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The actual clinical utility of the molecular assays is being tested in randomized clinical trials that require an unprecedented coordination of the activity of clinical investigators, pathologists and translational researchers worldwide.
Still, a number of other novel approaches such as immunotherapy and alternating electric fields are being tested in randomized controlled trials, but clearly, further intensive research is needed.
Some of these signatures are commercially available (Table 1) and two of them (MammaPrint, Agendia BV, Amsterdam, The Netherlands, and Oncotype DX, Genomic Health, Redwood City, CA, USA) are currently being tested in randomized prospective clinical trials [ 14, 15].
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Available and emerging new agents in the treatment of anemia of heart failure will need to be tested in randomized, controlled studies.
The effectiveness of U-PRIM and U-CARE is being tested in a three-armed, cluster randomized trial in 58 general practices in the Netherlands, with approximately 5000 elderly individuals expected to participate.
The CPM is being tested in Alaskan rural communities as part of an inprogress eight-year National Institute on Drug Abuse randomized-controlled trial.
These hypotheses have been tested in a randomized, controlled folic acid supplementation trial of adults chronically exposed to arsenic-contaminated drinking water in Bangladesh.
ZMapp will be the first Ebola treatment that will be tested in a randomized, controlled study.
HEV 239 was tested in a randomized, controlled trial involving 112,604 participants in Jiangsu Province, where genotypes 3 and 4 are predominant.
The neuroprotective effect of l-deprenyl and rasagiline was tested in prospective randomized multicentre placebo-controlled studies: the DATATOP (Deprenyl and Tocopherol Antioxidative Therapy for Parkinson's disease) (Shoulson et al. 1993) and TEMPO study TVP-10122 (rasagiline mesylate) in Early Monotherapy for Parkinson's disease Outpatients) (Parkinson Study Group 2004a).
Taking a quarter-dose of three or four different medications looks like a promising strategy, but it needs to be tested in a larger, randomized trial, says Dr. Gibson.
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