Clinical trial, Journals, Pharmaceuticals, Sports, Sports Science

Providing a Defined Standard for Research.

Currently there are a variety of things confounding the applicability and power of sports science literature. Outside of things that require money (sample size, taking total control of the subjects for a period, involving elite level athletes etc.) there are procedures and systems that could be implemented to make studies far easier to review and make the body of evidence much more robust. In this blog I will look at a few relatively easily implemented and cheap solutions.

Copy Cat

The pharmaceutical industry have a set number of stages that any drug must go through before it is made available for medical use whilst these a through and strict for good reasons their is no reason that sports science could come up with something similar.

  • 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.

When performing analysis or reviews of data a lot of journals get put to the side and not included in the review because of the lack of quality in the study design. It is not uncommon for sports science studies to be completely devoid of blinding or placebo control both of which are extremely important to study design when you are dealing with people.

The placebo effect has been shown to have a massive effect on many trials and is now controlled for in clinical trials. Since we are dealing with therapies and interventions performed on people we should look to try and emulate good quality clinical trials.

Blinding is also very important to try and eliminate bias if I was the CEO of nautilus and wanted to perform a trial on the effectiveness on my machines I might want to skew it slightly. The inclusion of blinding when used on independent researches goes a long way to improve study design.


A few administrative tweaks here and there could help improve the overall quality of research in sports science. If studies where more standardised in hypothesis, design and measurement pooling them together in meta analysis would become much more powerful and it would go some way to easing the huge limitation that population size has on this field.

Enhanced by Zemanta