Clinical news roundup for the week of January 15, 2017 with information on the financial relationship between pharma and patient advocacy groups, the FDA take on diversity in trials, HHS rules on patient safety, venture funding of mobile apps, and more.
David Kim has spent most of his career working on clinical trials. His areas of expertise include implementing strategic alliances, leading and directing sourcing and vendor management teams, and partner negotiations. In this interview with Clinical Leader, Kim discusses the challenges of CRO qualification, oversight, and audits, and how to make sure you are not being overcharged for the work you outsource.
With the number of biologics now in development and soon to be making their way into clinical trials, the preservation of cells, tissues, and organs are suddenly increasing in importance. Companies handling the manufacturing, storage, and transportation of these materials need to be focused on improving the yield and extending the shelf life of these time and temperature sensitive biologics.
If you are like me, you get bombarded with clinical conference promotions on a daily basis. In an age where we are inundated with electronic interactions, connecting with individuals face-to-face has become a rarity. While conferences enable that interaction, job requirements limit your out-of-office opportunities. So how do you decide which clinical conferences are worthy of your time?
Clinical News Roundup for the week of January 8, 2017 with information on Duke clinical trials, the new NCI drug formulary, how poor physician and nurse engagement by pharma leads to low patient recruitment, and ways to become more patient centric.
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.
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.
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.
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.
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.