Results: The results concluded that the medical practitioners are of uniform opinion of having QoL as one of the essential parameter in their routine daily practise out of which 64.3% are in favour of enforcement of QoL index as a parameter in all clinical studies. Further 57.1% and 47.6% felt that there is moderate level of acceptance by Investigators and Indian Regulators respectively. Though 54.8% respondents were aware of standardized QoL questionnaire used in the industry, it varies based on disease area resulting in lack of generic standardized QoL questionnaire due to number of challenges that act as a barrier in implementing this change in the industry.

Conclusion: Although literature shows that importance of QoL assessment has increased over the years, reporting it as end-point remains uncommon in clinical trials and it is particularly lacking in developing countries. The enforcement of standardization of QOL index in Clinical trials may be of particular value in future.

DOI: http://dx.doi.org/10.51505/ijmshr.2022.6103