Oftentimes, patients with rare diseases suffer from a myriad of complex symptoms. Unfortunately, given this complexity, rare diseases are not well understood by most general physicians. “With rare diseases, we do not have hundreds or thousands of physicians who are experienced in treating these diseases,” says Dr. Pushkal Garg, Chief Medical Officer at Alnylam Pharmaceuticals. To bring forward meaningful advances for the care of these patients, we must personally speak and listen to them and aggressively integrate their insights.”
While controversy continues to simmer over who is accountable for posting results on ClinicalTrials.gov, perhaps the “results debate” masks the more challenging problem: ClinicalTrials.gov is not working for its intended audience.
This is part 2 of a two-part roundtable Q&A on real-world evidence (RWE) in the 21st century. In this installment, our experts discuss how RWE is utilized, why real-world data (RWD) analyses are getting more attention, and what the recent attention means for the future of medical practice and drug development. RWD analyses are utilized to generate insights about a medicine’s effectiveness, safety, and associated costs.
The clinical research industry has been slow to efficiently use and repurpose data collected in clinical trials. The lack of ease, both from an ethos and technical perspective, with which pharmaceutical companies can access and share data can lead to lengthier product development, untapped study findings, and reduced collaboration between industry stakeholders. As trials become increasingly complex and costly, it is especially important to develop approaches that facilitate and encourage R&D data sharing. This not only helps clinical trial sponsors to create better informed clinical development plans and run smaller, more efficient trials, but allows patients to enroll in trials sooner and, therefore, bring innovative new therapies to the market faster.
As electronic research systems are increasingly relied upon to store participant data, report results, and confirm informed consent, regulatory bodies around the world are re-examining old regulations and developing new ones. Discover what it means for US research.
Automation is a foregone conclusion, and research sites need to prepare themselves for the electronic future that lies ahead.
This paper discusses the challenges inherent in the current practices of providing trial results summaries to trial participants. It presents an alternative approach to distributing trial results summaries that takes advantage of commonly used technologies to more quickly, efficiently and reliably provide trial results summaries to trial participants. The benefits of this approach to clinical trial sponsors, patients, and their relationship with each other are also discussed.
The following paper discusses the challenges of tracking global disclosure performance and how clinical trial sponsors can use Atlas Global Compliance to manage track and reduce the risks of non‐compliance.
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After the experiences you've had with email and paper reports, why wouldn't you opt for an incorporated module?
Five things into consideration before selecting a vendor.
Why being prepared, thinking big, and getting organized are important when implementing a protocol amendment to your EDC.
To address non-compliance and improve the ratio of completed trials with results, we recommend the following two-step process to take control of your compliance.
Five common CDA pain points that can make a simple sounding agreement so challenging for clinical teams.