Inconclusive Data in IA: Experts Fill the Void To Avoid Horror Vacui

Often we come across a study which raises more questions than it answers.  Sometimes we read a study publication again and again, and still we cannot figure out what the take-away learning is, as results are simply inconclusive or discordant. Continue reading Inconclusive Data in IA: Experts Fill the Void To Avoid Horror Vacui

Choose your Outcome: How Design Minutiae Affect Trial Results

When you search for ‘ceftidoren’ on Wikipedia, you will get a surprise: there is no entry. However, a search on the web tells us that Spectracef (ceftidoren pivoxil) still exists. Gee, now the drug is spelled ‘cefditoren’ and – looking Continue reading Choose your Outcome: How Design Minutiae Affect Trial Results

Is LAIV Dead or Just on LAIV-Support?

Very recently we came across several studies in which small differences in design had a major impact on outcomes. A blog is not a good place to dig deeply into the minutiae of study design as the discussion becomes quickly very dry and quite technical. However, readers Continue reading Is LAIV Dead or Just on LAIV-Support?

Why Did PK/PD Modeling Fail Doripenem in VAP?

When imipenem is dosed at 1 g q8h for serious infections, it is infused over 40-60 min. Its label states that it is indicated for “lower RTI”, an old-fashioned term from the days when bronchitis and pneumonias were still lumped Continue reading Why Did PK/PD Modeling Fail Doripenem in VAP?

CMV Hyperimmune Globulin Data Inconclusive but New Drug Shows Promise

Treating CMV was never easy making prophylaxis the preferred approach for HSCT patients. Since the late 80ies, trials using hyperimmune globulin have come up with mixed results. While treatment was usually safe, efficacy was a lot much harder to prove.  More specific Continue reading CMV Hyperimmune Globulin Data Inconclusive but New Drug Shows Promise