The clinical trial industry's single greatest challenge continues to be timely patient recruitment and retention. One major obstacle is trial drift -- the gradual reduction in study knowledge as a clinical trial ages, resulting largely from inadequate staff training about the protocol and good clinical practices (GCP). The problem is further compounded by high turnover among site staff, with industry data suggesting an average CRA tenure of only 18 months to 2 years -- shorter than many studies.
At the same time, regulatory agencies are increasingly demanding proof that global clinical study staff are appropriately trained and assessed in a standardized manner and, depending on the therapeutic area, that ongoing "recalibrations" in staff education and training are performed during the term of a study in order to minimize trial drift. What's more, there is a growing movement in the industry to require site managers and CRAs to earn GCP certification, further underscoring why effective training is a business imperative.
This presentation focuses on how a well-planned, consistent training program can help sponsors and CROs meet or even exceed enrollment deadlines, and thereby speed drug development.
Improving Patient Recruitment Through Better CRA Training was presented by Linda Wolf, with BBK Worldwide Alliance and aired on 2008-05-22. For more details, or to download this conference please visit our site at www.fxconferences.com
