Navigating the Complexities of Women’s Reproductive Health: A Case Study

With a rigorous at-home and in-office assessment schedule, a contraceptive device trial highlights challenges of conducting women’s reproductive health research

By: Jessica Hatheway, Program Director, Health Decisions

Designing a study that will accurately assess the performance of a contraceptive product requires consideration for numerous factors, including the accuracy of measurement tools, the sexual activity of study participants, and the often unpredictable nature of the female reproductive system. In a study assessing the ability of a non-hormonal contraceptive ring to prevent sperm from penetrating midcycle cervical mucus, a […]

July 7th, 2020|Categories: Contraceptive Development, Women's Health, womens-health-blog|

Driving Advancements in Infertility Research

President and Founder of DSP Clinical Research discusses challenges in infertility research and where the industry is headed

Until about 15 years ago, research in infertility had been largely stagnate. Standard of care was accepted, and minimal effort was being made to further advance treatment or add new options to the market. As more and more women delayed pregnancy, a greater need for studying and combatting infertility arose. Significant progress has been made in recent years. Darlene […]

Teaming up with sites during trial design

National Women’s Health Week Part 3

With hands-on experience, site staff can provide valuable insights for proactively addressing challenges in clinical trials

By: Dr. Andrea S. Lukes, MHSc, FACOG, Chief Medical Officer, Health Decisions

According to the Tufts Center for the Study of Drug Development (Tufts CSDD), nearly half of all clinical studies require substantial—and potentially avoidable—protocol amendments that lengthen timelines and increase costs. Tufts CSDD also notes that more than half of the substantial amendments are implemented during the […]

Designing trials for patients

National Women’s Health Week Part 2

To deliver more meaningful clinical trial results, we need to take the time to gather patient insights

By: Elizabeth Yarber, Senior Clinical Project Manager, and Kristen Snipes, Director of Clinical Operations, Health Decisions

Clinical development is about finding new healthcare solutions that improve lives. This starts with identifying what matters most to people as they manage their health and wellbeing. Appropriate use of patient input can help improve development and regulatory decisions. Listening […]

Hearing patients loud and clear

National Women’s Health Week Part 1

As the FDA reinforces the use of the patient voice in the clinical development process, we need to listen to the women sharing their experiences

By: John R. Nocero, Senior QA Auditor, Health Decisions

In honoring National Women’s Health Week, it’s important to acknowledge the female volunteers in clinical studies. Enrollment is key to the success of all clinical trials. At  Health Decisions, we focus on women’s health research. We’re sensitive to the concerns […]

Addressing clinical development challenges amidst COVID-19

Things to consider when establishing R&D priorities as the world addresses the COVID-19 crisis

There is no doubt that the current public health crisis of COVID-19 is impacting the clinical research world. In the months since it was discovered, dozens of clinical trials aimed at treating, diagnosing and preventing COVID-19 and SARS-CoV-2 have been launched around the world. These trials launched with speed and efficiency that underscores the collaborative capabilities of the healthcare industry. Beyond research, healthcare resources are being diverted to cover immediate pandemic-related […]

April 7th, 2020|Categories: Industry Events|

Celebrating female participation in clinical research: International Women’s Day 2020

Ongoing efforts to recognize gender differences in clinical research are helping to address women’s health needs

International Women’s Day has been celebrated on March 8th for more than a century. This year’s theme, #EachforEqual, focuses on the importance of improving gender equality. In honor of International Women’s Day, we are celebrating the steps that have been taken to improve women’s participation in clinical trials. In clinical research, equality helps ensure safe and effective treatment options as medications may […]

March 6th, 2020|Categories: Awareness and Advocacy, Women's Health, womens-health-blog|

A look at the 2010s: Past advancement inspiring a new decade in women’s health

Health Decisions continues the quest for improved women’s health outcomes as the new decade begins

By Dr. Patrick Phillips, CEO, Health Decisions

I’m blessed to have a wonderful mother, wife and three incredible daughters. With so many important women in my life, it seems only natural that I’ve found my way to Health Decisions. The company has a longstanding history of driving positive change in women’s health – a tradition we plan to continue […]

January 31st, 2020|Categories: Women's Health, womens-health-blog|

Contraception: Past and Future

HD begins (another) new era of supporting vital reproductive health research

By Clint Dart, Vice President, Biostatistics and Programming, Health Decisions

The contraceptive market has changed substantially since the first birth control pill was approved by the US Food and Drug Administration (FDA) in 1960. Past research has led to the availability of new contraceptive methods, and helped to define the focus of future research addressing evolving consumer demand. As we embark on the start of our fourth […]

Low sex drive? It’s more complicated than you may think.

By Kristen Snipes, Director, Clinical Operations

Internet personality and women’s health advocate, Madge the Vag by Scary Mommy recently  shared two Instagram videos tackling hypoactive sexual desire disorder (HSDD), a bothersome decrease in the desire to engage in sexual activity affecting an estimated ten percent of women. The videos, launched in partnership with AMAG’s, highlight the impact of HSDD and offer tips for women as they prepare to speak with their healthcare provider. We’re excited to see an open dialogue around […]

September 10th, 2019|Categories: Women's Health, womens-health-blog|
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