[vc_row][vc_column][vc_column_text]A growing number of pharmaceutical, biotechnology and medical device companies are closing the loop with their study volunteers by providing clinical trial results summaries. Also referred to as lay language summaries or plain language summaries, the advent of these documents follow research initiatives showing that most clinical trial participants want to know what the research communities learned from their participation, yet most never hear from the sponsor or site staff at all after the trial has concluded.
To accommodate this void and fulfill other objectives including patient engagement and an ethical obligation to return trial results, research sites are increasingly turning to lay language trial results summaries to provide a digestible summary of the study, trial and outcomes. Read on to learn what exactly a lay language summary is, why more and more sites are using them and how you can promptly and easily deliver one to your study participants following your next clinical research trial.
What are lay language summaries?
Lay language summaries are an important emerging practice by sponsors, regulators and other healthcare authorities in effort to increase data sharing and transparency. Written in easy-to-understand lay (aka as plain) language for a general audience, a lay language summary is a non-promotional regulatory document that addresses and thanks volunteers directly and includes information such as:
- What is happening with the trial now?
- Why was the research needed?
- What treatments did the patients take?
- What happened during the trial?
- What were the results of the trial?
- What medical problems did have?
- How has this trial helped patients and researchers?
- Where can I learn more about this trial?
The summaries are often written by a third-party organization, guided by a high-quality, patient-focused editorial process and disseminated to volunteers via their investigative site. To accommodate different learning styles, summaries can be developed in multiple formats such as print, electronic and audio.
Why do you need lay language summaries?
There are many reasons to utilize lay language summaries, including fulfilling an ethical obligation to return trial results as well as to demonstrate to volunteers that they are respected as true partners in the clinical research process. While results summaries are not currently required by the FDA, studies consistently show that most volunteers want to know what was learned from their contribution:
- Participants want to know what was learned from their participation in a trial: 84% of clinical trial participants said it is ‘very important’ or ‘somewhat important’ to receive the results of their trial.1
- Patients need lay language summaries to comprehend the technical results: 91% of clinical trial participants understood the results of their trial well after reviewing a lay language summary when prior to review, basic facts about the trial were understood by less than 11%.2
- Lack of communication may negatively impact the clinical research enterprise: 91% of clinical trial participants want to be informed about research findings from their trial and would reportedly not participate in future clinical trials if left uninformed.3
While results are posted to scientific and medical journals and websites such as ClinicalTrials.gov, the writing is not intended for patients or other lay audiences. Rather, the expectation is only that these results would be understandable by an “educated reader of the medical literature,” as stated by Deborah Zarin, Director of ClinicalTrials.gov. Beyond that, other reasons sponsors are planning and implementing summary programs include supporting their patient engagement and retention objectives, nurturing relationships with investigative site personnel, anticipating regulatory pressure and reform, and finally, informing discussion between study volunteers and their healthcare providers.
How do you develop and deliver lay language summaries?
An accurate lay language summary is to be written at a validated 6th-8th grade reading level; when translating highly technical results into scientifically accurate lay language however, this is easier said than done. Most research sites and sponsors choose to work with an independent third-party to write their lay language summaries which includes the following considerations:
- Inclusion of non-promotional and unbiased plain language
- Use of a high-quality, patient-focused editorial process
- Adherence to regulatory compliant methods, including global mandates
- Use of proper patient protections
- Adherence to sponsor company specifications and operating practices
The timing of when to distribute the summary to study volunteers is up to the sponsor’s overall strategy – but often site staff will inform volunteers about the summary which can be expected a few months after the conclusion of the study. Available in multiple formats such as print, electronic and audio, a lay language summary is available to volunteers online and often provided in-person.
How do I get started developing lay language summaries for my patients?
If you’re interested in returning trial results and demonstrating to your volunteers that they’re regarded as true partners in the clinical research process, consider lay language summaries. At CISCRP, we’ve partnered with 30 of the top pharmaceutical companies to create and deliver lay language summaries that are non-promotional, unbiased and written in a way that participants will understand and appreciate. To give back to the participants who gave you their time, schedule a free 30-minute consultation with us today.
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Do you need other clinical research assistance, education or information? Contact CISCRP today.
- 2017 CISCRP P&I Study, n=12,427.
- Getz et al. 2012. Expert Rev. Clin. Pharmacol. 5(2): 149-156.
- Sood et al. 2009. Mayo Clinic Proceedings. 84(3): 243-247.
To View the MT Pharmacy Video, click HERE.
Last month, CISCRP collaborated with Sanofi, Inc. to host our flagship clinical research education program, AWARE for All, at Rutger’s University in Newark, New Jersey. As part of the program, a special pop up pharmacy, named the “MT Pharmacy,” was set up 3 days prior to the AWARE event in an effort to engage with the Newark community. The purpose of the MT Pharmacy was to show that without clinical trials, pharmacy shelves would be empty, and would not carry the necessary medicines and therapies that are used to treat diseases and ailments for millions of people around the world. It was also a chance to share information about clinical research and to invite the community to attend AWARE for All.
This special pharmacy project was developed with the assistance of Langland, who initially proposed the concept and idea during CISCRP’s Inspiring Hope Ideathon event held in September of 2016. The idea stood out to CISCRP as a well-suited complement to our AWARE for All events, as both the MT Pharmacy and AWARE for All aim to educate the public about the importance of clinical trials. We piloted the idea of opening the MT Pharmacy a few days before our AWARE for All Newark event in an effort to reach more members of the local community to create greater awareness of clinical research and encourage them to attend the live AWERE for All event.
The location for the pharmacy was strategically chosen to be central to downtown Newark and in an area where there is high foot traffic. The temporary storefront was set up to attract passersby’s with the promise of free health screenings and other giveaways. Upon entering the pharmacy, individuals were met with brightly lit walls of empty shelves and barren displays. At first sight individuals appeared curious or even confused. Onsite representatives explained that the empty pharmacy was a demonstration of what our stores might look like without the medicines and treatments that are developed in clinical trials.
The pharmacy was open for 3 days and within that time, hundreds of people were in and out of the store learning about the impact of an empty pharmacy and learning about the AWARE for All live educational event that was being held at Rutger’s University later in the week. During their visit, people were encouraged to fill out and personalize empty pill boxes with a medicine or treatment that they wished was available. In total 465 boxes were filled out and placed on the empty shelves.
Charlotte Huyton from Langland shared her experience at the pharmacy explaining, “Curiosity drew people into the store; once they entered and chatted with the pharmacist and the team they filled out boxes and shared their story! Many were enthused to hear that a community event was coming to their area and that there was an opportunity to learn more.” Nearly 120 of the MT Pharmacy visitors also attended our AWARE for All Newark event.
The MT Pharmacy provided a creative platform for creating awareness of clinical research and for building up momentum about our AWARE event within the local Newark community. CISCRP plans to apply initiatives and programs such as this one for future AWARE events. A video of the pharmacy event, including interviews, visitor reactions, and footage of the three days is available to view HERE and will also be made available on www.everyonesinvited.org. This video will be free for the public to view and share.
By: Leslie Perez
Robyn Ryan’s medical journey officially began in 1994 when she was running to catch a school bus and was hit by an oncoming car. Robyn cartwheeled through the air and landed, unconscious, on the asphalt.
The 12-year-old spent the next two months recovering from a torn ligament in her leg. In time, Robyn’s leg healed, and she returned to school, but things still didn’t seem quite right. She was dizzy and light-headed and suffered from frequent headaches. She also seemed strangely unaware of her surroundings, which led to dangerous behaviors.
“I’d cross streets against the light or ride my bike into traffic,” she says. “Everybody thought I was reckless and a daredevil. I didn’t think much of it.”
Robyn’s risk taking led to a string of accidents – falls down icy stairs, bicycle collisions, motorcycle accidents – and a litany of ankle, leg, back and head injuries. Each time, doctors patched her up and sent her on her way.
With no one to connect the dots for her, Robyn persevered. She struggled through high school and went on to art school in Philadelphia, where she lives, and participated in her first clinical trial — a sleep study — just to earn a few dollars.
Despite her best efforts, Robyn couldn’t seem to “get it together.” After art school she had trouble holding down a job. She had trouble listening to instructions and following rules. She’d get tired and fall asleep on the job. Sometimes she wouldn’t show up at all.
Over the years Robyn moved from one temporary position to another, none of them lasting more than six or eight months. In 2007 she began suffering from debilitating headaches. Her doctor suggested she participate in a clinical trial to see if she could learn anything. Robyn signed up for a trial that required her to wear electrodes taped to her scalp for a few days. Although the study was painless, it didn’t alleviate her headaches or provide any answers.
Out of work and facing a mountain of student loans, Robyn took a shot in the dark.
“I called Health Partners, which is where my doctor was and asked ‘Do you have access to any kind of jobs?’ I explained about my accidents. I didn’t know anything about brain injury at the time, but whoever answered the phone listened and wanted to help.”
Someone at Health Partners connected her with the Pennsylvania Department of Labor & Industry’s Office of Vocational Rehabilitation, which in turn directed her to Moss Rehab at Einstein Healthcare Network.
Finally, Robyn’s luck started to change. Doctors at Moss asked her a lot of questions. They conducted a battery of neurological tests and brain scans, reviewed medical records from all of her accidents, and even asked her about two early childhood falls down staircases that were never documented in her medical record. They discovered Robyn had suffered traumatic brain injuries (TBI) on six different occasions.
The diagnosis enabled Robyn and her care team, which includes a case manager, neurophysiologist and therapist, to address her physical, emotional and social needs in a comprehensive fashion. Her case manager helped her apply for student loan forgiveness and register for a waiver program to pay for her services. Clinicians prescribed medications to alleviate her depression and help manage her anger. In addition, speech, occupational and physical therapists helped her develop skills associated with areas of her brain that hadn’t been damaged. The therapy helped strengthen Robyn’s communication skills and learn to cook.
Robyn, now 35, has had to give up some potentially dangerous activities – such as driving and riding her bike because of her inclination to take risks.
“In a lot of ways I’m still dealing with the same types of problems as before, but at least now I feel like I’m moving forward,” says Robyn, who will soon start work in a call center that employs people with disabilities.
What’s more, she knows there is cause for hope. “TBI has been one of the most difficult things for researchers to understand, but there is a lot of funding now that goes toward brain injury that wasn’t there before,” says Robyn, who hopes to participate in future trials that can shed more light on TBI.
She knows from experience that participating in clinical research doesn’t have to be a long and involved ordeal.
“I think it’s a misconception that a lot of people have that clinical research requires a lot of a participant,” she says. “Sometimes it’s as simple as being interviewed or answering a few questions.”
And no one knows better than Robyn that asking the right questions leads to important answers.
By: Shelly Reese
As 2017 begins to wind down, I’m excited to share some updates and information about what the remainder of the year has in store for CISCRP and what we’re looking forward to in early 2018.
In this edition of our newsletter we are honored to be spotlighting Robyn Ryan in our Medical Hero Spotlight. Robyn, who suffers from Traumatic Brain Injury (TBI), shares her experience with clinical trials and why she hopes that there will be more clinical trial opportunities for her in the future.
We’re also giving readers a look at how our Patient Advisory Board Panels are organized and conducted. This is a service that we offer to organizations who wish to solicit feedback and gather valuable insights directly from patients and their support network on a variety of critical clinical study-related areas. Patient Advisory Board Panels are an invaluable approach to engaging study volunteers, enhancing their participation experience, and providing insights for ways to improve study feasibility, recruitment, and retention.
Our events schedule has been a full and exciting one this Fall! We recently wrapped up AWARE for All Clinical Research Education events in Newark, Chicago, Wilmington and will be bringing the flagship event to Jacksonville, FL on December 5th. We also co-hosted a Medical Heroes Appreciation 5K Walk/Run with Stormont Vail Health in Topeka, KS on October 21st. Be sure to check out our upcoming events for 2018.
At the Newark AWARE for All event, we opened the first ever “MT Pharmacy,” a creative concept to help educate the public about the importance of clinical trials. You can read all about the purpose of the pharmacy, how it was set up, and some of the feedback we got from the local Newark community. You can also view a video of the MT Pharmacy by visiting www.everyonesinvited.org or view the video here on our Youtube page.
In other news, we were honored to be recognized at Sanofi US’ Sanofi in Our Communities, Celebrating Diversity; a reception held on October 24th at their offices in Bridgewater, NJ. Sanofi was the host sponsor for AWARE for All Newark and spoke about the success of both the AWARE event and the MT Pharmacy.
And if you haven’t had a chance to take a look yet, CISCRP just released our 2017 Global Perceptions & Insights Study results. The objective of the study is to establish routine global assessments of public and patient perceptions, motivations, and experiences with clinical research participation and represents the responses and opinions of 12,000+ members of the public and patients around the world.
Lastly, I invite everyone to check out our new Search Clinical Trials page that has been revamped. This free concierge service helps people find a clinical trial through online search or by phone with a live customer service representative.
Wishing the entire CISCRP Community a joyful and prosperous Holiday Season. Thank you for your continued support as we work to build greater awareness and education around clinical research.
Thanks for reading,
As a nonprofit organization, CISCRP relies on the support of generous donors to continue our efforts to increase and promote education and awareness about clinical research and clinical trial participation. Nearly 100% of all donations made to CISCRP go towards supporting specific educational and outreach assistance initiatives that are geared directly to patients and their families.
Each fall, CISCRP organizes an End of Year fundraising campaign to collect donations and support for the upcoming year. Every dollar raised during this time is put towards the development of both printed and live educational materials that help inform patients and the public about clinical research. Many individuals and companies choose to include CISCRP in their end of year donation giving to help support this important effort.
With the donations we raise each year, CISCRP reaches over 429,000 households with the AWARE For All Educational Outreach programs, distributes over 1 million copies of Educational Materials through investigative sites, sponsors, and CROs, generates over 120 million impressions with our Medical Heroes Campaign, and conducts over 5,000 unique searches to help patients and members of the public find relevant clinical trials through our free Search Clinical Trials Service.
CISCRP welcomes donations from individuals, companies, and groups. Some people choose to make a personal donation as part of their holiday or end of year giving. Others make a donation on behalf of their clients or patients. And some organizations make donations as part of their corporate gift giving or to support matching donations on behalf of their employees. All donations are tax-deductible and can be submitted online or sent in via mail to the CISCRP office. Donors can choose to make their pledge on behalf of a company or dedicate their donation to honor a specific individual. CISCRP makes a point to recognize and thank our donors and supporters on our Circle of Supporters page.
For certain donation amounts, CISCRP can assist organizations with designing and sending out a customized email to colleagues, clients, or patients to share that a donation was made to CISCRP on their behalf to support clinical research education and awareness.
CISCRP’s End of Year fundraising campaign is very important to help sustain our programs and initiatives. But there are also other opportunities and ways to support our organization. Individuals and companies can support us by purchasing educational items from CISCRP’s online store. Supporters can also fund the development of new materials to add to the store and education center by reaching out to Rachel Minnick, Senior Manager of Marketing and Patient Engagement Alliances at CISCRP. Individuals can also contribute to CISCRP by shopping online at AmazonSmile. And for those who are interested in making donations to specific programs and events, more information can be found by accessing CISCRP’s sponsorship packet.
By: Leslie Perez
Patients, volunteers, caregivers, advocates, health professionals, policy makers, and family members all make up CISCRP’s diverse community of engaged stakeholders. We work closely with our community members in a variety of activities to help promote engagement, education, and greater awareness of clinical research.
As CISCRP continues to support a growing number of initiatives, our need for more community volunteers and participants continues to also grow. We want to invite new CISCRP community members to lend expertise to our outreach and awareness programs. If you or someone you know are interested in participating in any of our outreach and awareness initiatives, please contact us today!
Read on for a description of our many community engagement opportunities and how you can get involved:
AWARE for All Panels
Throughout the year, CISCRP holds health education events, called AWARE for All, in different cities around the country. As part of each AWARE for All program, we put together a panel of patient speakers, advocates, and/or caregivers to share their experience of clinical trial participation with the audience. We are always looking for new community members to join the AWARE for All panels and share their own story. To view our upcoming AWARE for All events, click here. If you are interested in becoming an AWARE for All panelist for a future event, contact Ellyn Getz, [email protected]
Editorial panelists play an important role in many of CISCRP’s programs and services. We use editorial panels to review all of our educational resources and materials and to review plain language summaries for our Communicating Trial Results service. Patients, caregivers, advocates, and research professionals are all invited to join our editorial panels and help contribute varying perspectives to these reviews. To learn more about becoming an Editorial Panelist, click here.
Patient Advisory Boards
CISCRP organizes Patient Advisory Boards for research sponsors, contract research organizations (CROs), and research centers looking for patient feedback on various clinical research related activities. This includes review of study protocols, informed consent forms, data collection tools, new clinical trial technologies, and other trial materials. Volunteers are an integral part of our Advisory Boards and we are always looking for new patients, caregivers, and advocates to join these panels. Learn more about joining one of our Advisory Board Panels by clicking here.
Live Patient Panels
Another service we offer to research sponsors, contract research organizations (CROs), and research centers is to bring in a panel of patients, caregivers, or advocates to discuss their view of clinical research and experience with clinical trials. This is a way for companies to get a broader understanding of how important the patient is in the clinical research process from start to finish. These are held at locations all over the US, so there are many opportunities to get involved in a Live Patient Panel. Contact Rachel Minnick, [email protected], for more information about how to get involved in a Live Patient Panel near you.
Medical Hero Spotlights
Each quarter, we feature a clinical trial participant or “Medical Hero” in our e-newsletter. This is a chance for patients or caregivers to share their story and experience with clinical trials. The e-newsletter is distributed through our email channels and is also viewable on our website. If you would like us to share your patient story for our next newsletter, contact Rachel Minnick, [email protected].
If you are a patient who has participated in clinical trials or a caregiver, advocate, or research professional who is passionate about spreading the message of the importance of clinical research, then you may be interested in becoming a CISCRP Ambassador. Our Ambassadors speak at health fairs, conferences, and exhibits in their own city to help educate local members of the public about clinical research. CISCRP provides resources and materials to help assist the Ambassadors with their engagements. To learn more about becoming a CISCRP Ambassador, contact Rachel Minnick, [email protected].
If you enjoy communicating and sharing through online social sites, then we invite you to join our community on HealthUnlocked called “Understanding Clinical Trials”. This is a place for patients, caregivers, family members, and the public to share insights and information about clinical trials with a large online community.
If you are CISCRP community member who wants to get involved with any of these programs, please contact Rachel Minnick to learn more!
By: Rachel Minnick
As one of our fastest growing service areas, CISCRP’s patient advisory board panels, are used by research sponsors, contract research organizations (CROs), and research centers to solicit feedback and gather valuable insights directly from patients and their support network on a variety of critical clinical study-related areas. These may include assessment of protocol/study design, study synopses, informed consent form design, clinical trial medicine kits, and clinical trial technologies.
CISCRP’s unique position as an independent nonprofit organization allows organizations to gather unbiased, meaningful feedback from patients and their caregivers. CISCRP’s close relationships with various patient advocacy groups, patient communities, and study volunteers also play an important role in composing a diverse panel that best represents the desired target audience. To date CISCRP has conducted more than 30 patient advisory board panels.
CISCRP collaborates closely with organizations to organize these panels. As part of the service, CISCRP will work with an organization to develop a discussion guide and patient-facing materials, select and engage panel members, identify a venue, and moderate the panel meeting. Each panel is designed to allow for open dialogue among participants. The size of each panel typically ranges from 6 to 8 individuals and may include patients from varying disease areas, family members, or patient advocates. Depending on the needs of the organization, these panels can meet once or multiple times. CISCRP encourages in-person meetings to build the strongest rapport with patients and their caregivers.
After the panel meeting, CISCRP prepares a detailed report outlining key patient comments and recommendations to deliver back to the organization. Clinical operations teams then utilize these insights to shape proposed clinical trial designs and strategies within the organization. CISCRP’s Patient Advisory Board Panels are an invaluable approach to engaging study volunteers, enhancing their participation experience, and providing insights for ways to improve study feasibility, recruitment, and retention.
Both patients and sponsor organizations have found the experience to be very enriching. One patient who participated in a CISCRP Advisory Board Panel described his experience, “Our patient advisory board meeting proved to be an invaluable experience. We had a unique opportunity to have a voice in the process of how clinical trials are designed and presented to patients. The facilitators from CISCRP were great. We all felt that our opinions were heard, respected, and appreciated which made this a very empowering experience.” At the same time, sponsors value the opportunity to interact directly with patients and develop a better understanding of the patients’ needs. Lysogene’s Chief Patient Access Officer Samantha Parker explained, “The service provided by CISCRP exceeded expectations. The team is clearly well versed in the complex requirements of drug development and were able to quickly apply their established methodology to a new field. The team mastered the necessary balance of empathy and objectivity whilst running the patient advisory board. I will work with CISCRP again in the future.”
For more information about how to organize a Patient Advisory Board Panel at your organization, please contact Annick Anderson.
By: Leslie Perez
In this edition of the Supporter Spotlight, we are pleased to be featuring one of our long-time supporters, Praxis Communications. Praxis has worked with CISCRP to develop creative advertisements for the media campaigns that make up our National Clinical Trial Outreach and Awareness Initiative. They have done this for several of our campaigns and offer this service to CISCRP pro bono. Praxis’ Senior Vice President of Business Development & Strategic Planning, Robert Loll, also serves on the CISCRP Advisory Board.
We asked Praxis to comment on their company’s commitment to raising public awareness about clinical research and how this fits into their organization’s overall mission. We also asked what other specific initiatives – in addition to supporting CISCRP’s National Outreach Campaign – that their companies are working on at this time to raise awareness about clinical research.
CISCRP: Can you describe Praxis’ commitment to raising public awareness about clinical research and how this fits into your organization’s overall mission?
PRAXIS: “Praxis Communications, LLC is a focused recruitment and retention company dedicated to providing unique enrollment optimization solutions for our sponsors. This requires consistent efforts to raise awareness and literacy surrounding clinical trials.
We regularly leverage patient insights, thoughts, and perspectives; from this experience, we’ve learned many deep misconceptions regarding clinical research and what it entails. Educating the public is an essential initiative needed to move toward patient understanding. That’s why we’ve committed ourselves to raising public awareness for clinical research and organizations, such as CISCRP, who advance this common mission.
With Praxis’ extensive in-house capabilities, we have the platforms and tools necessary to spread the message, educate, and raise awareness; we see it as an extension of our mission to disseminate facts about clinical research – doing our part to create a world that trusts, understands, and embraces medical innovation.”
CISCRP: Are there specific initiatives — in addition to supporting CISCRP’s National Outreach Campaign – that Praxis is working on at this time to raise awareness about clinical research?
PRAXIS: “Praxis proudly supports CISCRP’s National Outreach Campaign with creative, digital and analytical services, contributing our resources to this worthy, living campaign throughout the years.
We thoroughly involve ourselves with patient-centered initiatives outside of CISCRP, as well. We attend, present at, and sponsor patient-focused conferences, promote patient perspectives through video series and on our company blog, and take every opportunity to connect with and understand the patient to perpetuate education beginning on the individual level.
In addition, we integrate awareness-raising efforts into our recruitment campaigns whenever possible – we pitch stories to local newspapers near study sites, engage digital influencers to spread awareness online, and hand out educational materials at community events. Our sponsors see recruitment results, and we continue doing our part to spread awareness, one community at a time.
For more information on Praxis, visit www.gopraxis.com.
We want to thank Praxis for their dedication to CISCRP’s mission and for helping to create awareness about the importance of clinical research.
We will spotlight a different supporter or volunteer in each Newsletter, so stay tuned for new features each quarter.
By: Rachel Minnick
Interested in sharing your opinion on a clinical trial being developed? CISCRP is holding a half-day advisory board for Sciatica on July 31st, in Boston! At the advisory board, we will be discussing various ways to improve the design of a clinical trial for patients with Sciatica. If you have been diagnosed with Sciatica, or pain from lumbosacral radiculopathy and are interested in sharing your opinion on how to make a clinical trial better for other patients with the same condition, please contact Nova at [email protected] or fill out this brief questionnaire by clicking here to see if you are eligible.Thank you!