With the number of biologics now in development and soon to be making their way into clinical trials, the preservation of cells, tissues, and organs are suddenly increasing in importance. Companies handling the manufacturing, storage, and transportation of these materials need to be focused on improving the yield and extending the shelf life of these time and temperature sensitive biologics.
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 typical relationship between clinical trial sponsors and CROs is rarely described as ‘simple.’ And few, if any, are based on the trust and collaboration that would improve efficiencies in clinical research. With over 70% of clinical trials being outsourced to CROs, and less than 10% meeting trial completion dates, the question becomes not when, but how can this critical relationship be improved to make clinical development more efficient?
Today is a big day. Today is the day your clinical protocol is finalized. Your inclusion and exclusion criteria are polished to perfection. Your informed consent form has “IRB APPROVED” stamped on it in big, bold letters. Now is the time to deliver it into the eager hands of eligible patients.
Back in 2014, a study in Nature Biotech showed that only 32% of drugs have a probability of making it to Phase 3 trials, and only one in 10 drugs overall actually makes it to market. Things haven’t improved since then. BIO recently put out a study reporting that the average overall likelihood of approval (LOA) by FDA from Phase I was 9.6 percent – a 1 in 10 chance. The rate is even lower for major disease areas like oncology.
Under 21 CFR Part 11, FDA-regulated companies that choose to maintain electronic records to meet predicate rules are required to validate their electronic record-keeping systems.
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There are many reasons to be excited by the science being presented at this year’s American Society for Clinical Oncology meeting. The data presented at a special section on Saturday morning opened the door to a future when tumor genetics and biomarkers will change the way we think of about cancer treatment. As a physician working in clinical development, there is also the excitement around intriguing new questions that when answered could lead to life-saving treatments unimaginable just a decade ago.
More than 2,000 people packed into a cavernous conference hall at 8 a.m. on Saturday – demonstrating the high level of shared interest in emerging immunotherapies.
From virtual biotech companies to large pharmaceutical companies, outsourcing is a key consideration in clinical packaging and distribution. According to Sherpa Clinical Packaging, although outsourcing is a valuable strategy for companies of all sizes and capabilities, it should be entered into for reasons specific to a company’s requirements.
With thousands of people, hundreds of investigative sites, multiple CROs and various eClinical source systems—all generating massive amounts of data—clinical trials are an enormous undertaking. While leading organizations use Clinical Trial Management Systems (CTMS) to centralize operational data and automate processes so they can make better decisions, a CTMS can be out of reach for many small to mid-size companies, leaving them with isolated spreadsheets and/or inefficient, manual practices.
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.
Electronic Data Capture (EDC), which collects clinical trial data electronically rather than on paper, is becoming an increasingly popular solution for streamlining data processing.