The NIH will now also require investigators of Phase I and Phase II trials to submit at the time of grant application "clinical monitoring plans" that explain how the trial will be conducted.
The T2 quantification results will be communicated to every local investigator: during Phase 3, and each investigator will be asked to give his personal opinion about the usefulness of T2 quantification during the follow-up of patients with heart transplant.
This was an investigator-initiated phase IIa, single-centre, single-arm, open-label clinical trial.
This is an investigator-initiated phase III double-blind, randomized, placebo-controlled, two-arm crossover clinical study.
The excellent tolerability and the promising clinical results from the feasibility study prompted the design of an investigator-initiated phase I/II study in 41 patients with advanced HCC and Child Pugh A or B disease.
The primary objective of this investigator-initiated, Phase 1, placebo-controlled, double blind, dose-escalating trial was to determine the safety and tolerability of a proprietary bioactive extract of chicory root in patients with osteoarthritis (OA).
This investigator-initiated phase II double-blind randomized controlled trial was registered at ClinicalTrials.gov (NCT01355835) and a detailed study protocol was published elsewhere (Weiss et al., 2011 b ).
AT was Principal Investigator for Phase-1/2 ruxolitinib study (NCT00509899) in myelofibrosis for the Mayo Clinic (Rochester) site.
Experience gained during the design and implementation of the START study will be useful to investigators planning future phase 1 clinical trials based in the ICU, as well as trials of cell-based therapy for other acute illnesses.
On Week 24 of the treatment phase, investigators judged that 50 and 67% of patients completing the study had shown mild, moderate, or marked improvement in adverse events and global clinical status, respectively, and 76% of patients rated lamotrigine as somewhat better (13%) or much better (63%) than valproate.
