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In medicine, indication refers to a health condition (therapeutic area) for which a specific intervention (medicinal product, medical device, treatment, procedure) is developed to cure, relieve symptoms, prevent or diagnose. The indication, as specified in the ˜Summary of Product Characteristics™ (SmPC) document, determines the boundaries of lawful use of such medicinal product.

Informed Consent

Informed consent is a person's voluntary agreement, based on an understanding of the relevant information, to participate in research or a clinical trial, or to undergo a particular medical intervention.

Before any research may be carried out, participants must be informed about all aspects of the study and/or intervention, including the aims, methods, anticipated benefits, and potential risks. Participants must also be made aware that they can withdraw from the research at any stage without any negative consequences to their ongoing care or treatment. This information must be given in an accessible and understandable way (for instance via a participant information sheet), and individuals should be given the opportunity to ask questions about the research.

Informed consent is usually documented in writing with a signed and dated consent form. However, informed consent should be an ongoing process throughout a study, and researchers should ensure that participants are made aware of any new information which might influence their decision about whether to take part or not.

In rare circumstances (for example, when an individual may not be able to give informed consent), the usual practices for informed consent may not be possible. Researchers may obtain delayed consent (for instance, for research into emergency situations) or consent by proxy (when the ability to consent is delegated to someone else). In some cases informed consent may be implied by a person™s actions or inaction or silence.

Innovative characteristics

In medicinal products, this may be defined as offering additional clinical efficacy or effectiveness as compared to the current best standard of care. Improvement to the use of a medicine in addition to an added clinical benefit (such as convenience to patients of, for example, a different mode of delivery, or other characteristics that may improve adherence to therapy, with resulting improvements in clinical outcomes and/or quality of life) may also be considered innovative characteristics.

Innovative Medicines Initiative

Innovative Medicines Initiative (IMI)"

Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen

Institutional Review Board

Institutional Review Board

Integrated Research Application System

Integrated Research Application System


Intention-to-treat (ITT) is an analysis of the participants taking part in a clinical trial, based on the group to which they were initially assigned, and not on the treatment eventually received. It does not matter if they drop out, whether they fully adhere to the treatment, or even if they switch to an alternative treatment.

Intention-to-treat analyses are often used to assess the effectiveness of a new treatment because they are seen to reflect real life: not everyone adheres to the treatment they are given, and doctors often change treatments depending on how their patient's condition changes.

Interim analysis

In clinical trials and other scientific studies, an interim analysis is an analysis of the current data from an ongoing trial, in which the primary research question is addressed. It has the potential to modify the conduct of the study. Depending on the results, an interim analysis may lead to changes, such as stopping one treatment arm or changing the number of participants in a group, or stopping the trial altogether.

An example of an interim analysis leading to the early stopping of a study comes from a trial to better identify patients with coronary heart disease who would benefit from an implantable device. The trial compared the devices to treatment with medicines in patients who had survived life-threatening coronary events. The trial was stopped when interim analysis showed a significant reduction in all causes of death in patients assigned to treatment with the implantable device.

An interim analysis requires careful advanced planning and appropriate adjustments to the statistical approach. An interim analysis and any anticipated changes to the trial must be described and justified in the study protocol. The option to modify the design of an ongoing clinical trial is becoming increasingly common and is known as adaptive design.

Intermediate endpoint

In clinical trials, intermediate endpoints are measures that may be associated with disease status or progression toward a primary endpoint (such as mortality or morbidity). It may be a measure of a body function or disease symptoms (e.g. measures of lung function in chronic obstructive pulmonary disease (COPD)) that is expected to correlate with changes observed on primary endpoints. Clinical trials are often designed to measure changes of an intermediate endpoint and evaluate the effects of an intervention on clinical outcomes.

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