Epidemiology & Drug Safety

Post-marketing surveillance of the safety of bio-pharmaceutical products is paramount in protecting and preserving public health. Epidemiology and drug safety studies are the cornerstone of drug development and life cycle management programs, and we have supported our clients in these endeavors through the conduct of studies designed to understand and quantify the incidence and prevalence rates of diseases and associated risk factors, disease specific mortality rates, treatment-related adverse events and detection of safety signals.

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Retrospective Database Analyses

Retrospective database analyses are an invaluable tool for understanding a myriad of facets related to healthcare delivery in clinical practice or the “real world.”

Comprising of a longitudinal record of care delivered in pharmacy, inpatient, and outpatient settings, retrospective databases are a wealth of information on a large number of patients. Studies utilizing these databases are a relatively inexpensive alternative to randomized controlled trials (RCTs) for answering ongoing questions about the effectiveness and safety of healthcare interventions. Such studies are also vital in informing the clinical development program through obtaining insights into the natural history of medical conditions and existing/recommended treatment patterns and treatment gaps. During the commercialization phase, or post-launch, retrospective database studies are used to profile factors related to the effective adoption of new treatments or technologies by patients and physicians.

Our staff has extensive experience working with a wide array of databases encompassing:

  • Various available commercial medical and pharmacy claims databases in the US including LifeLink Health Plan Claims Database provided by IMS, Thompson Reuters Commercial Claims and Encounters and Health and Productivity Management databases, Protocare Sciences, and others
  • Government databases in the US including Medicare and Medicaid claims databases, Surveillance, Epidemiology and End Results (SEER) cancer registries, National Health and Nutrition Examination Surveys (NHANES), Medical Expenditure Panel Survey (MEPS), National Health Interview Survey (NHIS), National Hospital Discharge Survey (NHDS), National Ambulatory Medical Care Survey (NAMCS), National Medical Expenditure Survey (NMES), Healthcare Cost and Utilization Project (HCUP), National Comorbidity Survey (NCS), and others
  • General practitioner and specialist medical records databases in Europe including IMS Disease Analyzer databases, The Health Improvement Network (THIN) database, General Practice Research Database (GPRD), and others
  • Disease-specific or product-specific private industry sponsored or medical association registries in the US, Europe, and Asia

At Avalon, our retrospective database studies have been instrumental in answering critical questions, and empowering our clients in making strategic business decisions at different stages during drug development.

Below are examples of some questions related to the epidemiology of medical conditions and safety of healthcare interventions our studies have answered for our clients:

  • What are rates of known treatment-related adverse events in the real world?
  • What are the background event rates and comorbidities in specific disease populations?
  • Do the rates of occurrence of adverse events vary by patient subgroups?
  • Are there any previously unknown treatment-related adverse events?
  • What are the incidence and prevalence rates of various diseases?
  • Have there been historical increases or decreases in the incidence or prevalence rates of specific disease? and what factors might contribute to these trends?
  • Do incidence and prevalence rates vary based on patient sub-groups or geographically?
  • What are the risk factors associated with various diseases?
  • What are the mortality rates of various diseases and are there any geographical variations in these rates?
  • What are the costs associated with managing various treatment-related adverse events?
  • What are the comparative costs of treating adverse events of competing therapies?
  • What are the cost savings associated with avoiding a particular adverse event?
Observational Epidemiology Studies
When our clients’ research questions and information needs extended beyond the scope of data available in retrospective databases, we provided solutions through the design and conduct of large scale observational studies.

Study objectives have ranged from direct and indirect costs including profiling costs associated with over-the-counter medications, alternative treatments, therapeutic procedures, surgeries, and impaired work productivity; functional and quality of life assessments for patients with specific medical conditions or taking specific treatments; long-term effectiveness and safety of bio-pharmaceutical products and medical devices; and patient preference, compliance, persistence and satisfaction with treatments.

Our observational studies have comprised longitudinal and cross-sectional patient surveys, physician and caregiver surveys, medical chart data abstraction, and patient, physician, and caregiver focus groups. Patients in our studies were recruited through their physicians; health plans, membership of advocacy groups, or from the general population using television or print media.

We undertake all aspects of these studies including:

  • Protocol development
  • Development of data collection instruments including case report forms for completion by patients, caregivers, physicians, nurses or other healthcare professionals
  • Study site identification
  • Managing all aspects of Institutional Review Board (IRB) submissions
  • Investigator training and study monitoring
  • Data collection and management
  • Data analysis and study report development
  • Publication and dissemination of study findings

Below are examples of some questions related to the effectiveness and long-term safety of economic implications of medical conditions and healthcare interventions our observational studies have been instrumental in answering for our clients:

  • What is the effectiveness of bio-pharmaceutical products in specific patient sub-groups?
  • What is the long-term safety of bio-pharmaceutical products and medical devices?
  • What are rates of known treatment-related adverse events in the real world and in specific patient sub-groups?
  • What are the background event rates and comorbidities in specific disease populations?
  • Do the rates of occurrence of adverse events vary by patient subgroups?
  • Are there any previously unknown treatment-related adverse events?
  • What are the costs associated with managing various treatment-related adverse events?
  • What is the incidence of a particular medical condition in the general population?
  • What are the prevalence rates of specific diseases in the general population?
Safety Registries

Our experienced researchers have been successful in developing and implementing safety registries in Ex-US markets. Our registries have been a powerful source of reliable and valuable information for internal and external stakeholders. Examples of the types of questions our safety registries have answered include:

  • What is the long-term tolerability and safety profile of a newly launched bio-pharmaceutical product or medical device in usual care or clinical practice?
  • What are rates of known treatment-related adverse events in the real world?
  • Do the rates of occurrence of adverse events vary by patient subgroups?
  • Are there any previously unknown treatment-related adverse events?
  • What is the frequency, intensity, time to onset, and duration of various treatment-related adverse events in clinical practice?
  • Are there any safety signals, for example patients with certain comorbidities or patients belonging to a specific ethnic group who may be at a greater risk of developing an adverse event?
  • Are there any previously unknown drug-drug interactions?
  • Are there any previously unknown treatment-related adverse events associated with doses higher than the recommended daily dose?
  • Is the severity of known treatment-related adverse events greater at higher than recommended doses?

 

 

Phase IV Safety Trials

We have supported our clients in select aspects related to designing and conducting post-launch safety studies. Designed to gather additional data on the safety of bio-pharmaceutical products, these studies were either required by regulatory authorities or were voluntarily undertaken by our clients. We have assisted with the following components of these studies:

  • Protocol development
  • Physician/investigator recruitment
  • Data analysis
  • Study report development
Evaluation of Spontaneous Adverse Event Reports (SAERs)

Our evaluation of SAERs has comprised simple manual reviews and tabulations of adverse events using the Food and Drug Administration’s (FDA’s) Adverse Event Reporting System database (AERS) and safety registries maintained by our clients on their products, or more complicated analyses including regression analysis, cluster analyses, proportional reporting ratios or reporting odds ratios.

Our analyses of SAERs have been designed to answer the following types of questions:

  • What is the long-term safety profile (describing and refining) of a given drug?
  • Are there any new safety signals?
  • What is the strength of known safety signals?
  • Is a single reported adverse event treatment-related or is it related to a comorbid illness or to a concomitant medication?
  • Is a reported adverse event more prevalent for treatment A versus treatment B?
  • Are there any previously unknown adverse events for a specific drug?
  • Are there any previously unknown treatment-related adverse events associated with doses higher than the recommended daily dose?
  • Is the severity of known treatment-related adverse events greater at higher than recommended doses?
Epidemiology Sections of Regulatory Submissions
  • Although we have been commissioned to develop a number of product dossiers both for internal use by our clients and also for AMCP, NICE and EMEA submissions, when such dossiers were produced internally by our clients, our services were often requested for the development of select sections including epidemiology sections of these documents
  • Our services have ranged from summarizing relevant incidence, prevalence, mortality, risk factor and background event rates information, to development of point prevalence estimates based on prevalence rates reported in the literature
  • We have also written epidemiology sections of clinical study protocols and study reports that were submitted to regulatory agencies
Literature Reviews, Backgrounders, Meta-analyses
  • Over the years, we have assisted our clients with numerous critical appraisals and reviews of pertinent epidemiology (incidence, prevalence, mortality, risk factors) and safety (treatment-related adverse events, background event rates) literature
  • Our reviews have been disease area-specific or product-specific and have informed the development of internal documents, background sections of study protocols and product dossiers, and supported the design of clinical and economic studies and development of case report forms and other data collection instruments
  • Our meta-analyses of safety data have predominantly been conducted in conjunction with our economic modeling projects. However, we have also been commissioned to complete such evaluations to support our clients’ internal modeling and clinical development initiatives and for clarifying conflicting safety data from multiple studies
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Therapeutic Areas

  • Anti-infectives
  • CNS
  • CVS
  • Dermatology
  • Endocrine and Metabolic Disorders
  • GI Disorders
  • Oncology
  • Ophthalmology
  • Organ Transplant
  • Pain
  • Respiratory