Sources of Data
Sources of Data
This topic discusses the various sources of information from which data on drugs are gathered.
Introduction
Medicines can provide benefits (in terms of treating a disease or managing a condition) but also have potential risks (in terms of side effects). In addition to clinical trials, there are many other sources that can be used to obtain information about a medicine and to help us understand its benefit and risk profile.
Pharmacoepidemiology is the study of what drug exposure does in large groups of people11335 . Pharmacoepidemiology studies usually look at a specific population of patients and follow their response to treatment. The results of these studies are used to obtain information about a medicine and to help us understand its benefit and risk profile.
What Are the Sources of Information?
Clinical trials, observational studies, and several other sources of data gathering are described below.
Clinical Trials
In order to find out what the benefit and risk profile of a particular drug actually is—in other words, how we should best use this medicine to benefit the greatest number of patients and minimize potential risk—data regarding the safety and effectiveness of that drug are required. These data are usually obtained from clinical trials, where the drug is ordinarily given under specific conditions to patients. Clinical trials follow a strict process to minimize factors that can affect the study results. The design of these studies will also influence the results, and this, in turn, is dependent on the research question being asked.7209
Observational Studies
These studies are designed to observe the effects of drugs on people as they receive routine medical care.11291
Insurance (Administrative) Claims
Insurance (administrative) claims are collected by medical insurance companies and stored in electronic databases. The large numbers of patients in these databases allow researchers to study rare events and provide additional data about clinical practice.
Registries
Registries use an observational study design (see above) to collect clinical data from a defined population. Registries are defined by what they collect (for example, consumer data, disease information, births, pregnancy, or adverse events).7210
Surveys
Surveys are questionnaires, often focusing on a particular population or disease (e.g., National Hospital Discharge Survey).11292
Surveillance
Surveillance databases are designed to help clinicians focus on a particular issue. These databases assist with the systematic collection, analysis, interpretation, and dissemination of health care data.An example is the Food and Drug Administration Adverse Event Reporting System surveillance database.11289
This concludes the discussion of the topic Sources of Data. We encourage you to read other topics on the MEDVERSATION™ website.
Content on this page was last changed on March 15, 2010.
References:| 7209. | US National Library of Medicine, National Institutes of Health. An introduction to clinical trials. http://www.clinicaltrials.gov/ct/info/whatis#whatis . Accessed July 12, 2007. |
| 7210. | Gliklich RE, Dreyer NA, eds. Registries for Evaluating Patient Outcomes: A User’s Guide. AHRQ Publication No. 07-EHC001-1. Rockville, MD: Agency for Healthcare Research and Quality. Prepared by Outcomes Sciences, Inc. 2007. http://effectivehealthcare.ahrq.gov/repFiles/PatOutcomes.pdf . Accessed January 7, 2010. |
| 11289. | U.S. Food and Drug Administration. CDER Adverse Event Reporting System (AERS). Available at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm . Accessed January 7, 2010. |
| 11291. | National Cancer Institute- United States National Institutes of Health. Dictionary of Cancer Terms. Available at: www.cancer.gov/dictionary. Accessed August 14, 2008. |
| 11292. | Centers for Disease Control and Prevention. National Hospital Discharge and Ambulatory Surgery Data- National Hospital Discharge Survey Description. Available at: http://www.cdc.gov/nchs/nhds.htm . Accessed January 7, 2010. |
| 11335. | World Health Organization. The Importance of Pharmacovigilance- Safety Monitoring of Medicinal Products. http://www.who.int/medicinedocs/es/d/Js4893e . Accessed September 9, 2008. |