SCORR Marketing, along with KNect365 Life Sciences, a global community of pharma stakeholders, has produced a report on the current status of patient centricity in clinical trials. The survey collected 208 responses from industry professionals in a variety of job functions and regions. The survey tried to determine if companies are taking patient preferences into consideration and, if so, how they are doing so.
The NYUSOM Working Group on Compassionate Use and Pre-Approval Access recently released a paper noting inherent problems with the proposed Right To Try (RTT) legislation proposed by Sen Ron Johnson and 46 cosponsors. The key findings were that RTT legislation would not allow patients to get drugs faster, and that FDA actually helps, rather than harms patients. Of course, not everyone agrees with the findings of the Working Group. One of those individuals is Michael S. Smith, Vice President of the Gastroparesis Patient Association for Cures and Treatments, Inc. and a patient who has lived with Chronic Intestinal Pseudo-Obstruction for nearly 30 years.
The need for clinical trials to meet the requirements of regulators, deliver high-quality data, and come in on budget has led to study designs that focus on timeliness and convenience, yet may unduly burden and inconvenience patients.
Several recent analyses have called attention to the increased scientific and operational complexity of today’s clinical trials.
At INC Research/inVentiv Health we have the ability to expedite clinical programs and build the foundation for continued development of the product.
According to FDA Draft Guidance published in March 2010, a pharmacokinetic (PK) study should be conducted in patients with impaired renal function when the drug is likely to be used in such patients and when renal impairment is likely to mechanistically alter the PK of the drug and/or its active metabolites.