Harnessing real-world evidence to reduce the burden of noncommunicable disease: health information technology and innovation to generate insights.

Noncommunicable diseases (NCDs) are the leading causes of mortality and morbidity across the world and factors influencing global poverty and slowing economic development. We summarize how the potential power of real-world data (RWD) and real-world evidence (RWE) can be harnessed to help address the disease burden of NCDs at global, national, regional and local levels. RWE is essential to understand the epidemiology of NCDs, quantify NCD burdens, assist with the early detection of vulnerable populations at high risk of NCDs by identifying the most influential risk factors, and evaluate the effectiveness and cost-benefits of treatments, programs, and public policies for NCDs. To realize the potential power of RWD and RWE, challenges related to data integration, access, interoperability, standardization of analytical methods, quality control, security, privacy protection, and ethical standards for data use must be addressed. Finally, partnerships between academic centers, governments, pharmaceutical companies, and other stakeholders aimed at improving the utilization of RWE can have a substantial beneficial impact in preventing and managing NCDs.

Harnessing Real-World Data for Regulatory Use and Applying Innovative Applications.

A vast quantity of real-world data (RWD) are available to healthcare researchers. Such data come from diverse sources such as electronic health records, insurance claims and billing activity, product and disease registries, medical devices used in the home, and applications on mobile devices. The analysis of RWD produces real-world evidence (RWE), which is clinical evidence that provides information about usage and potential benefits or risks of a drug. This review defines and explains RWD, and it also details how regulatory authorities are using RWD and RWE. The main challenges in harnessing RWD include collating and analyzing numerous disparate types or categories of available information including both structured (eg, field entries) and unstructured (eg, doctor notes, discharge summaries, social media posts) data. Although the use of artificial intelligence to capture, amalgamate, standardize, and analyze RWD is still evolving, it has the potential to support the increased use of RWE to improve global health and healthcare.

Systemic Solutions for Addressing Non-Communicable Diseases in Low- and Middle-Income Countries.

Non-communicable diseases (NCDs) have been on the rise in low- and middle-income countries (LMICs) over the last few decades and represent a significant healthcare concern. Over 85% of "premature" deaths worldwide due to NCDs occur in the LMICs. NCDs are an economic burden on these countries, increasing their healthcare expenditure. However, targeting NCDs in LMICs is challenging due to evolving health systems and an emphasis on acute illness. The major issues include limitations with universal health coverage, regulations, funding, distribution and availability of the healthcare workforce, and availability of health data. Experts from across the health sector in LMICs formed a Think Tank to understand and examine the issues, and to offer potential opportunities that may address the rising burden of NCDs in these countries. This review presents the evidence and posits pragmatic solutions to combat NCDs.

Beyond debacle and debate: developing solutions in drug safety.

In the 5 years since the Vioxx debacle, efforts have been made to enhance drug safety. These include the introduction of legislation that expands the power of drug regulatory agencies, new data transparency standards and increased requirements for funding of post-marketing drug surveillance. Nevertheless, some doubt remains that these changes will be sufficient to address the increasing challenges in the field of drug safety. Here, from the perspective of a drug researcher, I discuss key areas for further development that could deliver long-term solutions to these challenges: enhanced tools for the detection of safety signals, innovative phased drug launches, new risk stratification techniques and improved pharmacovigilance operations.

Changes in weight with depot medroxyprogesterone acetate subcutaneous injection 104 mg/0.65 mL.

INTRODUCTION: The study was conducted to assess the impact of depot medroxyprogesterone acetate subcutaneous injection 104 mg/0.65 mL (DMPA-SC 104) on body weight. METHODS: Changes in weight from pretreatment were analyzed using data from two 1-year, noncomparative trials of DMPA-SC 104 (North/South American, N=722; European/Asian, N=1065) and a 3-year, randomized study (SC/IM) comparing DMPA-SC 104 (N=266) with the DMPA intramuscular injection 150 mg/mL (DMPA-IM 150). For each study, additional analyses were conducted for changes in body weight by age (<25, 25 to 35 and >35 years) and body mass index (BMI) (25 to 30 kg/m2) subgroups. RESULTS: In both 1-year trials, the mean (+/-SD) weight gain at month 12 was <2 kg [1.7 kg (+/-4.5 SD) in the Americas trial and 1.4 kg (+/-3.6 SD) in the Europe/Asia trial]. In the SC/IM trial, mean weight changes were similar between DMPA-SC 104 and DMPA-IM 150 groups, with mean (+/-SD) gains at month 36 of 4.5+/-8.5 and 5.8+/-8.7 kg, respectively. Similar differences in weight gain were observed by age or baseline BMI in all studies. CONCLUSION: DMPA-SC 104 was associated with modest weight gain in most women.

Changes in bleeding patterns with depot medroxyprogesterone acetate subcutaneous injection 104 mg.

OBJECTIVE: This study aims to assess changes in bleeding patterns with the use of depot medroxyprogesterone acetate (DMPA) 104 mg/0.65 ml subcutaneous injection (DMPA-SC 104). STUDY DESIGN: An analysis was conducted using data from two 1-year, noncomparative clinical trials (N=1787) and a 2-year randomized study comparing DMPA-SC 104 (N=266) with DMPA intramuscular injection (DMPA-IM). Bleeding was analyzed per 30-day interval by category and number of days. Analyses also were performed for age and body mass index (BMI) subgroups and for the percentages of women shifting from bleeding/spotting to amenorrhea after each injection. RESULTS: Each study showed decreased incidence of irregular bleeding and increased amenorrhea with continued use of DMPA-SC 104. Rates of amenorrhea at Month 12 (52-64% across studies) and Month 24 (71% in the 2-year trial) were comparable with those originally reported for DMPA-IM. Changes in bleeding patterns showed no consistent differences according to age or BMI. The percentages of subjects shifting from bleeding and/or spotting to amenorrhea increased with each subsequent injection. CONCLUSION: Clinical data show that the incidence of amenorrhea increases over time with the use of DMPA-SC 104.