Safety/Efficacy Featured Articles
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Key Considerations For ICH-GCP Guidance On Quality Risk Management
1/10/2017
By now, many of you are probably wondering about the recent adoption of the Good Clinical Practices (ICH E6 Guideline, R2). More specifically, you are likely wondering how it will apply to your own organization. In this Q&A, Elizabeth Bodi, senior consultant at Halloran Consulting Group, answers some of your questions and sheds some light on the guidance and how it may impact research, resources, and patients.
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Lexicon Uses Patient Input To Support Primary Endpoint
1/4/2017
When Lexicon Pharmaceuticals began planning for a clinical trial on neuroendocrine tumors, there were two things it hoped to accomplish. First, it wanted to incorporate patient voice into the trial design. Second, the company wanted to incorporate some type of mobile technology into the trial to help track feedback from patients.
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Is CRA Shortage To Blame For CRO Turnover?
12/20/2016
The results of a study on compensation released by HR+Survey Solutions (HR+SS) show that turnover in the U.S. for clinical monitoring jobs at CROs remained high in 2015. Clinical monitoring jobs, such as clinical research assistants (CRAs), involve individuals whose job function is monitoring the health of study participants in clinical trials.
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Innovative Patient Study Examines Effect Of Drug Use In Pregnant Women
12/19/2016
In 2009 the European Medicines Agency (EMA) launched PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium), a new research program designed to strengthen the monitoring of the benefit risk of medicines in Europe. Stella Blackburn, vice president and global head of risk management for QuintilesIMS, was heavily involved with this groundbreaking study and discusses key findings of it with Clinical Leader.
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How Pfizer Uses Patient Video To Improve Sickle Cell Trials
12/16/2016
Sickle cell disease is a red blood cell disorder where patients have abnormal hemoglobin in those cells. In this interview Brenda Cooperstone, VP and chief development officer for the specialty care business unit at Pfizer, discusses the efforts made to understand sickle cell patients, their condition, and how the company should interact with them during visits to the emergency room.
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How One Rare Disease Firm Merged Gene Therapy With Patient Centricity
12/15/2016
Abeona Therapeutics is named after the Roman goddess who was the protector of children as they start out on their journey. Since launching as a private company in 2013, Abeona has partnered with a dozen international foundations to fund its development efforts. Currently it is seeking a treatment for children with Sanfilippo Syndrome, and engaging caregivers to determine how to best meet the needs of patients taking part in trials.
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IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For November 2016
12/9/2016
Below are my top three articles downloaded on Clinical Leader for the month of November 2016. In case you missed them, please take this opportunity to see what everyone else was learning about the growing clinical staff shortage, how Lilly is helping physicians become researchers, and how Duke and PatientsLikeMe are bringing a novel approach to ALS trials.
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Clinical News Roundup: Almac And inVentiv Health Partner On IRT
12/9/2016
Clinical news roundup for the week of December 4, 2016 with information on Almac partnering with inVentiv on IRT, ERT acquiring Exco In Touch, and the 21st Century Cures bill passing the Senate and moving on to the White House.
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Novartis Approach Slashes Study Startup Time
12/8/2016
“Study startup has essentially been the same since most folks in the pharma industry can remember,” says Stephanie Petrone, executive director, medical operations for Novartis. “The paperwork is the same and the process is the same.” But now, with standard contract language and a centralized IRB, Novartis is significantly reducing the time it takes to start a study.
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How To Fix The Patient Diversity Problem
12/5/2016
There are 38,000 zip codes in the U.S. today. Around 70 percent of African Americans reside in 2,500 of those codes, while half of Hispanics reside in 1,500 of them. These minority populations are served by approximately 500 hospitals and 40,000 primary care physicians. Despite the concentration of these numbers, enrolling minority patients in trials remains a challenge.