Glossary

Recruitment is the process used by investigators to enrol people (participants) into a clinical study. Recruitment is based on the inclusion and exclusion criteria that are documented in the study protocol.

Recurrence is the return of a sign, symptom, or disease after some time when the signs or symptoms could not be detected. It is applied to the return of symptoms of an incurable disease. For example, the reappearance of cancer cells at the same site as the original tumour, or in another location. The risk of a recurrence depends on many factors, including the type of illness and type and/or time of treatment.

When talking about biosimilar and generic medicines, a reference medicine is the existing medicine already on the market that biosimilar and generic medicines are developed to be similar to or copies of, respectively.

Regulatory affairs is a relatively new profession which developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including human medicines, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. The Regulatory Affairs departments of pharmaceutical companies ensure that their companies comply with the regulations and laws governing medicinal products or medical devices. They are the key interface between the company and the regulatory authorities.

In clinical research, is the economic compensation for legitimate expenses incurred by a participant taking part in a specific research project.

It can be defined as the extent to which an intervention does more good than harm compared to one or more alternative interventions for achieving the desired results, when provided under the usual circumstances of health care practice.

It is the extent to which an intervention does more good than harm compared to one or more alternative interventions, when provided under ideal circumstances.

The reliability of a measurement or tool is how consistent it is. A reliable measurement or tool will give the same result when repeated at random in the same patient or sample. In clinical trials, reliability is an important consideration in the choice of primary outcome measures (such as an improvement in certain symptoms). The reliability of measures should be formally assessed during the design of clinical trials.

Reliability is different to validity, which is the extent to which a measurement measures what it is supposed to.

Remission is a temporary end (or significant reduction) in the signs and symptoms of an incurable disease. A disease is said to be incurable if there is always a chance that the patient will become ill again, no matter how long they have been in remission.

In cancer, the term 'in remission' is often used. Partial remission means the cancer is still detectable, but tumours or smaller, or - as in leukaemia - when there is less cancer throughout the body. Complete remission means that cancer cannot be detected using tests or scans - but because there is always the chance that cancer cells are still present, patients are said to be in remission rather than cured.

Reproductive toxicology investigates the negative effects of a medicine that interfere with normal sexual function and fertility in adult males and females. Such negative effects include adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring.