There are a few important considerations for the Informed Consent Document (ICD), also called the Informed Consent Form (ICF), used by sponsors to consent clinical trial participants which could improve the quality of the consent process and possibly increase trial participation. The design of the ICD varies extensively due to the experience of the sponsors … Read more
There have been a few smartwatch apps and smart rings claiming to measure blood glucose levels without piercing the skin or sampling blood. These devices and apps are not regulated and hence can be sold directly to consumers without any independent validation and are popular because of their seeming ease of use. However, these devices … Read more
The format of FDA meetings has changed dramatically since the pandemic from mostly in-person to almost all virtual meetings. Should the in-person meetings come back to the pre-pandemic levels? There are several opinions to that debate. This week, FDA’s senior officials opined at a conference on the topic, and it seems there are divergent opinions. … Read more
ChatGPT can revolutionize the medical note taking process for clinical practices but it can exert unpredictable effects on clinical decision making by introducing nuances. A perspective in a recent publication in the Journal of American Medical Association (JAMA) provides a few pointers to what developers and practitioners must plan for when using ChatGPT or similar … Read more
FDA announced this week that it has noticed trends of fraudulent activities at non-clinical testing vendors located in India and China and warned the sponsors to be vigilant about using such data. Although the FDA did not name any specific vendor or devices that were affected, this raises an important issue for vendor selection and … Read more
Clinical trial sponsors are responsible for paying for the cost of conducting the trial which includes paying for the use of clinics, hiring staff or vendors to manage the trial, collection and review of the data, regulatory approvals, and anything else that may be needed to properly run the trial. In some specific circumstances, a … Read more
Since its first Guidance Document for Data Monitoring Committees (DMCs) in 2006, the role of DMCs in clinical trial and clinical development programs has expanded exponentially. Sponsors frequently debate the purpose, scope, and limitations of DMCs which in turn increases the time and cost to set-up these and creates confusing practices for their activities. Hence, … Read more
The concept of quality by design (QbD) has been used primarily in the context of GMP compliance. However, the FDA expects that this concept should be used in other compliance areas as well, particularly clinical trials. FDA and Duke University recently held a workshop describing various aspects of clinical trials that could be improved by … Read more
This week the US House of Representatives held a hearing on the lack of foreign on-site GMP inspections by the FDA where representatives from the GAO and other stakeholders including a “star witness” from India, presented their concerns about the quality of drugs imported into the US. The speakers and the committee members seemed to … Read more
It has been required since 1998 that race and ethnicity information be presented with clinical trial results included in market approval applications for all FDA-regulated products. However, there exists signification confusion about the specific demographic sub-groups that should be collected and the standardized approach that should be followed leading to variability in the reported data. … Read more
