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Bundesamt für Sicherheit im Gesundheitswesen
Bundesinstitut für Arzneimittel und Medizinprodukte
In the medicines development process, this is the compound among several (compounds), which meets criteria in efficacy and safety in order to be used in clinical trials with humans. Broad information on the mechanism of action and pharmacology has to be available for a candidate drug.
A candidate gene is any DNA sequence (gene) in a chromosome considered likely to cause a disease. The gene may be a candidate because it is located in a particular chromosome region involved in the disease, or its protein product is suspected to be the cause of the disease. Candidate genes have been used to identify genetic risk factors for complex disorders such as alcoholism.
These studies, called the candidate gene approach, test the effects of variants of a candidate gene in members of an affected family, or in unrelated cases and controls. The candidate gene approach is useful for quickly determining the association of a genetic variant with a disorder. However, this approach is limited by how much is known about the biology of the disease being investigated.
Studies that use animal models to evaluate the carcinogenic potential of pharmaceuticals. They are also used to test chemicals and food additives. The objectives of carcinogenicity studies are to identify a tumorigenic potential in animals and to assess the relevant risk in humans. Any cause for concern derived from laboratory investigations, animal toxicology studies, and data in humans may lead to a need for carcinogenicity studies. The fundamental considerations in assessing the need for carcinogenicity studies are the maximum duration of patient treatment and any perceived cause for concern arising from other investigations.
Case Control Studies
A case control study is one that compares two groups retrospectively.
For example, people who developed a disease might be compared with a group of people who have not. The researcher will look at whether there is any difference in the two groups in their previous exposure to possible risk factors. This kind of study is useful when studying risk factors for rare diseases, and is often used to create new hypotheses which can then be tested.
For example, there are fewer than 300 confirmed cases of new-variant Creutzfeldt-Jakob disease (CJD). A cohort study that follows healthy people over time to see what risk factors might lead to the development of the disease would need to recruit a huge number of people in order for just one to develop symptoms (around 200,000). It would also take a very long time, because the period between infection and the appearance of symptoms is thought to be between 10 and 30 years. A much better approach in this case is to carry out a case control study, beginning with people who have already been diagnosed with new-variant CJD, and comparing their past exposure to possible risk factors with a group of people who do not have the disease.
Case report form
A case report form is a paper or electronic data entry form used in clinical trials. It is used by sites taking part in clinical trials (such as hospitals) to collect data about each trial participant. All the data on each individual taking part in a clinical trial, including information on adverse events, are held in the case report form.
A case report form is developed specifically for each clinical trial so that all the data needed to answer the research question is captured. The organisation running the trial is responsible for designing a case report form in line with the protocol of the trial. They must also monitor and audit the data that is collected to ensure it is complete and accurate.
Personal data such as, the patients' names, medical record numbers, and any other identifying information are usually not disclosed in the CRF's. Each patient is instead given a unique identifier.
Is the relation between an event (the cause) and a second event (the effect), where the effect is a direct consequence of the cause.
The relationship between an event or situation and a possible reason or cause.
Center for Biologics Evaluation and Research
Centre within the US FDA that regulates biological products for human use. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/"