Summaries of clinical trial results for laypersons. Shepherd C, Fisher G, Beinarovicac J, Gardner J. It was stated that deficiency could be due to increased use during infection. 2 In this section are tips, as well as examples, of how to apply plain language techniques within the clinical research context. The unique requirements of the PLS have inspired this blog. “Health literacy is the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.”1. ... At the time of writing, 45 trials of vitamin C and Covid-19 were in progress. We build tools like PLS templates, work instructions, glossaries, and graphic designs that will streamline your process. © 2021 Medical Affairs Professional Society.All Rights Reserved. As part of study protocol, participants in Pfizer-sponsored trials are invited to join the PfizerLink alumni network upon the completion of the trial. Manuals on health literacy can also offer further guidance on this topic.6, Lastly, given that publishers are using different terminology and platforms for hosting the PLSs, how do we ensure that a PLS can reach the target audience? Plain Language Summary (PLS) A PLS is a written account of a clinical trial, prepared in simple language to communicate results, which can be easily understood by a non-scientific person. In addition, internal and external authors needed to be educated on the importance of the initiative, as it would result in added workload related to scientific congresses. These points were picked up by patient reviewers involved in the development and “sense checking” of the APLS. FitzGibbon H, King K, Piano C, Wilk C, Gaskarth M. Where are biomedical research plain‐language summaries? Proposed process for developing a manuscript publication PLS, Figure 3. The relevant plain language summary appears “TrialAssure is acutely focused on making it simple for all clinical trial sponsors to be transparent, providing the most effective and affordable tools in the industry,” said Zach Weingarden, Product Solutions Manager, TrialAssure. Some pharmaceutical companies have raised concerns around the potential for PLS to be considered promotional activity; therefore, we provide some clear practical recommendations to overcome this perceived barrier, as well as tips to optimize development and accessibility. A PLS is intended for a wider audience (patients, caregivers, public, media, and some healthcare providers [HCPs]), has a broader scope, and is generated in a wide variety of formats. The summary should remain factual and objective, avoiding any promotional language (See neutral language guidance in Annex 2) or promotional perception through formatting or tone3. Our experts have been providing PLS solutions and strategic advice since 2015 in this evolving area. Other recommendations, such as consistent naming and location, and ensuring that a PLS is search-engine optimized and linked to the original. In the plain language summary, you should ask participants if they wish to receive published results when these become available See if or how web-based platforms such as ClinicalTrials.gov or similar trial listing sites might be appropriate for sharing the summary People who participate in clinical studies, and others, may want to know information about clinical study results. Although in draft format, there is a similar templated framework that offers general considerations on content, ensuring the level of communication is appropriate for the audience, health literacy and numeracy, the timing of the PLS (within one year of the study ending), and appropriate methods of delivery. ABSTRACT. Lay summaries are a way to share clinical study results, but they do not replace other ways that information is shared. Plain language summary (PLS): A non-technical summary of clinical trial results or other content in a journal article or congress presentation. Summaries of Clinical Trial Results for Laypersons 26 January 2017 6 6. MAPS Appoints First Chair of New Exec Program Committee, CMC AFFINITY, McCann Health Medical Communications, https://www.linkedin.com/in/karen-king-phd-cmpp-07267716/?originalSubdomain=uk, https://www.linkedin.com/in/sarah-yelling-78a176178/, https://www.linkedin.com/in/dheepa-chari-9190943/, Medical Affairs Launch Excellence Standards & Guidance + Templates. Publication plain-language summary (PLS) – can be for congress abstracts and manuscripts, located on different sites, and developed in different formats. 536/2014 is a major regulatory initiative that will result in a large number of such plain language summaries (PLSs) posted in the public domain. Supported over 9 sponsors with expert strategic advice, building process document and implementing PLS writing, translation, and distribution. Your clinical trial is complete. The provision of an abstract and poster PLS thus helps to maintain that continuity of information provision to patients and caregivers in anticipation for final, full-text manuscripts being published. The content of these two formats is based on the same systematic review, but the ways of data presentation will differ: visual presentation in plain language and plain language only. The primary purpose of a CTS is to inform about the details of the trial itself, particularly for trial participants. Results of completed Teva clinical trials, including currently-available Plain Language Summaries and EMA Policy 0070 submission packages Transparency Policy Teva's policy regarding the public disclosure of clinical study results It increases the risk of bleeding during procedures including liver biopsy and transplantation. Of course, measuring reach and value will be important and these could be assessed by basic download metrics alongside other qualitative measures such as surveys and focus groups. Some recommendations regarding this process are outlined in Figure 2. The authors reviewed clinical research of vitamin C in colds, pneumonia, sepsis and Covid-19. Accessed 3 November 2020. publication (on journal site or other available platforms) would also help. The Plain Language Action and Information Network (PLAIN) is a community of federal employees dedicated to the idea that citizens deserve clear communications from government. Your inputs will be needed only in key areas while creating PLSs enabling you to focus on your main responsibilities. And on-site summary distribution means many patients never even receive results. Clinical trial summary results are available on this website. Given that clinical research communications can be very technical and complex, using plain language can help clearly explain information so that the target audience has a better chance of understanding. Plain language summaries are posted for … Paper-based workflows slow the publishing process. Clinical trial summary (CTS) – mandated by law in certain countries, typically on clinical trial sites, following a templated style with a narrow scope. Therefore, PLSs are the way forward to achieve greater transparency. Draft FDA Guidance on Provision of Plain Language Summaries. Recent research examining journals from 10 different publishers demonstrated that PLSs are typically outside of the journal paywall, which is a positive first step.7 However, more needs to be done to increase reach, highlighting the importance of planning a good dissemination strategy, such as reaching out to PAGs and medical research charities as they are one of the key vehicles to widening reach with the patient/caregiver community. Kinapse is a global leader in post-approval regulatory/pharmacovigilance and clinical trial transparency services. A CTS is templated with narrow scope and is aimed primarily for clinical trial … Could PubMed be a viable route to discovering plain language summaries? The European Clinical Trial Regulation (EU) No. In this article, we outline two key approaches: An awareness of health literacy is essential when writing for potential clinical trial participants and crucial when reporting trial results back to patients and caregivers who have directly participated in trials and/or contributed their time and effort. An APLS accurately conveys the core messages contained within the accepted abstracts while also providing concise “nuggets” of information about certain types of cancer and certain molecular targets. Readability and use of plain language Sentences should be kept short and succinct. Today, however, little is known about the extent to which PLSs are written and are available to the general public. She is responsible for the initiation, production, approval, translation and dissemination of aggregate clinical study results to Janssen study participants in compliance with regulatory authorities and other stakeholders. There are two types of PLSs, a clinical trial summary (CTS), which is mandated by law on clinical trial databases, and a publication PLS, which summarizes the results of a publication (abstract or manuscript) in plain language. Publication PLSs should be peer reviewed alongside the original manuscript and the scope should be primarily limited to that of the manuscript or congress abstract. Our experts share industry best practices in every area of PLS implementation. A PLS is a written account of a clinical trial, prepared in simple language to communicate results, which can be easily understood by a non-scientific person. ... Post plain-language summaries on a non-promotional, ... and plain-language summary authoring and creative design. Checklist for what to include in a publication PLS, courtesy of Envision Pharma Group. Now you have ethical and organizational obligations to communicate the results to participants and the public. 146 Sentences should be kept short and succinct. We eagerly await their publication to inform future direction for PLSs. Guidance is also given regarding the harmony between text and graphics to make certain the lay reader remains engaged in the content and understands the scientific data presented. A plain-language summary (PLS) can play a key role in communicating clinical research more broadly to patients. Upon trial completion, patients receive a plain language summary of the study. Several challenges were encountered in navigating compliance guardrails around patient-directed communication, which necessitated developing a new governance process that would allow for the APLSs to be written effectively. In recent years, pharmaceutical companies have become increasingly aware of the regulatory and ethical mandates to develop and disseminate plain language summaries of clinical trial results. A recent research study in partnership with patient advocacy groups (PAGs) examining optimal formats for PLSs suggested a visual infographic style and an optimal reading age of medium complexity.4 Cochrane has also examined the usefulness of different formats for translating the results of a systematic review and found that although there was no difference in knowledge translation between the infographic and text-based PLS formats, they preferred the infographic, giving it higher ratings for reading experience and user-friendliness.5 Therefore, infographic is likely to be the preferred option for people to digest, with text-based being useful for translation; however, other audience-specific points should be considered (such as age, culture, translation needs and accessibility requirements) before format/complexity is decided. Here are some examples, both historical and current. Ensure disclosure compliance, maximize trial transparency, improve patient engagement, and accelerate study recruitment like never before. Plain language summaries, which provide a patient- and public-friendly summary of clinical trial results, are not new to clinical investigations. Plain Language Summaries need to explain the key elements of the clinical trial in non‑technical language that can be understood by … Public, patient, and health care community demand for plain language information about the results of clinical trials is extremely high. The input of patient partners was critical for developing APLSs that were fit for purpose. Performed extensive benchmarking exercises on PLS implementation strategies and PLS template. Reports must now be written that are totally understandable to the general public, the vast majority of which will have no prior knowledge of the trial, as well as meeting the needs of trial participants and clinicians. To prevent any suggestion of bias by the sponsor, objective criteria should be developed and used consistently for selection of publications for which to include a PLS (e.g., Phase III data is more broadly applicable to a wider audience as it is more likely to imminently impact clinical practice relative to Phase I data). Producing a plain language trial results summary is a multi-step process. Poster presented at ISMPP Annual Meeting 2020. Health Sci Rep 2020; 3: e175. Both CTSs and publication PLSs have key roles to play in this process. This How-To guide refers to PLS for publications and conferences and do not include PLSs that are created per EU regulations (ie, layperson summaries) With our experienced team, health literacy review, and patient advocacy groups’ engagement, we anticipate reader’s questions and address them in the PLSs effectively. Our PLS solution has been designed to make sure you: Our experienced team offers strategic advice and help in driving the implementation of PLSs. The EU followed suit in 2014, with the introduction of the more enforceable “EU Clinical Trials Regulation 536/2014/Article 37”. While literacy is the ability to read and write, health literacy is all that and more, particularly when it is a lay audience of patients, their caregivers, and the general public who must be engaged and educated. Visit our contact page to find our contact information. Although medical writers trained in writing a PLS are well placed to facilitate their production, the patient voice cannot be overlooked. The primary purpose of a publication PLS is to outline the results of a publication in plain language intended for a wider audience beyond HCPs. Buljan I, Malički M, Wager E, et al. Sykes A, Chari D, Meloro JR. Therefore, PLSs are the way forward to achieve greater transparency. A centralised, widely accessible, non-promotional, and unbiased portal, www.ClinTrialDataShare.com for sharing PLSs. Silvagnoli LM, Gardner J, Shepherd C, Pritchett J. Get access to a centralised, widely accessible, non-promotional, and unbiased portal, www.ClinTrialDataShare.com for sharing PLSs. A CTS is templated with narrow scope and is aimed primarily for clinical trial participants. More and more of these meetings have patient and caregiver streams running in parallel with, and even fully integrated into, the scientific program. Some industry colleagues have concerns over the interim reporting of findings that have not been formally peer reviewed; therefore, such disclaimers could be included on each PLS to make it clear to readers that the data may not fully reflect those reported in the final results. This publication represents the consensus opinions of the authors and various members of MAPS but does not represent formal endorsement of the conclusions by their organizations. Summaries written in plain language help people who are not scientists or doctors understand complex medical information. Plain language is grammatically correct language that includes complete sentence structure and accurate word usage. Accessed 3 November 2020. Effective implementation of PLSs requires both a strategic approach and alignment across all functions involved in the generation and reporting of a clinical study’s results. The CTS became a requirement after the advent of the European Union/European Medicines Agency (EU/EMA) guidelines that mandated transparency in reporting clinical trial data to both study participants and the general public.2 A templated framework is part of this directive and ensures that all relevant information is provided to the lay reader in a balanced way. Both the Plain Language Summaries and the Blue Button data are accessible via PfizerLink, Pfizer's secure clinical trial alumni network site. The entire community must remember that without patients, there would be no industry. Debra Guerreiro is the lead for the plain language summary initiative at Janssen R&D. It was important to make certain that any APLS is developed with comprehensible reading-level requirements while ensuring an accurate reflection of the original scientific content. Many patient and caregiver advocates and organizations use these congresses as opportunities to gather the latest research findings to report back to their communities online or via standalone meetings. Recognizing the vital role of patients in medical and scientific research, the Future Science Group (FSG) has today published a new style of article – a Plain Language Summary of Publication, the first of its kind for FSG. Sharing of Clinical Trial Results with Participants. A defined development process should be used. Writing that is clear and to the point helps improve communication and takes less time to read and understand. See What is a plain language summary. The EU Clinical Trials Regulation 536/2014’s (EU CTR Article 37) demand for plain English synopses will bring specific challenges. Although journals do typically offer other “bite-sized” content which may be more valuable to certain HCPs. Plain language summaries (short format intended for the general public) (phase 2-4). Best practices for pharmaceutical companies to adopt when working on a PLS. You will be working with one of the most experienced Clinical disclosure teams in the industry, from statisticians to project managers with hundreds of years of combined experience under our belt. With increasing awareness of the benefits of communicating clinical trial research to patients there has been increased interest in how we can do this in a compliant and non-promotional way. A checklist for what should be included in a publication PLS is shown in Figure 1. Clinical trial reports and synopses are posted for phase 1-4 trials dating back to 1990*. We offer our clients a truly end-to-end service using our ‘advise-build-operate’ model to help drive greater productivity for our clients. This includes reporting of “adverse reactions” (a statutory term) and study outcomes, both positive and negative. Available at: https://mrctcenter.org/wp-content/uploads/2017/06/2017-06-13-MRCT-Draft-FDA-Guidance-Return-of-Aggregate- Results.pdf. Most firms can sympathize with the motivation behind plain-language summaries. TrialScope gives your clinical trial data superpowers™. Because the intent in communicating scientific data transparently with patients is to help them understand research developments in a timely and credible manner, our recommendations to tackle this are: Even if a journal does not currently mention PLS in its author instructions, in our experience, many are open to having discussions about how they can facilitate this option. With the aim to … Why write Plain Language Summaries and the benefits. Plain language has been around in the government for over 40 years. A summary of clinical trial results for laypersons, referred to as a lay summary of results or plain language summary (PLS), is a brief description of the clinical trial results in everyday language that is understandable to people who do not have a medical or scientific background. This regulation required plain language summaries of clinical trial data to be accessible in a new database known as the “EU Clinical Trials Register,” which is expected to be available in late 2018.

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