While it's an issue that's not limited to the pharmaceutical industry, miscommunication between the "doers" - those actually performing clinical trials - and the "planners," who set and monitor the budget, is particularly prominent. While research and development in a non-pharmaceutical business can often be put on indefinite hold while funding is secured, clinical trials don't share that luxury. Variables such as timing, resources, and the ability to make adjustments if obstacles arise are freedoms all crucial to a given trial's success. This means, in turn, that "holding" isn't really a viable option. So how can the behind-the-scenes program teams work in tandem with those on the front lines?Read More
CBI Scene Blog
Approximately a third of clinical trials conducted utilize some elements of Risk Based Monitoring (RBM), with this figure expected to increase. Site monitoring has been identified as one of the largest components of clinical trial expenditure. With the change in the way that site monitoring is performed, the role of the Clinical Research Associate (CRA) is significantly changing.Read More
We recently had an opportunity to speak with Michael C. Barnes, Executive Director of CLAAD, about some of the obstacles and future trends that Life Sciences ADF drug manufacturers are facing today. Read his answers and begin to prepare for the FDA led discussions at CBI's Abuse-Deterrent Formulations Summit in March.Read More
With increased pressure on the pharmaceutical industry to come up with creative solutions for the growing drug abuse epidemic in America and a new FDA legislation in effect, the time is now for bio/pharma manufacturers to analyze their formulations and ensure that new and existing products are meeting regulatory standards, reducing misuse potential and minimizing abuse liability. It is critical that the industry adapts quickly in order to ensure their drugs adhere to pre-marketing and post-marketing study requirements, as well as labeling mandates for improving drug safety and achieving market access.Read More
Rare diseases have traditionally received far less attention from legislators, researchers and pharmaceutical companies than more prevalent health issues. Rare diseases have often been overlooked because of a myraid of reasons including: lack of research on the disease state, difficulty in finding and retaining patients to participate in clinical trials, getting coverage approvals from payers, spreading market awareness about the disroder, and the financial return of such therapies.Read More
According to the Centers for Medicare and Medicaid Services, there has been a final ruling on the National Physician Payment Transparency Program: Open Payments, better known as the Sunshine Act. Under the Open Payments program, data collection of medical device and drug manufacturers who send gifts and payments to physicians and teaching hospitals is now mandatory. This applies to any manufacturer who receives government reimbursement, and collection data will be posted on a public website as of September 30, 2014.
Standardizing IRT implementation and management is important to moving forward with clinical trials. IRT, or interactive response technologies, is also very important in increasing the efficiency and decreasing the cost of clinical trials and applications. While there is no perfect, foolproof method of standardizing IRT, there are options that are more likely to be successful for the majority of applications.
Over the past several years, some sponsors and CROs implemented their eTMF without considering the impact it had on study teams, regulatory/compliance/IT groups, CRO partners and sites. In most cases those quick decisions resulted in extra manual processes, more double (or even triple) data entry, critical mistakes, extended implementation timelines, frustrated end-users, and escalated costs. While early adop