Cathy Anne Pinto's research while affiliated with Merck & Co. and other places

Publications (34)

Article
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To understand industry practices and challenges when submitting patient experience data (PED) for regulatory decisions by the US Food and Drug Administration (FDA). A two-part online survey related to collection, submission, and use of PED by FDA in regulatory decision-making (part 1) and a best-worst exercise for prioritizing potential PED initiat...
Article
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Objective: Patients have unique insights and are (in-)directly affected by each decision taken throughout the life cycle of medicinal products. Patient preference studies (PPS) assess what matters most to patients, how much, and what trade-offs patients are willing to make. IMI PREFER was a six-year European public-private partnership under the Inn...
Article
The European Medicines Agency (EMA) and FDA have policy goals of strengthening benefit-risk (B-R) capabilities; but how this has been translating into regulatory practice is unclear. A systematic review of oncology drug approvals between 2015 and 2020 was conducted with approvals identified through review of FDA and EMA annual reports, with extract...
Article
4531 Background: Data from a natural history study can be used to benchmark results from single arm trials with comparable ascertainment of exposures and outcomes. Despite limitations of externally controlled trials, natural history study data can provide important information, especially when clinical trial results provide compelling evidence of c...
Article
635 Background: Although a handful of studies have elicited treatment preferences in renal cell carcinoma (RCC), most focused on advanced disease. This study elicited United States patients’ and physicians’ preferences for adjuvant treatment characteristics. Methods: Patients with physician-confirmed RCC and (physician-defined) intermediate high or...
Article
661 Background: To inform shared decision-making, it is important to learn how patients or physicians trade off the features of adjuvant treatments and whether there is heterogeneity within preferences. Methods: An online discrete-choice experiment survey was administered to patients with physician-confirmed renal cell carcinoma (RCC) and physician...
Article
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Background and Objectives Case 2 best-worst scaling (BWS-2) is an increasingly popular method to elicit patient preferences. Because BWS-2 potentially has a lower cognitive burden compared with discrete choice experiments, the aim of this study was to compare treatment preference weights and relative importance scores.Methods Patients with neuromus...
Article
Introduction To understand the importance of the preference methods criteria to stakeholders at each decision point in the Medical Product Lifecycle (MPLC) and to determine the suitability of commonly applied preference methods (Discrete Choice Experiment [DCE], swing weighting [SW], probabilistic threshold technique [PTT], Best-Worst Scaling case...
Article
Objectives To understand the importance of criteria describing methods (e.g., duration, costs, validity, and outcomes) according to decision-makers for each decision point in the medical product lifecycle (MPLC). And to determine the suitability of a Discrete Choice Experiment (DCE), Swing Weighting (SW), Probabilistic Threshold Technique (PTT), Be...
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Background Prior biomarker studies have mainly been restricted to advanced RCC patients treated in clinical trials or have had limited integration of immunotherapy features such as programmed death ligand (PD-L)-1 with gene expression signatures intended to capture other canonical pathways to confirm their prognostic value. Material and methods PD...
Article
Objective : To assess the effect of patient preferences on the net clinical benefit (NCB) of an antiplatelet therapy for the secondary prevention of cardiovascular complications. Study Design and Setting : Risk equations were developed to estimate the individual predicted risk of key outcomes of antiplatelet treatment in patients with a prior myoc...
Article
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Background Antithrombotic drugs are used as preventive treatment in patients with a prior myocardial infarction (MI) in both the acute and chronic phases of the disease. To support patient-centered benefit–risk assessment, it is important to understand the influence of disease stage on patient preferences.Objective The aim of this study was to exam...
Article
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Patient preferences are gaining recognition among key stakeholders involved in benefit-risk decision-making along the medical product lifecycle. However, one of the main challenges of integrating patient preferences in benefit-risk decision-making is understanding differences in patient preference, which may be attributable to clinical characterist...
Article
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Introduction: It has become increasingly important to include patient preference information in decision-making processes for drug development. As neuromuscular disorders represent multisystem, debilitating, and progressive rare diseases with few treatment options, this study aimed to explore unmet health care needs and patient treatment preferenc...
Article
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Background Immuno-oncology (I-O) plays a major role in the treatment of advanced melanoma (aMel); however, resistance to therapy remains an important clinical problem. This study examined treatment patterns and overall survival (OS) for aMel patients who progressed on anti-programmed death ligand 1 (anti-PD-1) therapy in a real-world clinical setti...
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Objectives: Patient preference studies are increasingly used to inform decision-making during the medical product lifecycle but are rarely used to inform early stages of drug development. The primary aim of this study is to quantify treatment preferences of patients with neuromuscular disorders, which represent serious and debilitating conditions w...
Article
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Background Patient preference (PP) information is not effectively integrated in decision-making throughout the medical product lifecycle (MPLC), despite having the potential to improve patients’ healthcare options. A first step requires an understanding of existing processes and decision-points to know how to incorporate PP information in order to...
Poster
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Explore if gamified educational tools have been used to construct or elicit patient preferences regarding treatment and to assess how and to what extent they may support the construction or elicitation of preferences. Design criteria were also evaluated to formulate a set of requirements. A scoping literature review was performed to identify gamifi...
Article
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Background: Incorporating patient preference (PP) information into decision-making has become increasingly important to many stakeholders. However, there is little guidance on which patient preference assessment methods, including preference exploration (qualitative) and elicitation (quantitative) methods, are most suitable for decision-making at...
Article
BACKGROUND NF1-related PN can cause substantial morbidity, with no currently approved drug treatment available for PN treatment. Although surgery is the standard of care, complete resection of PN is often difficult due to encasement of vital structures and invasive and extensive PN growth. With limited real-world data among children with NF1-relate...
Article
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Preference studies are becoming increasingly important within the medical product decision-making context. Currently, there is limited understanding of the range of methods to gain insights into patient preferences. We developed a compendium and taxonomy of preference exploration (qualitative) and elicitation (quantitative) methods by conducting a...
Article
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Background: Research has been mainly focused on how to elicit patient preferences, with less attention on why patients form certain preferences. Objectives: To assess which psychological instruments are currently used and which psychological constructs are known to have an impact on patients' preferences and health-related decisions including the f...
Article
Purpose Quantitative benefit‐risk (B‐R) assessments are used to characterize treatment by combining key benefits and risks into a single metric but have historically been done for the “average” patient. Our aim was to conduct an individualized assessment for the oral antiplatelet vorapaxar by combining trial and real‐world data to further personali...
Article
Objective The aim of the study was to describe recent medication patterns and changes in medication patterns and glycemic control in adolescents and young adults with incident type 2 diabetes (T2D). Methods Using data from the SEARCH for Diabetes in Youth Study, we conducted a cross‐sectional analysis of treatments for adolescents and young adults...
Article
The number and complexity of regulatory and legislative policy initiatives for benefit–risk (B-R) assessments and the challenges associated with operationalizing and integrating these initiatives in the drug development process have increased exponentially in the last 10 years. Although there are some similarities in the approaches being used among...
Article
Our aim was to assess the effects of the cholesteryl ester transfer protein (CETP) inhibitor anacetrapib and atorvastatin, both as monotherapy and in combination, on particle concentrations of low-density lipoproteins (LDL), very low-density lipoproteins (VLDL), and intermediate-density lipoproteins in dyslipidemic patients. Although increases in h...
Article
Background Anacetrapib (ANA), a cholesteryl ester transfer protein inhibitor, has been shown to increase plasma HDL cholesterol and reduce LDL cholesterol, both as monotherapy and in combination with atorvastatin (ATORVA). The effects of these regimens on lipoprotein subfractions have not been reported. Methods ApoB-containing lipoprotein particle...
Article
A prospective, multicenter (18)fluorine-fluorodeoxyglucose ((18)F-FDG) positron emission tomography (PET)/computed tomography (CT) imaging study was performed to estimate the correlations among arterial FDG uptake and atherosclerotic plaque biomarkers in patients with peripheral artery disease. Inflammation within atherosclerotic plaques is associa...
Article
Full-text available
We investigated the effects of the cholesteryl ester (CE) transfer protein inhibitor anacetrapib (ANA) on plasma lipids, lipoprotein subfraction concentrations, and lipoprotein composition in 30 healthy individuals. Participants (n = 30) were randomized to ANA 20 mg/day, 150 mg/day, or placebo for 2 weeks. Changes in concentration of lipoprotein su...
Article
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Atherosclerosis imaging with 18F-FDG PET is useful for tracking inflammation within plaque and monitoring the response to drug therapy. Short-term reproducibility of this technique in peripheral artery disease has not been assessed, and the optimal method of 18F-FDG quantification is still debated. We imaged 20 patients with vascular disease using...
Article
ObjectivesA prospective, multicenter 18fluorine-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) imaging study was performed to estimate the correlations among arterial FDG uptake, and atherosclerotic plaque biomarkers in patients with peripheral arterial disease.

Citations

... Moreover, the patient-centric approach is being advocated in the context of BR assessment through the meticulous collection of patient preferences (Smith et al., 2016;Janssens et al., 2023). PV physicians are encouraged to actively collaborate with healthcare professionals, patients, and advocacy groups to ensure patientcentric approaches to drug safety. ...
... It offers an efficient and costeffective sample if this is an important criterion. 43 However, a general population might not be appropriate where weights may be required (e.g., MARs or market share) among potential patients. It might be plausible to assume than the general population sample provides lower MARs that a patient population does. ...
... Immune cells respond to this oxygen deficiency by activating a series of hypoxia-inducible factors (HIFs) (113). Both HIF-1a and HIF-2a have been shown to physically interact with the hypoxia response element (HRE) in the promoter region of PD-L1 (83,114). ...
... In a study of patients receiving palliative chemotherapy for advanced bile duct cancer, poor ECOG PS was associated with shorter OS [37]. Similar results were obtained in patients with advanced melanoma [38]. ...
... [1,2] Stroke is the leading cause of chronic disability, with an increasing burden on patients and society. [1,3] Management of stroke leads to an improved prognosis due to recanalization and restoration. [4][5][6] Nevertheless, primary prevention remains the most effective means of reducing the stroke burden. ...
... The most important research priorities identified were related to four high-level concepts: evidentiary standards, assessment of preference heterogeneity, means to minimize patient burden, and means to maximize patient understanding of concepts presented in preference studies. These were used to guide the research questions addressed in ten PREFER case studies that provided evidence to support recommendations on when and how to execute health preference studies [12][13][14][15][16][17][18][19][20][21][22]. ...
... There are few data on the impact of factors such as support from family or friends on preference for treatment. In a consensus study that drew on systematic reviews and input from experts, social support was relegated to the category of "inconclusive" with no data available [6]. ...
... There are small numbers of patients, and they can present with considerable phenotypic and genotypic heterogeneity, so finding a significant number of individuals that would fit within inclusion criteria of a clinical trial can be challenging. Stakeholders such as industry and regulators are therefore increasingly seeking input from patients in order to advance understanding the disease and the patient community's needs [15]. ...
... When designing the survey instruments, additional evidence such as a literature review and experience-based opinions from the key members of the team (patients, clinical experts, and methodological experts) were also considered. More details regarding these qualitative findings were reported elsewhere [26,27]. These findings showed that 11 attributes were eventually narrowed down to six final attributes that were included in the DCE and BWS-2 as minimizing the cognitive burden was key: muscle strength, energy endurance, balance, cognition, chance of (temporary) blurry vision, and chance of (permanent) liver damage. ...
... Additionally, the comparison of different methods for preference elicitation, study of nondiscrete choice experiment methods, and the consistency of preference outcomes from different methods were highly prioritized topics in the previous exercise. In the current study, this topic remained an important topic with indications that while additional research has been done in these areas since the first prioritization exercise [23,[50][51][52][53], more research would help to understand which method to choose when conducting a preference study. Interestingly, the topic of stability of preferences over time was previously ranked as least important, but in this updated exercise it was considered the second most important research topic. ...