Abstract
Translation failure occurs when the results of preclinical, observational and/or early phase studies fail to predict the results of well done (i.e. appropriately controlled, adequately powered, and properly conducted) phase III or randomised clinical trials. Some failures occur when promising basic science findings fail to replicate in human studies, while others happen when promising uncontrolled trial data show an exaggerated effect that vanishes in the setting of a randomised trial. Medical reversals occur when the results of preclinical, observational and/or early phase studies fail to predict the results of subsequent randomized clinical trials, but the practice has already gained widespread acceptance. Oncologic examples include bevacizumab and the use of autologous stem cell transplant in metastatic breast cancer. In a well-intentioned effort to reduce the rate of translation failure, oncologists must be careful that changes to regulatory processes and clinical trial design do not actually work to increase the approval of ineffective compounds. By trying to cure translation failure, we should be careful to avoid medical reversal. The rise of surrogate end-points and role of hard-wired bias in oncology trials suggest that we may be currently ignoring the simple fact that translation failure and medical reversal are two sides to the same coin.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 197-200 |
| Number of pages | 4 |
| Journal | European Journal of Cancer |
| Volume | 52 |
| DOIs | |
| State | Published - Jan 1 2016 |
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Keywords
- End-points
- FDA approval
- Hard-wired bias
- Medical reversal
- Oncology drugs
- Randomised trials
- Regulatory bar
- Translation failure
ASJC Scopus subject areas
- Cancer Research
- Oncology
Cite this
Translation failure and medical reversal : Two sides to the same coin. / Prasad, Vinay.
In: European Journal of Cancer, Vol. 52, 01.01.2016, p. 197-200.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Translation failure and medical reversal
T2 - Two sides to the same coin
AU - Prasad, Vinay
PY - 2016/1/1
Y1 - 2016/1/1
N2 - Translation failure occurs when the results of preclinical, observational and/or early phase studies fail to predict the results of well done (i.e. appropriately controlled, adequately powered, and properly conducted) phase III or randomised clinical trials. Some failures occur when promising basic science findings fail to replicate in human studies, while others happen when promising uncontrolled trial data show an exaggerated effect that vanishes in the setting of a randomised trial. Medical reversals occur when the results of preclinical, observational and/or early phase studies fail to predict the results of subsequent randomized clinical trials, but the practice has already gained widespread acceptance. Oncologic examples include bevacizumab and the use of autologous stem cell transplant in metastatic breast cancer. In a well-intentioned effort to reduce the rate of translation failure, oncologists must be careful that changes to regulatory processes and clinical trial design do not actually work to increase the approval of ineffective compounds. By trying to cure translation failure, we should be careful to avoid medical reversal. The rise of surrogate end-points and role of hard-wired bias in oncology trials suggest that we may be currently ignoring the simple fact that translation failure and medical reversal are two sides to the same coin.
AB - Translation failure occurs when the results of preclinical, observational and/or early phase studies fail to predict the results of well done (i.e. appropriately controlled, adequately powered, and properly conducted) phase III or randomised clinical trials. Some failures occur when promising basic science findings fail to replicate in human studies, while others happen when promising uncontrolled trial data show an exaggerated effect that vanishes in the setting of a randomised trial. Medical reversals occur when the results of preclinical, observational and/or early phase studies fail to predict the results of subsequent randomized clinical trials, but the practice has already gained widespread acceptance. Oncologic examples include bevacizumab and the use of autologous stem cell transplant in metastatic breast cancer. In a well-intentioned effort to reduce the rate of translation failure, oncologists must be careful that changes to regulatory processes and clinical trial design do not actually work to increase the approval of ineffective compounds. By trying to cure translation failure, we should be careful to avoid medical reversal. The rise of surrogate end-points and role of hard-wired bias in oncology trials suggest that we may be currently ignoring the simple fact that translation failure and medical reversal are two sides to the same coin.
KW - End-points
KW - FDA approval
KW - Hard-wired bias
KW - Medical reversal
KW - Oncology drugs
KW - Randomised trials
KW - Regulatory bar
KW - Translation failure
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U2 - 10.1016/j.ejca.2015.08.024
DO - 10.1016/j.ejca.2015.08.024
M3 - Article
VL - 52
SP - 197
EP - 200
JO - European Journal of Cancer
JF - European Journal of Cancer
SN - 0959-8049
ER -