Even clinical trials, which only begin
long after the basic research is done and which involve more ordinary
therapeutic treatments than stem cells, fail at an astonishing rate.
Only one out of five that enter the clinical trial gauntlet
successfully finish the second stage, according to industry data
cited last spring by Pat Olson, executive director of scientific activities at the stem cell agency. And
then come even more challenges.
But at a much earlier stage of
research there is the “problem of irreproducible results,” in the
words of writer Monya Baker of the journal Nature. Baker last month reported on
moves by a firm called Science Exchange in Palo Alto, Ca., to
do something to ease the problem and speed up preclinical research.
The effort is called the Reproducibility Initiative and also involves
PLOS and figshare, an open science Internet project.
Elizabeth Iorns Science Exchange Photo |
Science Exchange is headed by Elizabeth
Iorns, a scientist and co-founder of the firm. She wrote about test-tube-to-clinic translation issues in a recent article in New
Scientist that was headlined, “Is medical science built on shaky
foundations?”
Iorns said,
“One goal of scientific publication is to share results in enough detail to allow other research teams to reproduce them and build on them. However, many recent reports have raised the alarm that a shocking amount of the published literature in fields ranging from cancer biology to psychology is not reproducible.”
Iorns cited studies in Nature that
reported that Bayer cannot “replicate about two-thirds of published
studies identifying possible drug targets” and that Amgen failed at
even a higher rate. It could not “replicate 47 of 53 highly
promising results they examined.”
The California Stem Cell Report earlier
this week asked Iorns for her thoughts on the implications for the
California stem cell agency, whose motto is "Turning stem cells into cures." Here is the full text of her response.
“First, I think it is important to accept that there is a crisis affecting preclinical research. Recent studies estimate that 70% of preclinical research cannot be reproduced. This is the research that should form the foundation upon which new discoveries can be made to enhance health, lengthen life, and reduce the burdens of illness and disability. The irreproducibility of preclinical research is a significant impediment to the achievement of these goals. To solve this problem requires immediate and concrete action. It is not enough to make recommendations and issue guidelines to researchers. Funders must act to ensure they fund researchers to produce high quality reproducible research. One such way to do so, is to reward, or require, independent validation of results. The reproducibility initiative provides a mechanism for independent validation, allowing the identification of high quality reproducible research. It is vital that funders act now to address this problem, to prevent the wasted time and money that is currently spent funding non-reproducible research and to prevent the erosion of public trust and support for research.”
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