There were numerous articles in November 2016 that covered a wide range of topical issues. Here are five of the best stories you might have missed… (click the headline to finish reading the story)
As the news of Donald Trump’s stunning election victory begins to sink in, the question of what this means for the industry is a pressing one. Certainly, it can be argued that Trump’s win has raised more questions than answers. This is largely because much of the industry appears uncertain as to what exactly his intentions are. Much like the Brexit vote months before and the fears that rose for the UK industry, there’s a cloud of doubt over what impact a Trump presidency will have for clinical research in the US.
The drug development process is at the epicenter of a seismic shift. Gone are the days when pharmaceutical companies would partner solely with scientists and physicians to develop new medicines, with patients only becoming part of the process upon enrolling in a clinical study. Today, the path from development to FDA approval looks vastly different – with the patient’s perspective and voice playing a critical role in regulatory decision making. And while one voice can add significant value, it’s the collective amplification of many voices that has proven to be most effective in accelerating research.
Recruitment continues to be on the critical path for timely, on budget clinical trial completion. Despite the attention paid toward the tools that help stimulate enrolment including, educating patients regarding their condition, and ensuring that their participation is recognized at the end of the study, there has been only modest improvement in patient recruitment methods. While these are laudable initiatives, they are for the most part, directed to a certain demographic of clinical trial participants who are largely non-Hispanic, white, married, and middle-class. Being in the middle-class is associated with the following attributes: having money to manage, having health insurance, having a physician, being medically literate, and being interested in personal health1.
In the early part of 2016, headlines were dominated by the Zika outbreak in large parts of South America. Linked to birth defects, the Zika virus is believed to cause microcephaly, a condition affecting brain development. As concerns over the outbreak have risen, the pharma industry stepped up efforts to find a vaccine to combat the virus.
CTA spoke to Joel Maslow, Chief Medical Officer of GeneOne Life Science. As part of the company’s Zika vaccine trial, being conducted in collaboration with Inovio Pharmaceuticals, GeneOne is running the first and second first-in-man trials to assess the safety and immunogenicity of the vaccine. In this interview, Maslow explains the challenges in conducting the vaccine trial.
Data integrity is the cornerstone of successful clinical research. Without solid integrity, the data collected in clinical trials is worthless. Ensuring data integrity is as much for the research, as it is for the patients who will receive treatment based on that research. The code of Federal Regulations (CFR) parts 210, 211 and 2012, addresses the role of data integrity in clinical research. The FDA also released in April 2016, a “Data Integrity Guidance” to clarify the FDA expectations on this topic.