Many patients who suffer from cardiovascular, renal and metabolic (CVRM) diseases face not one, but several overlapping co-morbidities that can critically impact quality of life and overall health. AstraZeneca is bringing renal into focus, by developing CVRM medicines that attempt to both answer important clinical questions and put patients’ needs first.
In medical product development, the harsh reality is that failure is the overwhelming norm. Over the past several decades the lupus community has seen promising treatments face this reality. There has been only one treatment designed specifically to treat lupus approved by the FDA in the last 50 years: belimumab.
The current approach to clinical trial recruitment is prolonged, costly, and inefficient and often causes major delays and challenges for research across multiple disease states. The vast majority (85 to 90 percent) of studies in the U.S. experience significant delays in recruitment and enrollment. Nearly one-third of trials under-enroll, and only 7 percent meet their target enrollment number on deadline.
Pharmaceutical companies have three targeted users: physicians, pharmacists, and patients. Various digital platforms are used to create a good customer experience for educating these end users. The core focus is on patients driving patient care, education, and adherence.
While adaptive design is associated with many potential benefits, it may also present challenges to observing the basic ethical principles of research in human subjects. In this white paper, we review the features of particular clinical trial design adaptations and discuss the ethical obstacles they can present and those they can potentially resolve. Using examples of both published and unpublished clinical studies, we highlight the importance of proper design and planning and appropriate ethical due diligence in the successful conduct of an adaptive design clinical trial.
NGS sequencing presents new possibilities for influenza vaccine development. This white paper covers the challenges of developing influenza vaccines and new approaches that may eventually lead to a more universal solution.
Read how recently released draft guidance documents can provide clarity on abbreviated approval pathways and highlight priorities of the FDA to increase competition in the marketplace with a focus on speeding generic approvals, including complex generic drug products.
Digital innovations and their emerging technologies, such as artificial intelligence (AI), advanced analytics, and cloud-based computing, are transforming industries and markets across the world as they offer novel ways to boost R&D, increase product quality and safety, and ultimately improve customer satisfaction.
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.
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Any capable CRO can provide manpower and execute orders on behalf of a sponsor, no questions asked, with little stake or interest in the endeavor’s ultimate success. What you need is a strategic ally, a company that joins you, lockstep, in pursuing shared goals and greater outcomes. Not a vendor, but a partner.
The optimal dose-finding strategy for a given therapeutic agent and indication is based on a multitude of factors, accentuating the need for individual tailoring in oncology drug trial design. Read on for a look at six of the most common dose-finding trial designs in oncology today to get your process started.
Mark P. Wade, Executive Director, Life Sciences at TransPerfect shares his thoughts on the ISOQOL 25th Annual Conference in Dublin. Hear what professionals that live and breathe Clinical Outcome Assessment (COA) measures learned from this event.
Recent scandals surrounding Chinese drug manufacturers have Chinese nationals looking outward, and have even sparked regulatory reforms. This lost faith in local drug companies begs the question: what does this mean for foreign investors?
These recent events stressed the importance of the use of an electronic content management system and striving for a paperless environment. Read key take-aways from attendees at these events regarding what the future of TMF could look like.
