A Method to Redesign and Simplify Schedules of Assessment and Quantify the Impacts. Applications to Merck Protocols.

The growing complexity of biopharmaceutical sponsored trials has adverse impacts on increased burdens on participants, clinical sites, and sponsors, including greater difficulty recruiting and retaining participants, difficulty engaging sites to participate in trials, excessive cost of trials, and increased cycle times. The schedule of assessments (SoAs) is the origin of and blueprint for complexity that is often generated by copying and pasting from previous SoAs. We developed an approach, termed Lean Design, for redesigning the assessments in SoAs that generate data, the 'Data SoA.

Neural networks in cardiac electrophysiological signal classification.

The aim of this work was to develop a method by which intra-cardiac electrograms could be classified. A new algorithm for training this particular network has been established and applied to the task of finding the onset times of intra-cardiac electrograms. The algorithm is based on adding a choice function to the combination function of each neuron.

Survival of anti-Clostridium difficile bovine immunoglobulin concentrate in the human gastrointestinal tract.

To be therapeutically active, oral hyperimmune bovine immunoglobulin concentrate (BIC) must survive its passage through the intestinal tract. This led us to study the gastrointestinal stability of orally administered BIC directed against Clostridium difficile toxins (BIC-C. difficile).