Oncology

Cancer remains a major global health challenge, necessitating continuous innovation in oncology therapeutics. While randomized controlled trials (RCTs) are the traditional gold standard for evidence generation, they often lack applicability to diverse real-world populations. This has fuelled growing interest in incorporating Real-World Evidence (RWE), derived from Real-World Data (RWD), into regulatory decision-making processes, especially in oncology. This study aims to compare how RWE is integrated into oncology drug regulation by two key regulatory bodies, Health Canada and India’s Central Drugs Standard Control Organization (CDSCO), in order to identify lessons and opportunities that can support India's evolving regulatory framework. A qualitative comparative analysis was conducted using regulatory documents, guidance frameworks, and real-world case examples. Canada’s CanREValue initiative was explored in depth, alongside an assessment of India’s emerging digital health infrastructure and policy efforts. Health Canada has established a mature RWE framework supported by multi-stakeholder collaborations and pilot projects, facilitating dynamic regulatory decisions in oncology. In contrast, CDSCO is in the early stages of RWE adoption, with limited formal guidance. However, initiatives like the Ayushman Bharat Digital Mission (ABDM) and national health registries offer promising pathways. Canada’s regulatory progress offers valuable insights for India. Strengthening digital infrastructure, developing national RWE frameworks, and fostering collaboration could transform India’s oncology regulatory ecosystem. This study highlights the potential of RWE to improve evidence-driven decision-making and enhance access to cancer therapies.

There is an increasing incidence of cancer not just in our country but worldwide. The aim of this study is to evaluate socio-demographic data, knowledge, awareness, practice level in cancer patients through assessment of their respective attendants. A self-administered, structured, open ended and pretested questionnaire covering the general characteristics, KAP about cancer, screening and treatments was used to collect responses of cancer patient attendants in KIMS a Teaching Hospital at Hyderabad. Their age group was between 18-79years. The educational preparations of the attendants are as follows: 50 attendants are grouped as “CONTROL”, 50 are grouped as “TEST”. The information thus collected was entered and analyzed in SPSS and Microsoft Excel software. Responses from 100 attendants were recorded and analyzed. The results of both groups i.e. TEST and CONTROL pre-post interventions were tabulated and compared between the groups, educational intervention was given to only test group thus paired t-test results obtained at level of significance 0.005, shown that only test group attendants shown significant difference in aspects of knowledge and practice when compared to that of the control group who received information only at the end of the study. Our study has shown that educational interventional study give high scope in comparative studies where pre-post interventions were in use.