Background Traditional clinical trials are often expensive, inefficient, include selected populations, and can create significant participant burden via travel and other logistical demands. Using new technologies and methodologies to promote a decentralized approach has the potential to improve the efficiency of clinical trials. The Clinical Trials Transformation Initiative (CTTI)-a public-private partnership to improve clinical trials-launched a multi-stakeholder Decentralized Clinical Trials (DCTs) Project to provide recommendations on addressing the actual and perceived legal, regulatory, and practical challenges with DCT design and conduct in the United States. Methods Informed by qualitative group interviews and an expert meeting, CTTI engaged stakeholders to identify key challenges to implementing DCTs and possible solutions. Results The CTTI DCT project team used the interview findings and expert feedback to develop recommendations that will drive broader use of DCTs. Conclusions CTTI's recommendations cover protocol design, use of telemedicine and mobile healthcare providers, medical product supply chain, investigator delegation and oversight, and safety monitoring considerations. By implementing these recommendations, sponsors, contract research organizations, and others can help advance successful medical product development using mobile technologies and methodologies in DCTs.

Women with POI have lower bone density compared to regularly menstruating women. Compared to Caucasians, minority women with estrogen deficiency are more likely to have BMD below the expected range for age. This racial disparity appears to be related to a combined effect of several modifiable risk factors. Delay in diagnosis of POI also contributes to reduced bone density by delaying proper therapy.

Long-term physiological transdermal estradiol replacement in combination with oral medroxyprogesterone acetate restores mean femoral neck BMD to normal in young women with spontaneous 46,XX primary ovarian insufficiency. However, the addition of physiological transdermal T replacement did not provide additional benefit.

Objective To examine factors associated with emotional well-being in women with spontaneous primary ovarian insufficiency Design Cross-sectional and case control Setting Clinical research center, national US health research facility Patient(s) Women diagnosed with spontaneous 46,XX primary ovarian insufficiency (N=100) at a mean age of 32.4 years and healthy control women of similar age (N=60) Intervention(s) Administration of validated self-reporting instruments Main Outcome Measure(s) Illness Uncertainty, Stigma, Goal Disengagement/Reengagement, Purpose in Life, Positive and Negative Affect Schedule, Center of Epidemiologic Studies Depression Scale, State-Trait Anxiety Inventory Result(s) Compared to controls, women with spontaneous primary ovarian insufficiency scored adversely on all measures of affect. Illness Uncertainty and Purpose in Life were significant independent factors associated with Anxiety (R2=0.47), Stigma and Purpose in Life were the significant independent factors associated with Depression (R2=0.51), and Goal Reengagement and Purpose in Life were significantly and independently associated with Positive Affect (R2=0.43). Conclusion(s) This evidence supports the need for prospective studies. Our findings are consistent with the hypothesis that clinicians could improve the emotional well-being of their patients with primary ovarian insufficiency by a) informing them better about their condition, b) helping them to feel less stigmatized by the disorder, and c) assisting them in developing alternative goals with regard to family planning as well as other goals.