This webinar provides a greater understanding on how Plain Language Summaries of Publication (PLSP) can help meet the demand and expectations for the disclosure of clinical trial results. Additionally, gaining insights on how to plan and turn a scientific manuscript into a PLSP.
The importance of clinical research is widely recognized, and while many decide to participate in clinical trials, there is a lack of representation of individuals from underserved communities.
In 2019 alone, 46,391 individuals participated in clinical trials that resulted in the approval of 48 new drugs. However, a limited number of study volunteers identified as Black/African American, Asian, and/or Hispanic.
Current efforts to address this lack of representation include a guidance document released by the FDA encouraging pharmaceutical companies to broaden their eligibility criteria. While these efforts are critical in increasing diversity and inclusion in clinical trials, it is equally important to understand how clinical research is viewed from a broad audience.
Every two years, the Center for Information and Study on Clinical Research Participation (CISCRP) conducts a global online study to gather insights on the public and patients’ perceptions and experience with clinical research. Responses from over 12,450 individuals were collected, with representation from many communities, including Black (6 percent), Asian (10 percent), and Hispanic (13 percent) communities.
Importance of clinical research
Individuals across many races and ethnicities acknowledge the value of clinical research studies. Many consider clinical trials to be “somewhat” or “very important” to the discovery and development of new medicines. Additionally, the greatest benefits of participation in clinical research include helping to advance science and the treatment of patient’s disease/condition (26 percent) and the possibility of improving or saving the lives of others with the same condition (21 percent). This highlights how individuals perceive and understand the positive impact participation can have. However, few individuals had recently seen or heard about a clinical trial opportunity.
Where do we look?
Many would begin looking for a clinical trial opportunity by asking their healthcare provider or by using an online resource. For example, over half of Black individuals (52 percent) would use an online clinical trial registry, such as clinicaltrials.gov, and 42 percent of Asian individuals would use an internet search engine like Google. Recommendations from family members are also important to underserved populations in their search for clinical trials.
The relationship between healthcare providers and their patients can be leveraged to increase awareness of and participation in clinical trials. It is important to many that their healthcare provider be aware of ongoing clinical trials in their local communities. Pharmaceutical companies can take an important first step by informing healthcare providers about new clinical trial opportunities in underserved communities.
Why One Cancer Survivor Wants All Patients to Consider Clinical Trials
When melanoma unexpectedly returned after a successful surgery twelve years prior, T.J. Sharpe was both a husband and a father. Second, third and fourth opinions later, Sharpe was finally offered a life-changing option.
“I wanted a chance to see my children grow up and be the husband and father I could be,” says Sharpe. With the first few doctors, Sharpe’s predicted life expectancy was under two years, which he was determined to extend. “I wanted the best chance at a long-term response.”
Seizing an opportunity
Sharpe was on his fourth oncologist when he was offered his first clinical trial. It was for a new treatment in the form of a pill, and Sharpe was the first patient in the trial. Because it was so new, he ran into bureaucratic barriers. “I was the first patient to try it, so there were a few stakeholder companies and pharmaceutical companies that I had to wait for over a month to get the contract approved.”
After contacting the stakeholders himself to push the paperwork through, Sharpe started the trial. “When you have a family and you are facing mortality, I wasn’t going to miss the chance to see these kids grow up because I was missing part of a signature.”
An incredible recovery
After months on the pill treatment, Sharpe’s tumors weren’t responding. But with determination came plan B, and Sharpe started on his second trial. After twelve weeks, he saw a 46 percent reduction in his tumors. Four years later, Sharpe’s only signs of cancer are small spots that have stabilized for over two years. Today, he remains in the trial to continue monitoring his response and overall system.
The results of the clinical trial have so far doubled his life expectancy, an accomplishment Sharpe does not take lightly. “Clinical trials should be considered as an option for care in every single case,” he says. For Sharpe, the norm should be to hear your standard care options, but in conjunction with the clinical trial options.
At that point, let the patient and their doctor make the most informed decision. “When it comes down to it, we are all patients at some point, so we should know what all of our options are before making decisions.”
A mother and son share their experiences at the forefront of cochlear implant clinical research.
We’ve all seen the viral videos online of children born deaf hearing their parent’s voice for the first time and lighting up with glee or breaking into sobs at the foreign sensation of audibility. But what many of us do not realize is that behind that technology, be it a common hearing aid or a cochlear implant, were ambitious researchers and a brave group of patients willing to give it a shot in a clinical trial.
Today, hundreds of thousands of clinical trials and studies are ongoing, and they may lead to the next big advancement in restoring lost hearing or improving the quality of life for those individuals living with it.
Years ago, Sonia Morreale didn’t hesitate to sign her son, Justin, then 8, up for a clinical study on how children who grow up with cochlear implants tend to fare in language and comprehension. “I wanted to know that information,” she shares. “And I knew that it would help not just my own child, but that [the researchers] would be giving this information to other parents.”
As the results suggest, and as Justin demonstrates, growing up with cochlear implants isn’t as limiting as many may suspect. Now age 16 and living with two cochlear implants to correct the genetic profound deafness he was born with, Justin has over a 4.0 GPA, is enrolled in AP and honors classes and is in the process of getting his driver’s license.
From the moment she heard Justin cry at the sound of her voice after receiving his first cochlear implant at age 2, Sonia knew the future held big things for her teen-age son. “It gave me a lot of hope.”
Dr. Laurie Eisenberg, professor of research otolaryngology at the Keck School of Medicine of USC, which conducts the study, says the Morreales’ inspiring story is one of many she’s seen in the 41 years she has worked in the field.
“Seeing a patient hear for the first time is always an emotional experience,” Eisenberg explains. She notes that while some patients may be hesitant to enroll in trials due to safety concerns or feeling inconvenienced about travel, those who do enroll are carrying out a selfless act.
“Many adults feel like, ‘If I can help a child, then maybe it is worth it,’” Eisenberg says. “It’s an intrinsic motivation that, ‘My experience and involvement in science can help others.’”
Sonia put it simply: “I just think that, as a parent, I don’t see any cons — I see only the opportunity for gain.”
Article from our 2017 Clinical Trials Supplement, USA Today. Read more articles here >
Remembering Rachel Minnick
Rachel Minnick dedicated much of her life as a medical hero. We honor and remember her legacy.
Diagnosed with stage 2 breast cancer in 2013, the wife and mother of two fought back fiercely against the disease with double mastectomy, chemotherapy and radiation. She participated in a clinical trial. And she worked tirelessly to educate others about their treatment options and the clinical research process.
“Rachel was always pro research, pro clinical trials,” says her husband, Pete Minnick. “She always had that mindset ‘we’re on the cutting edge of medical breakthroughs and technology,’ and she wanted to be on that cutting edge.”
Her cancer was in remission from 2014 to early 2017, until she began experiencing pain in her back and neck. It was at this time that her doctors informed her that the cancer was back and had spread to her bones. “That was a huge blow to us,” Pete says, noting it was stage 4 cancer. ”She knew she wasn’t going to be cured.”
In early 2018, the cancer spread to Minnick’s Iungs and liver. She was actively looking for her next clinical trial when she passed away in April, at age 39, but her legacy lives on.
Prior to her cancer spreading, Minnick took a position as a Senior Manager of Marketing and Patient Engagement Alliances at The Center for Information and Study on Clinical Research Participation (CISCRP), a non-profit dedicated to educating the public and patients about clinical research.
She was passionate about her job for many reasons not only was there a focus on the patient community but it also allowed her to work from her Philadelphia-area home which gave her the opportunity to continue her medical care as well as spend time with the couple’s children, Emily and Sam, now ages 9 and 7.
Being a part of CISCRP was more than a job for her.
“She felt like she was helping the entire clinical trial community as well as doing something she liked,” says her husband. CISCRP gave her the opportunity to offer hope to other people who were in her same situation.
“Rachel had direct experience which gave her such an inside perspective,” says her former boss, CISCRP founder, Ken Getz. “It fed her compassion and helped her understand, even more deeply, what so many patients are going through.” Getz says Minnick’s legacy lives on through her work; the panels she moderated, the clinical trial awareness initiatives that she spearheaded, her collaborative projects, and the enduring educational brochures, newsletters and other patient communications that she wrote during her time with CISCRP.
“Her passing was truly a shock to me,” says Pete Koerner, a pharmaceutical industry colleague, who worked with Rachel and the CISCRP team for two years.
He described Minnick as someone who was always enthusiastic, passionate and dedicated to her family, her staff and her work.
“She was invested in clinical research,” says Koerner, explaining Minnick was proud to be the patient voice and wanted to advance the techniques and technologies in the clinical trials process.
“She felt like she was helping the entire clinical trial community.” Getz reflects on Minnick’s lasting impression, “Her compassion combined with her professionalism and the passion that she brought to CISCRP has inspired so many people – those who reported to her, those who she mentored, and those with whom she collaborated. That will stay with us forever. She truly helped to define our culture and evolve it in such meaningful ways.”
To search for medical conditions in a specific location visit our Search Clinical Trials page.
To stay informed about clinical trials, visit our Resources page.
Center for Information and Study on Clinical Research Participation (CISCRP) Announces Second Annual AWARE for All 2021 Virtual Event Series
The nonprofit organization aims to boost awareness and interest around clinical trial research through FREE interactive, educational events
BOSTON, MA, March 18, 2021 – Today, the Center for Information and Study on Clinical Research Participation (CISCRP), a nonprofit organization dedicated to engaging the public and patients as partners in the clinical research process, announced the upcoming launch of AWARE for All 2021 – a free virtual event series designed to educate the general public about clinical trial research and participation. In the series’ second year, CISCRP will host five regional AWARE for All 2021 virtual events across the country from April through November 2021, with a focus on engaging diverse communities to ensure representative and inclusive clinical research for the future.
Supported by local research teams, advocacy groups, and members of the AWARE Industry Consortium (AIC), each regional AWARE for All 2021 event will focus on select medical conditions and therapeutic areas including but not limited to COVID-19, cancer, heart disease, diabetes, hypertension, and asthma. The events offer participants a 90-minute user-friendly webinar led by medical professionals, short informational videos to help participants better understand the process and importance of clinical research, facilitated conversations with real patients sharing their experiences with clinical trials, and a five-minute exercise break to help encourage healthy habits.
Attendees are also able to visit an online informational exhibit center, featuring clinical research and healthcare resources that are free to access throughout the event. The informational center for each event will include exhibits presented by AIC members, including Genentech, Janssen, Otsuka, Pfizer, Biogen, IQVIA, Novartis, CSL Behring, EMD Serono, and WCG, in addition to local advocacy organizations. Attendees can expect a “traditional” event booth experience in a digital format, like one-on-one conversations with company representatives, interactive informational collateral, and digital downloads.
“As we head into our second year with AWARE for All 2021, we have been able to expand to even more communities across the U.S., driving attention to clinical research via locally common conditions and therapeutic areas – all of which are currently the focus of clinical research and require a diverse patient population,” said Phyllis Kaplan, senior manager, events and community engagement, CISCRP. “Through this event series, we hope to give participants a front row seat to learn about not only what clinical trials are but also what clinical research could mean for the community as a whole and, potentially, themselves as they pursue the best treatment possible.”
The first event begins in April and will follow the timeline listed:
- AWARE for All Northeast (Boston, New York, Washington, D.C., Hartford/New Haven, Baltimore), Thursday, April 15, from 4:30 to 6:00 p.m. EDT.
- AWARE for All Northwest (Seattle, Portland, San Francisco, Boise, Billings), Thursday, May 20, from 4:30 to 6:00 p.m. MDT.
- AWARE for All Midwest (Chicago, Columbus, Detroit, Indianapolis, Minneapolis), Thursday, July 22, from 4:30 to 6:00 p.m. CDT.
- AWARE for All Southwest (Los Angeles, Dallas/Houston, Phoenix, Denver, Las Vegas), Thursday, October 21, from 4:30 to 6:00 p.m. MST.
- AWARE for All Southeast (Nashville, Charleston, Atlanta, Charlotte, Jacksonville), Thursday, November 18, from 4:30 to 6:00 p.m. EST.
“For nearly 20 years, CISCRP’s mission has been to educate individuals on the positive effects clinical research has on patient outcomes, and we’ve found reaching out through thoughtful, community-based efforts like AWARE for All – even amid the pandemic – is where we can make the biggest impact,” said Ken Getz, founder and chairman, CISCRP. “While awareness for clinical research has never been higher, we understand there is still a level of hesitation and lack of clarity among the general public. Now is arguably the most important time in history to educate these communities about the clinical trial process and introduce potential participants to studies that can lead to even more groundbreaking discoveries.”
To learn more about AWARE for All 2021, including community registration information, visit ciscrp.org/events/aware-for-all/aware-for-all-events-2021. Organizations interested in sponsoring the series or exhibiting in the virtual informational exhibit center should contact CISCRP at firstname.lastname@example.org or 877.633.4376.
The Center for Information and Study on Clinical Research Participation (CISCRP) is a 501(c)(3) non-profit organization dedicated to engaging the public and patients as partners in the clinical research process. CISCRP provides free education and outreach to the general public and patient communities. Visit www.CISCRP.org for more information or to participate in CISCRP’s educational initiatives. For additional questions about AWARE for All, contact email@example.com or call 877-633-4376.