INVESTIGATIONAL THERAPY
\ɪnvˌɛstɪɡˈe͡ɪʃənə͡l θˈɛɹəpi], \ɪnvˌɛstɪɡˈeɪʃənəl θˈɛɹəpi], \ɪ_n_v_ˌɛ_s_t_ɪ_ɡ_ˈeɪ_ʃ_ə_n_əl θ_ˈɛ_ɹ_ə_p_i]\
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Pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.
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