This week, Clinical Trials Arena will be shining a spotlight on patient diversity as part of November’s 'Patient Diversity Week'. Running throughout the week of November 21st, 2016, CTA will post articles uncovering the most pressing issues facing industry today.
Be on hand to gain expert views as Karen Brooks (Adare Pharmaceuticals) tackles the elephant in the room and explains why the industry must champion the benefits of clinical trials to boost participation among ethnic minorities. Meanwhile, Lisa Valtierra (Valtierra Consulting) who feels the lack of patient diversity is a deep rooted problem in the US health care system.
Tomorrow, however, be sure to check out Colin Scott’s article (Nairn International), as he examines the challenges of recruiting minority patients for phase III chronic condition clinical trials.
But before we get things underway, catch up on some of CTA's most recent patient-themed stories below... (click on the headline to finish reading)
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.
Global health care in the 21st century is increasingly focused on structuring health care systems around value for the patient. That value can be measured by cost effectiveness, knowledge gained from the practice of evidence-based medicine, and other key concepts.
At Lilly, we believe that the results and practice of clinical research can help support value-based health care delivery. Knowing that it will take cooperation across health care systems, the pharmaceutical industry, and academia to develop feasible solutions, we have recently collaborated with representatives from Wilmington Health, PMG Research, Quintiles, Pfizer, and Harvard to investigate the impact of clinical research on health care overall.
Below is a brief summary of what we found...
In May of this year, the US Food and Drug Administration (FDA) released a Guidance for Industry on group-level “Expanded Access” for unapproved drugs. Journalists and investors reacted with wide speculation as to what these “new rules” might mean for drug development. The answer is: not much; the rules are not new at all. Today's regulations on Expanded Access in the US have been the same since 2009, when two minor modifications were made (one relating to cost recovery, the other relating to distinct authorization criteria for intermediate size and large size group programs.) The FDA periodically issues ‘Guidance for Industry’ documents on various regulatory topics. They clarify existing rules, rather than set new ones. Furthermore, the recent Guidance on Expanded Access was released in its draft form in 2013, meaning those who are interested or already involved in the practice have had plenty of time to familiarize themselves with the information. But there is a lot more to Expanded Access than regulatory policy.