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.
SynteractHCR is a multinational clinical research organization, formed from the merger of Synteract with Harrison Clinical Research in 2013, which provides global, full-service clinical trial services. We have more than two decades of experience supporting biopharma companies in all phases of clinical development across multiple therapeutic areas. We customize programs that will deliver timely, high quality data to help you get to decision points faster, taking time and cost out of drug development.
As FDA guidelines evolve and drug products on the market begin to age, Bio/Pharmaceutical manufacturers face scrutiny of the original methods used to support these products. Therefore, manufacturers must re-evaluate these methods to ensure they comply with current FDA expectations.
In July 2012, a series of pharmaceutical legislation became effective in the European Union (EU), which included new requirements for Marketing Authorization Holders (MAH).