Innovative highlights of clinical drug trial design

Innovative approaches to clinical development and trial design.

Pharmaceutical innovation is increasingly risky, costly and at times inefficient, which has led to a decline in industry productivity. Despite the increased investment in R&D by the industry, the number of new molecular entities achieving marketing authorization is not increasing. Novel approaches to clinical development and trial design could have a key role in overcoming some of these challen...

Considerations for clinical trial design and data analyses of thorough QT studies using drug-drug interaction.

The Innovative Applications Conference Highlights and Changes

tains several papers from the 1995 Innovative Applications of Artificial Intelligence (IAAI-95) conference. IAAI has been held annually since 1989 and has been collocated with the national (or international) AI conference since 1991. The proceedings were published in book form through 1992. Since 1993, a conference proceedings volume has been published, and selected papers have been republished...

Adaptive Clinical Trial Design

Adaptive design is usually defined as the use of accumulating data obtained during the conduct of the trial to decide how to modify aspects of the trial as it progresses, without affecting its validity and integrity (Gallo et al., 2006). This form of research design involves a prospectively planned opportunity to modify the parameters of the study based on analysis of interim data while the stu...

NCI launches an innovative design for a breast cancer clinical trial.

A new clinical trial will use a comprehensive genetic profi le to test whether early-stage breast cancer patients need chemotherapy. The National Cancer Institute – sponsored trial is among the fi rst to tailor a patient’s therapy to her individual genetic profi le. Many researchers say this as yet unproven approach is a logical step in cancer treatment. “ It’s very different. It’s very novel b...