Rare disease advocacy groups often use the phrase “rare is not rare” to drive home the point that, although individual diseases and conditions might affect only a small number of people, together they constitute a large patient population. Read More
Rare disease advocacy groups often use the phrase “rare is not rare” to drive home the point that although individual diseases and conditions might affect only a small number of people, together they constitute a large patient population. Another way of putting it, according to a 2023 paper published by researchers at the Mayo Clinic: “Rare diseases are individually rare but collectively common.”
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There’s been a rising concern with clinical trial fraud and misconduct, particularly over the number of “zombie” trials that have been discovered in recent years — that is, trials in which a portion of the data is either invented out of whole cloth or is manipulated to the point of dishonesty. Researchers should expect greater scrutiny from both sponsors and regulators and should make sure their data integrity plans are solid to catch any bad actors before they can irreparably tarnish a study. Read More
When it comes to exploring new treatments and therapies that may not generate sufficient return on investment to attract corporate sponsors, clinical researchers typically turn to private and public grants to support their endeavors. But landing grants isn’t easy, particularly for early-career researchers and those who don’t have a proven track record of successful grant management. Read More
The best tools for capturing patient-reported outcomes (PRO) are ones patients helped develop, according to recently published guidelines on PRO best practices that point to increased accessibility, decreased patient burden and improved data consistency as major benefits. Read More
The increasing adoption of decentralized trial methods has brought with it a number of benefits, most of which outweigh the challenges remote operations present. But data management hurdles, technology limitations and the possibility of over-burdening study participants with self-managed tasks all need to be overcome to make decentralization successful. Read More
When negotiating a clinical trial agreement (CTA), some of the most important provisions — and the most contentious — are those dealing with study data and intellectual property. Sponsors will want to own all the data, as well as any future inventions derived from it, but there are good reasons for sites to push back and insist on some exceptions. Read More
This is the last installment of a four-part CenterWatch Weekly series on the principles and best practices of setting investigator compensation levels that are both fair and compliant with federal laws. In this article, we look at how a large healthcare network built a hybrid compensation model using various methodologies.Read More
This is the third installment in a four-part CenterWatch Weekly series on the principles and best practices of setting investigator compensation levels that are both fair and compliant with federal laws. This week, we look at how methodologies for determining compensation can be combined and customized. Links to previous installments of the series are at the end of the article.Read More
This is the second in a four-part CenterWatch Weekly series on the principles and best practices of setting investigator compensation levels that are both fair and compliant with federal laws. This week, we look at various methodologies for determining compensation. Read More
