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Clinical research in Turkey

Hamdi Akan

    Turkish Journal of Haematology : Official Journal of Turkish Society of Haematology
    |June 7, 2016
    PubMed

    Insights

    Turkish clinical trials began in the early 20th century but lacked Good Clinical Practice (GCP) compliance for many years. Early legislation in 1926 addressed patient permission for experimental drugs.

    Area of Science:

    • Medical Research
    • Pharmaceutical Science
    • Regulatory Affairs

    Background:

    • Clinical drug trials in Turkey have a long history, originating in the early 20th century.
    • Historically, many studies were conducted without adherence to Good Clinical Practice (GCP) guidelines.
    • Despite a lack of GCP compliance, legal frameworks for drug use existed early on.

    Purpose of the Study:

    • To trace the historical development of clinical drug trials in Turkey.
    • To highlight the evolution of regulatory compliance in Turkish clinical research.
    • To examine the early legal considerations for experimental drug use in patients.

    Main Methods:

    • Historical analysis of legal documents and pharmaceutical regulations in Turkey.
    • Review of early legislation pertaining to drug trials and patient consent.
    • Examination of the timeline of clinical trial practices in relation to regulatory standards.

    Main Results:

    • The first legal mention of clinical trials appeared in "The Code of Pharmaceutical Products and Preparations No. 1262" in 1926.
    • This early law stipulated that experimental drugs could only be administered with patient permission.
    • Despite this early legal precedent, widespread adoption of GCP guidelines was significantly delayed.

    Conclusions:

    • Turkey's legal framework for experimental drug use predates formal Good Clinical Practice (GCP) adoption.
    • Early legislation indicates an awareness of patient rights in clinical research.
    • The history of clinical trials in Turkey is marked by a long period of regulatory evolution.

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