Pub Date : 2024-01-08DOI: 10.2174/0115733947273426231128054645
Pinky Sharma, V. Jhawat, Jatinder Singh, Rohit Dutt
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.
{"title":"Understanding the Challenges Associated with Approval of Anticancer\u0000Products to Facilitate the Regulatory Approvals: A Cross-sectional Study","authors":"Pinky Sharma, V. Jhawat, Jatinder Singh, Rohit Dutt","doi":"10.2174/0115733947273426231128054645","DOIUrl":"https://doi.org/10.2174/0115733947273426231128054645","url":null,"abstract":"\u0000\u0000Oncological medications face a myriad of challenges, including technological,\u0000pre-clinical, clinical, and manufacturing, that lead to regulatory approval delays or failures. The present\u0000study aims to identify some challenges encountered by researchers or regulators during the development\u0000of novel cancer therapies.\u0000\u0000\u0000\u0000The present cross-sectional observational study used a mixed-method design methodology.\u0000The participants were selected via a non-random sampling method via self-selection and snowballing\u0000approach. A survey questionnaire was developed and circulated among the selected participants as a\u0000hard copy or email or a Google form. Open-ended and closed-ended questions were incorporated to\u0000identify the regulatory challenges faced during oncology drug development. The responses were collected\u0000from September 2021 to June 2022. These responses were then coded and themes were identified\u0000for the challenges.\u0000\u0000\u0000\u0000A total of 87 responses were obtained for the questionnaire among the individuals contacted.\u0000Seven themes were identified from the collated responses that depicted the challenges for the regulatory\u0000approval of anticancer drug products. The majority of responders (38.2%) suggested reduced\u0000approval time whereas endpoint selection and study design were considered as a challenge by 12.0%\u0000of responders each. Furthermore, 6.0% of responders admit that timely interaction with the regulators\u0000is also a challenge that delays approval. Many challenges also exist during the product development\u0000phase; hence, 12.0% of responders reported safety issues, and 22.0% of responders reported technical\u0000issues during manufacturing as the cause of regulatory failure. Moreover, 12.0% of responders suggested\u0000the need for improvements in regulatory guidelines for oncology drug development.\u0000\u0000\u0000\u0000The survey indicates a lack of Indian guidelines for anticancer products, whereas limited\u0000guidance is available from other countries such as Europe or the United States. Thus, the survey\u0000points to the necessity for improvement in the regulatory guidelines and drug approval process to address\u0000the challenges unique to cancer drug development.\u0000","PeriodicalId":43754,"journal":{"name":"Current Cancer Therapy Reviews","volume":"23 9","pages":""},"PeriodicalIF":0.6,"publicationDate":"2024-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139446579","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}