08 Jun 23
By Judi Proctor
Clinical trials are regulated to ensure the safety and well-being of people taking part in the studies and to ensure the validity of trial results. Clinical trial regulation is governed by various international, national, and regional laws and guidelines. The main international guideline for clinical trial regulation is the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). ICH provides a number of guidelines for the conduct, reporting, and evaluation of clinical trials. In the United Kingdom (UK) and the European Union (EU), clinical trials are now regulated by the Clinical Trials Regulation (CTR; EU No 536/2014), which aims to harmonise the regulatory process for clinical trials across the EU and ensure the protection of trial participants.
Clinical Study Reports (CSRs), scientific papers, and conference presentations are typically written for an audience of experts in a particular field, using technical jargon and specialised language that may not be easily understood by non-experts. As part of efforts to promote greater transparency and public engagement in science, the CTR requires the provision of Lay Summaries of clinical trial information that typically are required to be made available to the public. Lay Summaries are written for a general audience that may not have any specialised knowledge in the field, providing a plain-language explanation of the study’s objectives, methods, results, and implications which must be easily understandable to a broader audience, including patients, caregivers, and the general public. Many funding agencies and institutions now also require that researchers provide a Lay Summary of their findings as part of their dissemination plan. This is because Lay Summaries can help to increase the impact and scope of research findings, and promote greater public engagement with scientific research.
Lay Summaries help to bridge the communication gap between researchers and their stakeholders by translating complex scientific concepts into plain language, ensuring that their research findings are disseminated in a way that is meaningful and understandable to the people who can benefit from them the most. This includes patients and the general public, making it easier to communicate key findings for people to understand and engage with the research findings. They help to increase transparency and accessibility of clinical trial information. This can have a number of important benefits, such as increasing awareness of important health issues, helping to build public trust in the research process, and facilitating the translation of research findings into clinical practice. Lay Summaries are particularly important for clinical research, where patients and their families may be seeking information about their medical condition and treatment options.
Patient Advocate Groups are organisations that work to represent, support, and promote the interests and needs of patients with specific medical conditions or diseases and their families, for example, Leukaemia Care, Beacon: for rare diseases, Independent Cancer Patients’ Voice, INPUT Patient Advocacy – Diabetes UK, and AGE UK. They are typically led by patients, their families, or healthcare professionals, and are focused on advocating for improved healthcare policies, funding, and research, usually related to a particular disease or condition, though they may work more broadly to advocate for patient rights and access to quality healthcare, more research funding or improved insurance coverage.
These groups are a vital resource both for patients and for their families, providing support, information, and advocacy to help improve the quality of care and quality of life for those living with illness or disability. They provide a variety of services and resources to the group members, including education information and support, access to clinical trials and experimental treatments, and assistance with navigating the healthcare system. They may also work to raise awareness about their particular disease or condition, advocating changes in public policy and funding to support research and treatment. Many Patient Advocate Groups also raise money to support research, education, and patient care, and regularly offer support groups for patients and their families, providing a safe and supportive environment where people can share their experiences and find emotional support.
Lay summaries are important to patient advocate groups, providing easy-to-understand information about clinical trial results, which can help to empower patients to make informed decisions about their healthcare:
Overall, Lay Summaries are an important tool for improving the communication and dissemination of research, promoting transparency and engagement, and enhancing the overall quality of clinical research.
tranScrip’s highly experienced team of Medical Writers are skilled in translating complex scientific language into high-quality, clear, understandable Lay Summaries that are accurate, reliable, and accessible. They have a deep understanding of clinical trial data and can communicate it effectively to a lay audience. They use a rigorous quality control process to ensure that their summaries meet the highest standards.
tranScrip’s medical, regulatory, and writing teams are all very familiar with the regulatory requirements for Lay Summaries, and they ensure that their summaries comply with all relevant regulations and guidelines. tranScrip has efficient processes for creating Lay Summaries, allowing them to deliver high-quality summaries quickly and cost-effectively.
tranScrip’s team works closely with their clients to ensure that their Lay Summaries meet their specific needs and requirements. They can tailor their services to meet the unique needs of each client.
If you need high-quality, accurate, and compliant Lay Summaries of clinical trial results, our flexible expertise, quality, and efficiency make us a reliable and valuable partner for any organisation that needs to communicate clinical trial results to a lay audience.
We have teams of life science and R&D experts to help achieve your goals and seize opportunities. Whatever your project requires, we have the people to meet your needs.