Articles by Anna Rose Welch
-
Behavioral Science & “Social Listening”: The DNA Of Clinical Trial Recruitment
9/9/2014
As demand increases for treatments, patients, and investigators to understand and meet health needs, it is becoming more important to find new and creative ways to recruit and retain the right patients for a trial’s target indication.
Clinical Leader turned to Ramita Tandon, SVP and General Manager, inVentiv Clinical Trial Recruitment Solutions (iCTRS), to learn more about the roles behavioral science, social media outreach, and “social listening analysis” can play in clinical trial recruitment in an increasingly regulated industry.
-
Insights Into Clinical Trial Recruitment Trends
9/4/2014
Are you searching for patients that don’t exist? With the rise of social media and increasingly rigid trial protocol, clinical trial recruitment has inevitably become more complex. PRA Health Sciences’ Gretchen Goller, Sr. Director of Therapeutic Expertise-Patient Access and Retention Services, provides insight into the changing landscape of trial recruitment and highlights some best practices for efficiently enrolling trial participants.
-
“Irresistible” Data: How Big Data Holds The Keys To Clinical Trial Innovation
8/28/2014
As clinical trials accrue more actionable data, it is becoming increasingly important to manage that data efficiently to keep the clinical research industry moving forward.
Clinical Leader turned to PRA Health Sciences’ Mary Mattes, Executive Director Clinical Informatics Delivery, to learn more about the challenges of data management, the emergence of Big Data, and the impact all this data will have on the clinical landscape.
-
Taking The Guesswork Out Of Site Selection
8/26/2014
As the industry continues to be shaped by globalization, regulatory pressures, and a growing demand for trial participants, clinical trial site selection inherently becomes a more difficult task.
-
What You Missed From Regulatory Agencies Last Week—August 11-15, 2014
8/21/2014
Roche announced last week that its subcutaneous formulation of its rheumatoid arthritis drug RoActemra was approved by the Scottish Medicines Consortium (SMC). The NHS will be making the drug available to those either taking the medication at home or in the hospital. RoActemra, an anti IL-6 receptor inhibitor, is the first of its kind to receive SMC approval for subcutaneous and intravenous formulations in combination with methotrexate or as monotherapy. The treatment underwent the phase 3 SUMMACTA and BREVACTA trials, which both revealed its comparability to the intravenous formulation and its overall efficacy.
-
Risk-Based Monitoring: A Fundamental Shift In Clinical Trial Conduct, Quality
8/19/2014
Risk-based monitoring (RBM) is steadily becoming a buzzword in the clinical space. While it may still be awhile before there is a universal standard in place, RBM is nonetheless becoming a key component for quality in the shifting landscape of clinical trials.
To help shed some light on how this practice is being used in the industry today, Clinical Leader reached out to PRA Health Sciences’ RBM Management Team: Alan Simpson, Melissa Nezos, and Gareth Adams. In this Q&A, the team defines what makes up their RBM strategy and discusses the ways RBM could impact the entire industry.
-
What You Missed From The Regulatory Agencies Last Week—August 4-9, 2014
8/14/2014
The European Commission (EC) has granted conditional marketing approval for PTC Therapeutics’ Translarna in non-mutation Duchenne Muscular Dystrophy (nmDMD). The drug is indicated for ambulatory patients 5 years old and up. The drug will be marketed in 28 countries in the EU, as well as in Iceland, Liechtenstein, and Norway. The company is required to complete its phase 3 nmDMD trial (ACT DMD) and submit safety and efficacy results. The EC took into account the performance of the drug in 174 patients in a 48-week study examining the drug’s effect on ambulation.
-
What You Missed From Regulatory Agencies Last Week—July 21-25, 2014
7/31/2014
The National Institute for Health and Care Excellence (NICE) backed Bristol-Myers Squibb’s Yervoy (ipilimumab) as a first line treatment in cases where the cancer has spread or tumor removal is impossible. The drug was already NHS approved as a second line treatment for advanced malignant melanoma. Now, with NICE’s ruling, the drug can be provided to patients before they receive chemotherapy. In order for this recommendation to be valid, BMS is required to provide the drug at a discount through a patient access scheme. The drug, which earned $1B in 2013, is expected to go up against GSK’s Mekinist and Merck’s pembrolizumab.
-
What You Missed From Regulatory Agencies Last Week—July 14-18, 2014
7/24/2014
The Medicines Company announced that the EMA, CHMP, and EC have approved the marketing authorization renewal for Angiox (bivalirudin). Angiox is an anticoagulant for adult patients undergoing percutaneous coronary intervention (PCI). This patient group also includes patients with ST-segment elevation myocardial infarction (STEMI) that are undergoing PCI. The drug is also indicated for the treatment of unstable angina/non-ST segment elevation myocardial infarction.
-
What You Missed From Regulatory Agencies Last Week — July 7-11, 2014
7/17/2014
GSK and Theravance’s Anoro Ellipta has received a nod of approval from the Japanese Ministry of Health, Labor, and Welfare (MHLW). Anoro Ellipta is indicated to relieve the symptoms caused by airway constriction in COPD, which affects roughly 8.6 percent of Japan’s over-40 population. The MHLW approved a once daily inhaled dosage of 25 mcg of the umeclidinium and vilanterol combination treatment following review of eight phase 3 clinical trials. This news has also triggered a $10 million milestone that Theravance will pay to GSK. The drug is expected to be released in Q3’14.