Autoimmune/Inflammatory Archives - Insights From Our Labs to Yours

Addressing Challenges with Ulcerative Colitis Clinical Study Recruitment

by Martin Knight, BSc, Dip Clin Sci Senior Director, Strategy & Planning, Inflammation & General Medicine, Labcorp Drug Developmentupdated on Monday, January 10, 2022Monday, November 29, 2021

We understand the significant challenges sponsors face with patient recruitment in their ulcerative colitis (UC) clinical studies. While the prevalence of UC is relatively high (~0.2% in North America, Oceania and much of Europe – and rising in urbanized/industrialized countries in Africa, Asia and Latin America1), recruitment rates into clinical …

Preparing for European Union Clinical Trial Regulation

by Martin Knight, BSc, Dip Clin Sci Senior Director, Strategy & Planning, Inflammation & General Medicine, Labcorp Drug Developmentupdated on Monday, January 31, 2022Wednesday, October 27, 2021

How Labcorp Drug Development Can Support Strategic Submission Planning The European Union Clinical Trial Regulation 536/2014 (EU-CTR)1, which will be implemented on January 31, 20222, aims to enable more efficiencies in clinical trials, but will also impact legacy processes. Our team at Labcorp Drug Development is here to support strategic …

Decentralized Clinical Trials (DCT) Monthly Blog – January 2021

by Dr. Bola Oyegunwa, VP & Global Head, Decentralized Clinical Trialsupdated on Thursday, September 1, 2022Wednesday, January 27, 2021

What’s Next? In the aftermath of a turbulent 2020, in which the overall industry perception of the decentralized clinical trial (DCT) approach transitioned from being “promising but still largely experimental” to “a new-normal paradigm for the industry to adopt,” we have been considering “what’s next?”

Decentralized Clinical Trials (DCT) Monthly Blog – December 2020

by Dr. Bola Oyegunwa, VP & Global Head, Covance Decentralized Clinical Trialsupdated on Thursday, September 1, 2022Sunday, December 20, 2020

Welcome to the December edition of the DCT blog. In our final edition for 2020, we look back on an eventful year. As we entered into the year, we had a plan for building on prior successes in patient-centric trial design. We had plans for client outreach and events to …

Inflammatory Bowel Disease clinical studies and the importance of patient centricity

by Martin Knight BScupdated on Monday, June 7, 2021Tuesday, June 9, 2020

In today’s exceptionally crowded clinical trial environment of inflammatory bowel disease (IBD), patient-centric practices can help your study of Crohn’s disease (CD) or ulcerative colitis (UC) stand out to both patients and sites. Learn about your options to increase your trial’s patient centricity, encourage recruitment and promote ongoing patient retention. …

Is a different recruitment strategy required to enroll RA biosimilar studies? How to succeed despite increasing volume of RA biosimilar development programs

by Mark Fletcher and Martin Knightupdated on Monday, June 7, 2021Monday, February 17, 2020

Introduction Although a range of regulatory definitions exist, a biosimilar drug is generally defined as \a biological compound that is highly similar to the reference drug, with no clinically meaningful differences in safety, purity and potency.1,2 In addition, biosimilars can be characterized as reducing healthcare costs while maintaining clinical efficacy …

Minimizing placebo effect in inflammatory bowel disease clinical studies

by Martin Knight BScupdated on Tuesday, June 9, 2020Thursday, January 16, 2020

With 93 Crohn’s Disease (CD) and 168 Ulcerative Colitis (UC) Phase I-III industry-sponsored studies planned and open to enrollment, there is a significant focus on research into new therapies for inflammatory bowel disease (IBD)1. Remission is the main aim of IBD therapy, but IBD studies often face challenges with minimizing …

Inflammatory bowel disease clinical studies – where do we go from here?

by Labcorpupdated on Monday, June 7, 2021Friday, December 14, 2018

Inflammatory bowel disease (IBD), incorporating Crohn’s disease (CD) and ulcerative colitis (UC), is a chronic relapsing-remitting inflammatory disorder of the gastrointestinal tract.1 There is currently no cure for IBD and available treatments (e.g. aminosalicylates, immunosuppressant, biologics) have variable degrees of efficacy and tolerance. As a consequence, there is a large …

The advantage of applying a multifaceted approach in Cystic Fibrosis clinical research

by Labcorpupdated on Monday, June 7, 2021Thursday, June 28, 2018

As a complex, inherited disease, cystic fibrosis impacts the respiratory, gastrointestinal and reproductive systems. Many clinical trials are examining therapies that target this rare disease from different therapeutic angles, such as restoring function to a faulty protein, reducing inflammation, clearing mucus buildup, addressing gastrointestinal manifestations or fighting cystic fibrosis-related infections.

The promise of vaccines for fighting C. difficile

by Pritty Patel, MS MBAupdated on Monday, June 7, 2021Tuesday, May 8, 2018

Over the last decade, Clostridium difficile (C. difficile) infection has rapidly become more prevalent. C. difficile, often abbreviated as C. diff, usually spreads through hospitals and other healthcare facilities, and the elderly are particularly vulnerable. Our society’s overuse of antibiotics has been eliminating normal microbes, allowing C. difficile to take …