National Institutes of Health (NIH) Clinical Center and National Center for Advancing Translational Sciences (NCATS) has hosted Rare Disease Day at the NIH to participate in the global observance since 2009. Updates from stakeholders regarding their achievements and current initiatives make it evident that the collaboration of patients and researchers is critical to continue to make advancements in rare disease treatment. Here are some key messages from the event.
In this digital age, virtual trials may very well become the norm at some point in the future, but there are many questions to answer before this can become a reality. In this white paper, we propose how virtual trials may be able to solve all these issues at once while also providing the added benefit of reducing costs related to study sites.
Some clinical trials face numerous and critical complexities which increase pressure and risk for the success of the trial. This case study, highlights the complexities faced by one sponsor that were compounded by rigid timeframes, comparator sourcing availability, sensitized drug product and intricate kit design. By partnering with Almac, the sponsor was able to harness Almac’s expertise in project management and comparator sourcing to deliver multiple shipments to sites and depots on time and within specified conditions.
Watch Almac’s on-demand webinar to gain an understanding of data integrity regulations and key considerations when utilizing a computerized system to manage temperature data during clinical trials. This webinar will demonstrate how a secure, validated system is key in ensuring effective collection and management of accurate temperature data from the entire clinical supply chain.
Ensuring that studies meet the business goals of sponsors and increase the range of treatment options available to patients and healthcare providers can be challenging when a trial must enroll subjects with a bothersome health condition and ask them to risk randomization to placebo. The project team in a study of an investigational treatment for bacterial vaginosis addressed such challenges and enabled the study to meet the sponsor’s goals.
Nothing derails a clinical study timeline more than poor planning and not anticipating and preparing for the potential roadblocks. While you may not be able to anticipate everything, many of the risks and challenges outlined in this article can in fact be averted if you understand the landscape and prepare accordingly.
Life sciences companies are embracing the essential roles that real world data (RWD) and the generation of real world evidence (RWE) play in the development of new treatments for patients.This paper will explore three areas where RWD and RWE are being applied to improve the design and execution of clinical studies.
Revised study now includes the opportunity to demonstrate the cardiac safety of a new drug by utilizing Exposure-QT response study data in dose escalation and other studies.
Making a meaningful impact on the survival and quality of life of patients with cancer remains a significant challenge. This white paper discusses considerations and strategies for maximizing the likelihood of success in early phase oncology trials and developing significantly improved therapeutics for patients.
Contraception studies involve a variety of unique operational and methodological considerations that may vary at different stages of development. This paper explains those considerations as well as key risks and mitigations in contraception studies.
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