Phase I trials: Role of the nurse investigator

  • Teresa J. Melink
Part of the Cancer Treatment and Research book series (CTAR, volume 42)


The development of new anticancer therapy remains an essential strategy in our efforts against cancer. While notable advances in the treatment of certain malignancies have been achieved [1–5], many are still without successful therapies. The clinical trial serves as a mechanism whereby new and previously existing treatment modalities are evaluated in humans [6]. Such trials proceed in an orderly process following preclinical evaluation of antitumor activity and toxicologic and pharmacologic determinations [7]. The three phases and objectives of clinical drug development include:
  • Phase I studies To determine the safest maximum tolerated dose and establish a dose that can be used for phase II trials. To define qualitative and quantitative toxicities of a new compound on a given schedule. To evaluate the basic clinical pharmacology of the drug.

  • Phase II studies To identify the therapeutic efficacy of a new treatment in a variety of tumor types with specific regard to objective response rates and duration.

  • Phase III studies To determine the effects of a new treatment on the natural history of the disease. To discover whether a new treatment is more effective than standard therapy and whether it is associated with less morbidity.


Maximal Tolerate Dose Cancer Clinical Trial Chemotherapy Administration Pharmacokinetic Sampling Anticipatory Nausea 
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Copyright information

© Kluwer Academic Publishers 1989

Authors and Affiliations

  • Teresa J. Melink

There are no affiliations available

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