Paving the way for plain language summaries and patient engagement
Engaging the patient is key to support clinical trial recruitment and have truly patient-centric drug development. Writing for patients and the general public is vastly different from writing for regulatory authorities or clinicians. Plain language summaries (PLS) of clinical trial results ensure that study participants are informed about study results and that they understand the value of their contribution to science and public health.
It is expected that by December 2021, pharmaceutical companies will be required to develop PLS for the results of all clinical trials with participants in the European Union for the public. Thus, the biopharmaceutical industry is seeking expertise not only in the authoring of PLS, but also in the challenge of patient engagement. The goal of patient engagement is to enable patients, caregivers, patient advocates, and clinicians to provide input during the development of PLS.
Having authored 200+ PLS to date, Certara Synchrogenix medical writers produce PLS in the voice and advocacy of the patients’ interests, effectively and efficiently. As a complement to our commitment to enhance engagement of patients, caregivers, clinicians, and patient advocates in drug development, we’ve developed a secure, user-friendly electronic patient portal called Podium, which enables them to review and make suggestions for improvement of PLS from their perspective. Podium also enables us to assess reviewers’ understanding of the PLS content.
“Patients want to learn everything they can about their health. Unfortunately, much of the available literature is so complex that it is not usable for patients. Synchrogenix is working with Rare Patient Voice patients to incorporate their voices into clinical trial summaries. This is a wonderful way to ensure that important scientific data is available to patients in a clear and understandable format.”
– Pam Cusick, Vice President, Business Development | Rare Patient Voice
Customizable PLS template
Certara Synchrogenix’s customizable PLS template provides readers with a visually appealing, easy to understand PLS. The template is customizable to a sponsor’s corporate style guide, preferred word use, and graphics and encourages greater efficiency in the drafting, review, and finalization process.
Highlights of using our template for your PLS include:
- Incorporation of simple graphics used to convey study treatment and results. This makes the PLS user-friendly, and read less like a manuscript and more journalistic
- Customization of graphics, eliminating the need for a graphic designer
- Access to standard glossaries for preferred terms, condition definitions, and word choices
Engage with patients via PODIUM
As a complement to our commitment to enhance engagement of patients, caregivers, clinicians, and patient advocates in drug development, we’ve created PODIUM. Using our secure PODIUM platform, sponsors can receive valuable responses throughout the clinical trial process from patient groups within specified therapeutic areas.
- Inform protocol feasibility by engaging with patients in the study planning/development stage
- Provide feedback on documents intended for patient use, including informed consent forms and patient summaries of EU Risk Management Plan
- Allow patient groups an opportunity to provide comments and assess readability of the PLS
Clear and concise communication with BaseCase
A ‘no-code’ app development platform, Certara’s BaseCase software allows you to build and distribute interactive dashboards that simplify complex science and communicate findings in a clear and user-friendly way.
- Reinforce key messages and supporting data with clear, easy-to-build visualizations.
- Produce multiple dashboards, each tailored to a specific audience, contained within a single mobile app.
- Use tabs, pop-ups, and other interactive features to layer information and not overwhelm audiences with scientific terms, jargon, and references.
Increase accessibility by making summaries available to access on relevant webpages or through an iOS/Android app.
Featured Experts
Gabriella Mangino Product Manager, Synchrogenix
Theresa Shalaby, MSN, RN Senior Manager, Regulatory Services
Gabriella Mangino Product Manager, Synchrogenix
Theresa Shalaby, MSN, RN Senior Manager, Regulatory Services
Gabriella Mangino has years of patient narrative production and project lead experience in the pharmaceutical industry. As a Product Manager at Synchrogenix, Ms. Mangino works with the commercial and services groups to help develop and improve the software that supports our technology-enabled authoring capabilities.
Ms. Shalaby has over 30 years of experience in the clinical research and drug development industry. Throughout that time,, she held several writing roles including lead author and contributing writer for investigator’s brochures (IBs), phase 2 and phase 3 clinical study reports (CSRs), investigational new drug applications (INDs), new drug applications (NDAs), study protocols, informed consent forms (ICFs), and plain language summaries (PLS). She has experience in the therapeutic areas of pediatrics, neonatology, pediatric and adult oncology, hematology, gastroenterology, pulmonary and respiratory diseases, genetic diseases, cardiology, multiple sclerosis, and rare diseases. She is the functional lead for PLS at Certara Synchrogenix.
Gabriella Mangino has years of patient narrative production and project lead experience in the pharmaceutical industry. As a Product Manager at Synchrogenix, Ms. Mangino works with the commercial and services groups to help develop and improve the software that supports our technology-enabled authoring capabilities.
Ms. Shalaby has over 30 years of experience in the clinical research and drug development industry. Throughout that time,, she held several writing roles including lead author and contributing writer for investigator’s brochures (IBs), phase 2 and phase 3 clinical study reports (CSRs), investigational new drug applications (INDs), new drug applications (NDAs), study protocols, informed consent forms (ICFs), and plain language summaries (PLS). She has experience in the therapeutic areas of pediatrics, neonatology, pediatric and adult oncology, hematology, gastroenterology, pulmonary and respiratory diseases, genetic diseases, cardiology, multiple sclerosis, and rare diseases. She is the functional lead for PLS at Certara Synchrogenix.
