insights From Our Labs to Yours.

Trials 52

Trials Disease Clinical Research Research 52

Reprocell

MARCH 19, 2025

Tissue biopsies have long been a cornerstone of clinical research, providing researchers with direct access to diseased and healthy tissue for analysis. In recent years, their role in clinical trials has expanded, offering invaluable insights into disease mechanisms, drug efficacy and personalised treatment strategies.

Clinical Research 52

Clinical Research Research Clinical Trials Disease 52

The Pharma Data

JUNE 12, 2025

The data, presented at the annual European Alliance of Associations for Rheumatology (EULAR 2025) congress in Barcelona, Spain, show that dapirolizumab pegol resulted in significant and clinically meaningful improvements in disease activity while addressing a major symptom that profoundly impacts patients’ daily lives — fatigue.

Disease 40

Disease Treatment Therapies Trials 40

Conversations in Drug Development Trends

JULY 29, 2024

Evolving sentiments recognize obesity as a medical condition and lifestyle choice as well as a chronic disease with genetic, psychological, cultural, and environmental causes (Figure 1). They should include a comprehensive set of outcomes and endpoints to capture multiple areas of potential improvement within obesity as a disease.

Clinical Research 52

Clinical Research Research Clinical Trials Treatment 52

Quanticate

SEPTEMBER 27, 2024

Advancements in preclinical and clinical research are driving major changes across various therapeutic areas, steering the industry into a new phase of medical innovation. Our aim is to provide valuable insights for industry professionals, stakeholders, and all those invested in the future of medical science.

Clinical Research 52

Clinical Research Research Pharmaceutical Companies Science 52

PPD

JANUARY 5, 2023

In an industry survey led by PPD, Thermo Fisher Scientific’s clinical research business, rare diseases emerged as a top therapeutic area in drug developers’ pipelines, with 39% of global biotech and biopharma leaders pursuing therapies in the broad rare disease space.

Disease 52

Disease Trials Clinical Trials Clinical Research 52

Olympian Clinical Research

OCTOBER 30, 2020

The disease is more common than many may realize, with approximately 2.6 At Olympian Clinical Research we’ve gotten a chance to work with countless Schizophrenia patients over the years through our clinical trials, and we know just how untrue many of the common assumptions about Schizophrenia really are. .

Clinical Research 98

Clinical Research Clinical Trials Treatment Disease 98

Broad Institute

NOVEMBER 25, 2024

Ladders to Cures (L2C) Accelerator By Maria Nemchuk November 25, 2024 Breadcrumb Home Ladders to Cures (L2C) Accelerator The Ladders to Cures (L2C) Accelerator aims to catalyze progress across the research ecosystem and accelerates advances leading to treatments and cures for patients with rare genetic diseases.

Clinical Trials 52

Clinical Trials Disease Trials Therapies 52

Conversations in Drug Development Trends

MARCH 1, 2024

These designs facilitate streamlined trial logistics and centralized governance and create higher-quality data. Master protocols allow a trial to perform multiple tests on diverse patient populations or diseases under a unified design. But how do they work, and when are they appropriate? What Are Master Protocols?

Trials 78

Trials Disease Drug Development Clinical Trials 78

PPD

SEPTEMBER 16, 2024

In a recent panel discussion at DIA Global , our experts explored how these elements are reshaping clinical research and drug discovery. This can be converted to a clinical trial simulator, which can model a clinical trial before the trial design is finalized and initiated.

Clinical Development 98

Clinical Development Clinical Trials Clinical Research Drug Development 98

Vial

DECEMBER 4, 2023

Clinical research is an integral component of the healthcare ecosystem. It is pivotal in the development of cutting-edge treatments, therapies, and interventions for a wide array of diseases. Patient Payments in Clinical Research: Perception Over the Years In the U.S.,

Clinical Research 52

Clinical Research Research Clinical Trials Regulations 52

Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. billion in 2023 and is expected to grow at a CAGR of 7.0% between 2024 and 2030.

Clinical Research 52

Clinical Research Clinical Trials Research Trials 52

Olympian Clinical Research

MARCH 3, 2020

There’s no doubt that research volunteers play a significant role in getting these vital solutions out on the market for the people in need. Sometimes people are afraid to enroll in a clinical trial out of fear, confusion, or misinformation. What is a clinical trial? Why should I participate in a clinical trial ?

Clinical Trials 52

Clinical Trials Trials Clinical Research Treatment 52

KIF1A

JUNE 20, 2025

Wearable Digital Data Collection Is On the Horizon: Meet BioSensics KIF1A.ORG is thrilled to announce an exciting new initiative to enhance our natural history study and accelerate progress toward clinical trials: wearable digital data collection in partnership with BioSensics , a leading innovator in digital health monitoring for rare diseases.

Clinical Trials 40

Clinical Trials Trials Disease Clinical Research 40

Olympian Clinical Research

MARCH 19, 2024

Clinical trials are essential for advancing medical knowledge and developing new treatments that can improve patient care and outcomes. Participating in a clinical trial is a significant decision that can have profound benefits, not only for the individual participant but also for future patients and the broader medical community.

Clinical Trials 52

Clinical Trials Trials Clinical Research Nurses 52