Clinical news roundup for the week of October 21, 2016 with information on Sanofi and Science 37 bringing clinical trials to the home, SCRS Eagle Award winners, a precision master trial for AML, promoting trials to patients, stopping the progression of Alzheimer’s disease, and more.
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.
As life science companies progress through clinical development towards regulatory submission, if a quality management and process is not laid out from the beginning they face significant risks.
In the clinical trials industry, profitability and regulatory compliance pressures continue to mount. Consequently, pharmaceutical companies are striving to maximize their research and development spending by reducing clinical trial cycle times and focusing on their core competencies—all while maintaining high standards of quality. By James M. Dicesare and Kevin T.Williams, Clinical Financial Services, LLC (CFS).
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Intense interest surrounding RBM shows alignment of all the right elements — technology, regulatory bodies and the industry itself – to make risk-based monitoring a reality. If implemented with the right components, this approach could result in the most efficient trial management possible.
In the draft guidance, the FDA focuses its attention on the opportunity to leverage existing clinical data (adult and/or non-pediatric data) for use in pediatric indications. By leveraging the data, the FDA hopes to increase the number of pediatric medical devices introduced to the market.
Almost anyone involved in clinical research can tell you — the role of the biorepository has changed tremendously over the last decade. Two-thirds of the world’s biorepositories have been established in the past 10 years due in part to the completion of the Human Genome Project as well as the emergence of endeavors such as proteomics, genomics and personalized medicine.
With more complex molecules in development, changing capacity needs, uncertain forecasts and increased competition, the market demands flexibility and innovative approaches to address today’s new challenges.
In the United States alone, approximately 2.9 million women have faced or are currently facing breast cancer1. As the second most commonly diagnosed type of cancer among American women, breast cancer always needs new, advanced treatment options. At UBC, we’re passionate about helping our manufacturer partners develop the cancer-fighting drugs that have given hope to millions of women.