Background: Globally, there have been tremendous efforts by regulatory authorities to
make clinical trials safer by making stringent clinical trial regulations. Despite this, we witnessed several
tragic events. TGN1412 and BIA 10-2474 phase I trials are infamous trails in which healthy volunteers
either succumbed to severe adverse effects or faced irreversible impairments of the test drug.
Such afflictions in clinical trials are not only turbulent to the image of pharmaceutical industry but it
also conveys dispiriting message for clinical trial participants.
Objective: To make clinical trials safer for participants, some regulatory changes are warranted.
Methods: Some stipulated measures to improve safety of clinical trial participants include inclusion of
patients instead of healthy volunteers in phase I clinical trials, all compounds which are used for first
time in humans should be considered as high risk compounds, amendments in first in human clinical
trial design to N of 1 randomized control trial in place of 6+2 design with the sequential dosing of subjects
both within and between cohorts and the individual patient pharmacokinetic and pharmacodynamic
data should be used to calculate sequential dosing. Besides these, there should be appropriate
process for systematic risk assessment involving the use of statistical techniques to select pertinent
risk factors with high predictive values of studies or sites that may be procumbent to non-compliance.
Conclusion: Inclusion of above mentioned measures in clinical trials are bound to make them safer
and may help in pacifying the insecurity that has emerged among humans to participate in clinical trials.