Postpartum Depression (PPD) & Clinical Trials Part 2

Part 2 of a 2-part series. Medical professionals and patient advocates discuss their experiences with postpartum depression, one of the most common medical complications during and after pregnancy.

Webinar recording coming soon.

Medical Hero Spotlight: Shanelle Gabriel, Lupus Advocate

When Gabriel was in college, she always felt tired and would wake up feeling stiff. She dismissed it as general soreness from working out with her dance team.

The Brooklyn-native Gabriel, then 21, went to her doctor, who told her she probably had sinus problems and encouraged her to take allergy medicine.

Diagnosis

A turning point came a month later when she noticed patches of hair missing. She went to a different doctor who asked her a series of questions, including about how tired she was and whether her hands changed colors when they got cold. After testing, Gabriel was diagnosed with lupus, an autoimmune disease.

At the time, there weren’t medications specifically designed to treat lupus. Instead, doctors had a blanket approach and prescribed a variety of medicines, including steroids, to treat symptoms, but nothing was specific to the illness.

“Nobody knew how much pain I was in,” said Gabriel, now 36, who describes lupus as, “a hidden disease.”

Many of the medicines had side effects, including increased risk for liver and kidney problems, as well as cataracts and glaucoma.

She still had flare ups that sent her to the hospital, including an inflammation of the membrane around her heart. It was so bad, she had to leave an internship and quit the dance team.

After graduating, Gabriel toured the country as a poet and singer. While in Montana for a performance, she suffered an episode that caused her to be hospitalized due to a lupus-related condition that causes blood clots.”

Clinical trials

When her doctor suggested trying a clinical trial for a new lupus treatment, Gabriel, who’s African American, balked. She was worried because, historically, people of color have been taken advantage of during medical trials.

She later found out the trial was a success and her doctor prescribed the approved drug. The treatment worked but it was demanding, as Gabriel needed to take a full day off from work to receive IV therapy.

Next, Gabriel decided to participate in the next clinical trial, which tested that approved medicine as a self-administered, weekly therapy.

For Gabriel, this drug helped make her symptoms more manageable allowing her to discontinue her use of steroids.

Stigma

While Gabriel was initially nervous about clinical trials, she’s glad she talked with her doctor and other medical professionals, and realized that clinical trials are essential for finding new therapies and cures.

“Due to a lack of participation by women of color in a lot of these trials, (researchers) were not able to actually track if it worked for us,” she said. “There’s only one way to find out if it works; somebody has to do it.

“I just felt like, ‘You know what? I’m fine with that, because there could be a really great benefit from it.’ And I did end up benefiting from it.”

Gabriel is on the patient advisory boards for The Center for Information and Study on Clinical Research Participation, a non-profit dedicated to educating and engaging the public and patients about clinical research.

She encourages patients with lupus and other diseases to consider clinical trials, which have many safeguards to minimize danger for participants. She recommends doing your own research, asking questions, and talking to your doctor about clinical trials.

She’s sharing her story and hopes to inspire others.

“It’s becoming a community of people that are advocating and I think there is hope for a cure,” Gabriel said.

Featured in the June 2020 Clinical Trials Supplement, USA Today.

Medical Hero Spotlight: Shanelle Gabriel, Lupus Advocate

When Gabriel was in college, she always felt tired and would wake up feeling stiff. She dismissed it as general soreness from working out with her dance team.

The Brooklyn-native Gabriel, then 21, went to her doctor, who told her she probably had sinus problems and encouraged her to take allergy medicine.

Diagnosis

A turning point came a month later when she noticed patches of hair missing. She went to a different doctor who asked her a series of questions, including about how tired she was and whether her hands changed colors when they got cold. After testing, Gabriel was diagnosed with lupus, an autoimmune disease.

At the time, there weren’t medications specifically designed to treat lupus. Instead, doctors had a blanket approach and prescribed a variety of medicines, including steroids, to treat symptoms, but nothing was specific to the illness.

“Nobody knew how much pain I was in,” said Gabriel, now 36, who describes lupus as, “a hidden disease.”

Many of the medicines had side effects, including increased risk for liver and kidney problems, as well as cataracts and glaucoma.

She still had flare ups that sent her to the hospital, including an inflammation of the membrane around her heart. It was so bad, she had to leave an internship and quit the dance team.

After graduating, Gabriel toured the country as a poet and singer. While in Montana for a performance, she suffered an episode that caused her to be hospitalized due to a lupus-related condition that causes blood clots.”

Clinical trials

When her doctor suggested trying a clinical trial for a new lupus treatment, Gabriel, who’s African American, balked. She was worried because, historically, people of color have been taken advantage of during medical trials.

She later found out the trial was a success and her doctor prescribed the approved drug. The treatment worked but it was demanding, as Gabriel needed to take a full day off from work to receive IV therapy.

Next, Gabriel decided to participate in the next clinical trial, which tested that approved medicine as a self-administered, weekly therapy.

For Gabriel, this drug helped make her symptoms more manageable allowing her to discontinue her use of steroids.

Stigma

While Gabriel was initially nervous about clinical trials, she’s glad she talked with her doctor and other medical professionals, and realized that clinical trials are essential for finding new therapies and cures.

“Due to a lack of participation by women of color in a lot of these trials, (researchers) were not able to actually track if it worked for us,” she said. “There’s only one way to find out if it works; somebody has to do it.

“I just felt like, ‘You know what? I’m fine with that, because there could be a really great benefit from it.’ And I did end up benefiting from it.”

Gabriel is on the patient advisory boards for The Center for Information and Study on Clinical Research Participation, a non-profit dedicated to educating and engaging the public and patients about clinical research.

She encourages patients with lupus and other diseases to consider clinical trials, which have many safeguards to minimize danger for participants. She recommends doing your own research, asking questions, and talking to your doctor about clinical trials.

She’s sharing her story and hopes to inspire others.

“It’s becoming a community of people that are advocating and I think there is hope for a cure,” Gabriel said.

Featured in the June 2020 Clinical Trials Supplement, USA Today

What is Informed Consent? eConsent?

Video provides a clear overview on Informed Consent and eConsent

  • Process of learning and agreeing to be in a clinical trial
  • Who to speak with and ask questions before participation
  • After giving consent, the choice to stop participating at any time for any reason
  • Understand the purpose, length, risks, benefits and what will happen during the clinical trial

Made possible by a sponsorship from Otsuka.

Plain Language Summary Publication of Key Results from Bayer’s Phase 3 ARAMIS Trial Published in Future Oncology

Boston, MA | February 16, 2021—The Center for Information and Study on Clinical Research Participation (CISCRP) and Oxford PharmaGenesis worked together with Bayer, an ARAMIS trial investigator and oncologist, an ARAMIS trial participant, and a prostate cancer patient advocate—Dr. Fizazi, Mr. Blue and Mr. Nowak, respectively—to write a plain language summary publication (PLSP) of the 2020 New England Journal of Medicine article on the ARAMIS trial.  The PLSP was recently published in Future Oncology on February 8, 2021 with the title ‘Darolutamide and survival in nonmetastatic, castration-resistant prostate cancer: A patient perspective of the ARAMIS trial’.    

Public, patient, and health care community demand for plain language information about the results of clinical trials is extremely high. For more than ten years, CISCRP — a non-profit organization — has been translating scientific clinical trial results information into plain, non-technical language for patients and the public around the world to be communicated in print and digital formats. 

The teams involved—Bayer, CISCRP, Oxford PharmaGenesis, Dr. Fizazi, Mr. Blue and Mr. Nowak—worked to ensure the PLSP was easy-to-read by adding creative visuals, tables and key questions answered about the ARAMIS trial.  The inclusion of patients’ perspectives in PLS publications are important as it conveys unique insights and perspectives that highlight the importance of patient participation in ongoing clinical trials and empower patients to engage in treatment discussions.  In addition, this PLSP was reviewed by an editorial panel inclusive of patients, patient advocates, public and healthcare professionals to evaluate and confirm that a ‘patient-first’ approach was taken in the writing, design, and layout to help patients and caregivers understand the trial results.

The PLSP highlights the ARAMIS clinical trial that began in September 2014 and ended in September 2018 with 1,509 male participants in ages ranging from 48-95. The demographics included 1,194 Caucasian participants, 52 African Americans or Blacks participants, and 193 Asians participants from 36 countries.

The clinical trial was conducted in adult participants with non-metastatic, castration-resistant prostate cancer (nmCRPC) who received a treatment called darolutamide (brand name Nubeqa®) plus androgen deprivation therapy (ADT) . Darolutamide is approved in several markets around the world, including the U.S., the European Union (EU), Brazil, Canada, Japan and China, as an oral treatment for adults with nmCRPC who are at high risk of developing metastases.  The product is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

“New therapies to treat prostate cancer in men are being developed rapidly,” wrote Mr. Blue, a patient author.  “After five years in the ARAMIS trial, I have been very pleased to see the positive outcomes of the trial which has given me hope for a continued good quality of life for the foreseeable future.”

“Clinical trials are life.  Very simply, for us patients, clinical trials are our life force,” wrote Mr. Nowak, a patient author. “Clinical trials have become so advanced. Today we evaluate if a new potential treatment extends our life. We are often asking if this new treatment will also improve the quality of our life. For me, improving the quality of my life is just as important as extending it.”

Read the full PLSP in Future Oncology here, https://www.futuremedicine.com/doi/10.2217/fon-2020-1291

About the Center for Information and Study on Clinical Research Participation (CISCRP)

CISCRP is a Boston-based, globally focused, non-profit 501(c)(3) organization providing public and patient education and advocacy.  CISCRP’s mission is to inform patients and the public about clinical research and the important role that it plays in advancing public health and to help stakeholders in drug development engage with patients and the public as clinical research partners. www.CISCRP.org

About Oxford PharmaGenesis

Oxford PharmaGenesis is an award-winning, independent, global HealthScience consultantcy—providing communications services to the healthcare industry, professional societies and patient groups.  Our clients choose us because we provide the highest level of quality, the deepest level of therapy area experience and the most compelling approaches to evidence communication.  www.pharmagenesis.com

About Bayer  

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.com.

PR Contact:                     Joan Chambers, Senior Director, Marketing
                                             jchambers@ciscrp.org
                                             617-725-2750 (Ext. 202)