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The article discusses the Sequenced Treatment Alternatives to Relieve Depression (STAR*D), a prospective study that began with adults diagnosed with a current major depressive episode who were treated in participating psychiatric and primary care clinics. Topics include treatment interventions in the study, reason for reaanalyzing the STAR*D data, and novel agents that have entered the antidepressant armamentarium with approvals from the U.S. Food and Drug Administration (FDA) since 2006.

OBJECTIVES: The study examined a commercial accountable care organization (ACO) population and then assessed the impact of an integrated care management program on medical spending and clinical event rates. STUDY DESIGN: Retrospective cohort study of high-risk individuals (n = 487) in a population of 365,413 individuals aged 18 to 64 years within the Mass General Brigham health system who were part of commercial ACO contracts with 3 large insurers between 2015 and 2019. METHODS: Using medical spending claims and other enrollment data, the study assessed the demographic and clinical characteristics, medical spending, and clinical event rates of patients in the ACO and its high-risk care management program. The study then examined the impact of the program using a staggered difference-in-difference design with individual-level fixed effects and compared outcomes of those who had entered the program with those of similar patients who had not entered. RESULTS: The commercially insured ACO population was healthy on average but included several hundred high-risk patients (n = 487). After adjustment, patients within the ACO's integrated care management program for high-risk patients had lower monthly medical spending (by $1361 per person per month) as well as lower emergency department visit and hospitalization rates compared with similar patients who had yet to start the program. Accounting for early ACO departure decreased the magnitude of the program effects as expected. CONCLUSIONS: Commercial ACO populations may be healthy on average but still include some high-risk patients. Identifying which patients might benefit from more intensive care management could be critical for reaping the potential savings. [ABSTRACT FROM AUTHOR]

An interview with Doctor Joseph R. Mickhael, lead author of a quality improvement initiative launched in 2020 to examine healthcare disparities in relapsed/refractory multiple myeloma. Topics discussed include electronic medical records audits, team-based audit feedback sessions, and challenges of bringing greater diversity to clinical trials.

OBJECTIVES: Extrapyramidal symptoms (EPS) affect 15% to 30% of patients with schizophrenia treated with antipsychotics and have been associated with poor outcomes. This study examined the incidence and economic burden of EPS in patients with schizophrenia initiating atypical antipsychotics (AAPs). STUDY DESIGN: Retrospective analysis of secondary deidentified administrative claims database. METHODS: Patients with schizophrenia initiating AAPs with no prior EPS were identified in the MarketScan Commercial and Medicare Supplemental databases from January 1, 2012, to December 31, 2018. Incidence of EPS (diagnosis or medication use) was assessed in the year following AAP initiation. Annual all-cause and schizophrenia-related health care resource utilization (HCRU) and costs were assessed in cohorts who did or did not develop EPS in the year following first EPS claim (EPS cohort) or randomly assigned index date (non-EPS cohort). Multivariate regression was used to compare all-cause and schizophrenia-related total health care costs and inpatient admissions between cohorts. RESULTS: A total of 3558 patients with schizophrenia newly initiating AAPs were identified; 22.1% developed EPS in the year following AAP initiation (incidence: 26.9 cases per 100 person-years). Multivariate analyses revealed that patients with EPS had 34% higher odds of all-cause (odds ratio [OR], 1.3361; 95% CI, 1.0770-1.6575; P < .01) and 84% increased odds of schizophrenia-related (OR, 1.8436; 95% CI, 1.0434-2.4219; P < .0001) inpatient admission compared with the non-EPS cohort. The EPS cohort also evidenced significantly higher adjusted all-cause ($26,632 vs $21,273; P < .001) and schizophrenia-related ($9018 vs $4475; P < .0001) costs compared with the non-EPS cohort. CONCLUSIONS: The 20% of patients who developed EPS in the year following AAP initiation evidenced significantly increased HCRU and costs over the postindex period. Schizophrenia therapies with reduced EPS risk are needed to improve patient care. [ABSTRACT FROM AUTHOR]

The article offers information on the emerging tools in data analytics, automation, EMR aggregation enabling faster and easier patient recruitment. It further discusses aspect of pharmaceutical development, because it involves a variety of factors beyond study sponsors' control; the emerging new ways that sponsors and contract research organizations (CROs) are conducting patient recruitment; and also mentions that COVID-19 pandemic also increased public awareness of clinical trials.

The article discusses the use of digital therapeutics (DTx) and their relationship with decentralized clinical trials (DCTs). Topics include its relationship in clinical trial practice that has been strengthened by the Covid-19 pandemic; and DCTs can impact pharmaceutical companies exploring DTx combination products and standalone DTx studies.

The article discusses the effectiveness of the bleeding reversal agent andexanet alfa from AztraZeneca in treating patients with acute intracerebral hemorrhage while taking oral factorXa (FXa) inhibitors based on a study presented at the 2023 World Stroke Congress (WSC). According to Doctor Stuart J. Connolly, andexanet is a decoy molecule that is proven to be effective against acute ICH.

The article discusses the 15th annual Summit for Clinical Ops Executives (SCOPE) that was held in Orlando, Florida, from February 11-14, 2024. Topics discussed include the application of real-world data (RWD) in clinical trials, driving efficiencies in trial strategy with generative AI, and discussions on decentralized clinical trials (DCTs) and site burden. Attendees included Alex Deyle from Flatiron Health, Todd Everhart from Signant Health.

An interview with Paige Bingham, chief executive officer of Meeting Protocol Worldwide is presented. She discusses her background in meeting planning and her involvement in addressing logistical challenges in rare disease clinical trials. She further talks about the creation and work of Scout Clinical, a clinical trial patient travel and reimbursement company.

The article discusses the best practices in the integration of technology in clinical trials to help partners across the trial process. Among the best practices are thinking beyond wearable devices to include innovations like artificial intelligence (AI), defining and building reliable data, and streamlining the patient experience. Also cited are the mistakes to avoid like neglecting technology (tech)-related regulatory standards.

The article offers information on how integrated data platforms can help find the best-suited patients for cancer studies and reduce the burden on care teams. Topics inlcude the academic medical centers and large cancer centers have traditionally been best equipped and have administered the bulk of oncology clinical trials, and the clinical research coordinators (CRCs) to find enough qualified patients to effectively triage through the clinical trial process.

On November 25, 2020, CMS announced the creation of an Acute Hospital Care at Home program to reimburse qualifying hospital-at-home models. As we increasingly adopt the Acute Hospital Care at Home program and similar home-based services, it is crucial to better define the value of these programs and their appropriate reimbursement rates. We provide a framework centered around cost, quality, and equity to help accomplish this task. Quality reporting should use both inpatient-specific and home health care--specific metrics, equity-focused process metrics and risk-adjusted outcome metrics, and validated diseasespecific tools. Costs should be measured comprehensively and uniformly through the use of time-driven activity-based costing and consider caregiver opportunity costs. It is also worthwhile to consider personal, societal, technical, and allocative value when determining the value and subsequent reimbursement rates of hospital-at-home programs. With careful patient selection, the hospital-at-home model has the potential to significantly benefit a subset of patients. To create sustainable reimbursement mechanisms for hospital-at-home programs, we first need a better definition of the value provided by this model of care. [ABSTRACT FROM AUTHOR]

The article focuses on the several ways decentralized clinical trials (DCTs) Can Positively Impact Trial Diversity. Topics discussed include Digital clinical trial tools–including eConsents, eSource, electronic patient reported outcomes (ePROs), electronic clinical outcomes assessments (eCOAs), telehealth visits, medication adherence apps; and this new approach dramatically reduced the most common burdens inherent to traditional trial participation.

The article offers information about the limitations and flaws in the widely-accepted statistic of eligible patients participate in clinical trials. It argues that this figure needs a serious reboot as it fails to consider various factors and is based on a narrow patient population. It also mentions that the evolving nature of investigational therapies and strategies for engaging study volunteers are not accounted for in this outdated estimate.

The article focuses on the attribution of social media in healthcare and pharmaceutical transformation. Topics discussed include the outline of social media attention and pursuits in adverse event reporting, the advance patient-centric approaches in clinical trials, the geo-based social media strategy, and the association between social media and patient recruitment.

The article presents a study to examines cost and benefits of patient recruitment and retention for bringing clinical research procedures of homecare by a medical profession. The study highlights benefits of homecare in healthcare setting include reduction in frequency of outpatient visits, quicker patient discharge and chronic-disease management. The study also looked at economic impact of treating patient in home compared to hospital outpatient setting.

The article discusses the key areas that the clinical trial industry should focus to ensure successful execution of an early phase oncology trial. These include new molecular entity selection, protocol development and optimization of design and patient selection. The author states that the development of safe and effective cancer therapies depends on the clinical and regulatory success of the new treatments and the continued use of existing products.

The article examines the investigator characteristics and patient recruitment in Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), a randomized, double-blind, active-controlled trial which adopted the community-based approach. The study involves classes of antihypertensive medications including amlodipine, lisinopril, and doxazosin. Characteristics found include physician-investigator ethnicity, clinical practice type, and attitudes and research experience.

The article discusses the systematic literature review conducted by the Recruitment Project team of public-private partnership Clinical Trials Transformation Initiative aimed at identifying some of the barriers clinical trial recruitment. Results found some barriers including transportation, trial visits, and out-of-pocket expenses by respondents from patient advocacy groups, contract research organizations, and research sites. The survey also suggests methods to improve recruitment.

The article discusses about European clinical trial rules. Topics discussed include that with effect from January 31, 2023, no new clinical trial applications in the EU can be submitted via national systems, all initial applications must go via the Clinical Trials Information System (CTIS) and that the European regulators are reflecting on how to implement the revised international guideline on good clinical practice.

The article discusses a study which provides an example of how iterative analysis of recruitment data may be used to optimize recruitment outcomes during ongoing recruitment. The study was conducted by researchers at the University of Wisconsin Center for Tobacco Research and Intervention (UW-CTRI). It reveals how iterative analysis of subject recruitment data can optimize outcomes during ongoing enrollment.

The article offers information on the Covid-19's disruption of clinical operations has made trial starts and execution challenges. It mentions the insights into the causes of delays and redundant user tasks, organizations that evaluate end-to-end study start-up processes, along with discusses the Study start-up as one of the most time and resource-intensive areas in clinical research.