OBJECTIVES:  Data collected using patient reported outcomes (PRO) tools in clinical trials provide unique information about patients’ experience with their treatment.  One of the major challenges with conducting clinical trials in linguistically diverse countries such as India, however, is identifying and using PRO scales that are linguistically validated in most of the representative regional languages.  Lack of availability of linguistically validated scales can limit the participation of a relevant population from clinical trials.  Therefore, the objective of this study was to determine if the PRO instruments used in clinical trials are linguistically validated in local languages across the various regions in India.   For this study we limited our therapeutic area focus to clinical trials conducted in oncology.   METHODS: : A detailed review of the registered trials in clinicaltrials.gov was conducted using quality of life (QoL) and oncology as key words.  Identified articles (n=103) were screened to exclude trials where QoL was not measured and studies with n < 30.  ProQoLID and official websites of questionnaires were used to determine the availability of translations and linguistic validity of the questionnaires included in clinical trials.   RESULTS:  EQ-5D is the most commonly used generic instrument in oncology trials and is validated in most 11 Indian languages.  EORTC-QLQC30, EORTC-QLQH&N35, EORTC-QLQBR23 and EORTC-QLQLC13 are the most commonly used cancer specific instruments and are validated in approximately 10 Indian languages. None of the generic or disease specific cancer instruments have been translated or linguistically validated for the Eastern & North-Eastern regions in India in languages such as Oriya, Santhali, Assamese, and Manipuri thereby limiting the participation of patients from these regions in clinical trials.  CONCLUSIONS:   The results of our analysis indicate that future efforts need to focus on translating and validating PRO instruments in 14 different Indian languages that should include the North Eastern regions of India.