ABSTRACT
Nonclinical tests are considered crucial for understanding the safety of investigational medicines. However, the effective translation from nonclinical to human application is limited and must be improved. Drug development stakeholders are working to advance human-based in vitro and in silico methods that may be more predictive of human efficacy and safety in vivo because they enable scientists to model the direct interaction of drugs with human cells, tissues, and biological processes. Here, we recommend test-neutral regulations; increased funding for development and integration of human-based approaches; support for existing initiatives that advance human-based approaches; evaluation of new approaches using human data; establishment of guidelines for procuring human cells and tissues for research; and additional training and educational opportunities in human-based approaches.
Subject(s)
Drug Evaluation, Preclinical , Animal Testing Alternatives , Humans , Inventions , Patient SafetyABSTRACT
Blacks are two to three times as likely as whites to die of preventable heart disease and stroke. Declines in mortality from heart disease have not eliminated racial disparities. Control and effective treatment of hypertension, a leading cause of cardiovascular disease, among blacks is less than in whites and remains a challenge. One of the driving forces behind this racial/ethnic disparity is medication nonadherence whose cause is embedded in social determinants. Eight practical approaches to addressing medication adherence with the potential to attenuate disparities were identified and include: (1) patient engagement strategies, (2) consumer-directed health care, (3) patient portals, (4) smart apps and text messages, (5) digital pillboxes, (6) pharmacist-led engagement, (7) cardiac rehabilitation, and (8) cognitive-based behavior. However, while data suggest that these strategies may improve medication adherence, the effect on ameliorating racial/ethnic disparities is not certain. This review describes the relationship between disparities and medication adherence, which likely plays a role in persistent disparities in cardiovascular morbidity and mortality.
Subject(s)
Black or African American/statistics & numerical data , Cardiovascular Diseases/ethnology , Healthcare Disparities/ethnology , Hypertension/drug therapy , Medication Adherence/ethnology , Antihypertensive Agents/therapeutic use , Awareness , Cardiovascular Diseases/mortality , Cardiovascular Diseases/prevention & control , Female , Hispanic or Latino/statistics & numerical data , Humans , Hypertension/complications , Male , Medication Adherence/statistics & numerical data , Retrospective Studies , Social Class , United States/epidemiology , United States/ethnology , White People/statistics & numerical dataSubject(s)
Cardiology , Drug and Narcotic Control/organization & administration , Hypertension, Pulmonary , Pediatrics , Randomized Controlled Trials as Topic , Sildenafil Citrate , Cardiology/methods , Cardiology/standards , Child , Child Advocacy , Child Health/legislation & jurisprudence , Dose-Response Relationship, Drug , Drug Development/methods , Drug Development/standards , Humans , Hypertension, Pulmonary/drug therapy , Hypertension, Pulmonary/mortality , Mortality , Off-Label Use/legislation & jurisprudence , Outcome Assessment, Health Care/ethics , Outcome Assessment, Health Care/statistics & numerical data , Pediatrics/methods , Pediatrics/standards , Randomized Controlled Trials as Topic/ethics , Randomized Controlled Trials as Topic/methods , Randomized Controlled Trials as Topic/standards , Sildenafil Citrate/administration & dosage , Sildenafil Citrate/adverse effects , Vasodilator Agents/administration & dosage , Vasodilator Agents/adverse effectsSubject(s)
Drug Development/legislation & jurisprudence , Health Policy/legislation & jurisprudence , Hypertension, Pulmonary/drug therapy , Pediatrics/legislation & jurisprudence , Phosphodiesterase 5 Inhibitors/therapeutic use , Sildenafil Citrate/therapeutic use , Vasodilator Agents/therapeutic use , Adolescent , Age Factors , Child , Child, Preschool , Drug Approval/legislation & jurisprudence , Government Regulation , Humans , Hypertension, Pulmonary/diagnosis , Hypertension, Pulmonary/physiopathology , Infant , Patient Safety/legislation & jurisprudence , Phosphodiesterase 5 Inhibitors/adverse effects , Policy Making , Risk Assessment , Risk Factors , Sildenafil Citrate/adverse effects , Treatment Outcome , United States , United States Food and Drug Administration/legislation & jurisprudence , Vasodilator Agents/adverse effectsABSTRACT
For Latinas with fasting plasma glucose (FPG) levels in the prediabetes and diabetes ranges, early detection can support steps to optimize their health. Data collected in 2009-2010 indicate that 36.7% of Latinas in the United States had elevated FPG levels. Latinas with elevated FPG who were unaware of their diabetes status were significantly less likely than non-Hispanic White and non-Hispanic Black women to have seen a health care provider in the past year (75.8%, 92.9%, and 90.2%, respectively; p = .018). With almost 1 million Latinas in the United States with elevated FPG unaware of their diabetes risk, and less likely than other at-risk women to see health care providers, there is an urgent need to establish alternate sites of opportunity for their diabetes screening.
