Population Council | Population Council Clinical Studies

POPULATION COUNCIL CLINICAL STUDIES

The database of information on the clinical studies the Population Council performs includes any study that

investigates a new drug, a new medical product, or a new medical procedure or investigates a new use or application of an approved drug or medical product, a modified dose or delivery system of an approved drug, a drug, product, or procedure in a new setting, or a new use for an existing medical procedure

and for which

the Population Council determines, supplies, or provides the funding for the drug(s), medical product(s), or medical procedure(s) that are being investigated in the study; or
the Population Council sponsors or controls the study that investigates the drug(s), medical product(s), or medical procedure(s).

A drug, medical product, or medical procedure is defined as "new" if that drug, product, or procedure is neither: (a) approved in the country in which the study is performed, nor (b) standard practice in the country in which the study is performed. Collection of biological specimens and the provision of accepted standard-of-care treatment, including drugs and products for conditions identified during a survey (assuming that such drugs and products have been approved for use in the jurisdiction in which they are being used), condoms for the prevention of sexually transmitted infections, or counseling alone do not fulfill the definition of a clinical study and therefore studies that are confined to these activities are not listed.

Information on Population Council clinical studies is available by clicking on a Protocol/IRB number in the table located here.

Note: As part of the product development process, the Population Council conducts a series of clinical studies to determine the safety and efficacy of these products in various subjects and settings. Clinical testing is normally carried out in three phases, each successive phase involving a larger number of people. After a product has been granted a New Drug Approval by the US Food and Drug Administration or by the regulatory agencies of other countries, it may undergo postmarketing or late Phase 3/Phase 4 studies to test different forms of the product, to determine whether the product is effective for other indications, or to monitor the product's long-term effectiveness and impact on subjects' quality of life. The information provided in these listings is not intended to promote any off-label or unapproved uses of any of the products that are used in a clinical study, including but not limited to Population Council products. All clinical studies are conducted in accordance with all applicable laws and regulations and have appropriate approval from the Institutional Review Boards in the countries in which they are being conducted.