Clinical news roundup for the week of February 12, 2017 featuring information on new CTTI recommendations, China’s trial application backlog, adaptive trial design adoption, growth in the mHealth market, and Merck’s Patient-Centered Cancer Care Access.
Sitting on one of those long, painful, study status update calls recently, I was reminded of the famous light bulb joke. You know the one: “How many engineers (lawyers, politicians, etc.) does it take to change a light bulb?” I was both flabbergasted and frustrated that, after 45 minutes, the project manager was still wading through status updates from a myriad of CRO and vendor partners and CRAs — just to figure out where the study was from a site activation and enrollment standpoint.
Medical imaging plays an instrumental role in the clinical development of new life science products. Although the medical imaging industry is in a constant state of flux — due to increased investment in medical imaging companies, as well as mergers and acquisitions — adoption of novel imaging technologies to support clinical trials for the pharma, biotech, and medical device industries continues to increase. In fact, “centralized” imaging data is now used as a primary endpoint in many clinical research studies. This article will explore the factors driving imaging implementation in clinical trials, the current hurdles to increased adoption, and some of the technologies available to help overcome those challenges.
Treatment of cancer using chemotherapy (chemo) drugs began soon after WWII, when a compound called nitrogen mustard was studied and found to work against cancer in the lymph nodes. In the years that followed, many chemo drugs have been developed that work by non-selectively inhibiting rapidly dividing cells. In other words, chemo drugs kill cancer cells, but they also kill healthy cells in patients. The effectiveness of chemo treatments has therefore traditionally been determined by how well the toxicity of chemo drugs can be tolerated and/or managed in a patient.
Patient recruitment is often highlighted as the key factor in ensuring clinical study success. Ensuring on-time enrolments of patients, investigators, etc. is a constant concern throughout the clinical trial phases. However, patient retention through engagement is also a key factor — and one that is often overlooked. Patient dropout rates for pharmaceutical clinical trials are estimated to range between 15 to 40 percent of enrolled participants, depending on the trial phase.
Donald Trump’s advance team will soon be headed to FDA’s White Oak campus to observe and learn about the agency, to help facilitate the transition from the Obama administration to the Trump administration. In this article, I describe what I expect the nascent 2017 agenda will be as Trump’s team walks in the door, and I offer a few thoughts as to why the Trump team would do well to consider the unique nature of FDA as transition planning takes shape.
The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using singleuse technology.
The expanding global pharmaceutical industry projects a 4%-6% annual growth and forecasts that it will reach a value of $1T by 2014. By Paul Dupont
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How should clinical endpoints be chosen to optimize the chances for both regulatory and reimbursement success?
The final days before First-Patient-In (FPI) on a global trial are normally hectic, but when last-minute changes are required by regulators, there’s typically little to no hope of meeting the start date.
Clinical trials are not for the faint of heart. Conducting even one clinical trial is a monumental task with complex processes and issues that can surface and derail a study’s timeline. As a result, delays in regulatory filing, market entry, and ultimately, the delivery of new therapies to patients are all too common.
In the summer months, we find that a lot of our clients are re-assessing clinical trial recruitment strategies. How is the study tracking to its milestones? What goals have been communicated to senior management?
Despite advancements in clinical research technology over the last decade, recent research from the Tufts Center for the Study of Drug Development (CSDD) suggests that we are not conducting site activation any faster today than we did 20 years ago . One of the biggest factors contributing to lengthy cycle times is the inability of sponsors and Contract Research Organizations (CROs) to engage investigative sites in a manner that supports effective patient recruitment and retention in the context of a swift budget and contract process.