Clinical News Roundup for the week of September 19, 2016 with stories on HHS and ClinicalTrials.gov, FDA approval of Exondys51, DCRI coordinating National Study of Childhood Health, and the world's largest breath-based clinical trial.
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.
The core addressable early phase market is USD 11.9 billion growing with a CAGR of 2 – 3 percent. Early-phase trials are outsourced at greater than 60 percent by pharma, as the trials are costly and small in number. The supply market for early phase is comprised by CROs, research centers, and academic institutes. The market size that is comprised by the CROs is estimated to be around USD 8 billion, which is about 67 percent of the early phase market.
Traditionally in the pharmaceutical and biotech industry worlds, a pharma company develops a candidate product and then works with a group of doctors to test that product under careful standards and procedures—very much managed by the pharma company. If the product shows therapeutic value and safety, it becomes available to prescribers to administer to patients.
In clinical trials involving patients with complex medical diseases such as chronic kidney disease or cancer, nursing skills are especially useful. Nurses are trained on how to interact with, evaluate and appropriately care for, patients. They are familiar with complex medical regimes and are comfortable talking with and educating patients.
Over the years, an entire system called ‘cold chain supply (or cold chain transport)’ has developed in the food industry to ensure that foods that need to be kept cold are stored and transported in appropriate conditions and are monitored so consumers and regulators can be assured of their safety.
Vaccines, one of the most useful and cost-effective means of reducing illness and death from infectious diseases, are enjoying a resurgence of interest that some have pronounced a renaissance. With hundreds of vaccines in research and development worldwide, vaccines are among the fastest growing segments of the biopharmaceutical market today.
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Novel therapeutics such as gene and cell therapies, nanoparticles, and combination products requiring targeted delivery, novel treatments for wound healing, cardiovascular disease, and bone regeneration, and new medical device technologies call for innovative surgical procedures in preclinical trials to determine safety and efficacy.
The clinical trial process plays an essential role in drug discovery by effectively demonstrating the efficacy and safety of a pharmaceutical compound. Unfortunately, current estimates show that only about 1 in 10 drugs that actually start the clinical trials process are eventually granted FDA approval.
I recently had the opportunity to attend DIA. While listening to the panelists, I realized TransCelerate companies appear to be the furthest along in their journey of risk-based monitoring (RBM), and even so, RBM is still relatively new for most of them. For the companies presenting at DIA, the main reasons given for implementing RBM were to comply with the impending ICH E6(R2) guidelines, increase the overall quality of their data, provide better oversight of patient safety and target their efforts on the areas of trials that matter most.
As eClinical data management continues its march toward becoming the norm in clinical research, the landscape becomes increasingly populated with companies offering EDC. It can be difficult for EDC providers to stand out among broadening competition. Here at Medrio, we’ve grown with the times and created a model that has kept us unique as the industry develops. Here’s a quick look at the ways we’ve remained a leader in EDC for clinical research.
There is no doubt that clinical research is critical to the advancement of medicine and public health. But conducting such research is a complex, resource intensive endeavor that relies on a multitude of stakeholders, workflows, processes, and information systems.
