- Clinical studies are grouped according to their objective into three types or phases:
Phase I Clinical Development (Human Pharmacology) – Thirty days after a biopharmaceutical company has filed its IND, it may begin a small-scale Phase I clinical trial unless the FDA places a hold on the study. Phase I studies are used to evaluate pharmacokinetic parameters and tolerance, generally in healthy volunteers. These studies include initial single-dose studies, dose escalation and short-term repeated-dose studies.
Phase II Clinical Development (Therapeutic Exploratory) – Phase II clinical studies are small-scale trials to evaluate a drug’s preliminary efficacy and side-effect profile in 100 to 250 patients. Additional safety and clinical pharmacology studies are also included in this category.
Phase III Clinical Development (Therapeutic Confirmatory) – Phase III studies are large-scale clinical trials for safety and efficacy in large patient populations. While phase III studies are in progress, preparations are made for submitting the Biologics License Application (BLA) or the New Drug Application (NDA). BLAs are currently reviewed by the FDA’s Center for Biologics Evaluation and Research (CBER). NDAs are reviewed by the Center for Drug Evaluation and Research (CDER).
Pacific Biolabs, Website, 2010.
There is no reason that sports science journals could not set a staged testing system for any new idea of intervention that is proposed or looked at in it’s journals. Whilst this is currently technically the case (first study to repeating of study to review/meta anlysis) a rigid frame work could be came up with to make meta analysis much easier.
For example one could come up with a new idea or concept and when writing it up for a journal it may need to be filed under something such as pilot. Then afterwards any study repeating the design could be filed under validation and finally when enough data has been gathered for a statistically powerful meta-analysis one could be performed.
The current harem-scarem process of publishing makes meta-analysis difficult on a specific question since people are looking for “similar designs” which makes the problem of small population size much worse.
Gold Standard Measures
The use of a common measurement tool or procedure is essential for the intra-validity of studies the research on muscular power shows this problem beautifully displayed in microcosm. For the measurement of Olympic lifts one can use a force transducer, force platform, accelerometer, indirect modelling using camera footage amongst other techniques.
This plethora of measurement techniques has lead to a body of research with multiple different answers to the same question. This lack of a common measure makes inferences taken form these studies and any meta analysis less powerful and direct comparisons between studies instantly less valid.
- If journals decided upon the equipment that best represents what is happening in the research and encourage researches to use these measurement techniques it would become much easier to synthesis data and make meta analysis much more robust.
Raising the Bar for published research.