Electronic Medical Record/Electronic Health Record (EMR/HER)
Electronic Medical Record (EMR) is an electronic version of a patient’s medical history, that is maintained by the provider over time, and may include all of the key administrative clinical data relevant to that persons’ care under a particular provider, including demographics, progress notes, problems, medications, vital signs, past medical history, immunizations, laboratory data and radiology reports.
This Real World Evidence (RWE) lets investigators see how medicines perform without their training wheels on – how doctors use them in the frantic setting of primary-care offices, and how patients use them when they are not screened for age, weight, education levels and willingness to comply with instructions.
We at MarksMan can analyze the EHR data for pharma companies, insurance companies and other interested parties, who are looking for data relevant to effectiveness, safety and cost benefit of a drug.
Registry can be defined as a prospective observational study of subjects, with certain shared characteristics, that collects ongoing and supporting data over time on well-defined outcomes of interest for analysis and reporting.
Disease specific registry: A disease registry is a special database that contains information about people diagnosed with a specific type of disease. Most disease registries are either hospital based or population based. A hospital-based registry contains data on all the patients with a specific type of disease diagnosed and treated at that hospital. A population-based registry contains records for people diagnosed with a specific type of disease who reside within a defined geographic region
Product specific registry: Product registry is a database which collects specific data about the products of interest, including route of administration, dose, duration of use, start and stop date, and, ideally, information about whether a generic or branded product was used (and which brand) and/or specific information about the product.
We at MarksMan can assist you in preparing disease as well as product specific registries, which can be utilized as an HTA tool itself. These can also act as evidence to inform disease knowledge, population/market identification, reimbursement and post-marketing effectiveness. Steps that are generally followed:
- Establish goals, scientific objectives and feasibility
- Design an effective program
- Develop protocols, study plans and materials
- Manage and support data collection, cleaning and reporting
- Analyze data, interpret results, present and publish
Such RWE studies help determine subsets of patients who can most benefit from a medicine, or where the most pressing medical needs are. One can also quantify the burden and cost of a disease, evaluate patterns of care, compare the performance of marketed products and explore market opportunities for targeting a new product.
Observational study data helps payers, not just to make well-informed and rational health care decisions but it can also supplement randomized clinical trial data. Several HTA decisions have been based on observational studies, helping pharma manufacturers achieve positive reimbursements in respective countries.