Clinical Development and Late Stage Research

 

Clinical Development and Late Stage Research

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Are Your Clinical Trials Mobile?
Nancy Mulligan
The fact that mobile technologies have penetrated most – if not all – industries is hardly surprising, given that they are able to deliver innovative answers to problems that have, traditionally, been hard to resolve. This article is taken from International Clinical Trials...

As our industry shifts importance from volume to value, it is more important than ever to have a strategic approach to collecting and analyzing evidence. UBC offers a robust history of building economic evidence to demonstrate and support the value of products on behalf of...

Second-generation anti-psychotic medication use has increased dramatically, although the prevalence of the indicated psychiatric conditions (bipolar, schizophrenia) has remained stable The potential harm from off-label prescribing for mild conditions that have little evidence...
Treatment satisfaction is an important predictor of real-world medication adherence in chronic medical conditions such as asthma and COPD. The objective of this study was to identify and describe measures used to assess treatment satisfaction and preference in patients with...
In the absence of secondary sources of health care data, chart review studies are necessary to fulfill peri- and post-approval evidence gaps such as informing on patient profiles, treatment effectiveness, and clinical and safety outcomes. Multinational studies (conducted in more...
Clinical trial nursing services UBC
UBC’s Clinical Trial Nursing Services support services increase patient recruitment, improve compliance, alleviate study burden and reduce costs.
Are Your Clinical Trials Mobile?
The fact that mobile technologies have penetrated most – if not all – industries is hardly surprising, given that they are able to deliver innovative answers to problems that have, traditionally, been hard to resolve. This article is taken from International Clinical Trials...
Patient Centricity article
A patient-centric approach to a Phase IV trial for MS treatment resulted in lessons that can be applied for future therapeutic studies for this and other rare diseases.
This study aimed to evaluate whether use of long-acting bronchodilators increases the risk of acute myocardial infarction (MI) in patients with COPD who are at high risk for cardiovascular disease.
To summarise and highlight what the EU Orphan Drug Regulation has accomplished since its inception.
The study objectives were to determine 1) if a clinical call center staff could teach patients how to measure their RA disease activity using the RAPID3 and track patient scores over time, and 2) whether patient use of RAPID3 increases patient satisfaction and improves patient-...
• To summarize regulations regarding orphan drug designation in the US and EU • To discuss and demonstrate how drug developers can take advantage of the regulators’ incentives to optimize their investment in orphan drug development
Understand what evidence and value messages can be generated from chart review studies in expanded access patient populations and describe best practices for collecting data from these programs to inform real-world use, treatment effectiveness and clinical outcomes.
Healthcare needs a hero | UBC
Biotech and pharmaceutical professionals typically don't get much recognition. That needs to change. It's time to shine a light on the heroes who walk among us, those who discover, develop and deliver life-saving medicine.
Clinical Trial Nurses
The convenience and care nurses provide through in-home clinical visits benefit most patients, including pediatric patients, those who are too sick to travel, or those requiring a more flexible schedule. Studies utilizing clinical trial nurses are more accessible, more...
Alzheimer's clinical trials | UBC
Alzheimer's disease is the 6th leading cause of death in the U.S. and affects more than 5 million people over the age of 65. UBC provides customized support and recruitment plans proven to optimize a site's existing support, accelerate recruitment and maintain momentum...
Cost-containment in health care paired with global regulatory approvals of biosimilar agents pave the way for less expensive alternatives to complex biologics. Regulators and payers increasingly demand robust safety and effectiveness data in real-world settings. Our objective...
Limited evidence exists regarding the risks and benefits of antipsychotic (AP) polypharmacy, however, antipsychotic polypharmacy is not uncommon and is compounded by widespread off-label prescribing. This study uses repeatable methods and real world data to profile AP users and...
When existing secondary data cannot address multiple stakeholder needs, primary data collection (retrospective and/or prospective) should be considered in combination to or as a standalone study design. Our objective was to explore the strengths of hybrid studies that combine...
Databases are essential tools for pharmacoeconomic research. North America has large administrative claims, hospital, and electronic medical record (EMR) databases. Databases in Europe are scarcer, integrated primary and secondary care data are rare, and claims with...
In August 2015, the US Food and Drug Administration (FDA) released a draft document to address some challenges in developing drugs for rare diseases. The following practical suggestions can be drawn from the FDA guidance.
To describe the psychosocial impact of facial aging in adult females and males.
In 2014, omacetaxine mepesuccinate became the first cytotoxic chemotherapy approved for subcutaneous injection by patients/caregivers at home. The FDA issued a post-market requirement (PMR) to identify associated risks using failure modes and effect analysis (FMEA). FMEA is a...
International Clinical Trials Dr. Don Gabriel
Pharmacogenomics is the study of individuals' genetic variations, and how that impacts the way patients respond to medication. What implications does the use of pharmacogenomics have on clinical studies, and on oncology in particular?
UBC was able to make 3 months and 17 days of difference on a phase III global oncology study.
UBC has worked with every major MS drug in the clinical pipeline over the last 19+ years and utilizes that experience to deliver global patient recruitment and retention offerings.
Pharmacogenomics whitepaper | UBC
Pharmacogenomics enables us to predict how an individual’s genes will affect his or her response to specific therapies. The role of pharmacogenomics is particularly significant to oncology, as tailored therapies maximize effectiveness and minimize adverse events. With experience...
Data driven approach to patient recruitment
As an Express Scripts company, UBC uses our unmatched, real-world data to accelerate enrollment in clinical trials.
MediCUBE | UBC
MediCUBE enables HIPAA- and Safe-Harbor-compliant access to de-identified prescription and medical claims information for more than 130 million unique patients.
Observational Studies and Registries | UBC
UBC offers strategic, scientifically rigorous studies designed to address stakeholder-driven evidence requirements. UBC is an industry leader in the design and global implementation of observational cohort studies, registries, large streamlined studies, other observational...

Generating real-world evidence is essential to uncovering the potential effects a product may have on pregnancy outcomes, particularly for women of childbearing age who require chronic therapy for diabetes, depression, epilepsy, asthma and more.

Understanding key...

Post Haste - Jess Sohal - International Clinical Trials
Providing vital real-world safety information on a launched drug, post-authorisation safety studies can be key to market acceptance and uptake – but detailed operational planning is essential
Few studies have estimated time and associated cost related to a paediatric vaccination visit. Time and Motion (T&M) methodology is suitable to collect efficiency-related outcomes.The aim was to quantify active healthcare professional (HCP) time and associated costs of a...
In patients with bone metastases from solid tumours, denosumab (Dmab) subcutaneous (SC) injection represents an alternative formulation to zoledronic acid (Zol) intravenous (IV) infusion and a superior efficacy for skeletal-related events prevention. This observational Time and...
Since 2011, denosumab (Dmab) subcutaneous (SC) injection is available as a superior treatment option in patients with bone metastases from solid tumours, compared with zoledronic acid (Zol) administered as an intravenous (IV) infusion. Although Zol was the mainstay treatment for...
For both prospective and retrospective observational study designs, data collection errors and missing data are inherent challenges. Our purpose was to outline principal challenges for either methodology and propose solutions aiming to increase overall quality of study data and...
The objective of this study was to compare the one-year costs related to cardiac adverse events post-index procedure discharge of Absorb and Xience.
Dexmedetomidine was approved for ICU sedation in adults in the EU in 2011, but has been available in other countries since 1999 and used in many different clinical situations including in children. This study evaluated off-label use of dexmedetomidine in usual care in the EU.
Infographic: Rare Disease Patients Have Many Questions
Do you have the right answers for patients with rare diseases? UBC can help with our comprehensive services.
This study utilizes 2 data sources: (1) retrospective patient medical chart review of demographics, including safety and tolerability of prolonged treatment with gefitinib as part of the ICAP; and (2) retrospective review of serious adverse event (SAE) reports in the AstraZeneca...
UBC’s Patient and Physician Services (PPS) team has supported every major multiple sclerosis drug in the clinical pipeline over the last 19 years. They discuss the challenges associated with recruiting MS patients and highlight various clinical trial recruitment strategies,...
Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity and mortality worldwide. Long-acting bronchodilators (LABs) are the mainstay of pharmacological maintenance therapy for COPD. However, the possibility that use of LABs may lead to risk of...
Increasingly, real-world observational DUS are being conducted as part of the marketing authorization process or post-market approval to assess risk management activities, off-label drug use, safety and effectiveness. Determine the best approach for conducting observational DUS...
How a pharmaceutical company and CRO partnered to build a first-of-its-kind clinical trial Alumni Community utilizing the Blue Button standard
Understand the latest guidance concerning safety reporting requirements including variation in Sponsor safety reporting for chart review studies.
Understand best practices for collecting chart review study data from multi-country/center initiatives.
Real-world evidence solutions
The current environment of tighter regulatory processes in relation to market access, combined with cost containment measures, has led to the increasing demand for post-market real-world evidence to demonstrate value. United BioSource Corporation (UBC) is a full-service provider...
Chart reviews
Retrospective chart review studies are often needed in the absence of suitable healthcare databases and/or other secondary sources of information. Chart review studies facilitate the rapid collection of clinical, safety, and healthcare resource utilization (HRU) data.
Feasibility Studies for Clinical Trials
More than just doing the groundwork before a trial starts, a preliminary feasibility assessment can be an important early indicator of site capabilities, study variables and potential hurdles – a reality check enabling sponsors to make changes while they still can
To understand the cost range for pediatric vaccine administration across different countries and to describe the costing methodologies employed for its calculation.
With oral antineoplastic agents (OAAs) becoming the mainstay of treatment for several cancer types, understanding risk factors for medication non-adherence is becoming increasingly important in oncology. Patient-reported outcome (PRO) instruments may provide valuable insight on...
Medication Guides are patient-directed, Food and Drug Administration (FDA)-approved labeling intended to provide risk and safe-use information for prescription medications in easy-to-read, lay language. They were introduced to help patients understand and manage risks and...
Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity and mortality worldwide. Long-acting bronchodilators (LABs) are the mainstay of pharmacological maintenance therapy for COPD. However, the possibility that use of LABs may lead to risk of...
United BioSource Corp. Names Renowned Hematological Oncologist to Staff
United BioSource Corp. (UBC), a subsidiary of Express Scripts (NASDAQ: ESRX), has appointed Don Gabriel, MD, PhD, an expert in targeted oncology treatments, to its Global Clinical Development & Operations team.
Market Research for Clinical and Commercial Programs
UBC delivers global solutions to patient recruitment challenges faced by pharmaceutical, government, and biotech sponsors. Among the services we provide are qualitative research with various stakeholder groups — healthcare providers, specialists, pharmacists, patients, and...
UBC’s Patient and Physician Services (PPS) team is a dedicated group of clinical trial experts who implement patient recruitment strategies, site selection, risk management programs and more. This team can accelerate clinical trial enrollment, increase patient adherence, and...

Nearly half of clinical trial study sites don’t meet enrollment requirements or fail to enroll a single patient. This contributes to extended study timelines and increased competition for high-performing study sites. Proactively preparing sites before the site activation...

We offer customised consulting, development and implementation solutions in clinical development and late stage research. This includes experts on the ground in the EU who can assist with clinical trials, peri & postapproval studies and value demonstration programmes. Our...
Task-based Versus Case-based Analysis of Time Outcomes in Multi-country Time and Motion (T&M) Studies: Methodological Considerations and Application
Time-based variables are challenging due to numerous sources of variability and potential confounding, including but not limited to, individual site characteristics, inter-rater variability, characteristics of personnel being observed, as well as selection bias and residual...
In-patient Hospital Costs of Stroke: A Focused Literature Review
Stroke is the 3rd leading cause of mortality worldwide, and is associated with enormous economic burden. The acute phase of stroke treatment is associated with significant hospitalization costs.This poster reports on the published costs of stroke over the past 5 years and...
Time Savings with Trastuzumab Subcutaneous (SC) Injection vs. Trastuzumab Intravenous (IV) Infusion: a Time and Motion Study in 3 Russian Centers
Time and Motion (T&M) studies are observational non-interventional studies to quantify efficiency-related outcomes.In Russia, trastuzumab (Herceptin®) is approved, among other indications, for the treatment of patients with HER2-positive Early Breast Cancer (EBC). A new...
Targeted Literature Review of Medication Event Monitoring Systems to Evaluate Adherence in Observational Real-world Studies
Oral anti-cancer treatments have become available at a rapid pace and are changing the usual care practice of the treating physician in oncology. Emerging literature on adherence with oral antineoplastic agents, mainly published in breast cancer and chronic myeloid leukemia (...
Implementation of International Chart Review Studies: An Assessment of Ethics and Regulatory Considerations
In the absence of suitable secondary sources of healthcare data, chart review studies offer an effective method to capture and analyze real-world data on patient demographics, clinical characteristics and outcomes, treatment patterns, treatment effectiveness, and safety. For...
In absence of patient-level databases, multi-national, retrospective chart review studies can be undertaken to provide robust naturalistic data to inform evaluations of treatment patterns, resource utilization, costs of care, clinical outcomes and safety.
Providing precise data capture and management as well as comprehensive statistical analysis of all phases of clinical research, REMS requirements, and outcomes and registries studies UBC’s Data Management and Biostatistics services bring together technology and therapeutic...
While majority of PASS studies are conducted in Western nations, other regions such as Asia have acknowledged the importance of PASS. In the absence of suitable databases, chart reviews can be used to evaluate drug utilization and satisfy PASS requirements.
A post authorization safety study (PASS) is a study of a marketed drug or biologic conducted in an effort to confirm the safety profile or identify potential safety issues not identified in the controlled clinical trial population. A PASS may be done voluntarily or in response...
Retrospective chart review studies can result in robust naturalistic data to inform evaluations of treatment patterns, resource utilization, costs of care, clinical outcomes and safety. Data quality control is challenging both as a result of poor quality documentation in the...
A challenge in multi-centre Time and Motion (T&M) studies is performing inferential statistics, in light of hierarchical data. Our objective was to investigate two approaches to analyze the data.
Stroke is the third leading cause of mortality worldwide, with significant associated acute care hospitalization costs. The objective of this literature review was to delineate the costing methodologies employed for the estimation of in-patient hospital costs of stroke.
Trastuzumab (TRA) subcutaneous (SC) injection is an alternative to intravenous (IV) administration for the treatment of HER2+ early breast cancer (EBC). The objective was to quantify healthcare professional (HCP) time and patient chair time related to TRA treatment to estimate...
To identify and review methods employed to evaluate medication adherence in studies of oral antineoplastic agents, with particular interest in the opportunities and challenges associated with medication event monitoring systems (MEMS) implemented in observational studies.
Compassionate use programmes provide peri-approval drug access based on unsolicited physician requests for patients with unmet need. Practice pattern evaluations in this context, using chart review methodology, permits the collection of pre-approval data outside of clinical...
In the absence of secondary sources of healthcare data, chart review studies can result in patient level data repositories including patient characteristics, care patterns, treatment effectiveness and clinical and safety outcomes. Data can be used to populate economic...
Compelling value messages are based on the right evidence resulting from the right design. UBC’s Value Demonstration team helps pharmaceutical and biotech clients build economic evidence to demonstrate and support the value of products.
Quantifying increased efficiency with medical interventions
Every journey is unique. Choose your guide wisely. UBC offers global product safety, brand loyalty and patient access strategies that span the full product lifecycle.
Achieve and maintain market authorisation in Europe. UBC offers customised consulting, development and implementation solutions.
Clinical Development Solutions
UBC’s experience in strategic clinical development and execution of both registrational and peri-approval studies spans four decades, across most therapeutic areas, and around the world. UBC’s clinical teams collaborate with sponsors to help ensure conclusive study results and...
PPS
At UBC, we use the latest technology and employ experienced and dedicated people to deliver global patient recruitment offerings.

Rising R&D costs and a shift toward patient empowerment are converging forces that are changing the face of clinical research. It is critical to design and implement clinical trials that minimize cost and leverage patient engagement.

Erem Latif, Trial Enhancement...

The international, randomised, two-cohort PrefHer study (NCT01401166) assessed patients’ preferences for subcutaneous trastuzumab (Herceptin® SC, F. Hoffmann-La Roche Ltd, Basel, Switzerland) via single-use injection device (SID, Cohort 1)1 or the European Medicines Agency (EMA...
UBC conducted a review of the T&M studies presented at ISPOR meetings in the last five years. The main characteristics of each study were reviewed and discussed: type of medical intervention, study design, source of data, number of groups examined, type of time measurements...
Results of this review confirm that different registry designs are being used in real-world data collection to meet specific research objectives, be it safety monitoring, understanding disease natural history, or long-term clinical outcome evaluation. Based on the types of data...
Prospective observational studies often require a combination of patient recruitment and data collection methodologies such as direct-to-patient outreach or the use of pharmacy claims.These case studies demonstrate a novel approach to study design from within a single research...
A case study presented at ISPOR in June 2014 illustrates a hybrid design combining a site survey, time and motion observations, patient questionnaires, and retrospective chart review. The study was successfully completed at 12 sites in the US and Canada, with 670 enrolled...
Article: Understanding the Natural History of Disease – A Fundamental Strategy During Drug Development and Beyond
Having an in-depth understanding of the disease or condition for which a drug or biologic is being developed seems fundamental, yet sponsors do not always fully understand disease natural history prior to or during drug development. In the overall scheme of product development,...
The objective of this abstract is to highlight main considerations when reporting drug safety outcomes in national and international retrospective chart review studies and describe strategies for ensuring safety reporting requirements are met.
The objective of this abstract is to describe new evidence requirement challenges imposed by regulators with respect to evaluations of drug safety post-market and discuss logistical challenges and timeline constraints associated with chart review DUS to inform dialogue and...
UBC offers big solutions for small patient populations. From clinical trials to high-touch adherence programs, we know that individualized patient care is important to patients with rare diseases.

Payer and regulatory evidence requirements are converging, resulting in both opportunities and challenges for real-world study designs. European pharmacovigilance legislation was revised in July 2012, defining Post-Authorization Safety Study (PASS) requirements and presenting...

Increasingly, value demonstration evidence requirements cannot be addressed with a single data source and/or methodology. The objective of this research is to present, using case studies to illustrate, a strategic and step-wise approach for the development of optimal study...
Research using observational data is complex and costly due to massive size and disparate format. Consequently, scientists frequently use one data source when conducting a study, which can result in inaccurate reflection of the target population or insufficient sample sizes. Use...
A targeted search was conducted in MEDLINE to identify all original research published in 2013 reporting results from registries. The search was restricted to English language publications. Abstracts of relevant citations were reviewed to obtain the country of study, therapeutic...
Efficiency may be crucial to a health technology’s value proposition. Measuring time endpoints prospectively is subject to variability and bias that makes Time and Motion (T&M) methodology complex. The aim was to investigate key design characteristics of T&M studies...
Direct observation of healthcare processes through time and motion (T&M) studies is increasingly warranted to provide evidence of medication or device efficiency. This methodology can be leveraged to collect comprehensive data on patient characteristics, and health and care...
Use of a Common Data Model (CDM) to standardize data format and assumptions facilitates consistent and efficient application of research methods across disparate data sources, producing meaningfully comparable results. This study compared patient and treatment characteristics...
Use of a Common Data Model (CDM) to standardize data format and assumptions facilitates consistent and efficient application of research methods across disparate data sources, producing meaningfully comparable results. This study compared treatment patterns for patients...
The convergence of payer and regulator evidence requirements warrants a strategic evidence generation plan and a mindful orchestration of peri and postapproval real-world studies. Study designs resulting in a diverse array of health economic and safety data are increasingly...
Krista Payne and Dara Stein discuss the use of retrospective chart review studies as a way of capturing real-world patient-level clinical, healthcare and safety data. PharmaPhorum, December 2013
The strategic uncertainty confronting big Pharma today has put a premium on generating new ideas from outside sources – it’s the fresh wind that lifts the sails. CROs and other biopharma vendors with a business mission to guide the industry through an era of rapid change are...

To be best prepared for postapproval safety monitoring, evaluation, and mitigation, biopharmaceutical companies must know what is required in terms of an RMP and a REMS. Preparation of these tools must begin during drug development. Postapproval safety is not just a...

Regulators, payers, providers, HTA agencies and other healthcare stakeholders are increasingly recognizing the importance of observational data from patient registries and related research studies.  Observational studies can be used to help sponsors and the varied...

Risk management plans and risk minimization plans as well as postapproval commitment studies are based on risks identified pre-approval that need to be further characterized or minimized in the postmarketing environment. Although the implementation of these activities are...
Trastuzumab (TRA) subcutaneous single-use injection device (SC SID) is an alternative to intravenous (IV) administration for the treatment of HER2+ early breast cancer. This study quantifies healthcare professional (HCP) time and patient chair time related to TRA SC SID vs. TRA...
Increasingly, to meet marketing authorization and risk management real-world data needs, regulators are requiring real world prescription pattern data including off-label information. In the absence of suitable databases, chart review studies can result in robust datasets...
Multicentric Castleman Disease (MCD) is a rare lymphoproliferative disorder with no established therapy. Little is known about MCD usual care treatment patterns and associated outcomes. The design and execution of a retrospective chart review study of patients with MCD are...
In multi-centre Time and Motion (T&M) studies, time endpoints can be highly variable due to differences in centre practices. Our aim was to assess the impact of the type of analysis employed on the results of a T&M study.
A major challenge for haemodialysis (HD) centres is to maximise efficiency in care provision while maintaining high standards of care. Our objective was to document health care professional (HCP) time for renal anaemia management for both shorter-acting erythropoiesis-...
To describe existing models of pharmaceutical care (PC) in England, Poland, Germany, Denmark, Italy and United States and to indicate similarities and specific attributes meant as differences (from the whole system point of view), identifying possibly promising solutions (...
To review design characteristics of T&M studies applied to healthcare, with a focus on choice of study design, statistical methodology, and handling of multi-centre data.
To elicit utility values from EQ-5D for patients with various stages of mCRC.
There is an increased need to conduct international chart review studies (chart reviews) since healthcare databases with required information are not consistently available. Chart reviews offer an alternative for the effective capture and analysis of real-world patient-level...

In the absence of available medical claims or other databases, retrospective chart review designs can be leveraged to support the gathering of real-world data appropriate for evaluations of burden of illness, drug utilization and safety outcomes.  Data collected from...

Use of a Common Data Model (CDM) to standardize data format and assumptions facilitates consistent and efficient application of research methods across disparate data sources, producing meaningfully comparable results. This study compared patient and treatment characteristics...
Little is known about usual care treatment patterns and associated outcomes in Multicentric Castleman Disease (MCD). Information on the management of this disease can inform clinical practice, treatment guidelines and elucidate areas of unmet medical need.
From September to December 2010, a recall of peritoneal dialysis (PD) solutions (1 Dianeal and 2 Nutrineal lots) was initiated in Europe. These 3 recalled lots (manufactured at 1 site in Ireland) were related to elevated endotoxin levels and associated with increased sterile...
Increasingly, to meet marketing authorization and risk management data needs, regulators are requiring real world prescription pattern data including empirical off label-use. In the absence of suitable databases, chart review studies can result in robust datasets appropriate for...
Little is known about usual care treatment patterns and associated outcomes in Multicentric Castleman Disease (MCD). Information on the management of this disease can inform clinical practice, treatment guidelines and elucidate areas of unmet medical need. The design and...
Time and Motion (T&M) studies quantify time-related outcomes. Any given intervention process can be broken down into a set of pre-defined tasks for repeated observations, allowing estimation of the mean task durations in support of health economic analyses. While aiming to...
In the absence of suitable healthcare databases, chart review studies can result in tailored datasets suitable for evaluations of burden of illness, unmet need and drug utilization and safety. This methodology, however, is associated with significant design and operational...
To describe survey methodology used to evaluate the burden of illness and racial differences in adult female acne (AFA).
To identify possible changes in patient-reported outcomes (PRO), including health-related quality of life (HRQoL), of multiple myeloma (MM) patients undergoing treatment in the USA. PRO of those meeting CRAB criteria (hyperCalcemia, Renal insufficiency, Anemia, Bone lesions) for...
To describe the design and execution of a hybrid, cross-sectional study of COPD patients, highlighting important strengths, weaknesses, and general considerations for use in burden of illness and health economic analyses.
Studies that estimate incidence of very rare diseases (less than 1 in 100,000 of the general population) often use cases seen at specialized centers. However, multiple potential sources of both systematic error and random error complicate this estimation. We calculated the...
This abstract will be available after the ISPOR 21st Annual Meeting concludes.
This abstract will be available after the ISPOR 21st Annual Meeting concludes.
This abstract will be available after the ISPOR 21st Annual Meeting concludes.
This abstract will be available after the ISPOR 21st Annual Meeting concludes.
This abstract will be available after the ISPOR 21st Annual Meeting concludes.