Full Package Research Articles

Healthcare provider’s performance monitoring for undercovered population during the Covid-19 epidemic, 2021, Tehran: a cross-sectional study

BackgroundConsidering the necessity and importance of providing health care to children during the Covid-19 epidemic, this study aims to investigate primary health workers performance for infants under 6 months during the Covid-19 epidemic and parent’s satisfaction level with these services.MethodsThis was a cross-sectional study conducted among the defined population of Tehran University of Medical Sciences. The descriptive analysis focused on frequencies and percentages. A chi-square test was used to compare the categorical data between the studied groups.ResultsThree-hundred seventy-two participants from two District Health Networks of Islamshahr 90 (24%) and Shahr-e-rey 107 (29%) and South Tehran Health Center 175 (47%) were included in the study. About 45% of 2 months old, 54% of 4 months old, and 42% of 6 months old received full basic healthcare package. Coverage of services such as vaccination and height, weight, and head circumference in all three age groups and health networks was 100%. Training in handwashing, touch the face, and hygiene while breastfeeding (64.4%, p = 0.043) and not to use a pacifier (64%, p = 0.038) in Islamshahr Health Network was significantly less than other health networks. The level of parental satisfaction with the provided services was 90.1%. There is a significant association between the dissatisfaction of the participants and not receiving the services completely (p = 0.000).ConclusionDuring the Covid-19 pandemic, the quality and quantity of primary health care to children have been declined. The focus of health workers was on essential physical health services for infants, and education was almost neglected during this period.

Cluster-Based Demonstration of Bread Wheat Variety (Danda’a) Production Technologies Packages: The Case of Select Districts Under Gedeo Zone in SNNPRS and Sidama Region, Ethiopia

Wheat is an important food security crop in Ethiopia, but its productivity is low. Hence, this cluster-based demonstration was conducted to demonstrate wheat production packages, measure wheat productivity, and assess farmers’ feedback. The sites were selected purposively based on production potential, land availability, and road accessibility. The training was given to farmers and development agents. Inputs were collected under the shared responsibility of the research center and the district agricultural office. Seed rate, fertilizer rate and lime rate were major used packages. The demonstration was evaluated through field visits and field days. Data were analyzed through descriptive statistics. The mean grain yield was 39 qt/ha and 40.5 qt/ha in Gedeb and Teticha districts, respectively. The farmers' appreciated the wheat variety in terms of grain yield, number of seeds per heading, disease resistance, tilling capacity, spike length, and well-covered seed. So, extension personnel need to give due attention to full packages application.

How did local wisdom and practice make schools thrive during the pandemic? Evidence from a positive deviance study in rural Uganda

PurposeThis research explores the impact of the locally grown strategies for learning support, as a positive deviance (PD) study, during the COVID-19 pandemic in rural Uganda.Design/methodology/approachThe researchers employed a randomized control trial (RCT) as an original design whereby 50 schools received a full package of SMS and WhatsApp peer groups of head teachers, 50 schools received SMS only and another 50 served as a control group. As an analytical method, this study adopted a difference-in-difference (DID) model to analyze the impact of the radio talk shows promoted through SMS followed by discussion among WhatsApp peer groups. The data collected in June 2021 and February 2022 were used due to the COVID-19-related data limitation of the baseline survey collected in 2019.FindingsThe authors found that the local radio talk shows as a PD intervention had a humble impact on preventing pupils’ dropout during the school closures for two years in Uganda. However, the authors did not obtain a significant result on the impact of the PD intervention on pedagogical support or learning outcomes at the school level. The authors also found that the pupils have significantly dropped their level of proficiencies in literacy and numeracy during the pandemic.Originality/valueThe findings could be of value for the leaders, educators and policymakers to understand the most recent update of learning situation in Uganda and the potential impact of locally grown strategies for learning which does not require external inputs.

ANCIENT KEDAH IRON SMELTING EXPERIMENT IN PREPARATION FOR OFFERING ARCHAEOLOGICAL TOURISM HERITAGE PACKAGES AT SUNGAI BATU ARCHAEOLOGICAL COMPLEX (SBAC), BUJANG VALLEY, KEDAH, MALAYSIA

In order to obtain primary data related to the iron smelting activities, the experimental process of furnaces, tuyere and air pumps making is carried out. The experiment has conducted since 2013 through the Knowledge Transfer Program (KTP) in Sungai Batu Archaeological Complex (SBAC). Through the experiment, the clay in this complex has been used as a raw material for furnaces and tuyere making while the bellows is made of wood, plywood and fabric. In order to complete the experiment regarding the raw material that use for iron smelting, iron ore was taken through survey activities in the area of Kampung Batu 5, UiTM Merbok and Bukit Tupah while charcoal was used from rubber wood in the rubber plantation near the Sungai Batu Archaeological Complex. After the experiment was conducted, the results recorded were different from the findings of the iron ingot excavation at the iron smelting site which is likely to occur due to the difference in technique and ratio of materials used during smelting activities. Although the results obtained during the experiment are different, the smelting process can be used as the main reference for offering tourism full packages related to the demonstration of iron smelting in this complex to foreign tourists.

The Effectiveness of Interactive Text Messaging and Structured Psychosocial Support Groups on Developmental Milestones of Children From Adolescent Pregnancies in Kenya: Quasi-Experimental Study

In sub-Saharan Africa, one-quarter of all pregnancies occur in adolescents. Children born to adolescent mothers have poorer physical and socio-cognitive development. One reason may be inadequate knowledge on childcare and psychosocial support during pregnancy and post partum, since adolescent mothers have less antenatal care attendance and overall interaction with the health care system. Mobile health technology has been used to relay health information to special groups; however, psychosocial support commonly requires physical interaction. We aimed to assess the efficacy of an interactive mobile text messaging platform and support groups in improving adolescent mothers' knowledge and practices as well as infant growth and development. This was a quasi-experimental study, conducted among adolescent mothers with infants younger than 3 months, in Homa Bay County, Kenya. Five of the 8 subcounties in Homa Bay County were purposively selected as study clusters. Four subcounties were assigned as intervention clusters and 1 as a control cluster. Adolescent mothers from 2 intervention subcounties received interactive text messaging only (limited package), whereas those from the other 2 subcounties received text messaging and weekly support groups, moderated by a community health extension worker and a counselor (full package); the control cluster only received the end-line evaluation (posttest-only control). The follow-up period was 9 months. Key outcomes were maternal knowledge on childcare and infant development milestones assessed using the Developmental Milestones Checklist (DMC III). Knowledge and DMC III scores were compared between the intervention and control groups, as well as between the 2 intervention groups. We recruited 791 mother-infant pairs into the intervention groups (full package: n=375; limited package: n=416) at baseline and 220 controls at end line. Attrition from the intervention groups was 15.8% (125/791). Compared with the control group, adolescent mothers receiving the full package had a higher knowledge score on infant care and development (9.02 vs 8.01; P<.001) and higher exclusive breastfeeding rates (238/375, 63.5% vs 112/220, 50.9%; P=.004), and their infants had higher average DMC III scores (53.09 vs 48.59; P=.01). The limited package group also had higher knowledge score than the control group (8.73 vs 8.01; P<.001); this group performed better than the full package group on exclusive breastfeeding (297/416, 71.4% vs 112/220, 50.9%; P<.001) and DMC III scores (58.29 vs 48.59; P<.001) when compared with the control group. We found a marginal difference in knowledge scores between full and limited package groups (9.02 vs 8.73; P=.048) but no difference in DMC III scores between the 2 groups (53.09 vs 58.29; P>.99). An interactive text messaging platform improved adolescent mothers' knowledge on nurturing infant care and the development of their children, even without physical support groups. Such platforms offer a convenient avenue for providing reproductive health information to adolescents. Pan African Clinical Trials Registry PACTR201806003369302; https://tinyurl.com/kkxvzjse.

A generic methodology for the statistically uniform & comparable evaluation of Automated Trading Platform components

Introduction:Although machine learning approaches have been widely used in the field of finance, to very successful degrees, these approaches remain bespoke to specific investigations and opaque in terms of explainability, comparability, and reproducibility. Objectives:The primary objective of this research was to shed light upon this field by providing a generic methodology that was investigation-agnostic and interpretable to a financial markets’ practitioner, thus enhancing their efficiency, reducing barriers to entry, and increasing the reproducibility of experiments. The proposed methodology is showcased on two automated trading platform components. Namely, price levels, a well-known trading pattern, and a novel 2-step feature extraction method. Methods:This proposed a generic methodology, useable across markets, the methodology relies on hypothesis testing, which is widely applied in other social and scientific disciplines to effectively evaluate the concrete results beyond simple classification accuracy. The first hypothesis was formulated to evaluate whether the selected trading pattern is suitable for use in the machine learning setting. The second hypothesis allows us to systematically assess whether the proposed feature extraction method leads to any statistically significant improvement in the automated trading platform performance. Results:Experiments were conducted across, 10 contracts, 3 feature spaces, and 3 rebound configurations (for feature extraction), resulting in 90 experiments. Across the experiments we found that the use of the considered trading pattern in the machine learning setting is only partially supported by statistics, resulting in insignificant effect sizes (Rebound 7 - 0.64±1.02, Rebound 11 0.38±0.98, and rebound 15 - 1.05±1.16), but allowed the rejection of the null hypothesis based on the outcome of the statistical test. While the results of the proposed 2-step feature extraction looked promising at first sight, statistics did not support this, this demonstrated the usefulness of the proposed methodology. Additionally, we obtained SHAP values for the considered models, providing insights for adjustments to the feature space. Conclusion:We showcased the generic methodology on a US futures market instrument and provided evidence that with this methodology we could easily obtain informative metrics beyond the more traditional performance and profitability metrics. The interpretability of these results allows the practitioner to construct more effective automated trading pipelines by analysing their strategies using an intuitive and statistically sound methodology. This work is one of the first in applying this rigorous statistically-backed approach to the field of financial markets and we hope this may be a springboard for more research. A full reproducibility package is shared.

QCSH: A full quantum computer nuclear shell-model package

The nuclear system is a promising area for demonstrating practical quantum advantage. A comprehensive computation of a nuclear system in a classical computer is beyond the capacity of current classical computers. With the rapid development of hardware, the prospect of using quantum computers in nuclear physics is close at hand. In this paper, we report a full quantum package, QCSH, for solving a nuclear shell model in a quantum computer. QCSH uses the linear combination of the unitary formalism of quantum computing and performs all calculations in a quantum computer. The complexities of qubit resource and the number of basic gates of QCSH are both polynomials to the number of nucleons in nuclei. For example, QCSH is used to calculate the binding energies of 12 light nuclei (i.e., 2H, 3H, 3He, 4He, 6Li, 7Li, 12C, 14N, 16O, 17O, 23Na, and 40Ca). Moreover, we experimentally demonstrate the calculation of deuteron binding energy using a superconducting quantum processor. The result indicates that QCSH can provide meaningful results already in near-term quantum devices.

Early exposure to STEM research as a foundational experience for STEM careers

The benefits of undergraduate research to student persistence and success has been established in the literature. Less studied, however, is the long term impact of early exposure to research among students from underserved backgrounds.This qualitative study of undergraduates participating in a unique summer research program uncovers the deeper meaning of the overall experience on the students: from the lab itself, to the mentors, peers, professional development, socials, and the impact of the program staff. Three major themes emerged: (1) Early exposure to research as a foundation for career direction; (2) Relationships with peers and mentors as highly valued; and (3) Development of skills leads to personal and professional growth, and confidence. Additionally, underrepresented students described the value of having minority role models and peers, and the excitement of continuing their research throughout their undergraduate careers. A full compensation package of stipend and housing made a practical difference for several of the participants. This qualitative study offers a deeper understanding of these impacts through the voices of the participants.

Evaluating operating models and urbanism for transportation operations of circular reuse platforms

Containers and packages contribute to about 28 % of more than 292 million tons of municipalsolid waste. Although a shift from single-use to reuse models seems inevitable for more sustainable packaging, there are economic and environmental aspects of reusables operations that are yet to be investigated. In this paper, we address the transportation operations of reusables (delivery of full packages and picking up empty ones) while accounting for the possibility of prioritizing serving deliveries prior to pickups. We model this problem as the Vehicle Routing Problem with Backhauls and showcase a heuristic solution approach on two real-world transportation networks that are representative of urban and rural areas. We also present an analysis of the transportation cost and CO2 emission under a variety of factors that provides relevant insights for decision makers that could help them to find solutions in adopting reusable packaging models.

Economic Efficiency of Onion Production in East Shewa Zone, Oromia Region, Ethiopia

In an economy where resources are scarce and opportunities for new technologies are lacking, efficiency studies able to show the possibilities to raise productivity by improving efficiency of farms without increasing the resource base or developing new technology. This study investigated Economic Efficiency of Onion Production in East Shewa Zone, Oromia Region, Ethiopia. Both primary and secondary source of data were used. Semi- structured questionnaires were used to collect data from Lume, Bora and Dugda districts. Totally 94 respondents randomly selected from each districts based on sample size determination. A stochastic production frontier function was fitted to the sample households. Tobit model was applied to determine factors affecting economic efficiency of onion production. The result revealed that the mean Technical, Allocative and Economic efficiency of onion production was about and 67.60%, 98.99% and 66.91% respectively. The tobit model result revealed that Onion Technical and Economic efficiency were positively and significantly affected by Experience in Onion production, frequency of Extension contact and Non- and off income activities while land allocated for Onion production affect Technical and economic efficiency negatively and significantly. District office of Agriculture, stockholders and concerned bodies should focus on extension service regarding of full package of production, provision of technical support and farmers should practice different Non-and Off-fam activities to improve his/her income that contribute to the improvement in efficiency of Onion production in the study area.

Feasibility of an Individualized Dispensing Program for Patients Prescribed Oral Anticancer Drugs to Prevent Waste.

Waste of oral anticancer drugs (OACDs) causes financial and environmental burdens. This study evaluates the feasibility of an individualized dispensing program to prevent waste of OACDs. Adult patients were dispensed individualized quantities of niraparib, abiraterone, enzalutamide, ruxolitinib, osimertinib, or imatinib as standard care, during the first 6 months of treatment. The first 50 patients participated in an feasibility evaluation conform five domains of Bowen's Framework. (1) implementation: reach (eligible patients included) and protocol fidelity (executions following protocol) assessed from pharmacy data, (2) acceptability: rated from 1 to 10 and agreement with theoretical framework acceptability domains via a survey among patients and pharmacy technicians, (3) practicality: program's costs, (4) effect: compared with previous practice (full package supply per month), defined as difference in unused OACD unit doses and net cost-savings, and (5) demand: potential scale-up of the program by including more OACDs. Participants' median age was 67 (interquartile range [IQR], 58-71) years, and 76% was male. (1) Implementation: reach and protocol fidelity were 89% and 90%, respectively. (2) Acceptability was high among patients (median, 9; IQR, 8-9) and pharmacy technicians (median, 7; IQR, 6-8). All acceptability domains were agreed on. (3) Practicality: program costs were €4,289. (4) Effect: unused OACD unit doses were reduced by 34%, causing net cost-savings of €693 per discontinued patient. (5) Demand: the program could be scaled up to seven times by including all OACDs. Individualized dispensing for patients prescribed OACDs is feasible for preventing waste in terms of implementation, acceptability, practicality, effect, and demand.

Infections averted by a comprehensive HIV prevention intervention and its cost-effectiveness: a prospective cohort study of persons who inject drugs in Delhi, India

ABSTRACT This paper presents the cost-effectiveness of a WHO-recommended harm-reduction programme implemented among a cohort of persons who inject drugs in Delhi, India. We estimate the number of infections averted using Bernoulli process model and calculate cost-effectiveness ratio as the total programme cost per infection averted. The intervention averted 996 HIV infections over 36 months, with a cost-effectiveness ratio of INR 24,763 (US$ 476) per infection averted per year. The first phase, when HIV testing and counselling were initiated, was more cost-effective than the second phase when full intervention package, including needle-syringe exchange, condom distribution, harm-reduction education, etc., was implemented.

Стратегическое планирование в России: история становления, критика, последствия, состояние (часть II)

The article is focused on the analysis of the strategic planning in Russia at the current stage of its development. The author comes to the conclusion that there are seven stages in the history of the formation of the strategic planning in modern Russia. Each of them is a natural consequence of taking into account the criticism and experience of the strategic planning, its documentary support, systematisation of strategic planning documents, their monitoring and execution. It is stated that the full package of fundamental documents of the long-term strategic planning of the socio-economic development of Russia was adopted only by the end of 2021. The creation and approval of the Strategy of the long-term socio-economic development of Russia is a natural consequence of the development of the strategic planning in Russia at the present stage of its development.

Nonclinical safety assessments of a novel synthetic toll-like receptor 4 agonist and saponin based adjuvant

A full nonclinical safety package was performed to support the clinical use of SPA14, a novel liposome-based vaccine adjuvant containing the synthetic toll-like receptor 4 agonist E6020 and saponin QS21.E6020 and QS21 were tested negative for their potential genotoxic effects in Ames, micronucleus, or mouse-lymphoma TK (thymidine kinase) assay. To evaluate the potential local and systemic effects of SPA14, two toxicity studies were performed in rabbits. In the first dose range finding toxicity study, rabbits received two intramuscular injections of SPA14 at increasing doses of E6020 combined with two antigens, a control (saline), the two antigens alone, or the antigens adjuvanted with a liposome-based adjuvant AS01B. No systemic toxicity was detected, supporting the dose of 5 μg of E6020 for the subsequent pivotal study. In the second repeated dose toxicity study, rabbits received four intramuscular injections of SPA14 alone, a control (saline), SPA14 combined with two antigens, the two antigens alone, or the antigens combined with AF03 adjuvant, which is a squalene-based emulsion. SPA14 alone or in combination with the antigens was well tolerated and did not cause any systemic toxicity. Finally, two safety pharmacology studies were conducted to assess potential cardiovascular and respiratory effects of E6020 and SPA14 in conscious telemetered cynomolgus monkeys and beagle dogs, respectively. One subcutaneous injection of E6020 in monkeys and one intramuscular injection of SPA14 in dogs had no consequences on respiratory and cardiovascular functions. Altogether these results support the clinical development of SPA14.

Enhanced cyan emission via competitive site occupancy engineering in Sr2SiO4:Eu2+ phosphor for achieving full-spectrum LED lighting

Highly efficient containing cyan-emitting phosphors are used to bridge the cyan cavity for near ultraviolet (NUV) light-emitting diodes (LEDs) to obtain high-quality full-spectrum white lighting. In this work, a series of Sr2-xNaxSi1-xNbxO4:Eu2+ (x = 0–0.25) (SNSNO:Eu2+) solid solution phosphors were prepared by a solid-state reaction method. The bright SNSNO:Eu2+ phosphors were proceeded to fill the cyan gap. Such a cosubstitution of Na + -Nb5+ ion pair improves the cyan sub-band emission peaking at around 500 nm owing to the competitive site occupancy of Eu2+ on the Sr2+ site. Notably, codoping Na+-Nb5+ ion pairs into the host can realize a tuning of spectrum of SNSNO:Eu2+ from yellow-green to cyan-green region by crystallographic site engineering. Finally, employing mixture of SNSNO:Eu2+ and commercial BAM:Eu2+ and CaAlSiN3:Eu2+ coated on a 365 nm NUV chip, a full spectrum wLED package with remarkable color rendering index (Ra = 95.1) and low CCT = 3167 K was generated. The results indicate that the SNSNO:Eu2+ phosphor is very significative on closing the cyan gap for full-spectrum white lighting.

Simulation of X-ray Hartmann wavefront sensing with the Synchrotron Radiation Workshop.

X-ray wavefront measurement is an important beam diagnostic tool, especially for the diffraction-limited X-ray beam. These in situ diagnostics give a better understanding of beam imperfections, and they enable feedback for possible corrections and/or optical alignment improvements. Hartmann wavefront sensing is one of the promising techniques to perform in situ X-ray wavefront measurements. In this work, a simulation tool of the X-ray Hartmann Wavefront Sensor (HWS) is developed under the Synchrotron Radiation Workshop (SRW) framework. Using this new simulation capability, one can take advantage of the full SRW package to simulate Hartmann wavefront sensing with the beam traveling from the X-ray source to the sample through different X-ray optical components. This SRW HWS simulation tool can help to optimize the wavefront sensor parameters for a specific X-ray energy range. It can also simulate an in situ wavefront measurement experiment with a particular beamline optical layout and predict the expected results of the wavefront measurement under different beamline configurations.

진정한 기업가성과 세계적 기업가정신

This study investigated a global fashion company with longitudinal two-staged in-depth case study research. Global luxury handbag stems from Aristocratic culture among European. Global luxury brand like Louis Vuitton, Buberry and others have roots in that region. Within dozens of years several global fashion brands such as DKNY, Michael Cors, Coach, and so on are launched in US. Behind the scenes, Simone Co., an entrepreneurial company takes the role of supportive partners. This company has first OEM order from a globally top-tier brand instead of European manufacturer. Since then, it has evolved to provide full package of services from design to delivery. The first entrepreneurial success story from Asia (Breaking the prejudice of ‘Asia discount’). The growth stages starts with the opening the window of opportunity. Authentic entrepreneurity can be stated as “Affordable Luxury in made in Asia.” Simone developed competence of design to be the first ODM in Asia. The vision of Brand Orchestra in Global Opera of Luxury Handbag with global brands continue to be realized with the lead customers and partners. Longevity with DKNY(since 1987), 11 years with LVMH (since 2000) are exceptional partnership. The deeper OCEAN of entrepreneurity was studied from the grounded theory approach to figure out 10 elements of entrepreneurity that linked with Entrepreneurial Orientation(EO) and actions: Innovation, risk taking, and proactive pursuit of opportunities. The global scale of success in fashion entrepreneurship are extraordinary for the sustainablity. The possibility in the sector is based on the combination of the three continental strength of entrepreneurity, and entrepreneurial orientation with innovation, proactiveness, and risk-taking. The value added are increasing with traditions, market, and the craftsmanship. There are some implications to the entrepreneurship scholars, educators, and practitioners in the field.

IOFS-SA: An interactive online feature selection tool for survival analysis

Background:Survival analysis is a primary problem before clinical treatments to cancer patients after their operations. In order to make this kind of analysis simple, many corresponding tools have been proposed. Though these tools are easy to use, there exist still two fatal flaws. One is that sample grouping is commonly empirical and wrongly based on original gene expressions or survival time. The other is that their feature selection methods mostly depend univariate semi-supervised regression or the multivariate one without considering the small sample size compared with the high dimension. Objective:In order to solve the two problems, we design an automatic feature selection web tool which can also satisfy interactive sample grouping. Methods:An automatic feature selection is performed on user-defined data or TCGA data. users can also perform manual feature selection. Then, hierarchical clustering is used and an automatic re-clustering strategy is proposed after interactive risk score split. Kaplan–Meier survival curve and log-rank test are utilized as the measurement. Results:Experimental results on 53 datasets from TCGA demonstrate the effectiveness of our method. The tree view, heat map and scatter map can intuitively display the result of the selected genes to the doctors for further research. Conclusions:This method is suitable for survival analysis of high-dimensional small sample data sets. At the same time, it also provides a platform for researchers to analyze custom data. It solves the problems of the existing web tools and provides an effective feature selection method for survival analysis. Availability:The full code package is freely available and can be downloaded at https://github.com/Yuan-23/IOFS-SA-ecp-data-main, and the online version at https://bioinfor.nefu.edu.cn/IOFS-SA/ is ready for use freely.

A Review of COVID-19 Response Challenges in Ethiopia.

Background: The COVID-19 pandemic has positioned fragile healthcare systems in low-income countries under pressure, leading to critical gaps in service delivery. The pandemic response demands the healthcare system to be resilient and continue provision of healthcare services. This review is aimed at describing the healthcare response challenges during the pandemic in Ethiopia. Methodology: Eligible studies dealing with challenges of the healthcare system in response to the COVID-19 pandemic in Ethiopia were included. The six World Health Organization (WHO) healthcare system building blocks were used to categorize healthcare challenges. PubMed ProQuest, databases were searched, and results were summarized using systematic review synthesis. Results: Financial constraints led to a shortage of mechanical ventilators. Furthermore, the pandemic hindered the capacity to avail full packages of personal protective equipment in health facilities and intensive care capacity. The pandemic also affected the delivery of maternal, child and new-born services, prevention, and treatment of childhood illness, including immunization services. Conclusions: The COVID-19 pandemic posed various challenges to the performance of the healthcare system in Ethiopia. It is recommended that policy makers and stakeholders enhance pandemic preparedness and strengthen response capacity by considering the six WHO healthcare system building blocks.

Biomarkers for Alzheimer's Disease: Context of Use, Qualification, and Roadmap for Clinical Implementation.

Background and Objectives: The US Food and Drug Administration (FDA) defines a biomarker as a characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention. Biomarkers may be used in clinical care or as drug development tools (DDTs) in clinical trials. The goal of this review and perspective is to provide insight into the regulatory guidance for the use of biomarkers in clinical trials and clinical care. Materials and Methods: We reviewed FDA guidances relevant to biomarker use in clinical trials and their transition to use in clinical care. We identified instructive examples of these biomarkers in Alzheimer’s disease (AD) drug development and their application in clinical practice. Results: For use in clinical trials, biomarkers must have a defined context of use (COU) as a risk/susceptibility, diagnostic, monitoring, predictive, prognostic, pharmacodynamic, or safety biomarker. A four-stage process defines the pathway to establish the regulatory acceptance of the COU for a biomarker including submission of a letter of intent, description of the qualification plan, submission of a full qualification package, and acceptance through a qualification recommendation. Biomarkers used in clinical care may be companion biomarkers, in vitro diagnostic devices (IVDs), or laboratory developed tests (LDTs). A five-phase biomarker development process has been proposed to structure the biomarker development process. Conclusions: Biomarkers are increasingly important in drug development and clinical care. Adherence to regulatory guidance for biomarkers used in clinical trials and patient care is required to advance these important drug development and clinical tools.