Opportunities and challenges of a university-based phase I research unit - Experience at the university of Miami

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Abstract

We have discussed some of the advantages and challenges of operating an academic phase I CRO and some of the challenges associated with conducting special population phase I research in an academic environment. In regards to a large academic center, the recruitment advantages, the availability of a wide variety of consultants, and the expertise in conducting special populations studies have proved advantageous for our operation. In addition, a streamlined IRB process and contracts have allowed for a shorter start-up time than the typical university-based research operation. On the other hand, special populations research is always challenging due to the nature of the special populations, recruitment challenges, concomitant illnesses, complications, and a variety of commonly encountered concomitant medications.

Original languageEnglish
Pages (from-to)175-178
Number of pages4
JournalJapanese Journal of Clinical Pharmacology and Therapeutics
Volume42
Issue number3
StatePublished - May 1 2011

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ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology

Cite this

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abstract = "We have discussed some of the advantages and challenges of operating an academic phase I CRO and some of the challenges associated with conducting special population phase I research in an academic environment. In regards to a large academic center, the recruitment advantages, the availability of a wide variety of consultants, and the expertise in conducting special populations studies have proved advantageous for our operation. In addition, a streamlined IRB process and contracts have allowed for a shorter start-up time than the typical university-based research operation. On the other hand, special populations research is always challenging due to the nature of the special populations, recruitment challenges, concomitant illnesses, complications, and a variety of commonly encountered concomitant medications.",
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