Can the peptide Lunasin help to reverse the debilitating effects of ALS? After one patient (and three experts) noted it could, PatientsLikeMe and the Duke ALS Clinic decided to get involved. Their novel trial will feature an unlimited number of patients, sharing of all patient data, and electronic patient reported outcomes. It also eliminated the use of a placebo.
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.
The healthcare industry’s transition to value-based care is putting a lot of pressure on pharmaceutical companies in terms of margins and the need to demonstrate improved outcomes at lower costs. In attempting to create breakthrough therapies and “beyond the pill” solutions with fewer resources, companies are demonstrating an increased appetite for outsourcing functions – and Contract Research Organizations (CROs) could be the beneficiaries.
Driven by the steep costs of hosting clinical trials in the United States and Western Europe, pharmaceutical companies have increasingly turned to global markets to conduct trials over the last decade. During that timeframe, Israel has emerged as an attractive market – bolstered by its high-quality medical infrastructure and well-trained physician workforce, diverse patient population and widespread adherence to Good Clinical Practice (GCP) standards.
Conducting clinical trials today is a complex set of activities that amass huge volumes of data from multiple systems. These varied systems -‐-‐ utilized to track patient information, manage inventory, capture patient images, enter medical records, detect issues and perform other functions -‐-‐ must efficiently provide trial stakeholders with a comprehensive understanding of trial performance across the entire clinical portfolio at multiple global sites.
At the Drug Industry Association’s (DIA) annual meeting held in June 2012, the TMF Reference Model Working Group released TMF reference model 2.0, which included significant updates from the group’s 2010, 1.0 release.
Welcome to Clinical Leader, the premier online community that helps streamline clinical research by connecting trial sponsors and cutting edge service providers. Clinical Leader is part of the Life Science Connect media group. The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.
Visitors are enriched with valuable information on CRO, Pre-Clinical Contract Research Organization, Bio-Analytical Contract Research Organization, Clinical Contract Research Organization, Pharmacovigilance, Clinical Data Management, Electronic Patient Reported Outcomes (ePRO), Point-of-Care Testing (POCT), Patient Recruitment, Electronic Data Capture (EDC), Clinical Trials Management Systems (CTMS) and more that can improve your business and make it more profitable.
Please take a moment to join our community and discover the benefits of your free membership.
Good news for the Duchenne Muscular Dystrophy (DMD) community. On June 8th, BioMarin announced the filing of a Marketing Authorization Application to the European Medicines Agency for Drisapersen, an antisense-mediated exon 51-skipping compound able to target the most prevalent genetic mutations responsible for the lack of production of functional dystrophin. The European filing follows the submission of a New Drug Application to the US FDA for Drisapersen back in April 2015.
When I read the EMA reflection paper on risk-based quality management in clinical trials, I had a déjà vu moment, or as the late baseball legend Yogi Berra would have said, "It's like déjà vu all over again." It spoke to the same guiding principles that embodied the Total Quality Management (TQM) system that received widespread attention in the manufacturing arena in the late 1980s and early 1990s.
In the last several years, we have seen tremendous advances in the amount of data we routinely generate and collect, as well as our ability to analyze and understand it.
Pharmaceutical and biotech companies are increasingly reliant on their CROs (contract research organizations) and vendor partners to provide innovative, cutting edge solutions that will help them bring new therapies to market faster. According to a recent market research report1, the global clinical development outsourcing market will reach more than $64 billion by 2020, with CROs managing close to 72% of all clinical trials. As sponsors continue to adopt the outsourced model, sponsor-vendor relationships will play a pivotal role in the success of the clinical trial.
Inappropriate drug storage can reduce the quality of product, potentially affecting efficacy and safety, so manufacturers, patients and prescribers must be aware of these risks. World Courier looks at the importance of ‘last mile distribution’ to understand the effects it has on patient safety as well as cost for pharmaceutical companies.