{"id":146,"date":"2014-01-17T18:44:23","date_gmt":"2014-01-17T23:44:23","guid":{"rendered":"http:\/\/www.imperialcrs.com\/blog\/?p=146"},"modified":"2022-02-22T16:35:40","modified_gmt":"2022-02-22T16:35:40","slug":"developing-regulatory-compliant-patient-materials","status":"publish","type":"post","link":"https:\/\/www.imperialcrs.com\/blog\/imperial-graphics\/developing-regulatory-compliant-patient-materials\/","title":{"rendered":"Developing Regulatory-Compliant Patient Materials"},"content":{"rendered":"<p><span style=\"color: #000000; line-height: 1.5em;\">Every study needs a voice &#8212; messaging that communicates the trial sponsor\u2019s core objectives. Patient recruitment professionals provide this through compelling content and artful designs that resonate with target audiences and inspire study participation. But beyond being current and compelling, study collateral must also be regulatory-compliant.<\/span><\/p>\n<p><span style=\"color: #000000;\">Though regulations vary slightly per country, generally speaking, patient-facing content that promotes an investigational product must make no expressed or implied claims of efficacy according to the Code of Federal Regulations Title 21, Sec. 312.7, <em>Promotion\u00a0and charging for\u00a0investigational drugs<\/em>. <\/span><\/p>\n<p><span style=\"color: #000000;\">That sounds simple enough, but the term \u201cimplied\u2019 is subjective and open to interpretation.<span style=\"font-family: Times New Roman; font-size: medium;\">\u00a0 <\/span>So what is one to do? Imperial adheres to the following guidelines in developing patient-facing materials for global audiences. <\/span><\/p>\n<p><b><strong><span style=\"color: #000000;\">Required Patient Content <\/span><\/strong><\/b><\/p>\n<ul>\n<li>A statement indicating a research study is being conducted<\/li>\n<li>The disease or condition being studied<\/li>\n<li>Key eligibility criteria in layman\u2019s language, for example, liver instead of hepatic, heart instead of coronary, etc.<\/li>\n<li>Contact information so potential participants can request more information<\/li>\n<\/ul>\n<p><b><strong><span style=\"color: #000000;\">Additional Permitted Patient Content<\/span><\/strong><\/b><\/p>\n<ul>\n<li>The purpose of the research<\/li>\n<li>The location of the research<\/li>\n<li>The company sponsoring the research (if the client agrees to include this)<\/li>\n<li>Whether the participant will be compensated for participation<\/li>\n<li>Balanced statements of potential benefits and risks of study participation<\/li>\n<\/ul>\n<p><b><strong>Prohibited Content<\/strong><\/b><\/p>\n<ul>\n<li>Claims of safety or effectiveness<\/li>\n<li>References to \u201cfree medical treatment\u201d when the intent is only to say participants will not have to pay for taking part in the study<\/li>\n<li>Undue emphasis on patient reimbursement by giving the dollar amount or through special text treatment, such as boldface, italics or underlining<\/li>\n<li>Claims that the investigational product is approved by the FDA or other regulatory body for use in patients with the target disease or condition<\/li>\n<li>Use of the term \u201cnew\u201d unless qualified as a \u201cnew investigational medication\u201d<\/li>\n<li>Use of the term \u201ctreatment\u201d in the context of the investigational medication<\/li>\n<li>The compound name, unless it is currently approved and marketed for another indication and the sponsor approves of its use in the materials<\/li>\n<li>Overly promotional terms such as groundbreaking, exciting, important, unprecedented, etc.<\/li>\n<\/ul>\n<p><b><strong><span style=\"color: #000000;\">Graphic Requirements<\/span><\/strong><\/b><\/p>\n<p><span style=\"color: #000000;\">To avoid subliminal implications of efficacy, avoid depictions of smiling faces or people who appear markedly healthier than the target population. For example, an advertisement aimed at patients with mobility issues should not feature images of people performing physically demanding feats, such as mountain-climbing. <\/span><\/p>\n<p><span style=\"color: #000000;\">When in doubt, err on the side of caution and consult your patient recruitment provider or regulatory agency. For further information, visit <\/span><a href=\"https:\/\/www.fda.gov\/\"><span style=\"text-decoration: underline;\"><span style=\"color: #0000ff; font-family: Times New Roman; font-size: medium;\">www.fda.gov<\/span><\/span><\/a><span style=\"color: #000000;\">.\u00a0<span style=\"font-family: Times New Roman; font-size: medium;\">\u00a0\u00a0<\/span><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Every study needs a voice &#8212; messaging that communicates the trial sponsor\u2019s core objectives. Patient recruitment professionals provide this through compelling content and artful designs that resonate with target audiences and inspire study participation. 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