Understanding the Challenges Associated with Approval of Anticancer Products to Facilitate the Regulatory Approvals: A Cross-sectional Study

Abstract

Oncological medications face a myriad of challenges, including technological, pre-clinical, clinical, and manufacturing, that lead to regulatory approval delays or failures. The present study aims to identify some challenges encountered by researchers or regulators during the development of novel cancer therapies. The present cross-sectional observational study used a mixed-method design methodology. The participants were selected via a non-random sampling method via self-selection and snowballing approach. A survey questionnaire was developed and circulated among the selected participants as a hard copy or email or a Google form. Open-ended and closed-ended questions were incorporated to identify the regulatory challenges faced during oncology drug development. The responses were collected from September 2021 to June 2022. These responses were then coded and themes were identified for the challenges. A total of 87 responses were obtained for the questionnaire among the individuals contacted. Seven themes were identified from the collated responses that depicted the challenges for the regulatory approval of anticancer drug products. The majority of responders (38.2%) suggested reduced approval time whereas endpoint selection and study design were considered as a challenge by 12.0% of responders each. Furthermore, 6.0% of responders admit that timely interaction with the regulators is also a challenge that delays approval. Many challenges also exist during the product development phase; hence, 12.0% of responders reported safety issues, and 22.0% of responders reported technical issues during manufacturing as the cause of regulatory failure. Moreover, 12.0% of responders suggested the need for improvements in regulatory guidelines for oncology drug development. The survey indicates a lack of Indian guidelines for anticancer products, whereas limited guidance is available from other countries such as Europe or the United States. Thus, the survey points to the necessity for improvement in the regulatory guidelines and drug approval process to address the challenges unique to cancer drug development.