{"id":4338,"date":"2021-10-21T11:03:00","date_gmt":"2021-10-21T11:03:00","guid":{"rendered":"https:\/\/www.vistaar.ai\/?p=4338"},"modified":"2024-07-01T06:46:25","modified_gmt":"2024-07-01T06:46:25","slug":"ich-guideline-e8-r1-on-general-considerations-for-clinical-studies","status":"publish","type":"post","link":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/ich-guideline-e8-r1-on-general-considerations-for-clinical-studies\/","title":{"rendered":"ICH Guideline E8 (R1) on General Considerations for Clinical Studies"},"content":{"rendered":"\n<p class=\"has-black-color has-text-color has-link-color wp-elements-6cad99c3ae2df0c9326cf26e21164c04 wp-block-paragraph\">Clinical studies of medicinal products are conducted to provide information that can ultimately improve access to safe and effective products with meaningful impact on patients, while protecting those participating in the studies. This blog provides general guidance on the clinical development lifecycle, including designing quality into clinical studies, considering the broad range of clinical study designs and data sources used.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-0f36cb504c30d4a46cf25c881743b3d6 wp-block-paragraph\"><strong>The ICH document &#8220;General Considerations for Clinical Studies&#8221; is intended to:<\/strong><\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-0bcae8d2e3d159c45df019151fb31317 wp-block-paragraph\"><strong>1<\/strong>. Describe internationally accepted principles and practices in the design and conduct of clinical studies that will ensure the protection of study participants and facilitate acceptance of data and results by regulatory authorities<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-c0d0bdd49b33628f3f21632e8bb424f6 wp-block-paragraph\"><strong>2.<\/strong>&nbsp;Provide guidance on the consideration of quality in the design and conduct of clinical studies across the product lifecycle, including the identification, during study planning, of factors that are critical to the quality of the study and the management of risks to those factors during study conduct<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-90f82af162854aa1ce990b30ddf1ab33 wp-block-paragraph\"><strong>3.<\/strong>&nbsp;Provide an overview of the types of clinical studies performed during the product lifecycle, and describe study design elements that support the identification of quality factors critical to ensuring the protection of study participants, the integrity of the data, the reliability of results, and the ability of the studies to meet their objectives<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color wp-elements-f1acbca11b61e81dc3a96f621ba924a4\"><strong>General principles<\/strong><\/h2>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-ef0543383e3b962b7d89717ee8968d9f wp-block-paragraph\"><strong>1. Protection of clinical study participants<\/strong><\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-11074d77c7cc22d3cb1c51b112345f46 wp-block-paragraph\">Important principles of ethical conduct of clinical studies and the protection of participants, including special populations, have their origins in the Declaration of Helsinki and should be observed in the conduct of all human clinical investigations.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-f809f72cfcab8c3d76f203f49248232e wp-block-paragraph\">The investigator and sponsor have responsibilities for the protection of study participants together with the Institutional Review Board\/Independent Ethics Committee. The confidentiality of information that could identify participants &nbsp;should be protected in accordance with the applicable regulatory and legal requirement(s).<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-64b2fc024534e8cc3ec174a651b3067e wp-block-paragraph\">Before initiating a clinical study, sufficient information should be available to ensure that the drug is acceptably safe for the planned study in humans. Emerging non-clinical, clinical, and pharmaceutical quality data should be reviewed and evaluated, as they become available, by qualified experts to assess the potential implications for the safety of study participants. Ongoing and future studies should be appropriately adjusted as needed, to take new knowledge into consideration and to protect study participants.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-4ccb5d3b2e289eed265caef54ac1bf07 wp-block-paragraph\"><strong>2. Scientific approach in clinical study design, planning, conduct, analysis, and reporting:<\/strong><\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-fa5e4f24f115b3e11742350a413c07e5 wp-block-paragraph\">Clinical studies should be designed, planned, conducted, analysed, and reported according to sound scientific principles to achieve their objectives. The purpose of a clinical study is to generate reliable information to answer the research questions and support decision making while protecting study participants.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-4e603cc60c4b6ad15470ecd7a407f1b7 wp-block-paragraph\">Quality by design in clinical research sets out to ensure that the quality of a study is driven proactively by designing quality into the study protocol and processes.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-e0c09f06fb2e014cb0e5a5c57a642b01 wp-block-paragraph\"><strong>3. Patient input into drug development<\/strong><\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-8f8c5dbffe3c7efcde4857d1355e3f44 wp-block-paragraph\">Consulting with patients and\/or patient organisations during drug development can help to ensure that patients\u2019 perspectives are captured. Involving patients early in the design of a study is likely to increase trust in the study, facilitate recruitment, and promote adherence. Patients also provide their perspective of living with a condition, which may contribute to the determination, for example, of endpoints that are meaningful to patients, selection of the appropriate population and duration of the study, and use of acceptable comparators. This ultimately supports the development of drugs that are better tailored to patients\u2019 needs<\/p>\n\n\n<div style=\"color:#00bab9;font-size:16px\" class=\"taxonomy-post_tag has-link-color wp-elements-927c70617f5f183ae903ddc7892f010b wp-block-post-terms has-text-color\"><span class=\"wp-block-post-terms__prefix\"><mark style=\"background-color:#ffffff\" class=\"has-inline-color has-black-color\"><strong>Tags:<\/strong> <\/mark><\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/center-for-drug-evaluation-and-research\/\" rel=\"tag\">Center for Drug Evaluation and Research<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/clinical-studies-of-medical-interventions\/\" rel=\"tag\">Clinical studies of medical interventions<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/ich-e8-general-considerations-for-clinical-studies\/\" rel=\"tag\">ich e8 general considerations for clinical studies<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/ich-e8-guidelines\/\" rel=\"tag\">ich e8 guidelines<\/a><\/div>","protected":false},"excerpt":{"rendered":"<p>Clinical studies of medicinal products are conducted to provide information that can ultimately improve access to safe and effective products with meaningful impact on patients, while protecting those participating in the studies. This blog provides general guidance on the clinical development lifecycle, including designing quality into clinical studies, considering the broad range of clinical study [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1885,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[647],"tags":[418,420,421,419],"class_list":["post-4338","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-standards","tag-center-for-drug-evaluation-and-research","tag-clinical-studies-of-medical-interventions","tag-ich-e8-general-considerations-for-clinical-studies","tag-ich-e8-guidelines"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\r\n<title>ICH Guideline E8 (R1) on General Considerations for Clinical Studies<\/title>\r\n<meta name=\"description\" content=\"Clinical studies of medical interventions are conducted to provide information that can ultimately improve access to safe and effective drugs with meaningful impact on patients, while protecting those participating in the studies. 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