Women’s Health 2018-08-23T14:21:03+00:00

If It Matters To Women’s Health, It Matters To Health Decisions

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Health Decisions is a full-service CRO offering therapeutic and operational excellence for clinical development in all areas of women’s health.  Our experience, expertise, site network and relationships with KOLs and investigators enable us to address the challenges of developing products to address key areas of women’s health including gynecology indications, contraception, sexual health, obstetrics, infertility, menopause and osteoporosis, gynecologic oncology and breast cancer, autoimmune diseases and other health conditions that affect women disproportionately, including migraine, depression and eating disorders. Health Decisions’ mission is to improve healthcare outcomes for women worldwide in the full range of health conditions across the lifecycle. This page summarizes Health Decisions’ expertise and capabilities in the development of women’s health products by category of indication. Please also visit our women’s health library.

We are the leading full-service women’s health CRO from pre-IND to NDA and beyond

With 28 years of experience in more than 300 clinical trials, Health Decisions is the clinical development partner of choice for de-risking development of women’s health products. We assist with regulatory strategy, program planning, protocol development, phase 1 – 4 clinical trials and NDA submission. Our capabilities include project management, site monitoring, biostatistics, data management, quality management, regulatory services and medical writing. Health Decisions draws on the therapeutic expertise of board-certified OB/GYNs and operational experience and expertise of clinical, biostatistical, data-management and regulatory teams to optimize clinical development of all types of women’s health products.

Health Decisions’ experience in women’s health studies includes:

  • 28 years of experience designing and conducting studies in women’s health

  • More than 100 protocols developed and studies conducted in women’s health indications

  • 21 years serving as Statistical and Clinical Coordinating Center for Contraceptive Research for the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)

  • Extensive experience designing, managing and monitoring large-scale international trials

  • Experience at all levels, including senior scientists, PMs and CRAs

  • Extensive KOL and investigator relationships

White Paper: Recruitment of Female Subjects for Clinical Trials

Drawing on extensive experience in women’s health studies, Health Decisions offers a white paper analyzing key issues in the recruitment of female subjects and presenting 35 tips to optimize results not just in women’s health indications but in studies across the therapeutic spectrum.

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Fact Sheet: Health Decisions’ Capabilities in Women’s Health Studies

Download this fact sheet for a summary of Health Decisions’ extensive capabilities for clinical studies in the full range of health conditions that affect only women or affect women disproportionately. Our women’s health expertise spans all functional areas and managerial and operational roles.

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Gynecology

Health Decisions brings extensive experience and expertise to clinical trials of novel therapeutics and diagnostics for health conditions commonly treated by OB/GYNs. Based on involvement in more than 100 women’s health projects in the last 28 years, the Health Decisions clinical affairs and biometrics groups have extensive experience in development of a wide range of women’s health products. Health Decisions draws on a network of principal investigators at approximately 300 women’s health sites, numerous Key Opinion Leaders (KOLs) in women’s health specialties, the expertise of a Chief Medical Officer who is a board-certified OB/GYN, and a Scientific Advisory Board with extensive expertise in therapeutics and diagnostics for women’s health conditions.  Extensive therapeutic expertise and operational experience in women’s health studies enable us to conduct efficient, high-quality clinical trials in indications including:

  • Bacterial vaginosis

  • Candidiasis

  • Menstrual disorders

  • Uterine fibroids

  • Endometriosis

  • Pelvic inflammatory disease

  • Chlamydia trachomatis and Neisseria gonorrhea

  • Trichomonas vaginalis

  • HPV (genital warts, cervical dysplasia)

  • Urinary tract infections and cystitis

  • Pelvic floor disorders

  • Polycystic ovary syndrome

Trial Tip

Site selection is a critical issue in women’s health studies and the optimal mix of sites varies by indication and especially with the age of the population. OB/GYNs are the best sites for most women’s health studies but not all.  For example, as of 2012, no less than 72% of women aged 45-64 received healthcare only from a family physician or internal medicine physician. Perhaps surprisingly, women in that age group who visited only an OB/GYN represented just 12% of the population. For site selection in health conditions prevalent in an older age cohort, determining the right mix of sites requires extensive experience, a robust site database and a rigorous feasibility process informed by the latest trends in patient care.

Contraception

Health Decisions has extensive experience and expertise in studies of contraceptives for commercial and institutional sponsors, including 21 years serving as Statistical and Clinical Coordinating Center for Contraceptive Research for the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD), a unit of the National Institutes of Health (NIH). Health Decisions has developed protocols and conducted studies of virtually all types of female contraceptives as well as male condoms and male hormonal contraceptives. Just as each type of contraceptive appeals to different women and couples in different life situations, clinical trials of novel contraceptives present different regulatory, design and operational challenges. Recruitment challenges in contraceptive studies vary based on perceived convenience and effectiveness of the investigative product. Health Decisions understands the challenges of protocol development for each type of contraceptive as well as the differing operational challenges in areas including project management, site selection, patient recruitment, informed consent, retention, site management, data management and statistical analysis. Health Decisions’ experience in contraception includes studies of:

  • Female hormonal contraceptives (oral, patch, vaginal ring)

  • Intrauterine devices (IUDs, IUS)

  • Birth control implants

  • Emergency contraceptives

  • Nonhormonal contraceptives

  • Spermicidal gels

  • Barrier methods (male condoms, female condoms)

  • Male hormonal contraceptives

Trial Tip

Trials of each type of contraceptive vary based on factors ranging from convenience of use to patient experience with different methods and perceived safety and pregnancy risks. Trials of male hormonal contraceptives present unusual challenges: a drug administered to one partner is evaluated primarily based on the response of the other; the female is at risk of pregnancy but the male for side effects; and the female must trust the male to administer the drug without fail. Mitigating risks in development of any novel contraceptive requires working with an experienced CRO that understands how to address the many and varied challenges between IND and successful NDA.

Sexual Health

Health Decisions provides therapeutic and operational expertise and site relationships for clinical development of novel products to address issues in women’s sexual health. This encompasses supporting the development of therapeutics and diagnostics for a variety of indications that compromise women’s ability to participate in and enjoy sexual activity. Such indications include but are not limited to female sexual dysfunction, sexual desire disorders, coital pain, vaginal atrophy, vaginismus and STIs. Etiology of many conditions in sexual health can involve one or more factors ranging from physical and hormonal issues to affective disorders, stress in personal relationships and side effects of common medications such as antidepressants and contraceptives. And, of course, male sexual dysfunction can significantly affect the sexual well-being of the female partner. Health Decisions understands the issues in clinical development of products in sexual health in indications including:

  • Female sexual interest/arousal disorder

  • Hypoactive sexual desire disorder

  • Female orgasmic disorder

  • Genito-pelvic pain/penetration disorder

  • Substance/medication-induced sexual dysfunction

  • Other sexual disorders causing clinically significant distress

  • Male hypogonadism (low testosterone)

  • Erectile dysfunction

Infertility

Potential causes of infertility are many and varied. Either the male or female partner may have an issue that renders conception impossible or highly unlikely. In perhaps one-third of cases, diagnostic procedures identify problems in both partners.  Sometimes exhaustive testing fails to identify a cause in either partner. Oligoovulation, anovulation, tubal blockage, endometriosis, polycystic ovary syndrome and uterine abnormalities are among potential issues for women. In male-factor infertility, there may be issues in sperm count, motility, morphology, volume, pH and other factors. As a result, the overall population of infertile couples is highly fragmented. While there are millions of infertile couples, the specific population eligible for any individual study may be small. Thus, planning for each infertility trial must begin with a meticulous review of the protocol to determine as precisely as possible just how many couples will be eligible. Health Decisions and our therapeutic advisors and clinical staff, as well as the KOLs and PIs in our site network, understand the challenges of planning infertility studies, recruiting eligible subjects and executing such studies with high efficiency and quality.

  • Ovulatory disorders

  • Uterine abnormalities

  • Tubal blockage

  • Pelvic adhesions

  • Male factor infertility

  • Ovarian cysts

  • Polycystic ovary syndrome

  • Endometriosis

Trial Tip

Infertile couples are often highly motivated to participate in clinical trials of novel protocols and techniques. However, detailed inclusion/exclusion criteria and potentially complex medical histories of both partners in an infertile couple sometimes present recruitment challenges despite the highly motivated population. The more comprehensive the medical records at participating fertility clinics, the better. To project enrollment accurately, it is essential to perform feasibility that thoroughly investigates site capabilities, including the quality of health records, in relation to the specific requirements of each study.

Obstetrics

Health Decisions understands how to address the unique challenges in clinical testing of investigational products to improve diagnosis and treatment of conditions arising during pregnancy, an area of significant unmet medical need. Availability of a wider range of medications that are safe and effective during pregnancy would benefit hundreds of millions of women. Preterm labor, preeclampsia and post-delivery analgesia are all areas of need.  Improvements in the timeliness and accuracy of diagnostics would enable earlier, better-informed treatment decisions. Challenges in the development of new products for obstetrical care, especially in maternal fetal medicine, include minimizing risks to both mother and fetus while making an accurate determination of safety and efficacy. Health Decisions’ therapeutic experts and advisors and our clinical staff understand the issues in conducting successful studies in pregnant women. The investigators in our site network understand the importance of the investigator-patient relationship in theses studies. Health Decisions offers capabilities for conducting clinical trials in areas including:

  • Prenatal screening

  • Preterm birth

  • Premature labor

  • Post-childbirth analgesia

  • Preeclampsia

  • Gestational diabetes

  • Medical devices for uterine observation

  • Fetal monitoring devices

  • Products for antepartum, intrapartum & postpartum care

  • Demonstrating the safety and efficacy of approved drugs during pregnancy

Trial Tip

Recruitment of women for clinical trials of novel therapeutics for administration during pregnancy can be extremely challenging. Prospective parents are typically focused on doing everything in their power to reduce risk and uncertainty. An invitation to participate in a study of a novel anesthesia technique or an investigative analgesia for postpartum pain is likely to come as a surprise and be perceived as an additional concern in a complex and sometimes overwhelming process. Nevertheless, the informed consent process must call attention to risks and uncertainties as well as stating that potential therapeutic benefits have yet to be demonstrated. Health Decisions understands how to address such challenges realistically and conduct studies in this population as efficiently as possible while generating high-quality data.

Menopause and Osteoporosis

Menopausal and postmenopausal women face many health challenges. Whether natural or induced by chemotherapy, menopause is a trying experience for many women. Health issues associated with menopause include vasomotor symptoms, vaginal dryness, moodiness and weight gain. For some women, vasomotor symptoms such as hot flashes produce intense discomfort that may continue for years. Other health issues associated with hormonal changes, including osteoporosis, develop gradually but can present serious risks both to fundamental health and quality of life. In some cases, women also experience significant side effects from today’s standard treatments for osteoporosis and some other postmenopausal health conditions. Women in this population are often open to new treatments and willing to participate in clinical trials of novel products. However, women who have identified any product that provides relief for vasomotor symptoms will hesitate to discontinue the product during a washout period or risk randomization to placebo. Health Decisions, our clinical staff and therapeutic experts understand the challenges of recruitment and retention in studies in menopausal and postmenopausal women. The investigators in our site network provide access to a large patient population that includes women open to new therapeutics for menopausal and postmenopausal conditions. Health Decisions offers capabilities for clinical development in areas including:

  • The genitourinary syndrome of menopause (GSM)

  • Nonhormonal treatments of vasomotor symptoms

  • Hormone replacement therapy (oral, patches, gels, vaginal rings)

  • Nutritional supplements

  • Bisphosphonates

  • Parathyroid anabolic agents

  • Osteoclast inhibitors

  • Selective estrogen receptor modulators (SERMs)

Trial Tip

Recruitment and retention of large patient populations for osteoporosis studies require a sophisticated and diverse strategy. It is important to test different communications channels, track response, identify the most productive sources and adjust strategy accordingly. Sometimes the key to recruitment is providing access to a service that women recognize as a health benefit. For example, women understand the health risks posed by bone loss. Providing access to free DEXA (dual-energy X-ray absorptiometry) screening may not only identify eligible patients but also increase interest in study participation.

Gynecologic Oncology and Breast Cancer

Health Decisions offers clinical development services for investigational products for treatment and diagnosis of gynecologic cancers and breast cancer. Clinical trials in cervical, ovarian, uterine and breast cancer present challenges in all operational areas, including recruitment and monitoring. Recruitment of gynecologic oncology and breast cancer trials often must face challenges such as multiple existing treatments, complex inclusion/exclusion criteria and competition from trials of other investigational products. Clinical monitoring presents challenges because patient health records often reflect long histories involving numerous procedures. Health Decisions’ senior scientists, clinical staff and therapeutic advisors understand the challenges of gynecologic oncology and breast cancer trials and how to address them. Health Decisions offers capabilities to conduct clinical trials in women’s oncology indications including:

  • Cervical cancer

  • Ovarian cancer

  • Uterine cancer

  • Breast cancer

  • Vaginal cancer

  • Vulvar cancer

Autoimmune Diseases

Although autoimmune diseases affect both men and women, many of them affect women disproportionately. Multiple sclerosis, lupus erythematosus,  rheumatoid arthritis and inflammatory bowel disease are all examples of immune-mediated diseases that affect more women than men. Health Decisions is committed to providing clinical development services for products that improve outcomes for all diseases that present significant health issues for women, including autoimmune diseases such as:

  • Multiple sclerosis

  • Lupus erythematosus

  • Rheumatoid arthritis

  • Fibromyalgia

  • Sjögren’s syndrome

  • Chronic fatigue syndrome

  • Celiac disease

  • Inflammatory bowel disease

  • Irritable bowel syndrome

  • Autoimmune thyroiditis

High-Female-Prevalence (HFP) Health Conditions

Health Decisions defines women’s health to include any health condition that affects women disproportionately. This includes issues beyond women-only indications that may be treated by OB/GYNs or other types of physicians. In straightforward terms: If it matters to women’s health, it matters to Health Decisions.  Many HFP health conditions affect quality of life as well as fundamental health for millions of women worldwide.  Examples of such indications include migraine, depression, anxiety disorders and eating disorders. Health Decisions offers capabilities for clinical development in HFP indications including:

  • Migraine

  • Eating disorders

  • Alzheimer’s disease

  • Stroke

  • Depression

  • Anxiety

  • Thyroid disorders

  • Obesity

The Goal

After listing the many women’s health conditions for which Health Decisions provides clinical development services, it is important to remember the goal: improved healthcare outcomes for women worldwide. Achieving this goal is why we do what we do. We express this goal as the Health Decisions wish for every baby girl.

View Our Wish
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