Koodivalmiste

Koodivalmiste is a term used in pharmaceutical research to describe a coded medicinal product whose true identity is concealed during a clinical trial. The code hides whether the preparation contains the investigational drug, a comparator, or a placebo, until unblinding is performed. Koodivalmiste is designed to support blinding, a key feature of many randomized controlled trials.

In double-blind trials, neither participants nor conducting investigators know which treatment a participant receives. The koodivalmiste may be identical in appearance, packaging, and labeling to the active drug or to a placebo, ensuring that expectations or biases do not influence outcomes. The coded products are prepared and labeled with unique identifiers by the hospital pharmacy or a contract manufacturer.

Handling and administration involve a controlled process. A randomization sequence determines which code corresponds to which treatment. Each coded product is linked to this sequence in a secure, access-controlled code list. The list is typically kept by the sponsor or an independent party, separate from trial sites to preserve blinding. Supply to trial sites follows strict documentation and traceability requirements, with records kept to permit eventual unblinding if necessary.

Unblinding is undertaken only under predefined circumstances, usually for safety reasons or after the trial ends for data analysis. When unblinding is required, the code key is revealed to authorized personnel following established procedures to minimize impact on trial integrity.

Regulatory context emphasizes adherence to Good Manufacturing Practice and Good Clinical Practice. In Finland, oversight by the national authority and applicable EU regulations governs the use, handling, and documentation of koodivalmiste to ensure participant safety and data validity.