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 language||English (US)|
|Number of pages||4|
|Journal||Japanese Journal of Clinical Pharmacology and Therapeutics|
|State||Published - May 2011|
ASJC Scopus subject areas
- Pharmacology (medical)