Voices from Within: Conversations on DCTs & Data Privacy

In a time when healthcare has adopted technology and data collection software at an exponential rate, it is important to educate patients and stakeholders on what that standard for patient data collection should be. In Episode Two of Voices from Within: Humanizing Clinical Research Data, Curebase experts share a comprehensive overview of how patient data is collected and how data is protected. This 15-minute Flash Webinar was led by Vice President of Clinical Trial Innovation at Curebase, Jane Myles, Vice President of Clinical Trial Operations at Curebase, Sean Lynch, and Type 1 Diabetes clinical trial participant, Phyllis Kaplan. 

Jane started the webinar by sharing a bit about Curebase’s mission, which is to allow patients to easily participate in clinical trials from anywhere. “We aim to modernize clinical trials and make them more aligned to the preference of patients and physicians. Ultimately, the work we do at Curebase is to help increase participation in trials so that researchers can get the data they need,” Jane shares. 

Before understanding the various methods used to protect patient data, it’s important to know the foundational process of clinical trial management. All data begins with patients and is collected through sources like wearable devices, questionnaires, or lab results from testing. After data is collected, it then is collated and stored, a process through which the data is organized and anonymized. 

Once data leaves a research site, it is coded by a number, anonymizing the patient’s information to ensure their protection and to ensure an unbiased study of that data. “Many patients participating in a clinical trial may think that the Principal Investigator (PI) or research team of their study have access to their data, but this is not the case,” Sean explains. 

The anonymized data is organized into data sets that can be used for statistical analysis. These data sets hold the information that are used to answer the question posed by the study and determine if the endpoints for safety and efficacy have been met. 

“That is ultimately the key outcome of every clinical trial, collecting those sets of data,” Sean says.
“Once this data is collected and stored, it’s then shared with the FDA and other regulatory agencies who will cross-check to ensure its accuracy.”

Looking at the numbers, one may think that finding data sets is where patient data collection ends in a clinical trial, but this isn’t the case for many of the participants. Once a trial concludes, many patients have lingering questions about their data privacy and the results of the study they were in that go unanswered. 

Phyllis Kaplan, a Type 1 Diabetes advocate, has participated in 5 clinical trials, most frequently for wearable medical devices. When joining these studies, she remained largely uninformed by her research team about where her data was going. 

“I didn’t ask a lot of questions, only because I felt that since I had already agreed to participate in the study there wasn’t room for push-back about data collection. It appeared to be an all-or-nothing choice,” Phyllis reflects. 

This is a common problem voiced by many patients when a study concludes. When joining a clinical trial, oftentimes patients aren’t aware what questions they should ask about their data and what their rights to privacy are. 

“In my experience, there is often a gap in communication to participants. Once the trial is done, I would love the loop to be closed where we receive thank you messages for participating and are informed how our data is being used,” Phyllis shares. 

Beyond, understanding where their data is going and how it is being protected, many study participants also are unaware of the overall outcome of the trial they participated in. Phyllis shares that of the 5 clinical trials she has been in, she’s never received any follow-up regarding the trial’s overall success or results. “If my data can shed light on a new treatment or advancement, I’m all for it,” Phyllis says. “I just want to be made aware of that as a patient.” 

This problem is what many who work in clinical trials refer to as a ‘data black hole’ and what industry experts are hoping to solve. “Sponsors need to step up and find appropriate ways to get a certain amount of data back to patients in a timely manner. This will add value to their experiences,” Sean says. 

Ultimately, the conversation provided several important takeaways regarding data collection and privacy: 

  • Not enough patients learn about where their data goes, how it is used, and the overall outcome of the study they participated in.
  • Patient data is protected through anonymization and not attributed to the individual.
  • A big opportunity exists to educate patients about data privacy and how to ask the right questions about data when participating in a clinical trial.
Learn more about patient data collection by accessing the webinar recording here. View CISCRP’s library of webinars and podcasts here. 
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. 
To learn more about Phyllis’s work as a Diabetes advocate, read her Medical Hero article here.

Medical Hero Spotlight: Sharan Khela, Crohn’s Disease Patient Advocate

Struggling with Crohn’s Disease

Sharan Khela had no prior knowledge of IBD or Crohn’s when she received a Crohn’s disease diagnosis in 2002. Coming from a Punjabi, Sikh family, her diagnosis came as a relief mixed with confusion and uncertainty for both her and her family. Very little was offered in terms of education and no efforts were made to involve an interpreter for her parents to accommodate the language barrier.

Sharan’s Pediatric team started her on enteral nutrition but failing this the next step was a course of Prednisolone, a steroid medication to combat the symptoms of her Crohn’s. Since steroids are meant as a temporary treatment option, Sharan was then recommended to have surgery a year after being diagnosed in 2003. Her Gastroenterologist (GI) felt that this would be the best option long term and although biologics were mentioned at the time, Sharan’s doctor felt that approval would be difficult for a moderate case. After her surgery, she remained on medication for several years and this allowed for her to continue with school as normal. However, things took a turn when it came to transitioning her care from pediatric to adult care.

Sharan started to flare soon after transitioning to adult care and her new GI only ever offered a course of Prednisolone as a treatment option. Although meant to be a temporary treatment, she continued to be on a high dose of steroids for almost 5 years.

“I felt like my quality of care had gone downhill with transitioning to adult care and my new GI wasn’t taking my condition seriously or even trying to escalate treatment. As a result, I started to neglect my health, becoming reckless with my diet and medication because it wasn’t helping me anyway,” Sharan recalls.

Already having attempted to complete her final year of university for the second time due to her Crohn’s, Sharan knew if she could not complete the year on her second attempt then she would have to drop out. She refused to let her condition undo 5 years of hard work and pushed herself to graduate and get her Crohn’s under control. Sharan advocated to be transferred to a new Gastroenterologist to see if they would be able to help her achieve remission, allowing her to then focus on completing her degree. Shocked to hear she had been on steroids for so long as a teenager, Sharan’s new doctor pushed for a biologic treatment to be considered. After several rejections, the treatment was finally approved and showed immediate results, allowing Sharan to graduate with her class.

Ileostomy Surgery & Reversal

 In 2014, Sharan underwent an emergency subtotal-colectomy to form an ileostomy. “I felt completely alone in my condition at the time,” Sharan remembers. “I had never met anyone with a stoma before or even heard of them. Although my GI had mentioned the possibility of needing an ostomy at some point, it seemed like a distant issue and not a health concern that would affect me in my twenties.” During this time, Sharan came across a Crohn’s & Colitis UK Facebook forum which gave her the opportunity to connect with other patients like herself. Sharan’s daily struggles regarding her ostomy were discussed and validated by other ostomy patients on the forum.

Almost three years after her initial surgery, Sharan had her ostomy reversed, a decision she came to regret soon after. Although she had become accustomed to having an ostomy, Sharan still struggled with the stigma of having one, and felt pressure to go ahead with the reversal so she could go back to being ‘normal’ again.

“I chose to go through with the reversal even though I was reluctant because of the cultural emphasis placed on being a fit and healthy prospect for marriage in South Asian families as well as the general stigmas attached to having an ostomy.” 
Advocacy Work & IBDesis

Shortly after her reversal surgery, Sharan decided to become more involved with patient advocacy work to help her through a period of mild depression. Taking inspiration from the original Facebook forum she had joined previously, she started volunteering with Crohn’s and Colitis UK as a local network volunteer in 2018. As a volunteer, Sharan worked closely with patients going through similar experiences to herself.

“It was liberating to speak with other patients who understood what I had gone through,” Sharan explains. “As I became more involved in this type of advocacy work, I realized there was a need for support, specifically within the South Asian community.” negative and HRD positive. I was thrilled to be on a treatment that was targeted for me,” Alicia shares. 

Alongside other patient advocates like Tina Aswani Omprakash and Madhura Balasubramaniam, Sharan founded the private Facebook group, IBDesis, a dedicated space for South Asian individuals living with IBD to share their experiences, struggles, and to support each other. The group focuses on addressing the stigmas and misconceptions that are so commonplace in South Asian culture. “There’s a lot of judgement even in other Asian support groups surrounding IBD, with many people advocating against western medicine and urging patients who are struggling to deal with their issues through natural methods only,” Sharan notes. “Because of this, there is hesitancy and fear ingrained within the community, so we stay out of clinical research. However, this reluctance to participate ultimately hurts South Asian patients in the long run.” 

Sharan recalls a conversation 20 years ago with her GP at the time who admitted after her diagnosis that the delay in referring onto a specialist was due to his belief that IBD was not a condition South Asians dealt with. With stigma so prevalent in the South Asian culture surrounding chronic conditions like Crohn’s, Sharan found that the biggest hurdle to navigate in the creation of IBDesis was creating a space where members felt safe enough to open up about their experiences, as many of them had never been represented before and shared isolating experiences similar to Sharan’s.

Since its initial launch, IBDesis has expanded to other social media platforms and joined together with South Asian IBD Alliance (SAIA). The group hosts community members from across the globe, relying on virtual meetings for now, but Sharan hopes to eventually expand to in-person conferences and events.  

As an advocate, Sharan believes in the importance of highlighting the positives of clinical research and being open to appropriate treatment methods. 

“There are new medications available today that didn’t exist when I was a child. We need to take advantage of these new resources to help the South Asian IBD community,” Sharan says.

With more conversation now surrounding IBD than ever before, Sharan is hopeful the stigma will decrease for South Asian IBD patients. For women in nearly all cultures but especially for southern Asian women, there are major milestones and expectations surrounding marriage and motherhood. The IBDesis community serves as proof that people living with IBD and Crohn’s Disease can have successful open, honest, and personal communication about their condition with their spouses, raise children, and live full lives despite their illness.

“Going at a pace that is right for you in terms of your treatment and learning to self-advocate is the most important thing for a patient to remember,” Sharan says. “Not everyone is ready to be an advocate and that’s okay. It’s a very personal decision. The role of those who do become advocates is to help all members of their community feel seen and recognized, no matter what decisions they make about their personal health.”

Looking ahead, Sharan hopes to encourage more advocates for chronic conditions from all parts of South Asia to share their stories. “We want to remove as much of the lingering uncertainty and fear as we can for patients. This will improve the diagnosis and treatment journey for those with IBD who come after us.”

Additional Resources:




IBDesis Private Support Group: https://www.facebook.com/groups/ibdesis  

IBDesis social media handles: @ibdesis 

SAIA social media handles: @southasianIBD 

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.

Volunteer opportunities with CISCRP, visit our Volunteer page.

Written by Lindsey Elliott, Marketing & Communications Manager, CISCRP | lelliott@ciscrp.org

Medical Hero Spotlight: Alicia Dellario, Ovarian Cancer Clinical Trial Participant

Ovarian Cancer Diagnosis

In 2014, Alicia had been struggling with increased urination for several months and assumed she had a UTI. She visited her gynecologist and asked for antibiotics and a urine analysis just to make sure. However, the urine analysis came back negative for a UTI, leaving Alicia and her doctor without answers for her symptoms. She was then referred to a urologist for further evaluation and testing.

Alicia credits her urologist with saving her life. “She decided to do a scan and then within an hour, called and told me I needed to see a gynecologic oncologist immediately. I had masses on my ovaries,” Alicia says. The next week, Alicia was referred to an oncologist near her in Philadelphia who scheduled her for surgery to remove all the tumors and perform a hysterectomy.

Alicia, who had just turned fifty with a seven-year-old daughter at home, was a candidate for a more intense and toxic form of chemotherapy treatment, due to her younger age and higher level of physical health she was in prior to her diagnosis.

“My oncologist had originally estimated I had about a 4-5 year life expectancy with this type of cancer and that chemotherapy would give me another 18 months of time,” Alicia remembers. “I was willing to start this chemo even if it just gave me 18 more minutes with my daughter.”
Treatment & Cancer Recurrence

The chemotherapy treatment Alicia was put on involved being pumped with chemicals through ports in her abdomen and her chest over the course of eight hours. The chemo left Alicia feeling incredibly sick and bloated while her stomach worked overtime to absorb the poison intended to destroy the cancer cells. Unfortunately, 17 months after Alicia finished this treatment, she experienced a cancer recurrence and needed a second surgery to remove new tumors. This time, Alicia received a different kind of treatment, which prevented the cancer for about a year until it returned. 

“Entering my third round of treatment for cancer, I was incredibly weak and had been through multiple doctors and care teams,” Alicia says. “I started off on a new medication and had terrible side effects, before making the decision to switch healthcare systems and doctors.” Alicia’s new oncologist recognized the toll chemotherapy had taken on her body and quality of life. He explained that she was living in a chronic disease phase with her cancer and told her to spend some time off medication recovering and enjoying life.

Finding a Clinical Trial

Six months after stopping the medication, Alicia’s cancer recurred for the fourth time in 2018. This time, her doctor recommended she participate in a clinical trial treatment specifically for ovarian cancer.

“Up until then, my chemotherapy had been standard of care treatment, but not specifically designed for ovarian cancer patients. The trial was also specifically for patients with my type of tumor mutation, BRCA negative and HRD positive. I was thrilled to be on a treatment that was targeted for me,” Alicia shares. 

Prior to her diagnosis, Alicia worked in healthcare for a pharmaceutical company, so she was familiar with how clinical trials worked and didn’t feel the fear that some people have about participating. Alicia started the trial medication on November 26, 2018. Now four years later, she remains a part of the trial and has had no cancer recurrences.

The trial Alicia joined is still ongoing, now tracking her progress in remission to see how long this medication effectively treats her cancer. Even four years later, Alicia receives blood work monthly and is closely monitored by her doctors. Because her oncologist is about an hour away, she receives a stipend for travel and her medication is free.

“I’m incredibly lucky! The only long-term side effect I have from this medication is chronic fatigue which is something I’ve adapted to over time. I’ll take being tired if it means I’m alive,” Alicia says.

When deciding to participate in the clinical trial, Alicia was heavily supported by her close friends and family. “We all knew I had run out of standard of care options and the trial was my best chance for survival,” Alicia notes. However, there were some acquaintances in her life who didn’t understand clinical research and made negative comments about her participation. “Ultimately, for cancer, there isn’t a treatment out there that doesn’t have some sort of side effect. For me, I had peace of mind knowing my care team was watching me closely,” Alicia says.

Raising Awareness for Ovarian Cancer

Prior to her diagnosis, Alicia knew nothing about ovarian cancer. When she went to her gynecologist about having increased urination, she was never told it was a potential symptom and screened for the other symptoms she already had. Like Alicia, many ovarian cancer patients have increased urination, bloating, back pain, and stomach pain. “In my mind, there were separate reasons for all these symptoms and didn’t think to tie them together. I was angry after being diagnosed that I wasn’t informed about the warning signs for ovarian cancer by my doctors,” Alicia recalls.

Alicia’s advocacy work began with researching her own medical journey, focusing on the chemotherapy treatment she was starting. She hoped to find other patients online who she could learn from to prepare for this experience.

“I made a promise to myself, that once I had made it through chemotherapy, I was going to work to raise awareness and education to give back,” Alicia says.

After finishing chemotherapy, Alicia got involved with the National Ovarian Cancer Coalition (NOCC) and the hospital network she was with. She began speaking with gynecologists in that network, encouraging them to share information and education early on with patients. 

“I view clinical trials as an opportunity and not something to fear,” Alicia says. Today, there are new cancer treatments now in clinical trial phases that are less toxic on the body and have fewer side effects. The medication Alicia takes has allowed her to keep her hair, something that most medicines and chemo will cause to fall out.

“There’s also the opportunity to help others and improve treatments for everyone living with cancer. In my opinion, the benefits outweighed any fear I had. I would not be here without clinical trials and I’m forever grateful to the pharmaceutical companies, oncologists, and care teams who have given me this opportunity.”

Additional Resources:


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.

Volunteer opportunities with CISCRP, visit our Volunteer page.

Written by Lindsey Elliott, Marketing & Communications Manager, CISCRP | lelliott@ciscrp.org

Medical Heroes Appreci-a-thon: Learn About the Importance of Clinical Research

With the New Year underway, many of us are setting new fitness resolutions, heading back to the gym, or looking for new ways to stay active with family and friends. As we make our new year’s resolutions, this season also serves as an ideal time to recognize and honor those who have volunteered, provided care, and helped make new treatments and vaccines possible. CISCRP, a nonprofit organization dedicated to educating and engaging the public in clinical research, invites you to register for the 5th annual Medical Heroes Appreci-a-thon event.

At CISCRP, Medical Heroes are clinical trial study volunteers, healthcare professionals, researchers, and those on the front lines treating and caring for the public. During the 2023 Medical Heroes Appreci-a-thon, we honor these heroes by sharing their stories and raising awareness about participation in clinical research.

“Recognizing and honoring all the medical heroes who make our work possible is immensely important to us, and the ability to do so while encouraging healthy living and a little company and industry-wide friendly competition. It just felt like a perfect fit.” – Jennifer Byrne, CEO of Javara.

The Medical Heroes Appreci-a-thon is the perfect opportunity to stay active with family and friends while supporting those who help make new treatments possible. This is a fun team-building event in a virtual fitness challenge style. Throughout the month of February, participants can log any physical activity they complete through our race portal. The logging activity will move racers along this year’s French Riviera virtual course. Racers can see Google street views of their location and track themselves, their team, and other racers along the map.

Along the way, racers will see mile marker pop-ups along the course, receive emails that spotlight different Medical Heroes, and share educational facts and resources about clinical trials. Weekly challenges will be throughout the month to keep things exciting, promote fun competitions, and allow dedicated racers to win prizes.

The event is open to everyone — you don’t have to be an athlete to participate! Racers can log their workouts, sports, or any intentional activities done throughout the day, such as dog walking, grocery shopping, or household chores.

Appreci-a-thon racers and sponsoring organizations have shared the following:

“Appreci-a-thon is a fun way to give back, learn about clinical research, and honor Medical Heroes.” – Racer

“This challenge is a great way to stay connected with friends, family, and colleagues!” – Racer

“As someone in their late twenties, clinical research was not really on my radar until working at CISCRP. The importance of research, and all the medical heroes who help make new treatments possible, affects everyone every day without us even realizing it. I think this event is a way to reach a demographic of people who may not be joining educational webinars, reading articles related to clinical research, or attending seminars or things like that. It meets people where they are in an exciting and engaging way while also exposing them to important information and inspiring stories.” – Justine Holleran, Senior Coordinator, Community Events & Programs, CISCRP

The Medical Heroes Appreci-a-thon begins February 1st, so invite your friends, family members, and colleagues to participate in this exciting challenge. Participants can learn more information and register here.

Article published by USA Wire here.

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.

Volunteer opportunities with CISCRP, visit our Volunteer page

Black Women’s Expo Provides Transformational Experience

The much-anticipated premier event for Black Women in cities around the country just made it’s Atlanta and Southeast regional stop at the Georgia International Convention center near Atlanta’s Hartsfield airport on Dec. 17 and 18.

Pitch Black and JP Morgan Chase joined the two-day event which brought out scores of industry leaders and game changers such as Keke Wyatt, Yandy Smith-Harris, Lisa Nicole Cloud and “Married to Medicine’s” Dr. Contessa.

Powerful exchanges between women in a range of fields and stations in life dominated the 2022 Black Women’s expo and participants were privy to an impressive series of panel discussions to underscore challenges to the wellbeing of Black women and their families, along with strategies for reducing the impact of health disparities and improving access to quality care.

CISCRP panel experts included (right to left): Ashley Nealy, COVID-19 Clinical Trial Participant; Melissa Hardman, Founder and CEO, Faces of Research, LLC; Dr. Lisa Lake, Executive Director of Telic Empowerment; Dr. Frita McRae Fisher, Founder and President of Midtown Atlanta Nephrology, P.C.

Pitch Black and JP Morgan Chase joined forces and collaboratively sponsored an important and comprehensive discussion of women’s health issues, disparities in health care and the importance of people of color participating in clinical trials. The expo also hosted a number of other powerful panel discussions between women in a range of fields who are making a difference in their professions and their communities.

Pitch Black media in concert with CISCRP provided a highly informative discussion panel of some of the region’s top leaders in health and medicine for Black people, emphasizing the disparities in health care and the need for Black people and other people of color to participate in clinical trials which are vital to developing new or improved treatments to eliminate or decrease infection and death rates along with quality-of-life issues for Black People.

The Center for Information and Study on Clinical Research Participation’s (CISCRP) core mission is to provide accessible, relevant, useful, high quality educational resources, programs, and services that increase awareness and understanding of the clinical research process is a vital organization for enhancing and enriching the participation experience for patients and their families; and promote engagement and partnership between clinical research professionals, patients, and the public.

Dr. Frita Fisher author of Under Pressure – A Guide to Controlling High Blood Pressure lead the health care panel discussion at Black Women’s Expo on Saturday, Dec. 17.

Dr. Frita, as she is affectionately known by patients and peers, lent her considerable expertise and commentary to Black Women’s Expo patrons and participants Saturday’s, CISCRP at the Georgia International Convention Center in Atlanta. This compelling and comprehensive discussion featured leading medical experts and health advocates to address health concerns and spotlight disparities in diagnosis, treatment and outcomes for women of color and Black women in particular.

Written by Roz Edward, Atlanta Daily World 

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.

Volunteer opportunities with CISCRP, visit our Volunteer page