Connecting with patients throughout the clinical trial lifecycle
与患者和护理人员接触是临床试验招募和保留的关键部分。Plain language documents can not only meet regulatory requirements but can also increase patient engagement by encouraging health literacy about clinical trials. Studies have shown that higher health literacy levels relate to increased willingness to enroll in clinical trials. From informed consent forms to plain language summaries, these documents ensure that the public is informed about clinical studies, and they understand the value of their contributions to science and public health.
Types of Plain Language Documents
- Plain language protocol synopses (PLPS)
- Informed consent forms (ICF)
- Plain language summaries of results (PLS)
- gov Brief Title and Description as well as other regulatory sites
- Individual return of results
Customizable plain language templates
Certara’s customizable plain language templates incorporate public health communication best practices to create easy to understand documents. Some of the highlights include:
- Plain language best practices and lean writing techniques based on the research of such groups as Multi-Regional Clinical Trials (MRCT) and the NIH.
- Infographics, information chunking, use of white space, and call out boxes to make documents visually appealing.
- Use of International English to make documents easy to translate and understand.
- Structuring documents to meet accessibility standards for people living with visual impairment.
- Numeracy literacy as well as health literacy principals to clearly communicate complex concepts.
Meeting Regulatory Requirements
Starting January 31st, 2023, the European Medicines Agency (EMA) requires PLS for clinical trials. The UK has also required PLS since 2022. Certara’s PLS templates meet all requirements set out in Annex V of EU Regulation No 536/2014.
Certara also creates PLPS for clinical trial applications as recommended by the EMA. EMA regulations require that review committees include members of the lay public. PLPS help the lay members of review committees easily understand the clinical trial protocol and inform their decisions.
Certara monitors regulatory intelligence and takes part in international working groups to ensure high quality plain language documents that meet regulatory requirements.
特邀专家
Laura Sheppard，MBA，MA 全球申报高级总监和科普摘要负责人
Lee Holland, PharmD, MPH Associate Director – Regulatory Services Management – PLS
Laura Sheppard，MBA，MA 全球申报高级总监和科普摘要负责人
Lee Holland, PharmD, MPH Associate Director – Regulatory Services Management – PLS
Sheppard 女士是全球申报高级总监兼医学作家，在合同研究组织和制药环境领域的文件质量控制、项目管理以及临床透明度和披露方面具有丰富经验。她拥有 20 年的转化科学、临床开发和临床业务经验，其中包括 15 年的医学写作和监管策略经验，涉及生物制剂和小分子的全球上市申请，以及新药临床试验申请 (IND) 和临床试验授权 (CTA) 申请。
Lee Holland is the Associate Director, Regulatory Services Management of Plain Language Summaries at Certara. She has a decade of research and medical writing experience and has overseen the authoring of over 200 plain language documents.
Sheppard 女士是全球申报高级总监兼医学作家，在合同研究组织和制药环境领域的文件质量控制、项目管理以及临床透明度和披露方面具有丰富经验。她拥有 20 年的转化科学、临床开发和临床业务经验，其中包括 15 年的医学写作和监管策略经验，涉及生物制剂和小分子的全球上市申请，以及新药临床试验申请 (IND) 和临床试验授权 (CTA) 申请。
Lee Holland is the Associate Director, Regulatory Services Management of Plain Language Summaries at Certara. She has a decade of research and medical writing experience and has overseen the authoring of over 200 plain language documents.
