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 [...]

Teaming up with sites during trial design2020-10-13T13:37:04-05:00

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 [...]

Hearing patients loud and clear2020-10-13T13:39:31-05:00

Making Strides in Women’s Health

This #CTD2019, there is much to celebrate. A guest blog by Dr. Sheryl A. Kingsberg, PhD, IF Chief, Division of Behavioral Medicine, Department of OB/GYN, MacDonald Women’s Hospital Professor, Departments of Reproductive Biology and Psychiatry, Case Western Reserve University School of Medicine Clinical Trials Day, on May 20, is an opportunity for our industry to [...]

Making Strides in Women’s Health2020-10-06T01:50:54-05:00

Let’s Talk About Sex

Why sexual health must be part of the conversation during Women’s Health Week and every week! A guest blog by Dr. Sheryl A. Kingsberg, PhD, IF Chief, Division of Behavioral Medicine, Department of OB/GYN, MacDonald Women’s Hospital Professor, Departments of Reproductive Biology and Psychiatry, Case Western Reserve University School of Medicine Today marks the launch [...]

Let’s Talk About Sex2020-10-06T01:58:45-05:00

Oh, How Far We’ve Come

Celebrating women’s health and looking to the future A guest blog by Dr. Amy M. Miller, President and CEO, Society for Women’s Health Research The Society for Women’s Health Research (SWHR) has spent the past 30 years promoting and improving women’s health through science, policy, and education. As we prepare for National Women’s Health Week, [...]

Oh, How Far We’ve Come2020-10-19T13:58:46-05:00

Patient Advocacy Groups and Clinical Trials: Impressions from DIA 2018

The Health Decisions team at DIA 2018 left with the impression that the biopharma industry values relationships with patient advocacy groups but use of such groups in study planning and protocol development remains the exception rather than the rule. Health Decisions' Chief Medical Officer Andrea Lukes, MD, MHSc, FACOG, chaired a DIA forum entitled "From [...]

Patient Advocacy Groups and Clinical Trials: Impressions from DIA 20182020-10-06T02:21:31-05:00

CEO Takeaways from BIO 2018: Focus on Women’s Health

Health Decisions CEO, Patrick Phillips, BSc (Hons), D.Phil., attended BIO 2018 in Boston to meet with companies active in development of new therapeutic and diagnostic products to improve healthcare outcomes for women. After the conference, Dr. Phillips offered observations on a variety of trends in evidence at the conference and on Boston as a conference [...]

CEO Takeaways from BIO 2018: Focus on Women’s Health2020-10-06T02:23:55-05:00

Key Issues in Choosing a Specialized Clinical Development Partner

Partnerships drive biopharma development today more than ever, especially in clinical development. The scope of partnerships ranges from contracts to conduct individual studies to functional-service-provider arrangements or outsourcing agreements encompassing whole development programs and sometimes even the whole of a company's clinical development activity. While clinical development partnerships are commonplace, they are seldom simple. Forming [...]

Key Issues in Choosing a Specialized Clinical Development Partner2020-10-06T02:26:55-05:00

Social Media Recruitment: Lessons from Two Studies with Different Results

Social media are useful recruitment tools but results vary, especially as to the quality of subjects. Examples from two recent Health Decisions trials illustrate. We utilized a variety of social media in both trials, including craigslist, Facebook, a social media recruitment vendor's sites and investigators' social media sites. In one study, social media accounted for [...]

Social Media Recruitment: Lessons from Two Studies with Different Results2020-10-06T03:18:06-05:00

Addressing High Failure Rates in Drug Development

FDA has published an excellent report on 22 instances in which phase 2 and phase 3 trials had divergent results. Appendix A of the report provides justifications for essential elements of modern clinical trials, including a control group, randomization and blinding. In addition, Appendix A highlights risks of techniques for improving efficiency in early development, [...]

Addressing High Failure Rates in Drug Development2020-10-13T15:47:07-05:00
Load More Posts
Go to Top