CASRO Statement on MR's Role in 'Pharmacovigilance'
June 29 2006
The board of directors at CASRO voted last week on issuing a statement to caution the pharmaceutical industry on requiring routine pharmaceutical surveys to report Adverse Events in the course of research.
CASRO believes that market research organizations should not be required to assume responsibility for formal reporting of adverse events (AE) uncovered in the course of routine pharmaceutical market research. The organisation says this is not a methodologically sound approach to post-market surveillance, and exposes research organizations to unacceptable legal and ethical risk.
However, in the event that a research organization chooses to accept the responsibility of reporting AE, it is urged that, at a minimum, the organisation obtain contractual terms that:
- fully specify all the conditions and procedures associated with those adverse reporting requirements, including stipulations associated with collection of both qualitative and quantitative data, as well as procedures to be taken in the event that respondents refuse permission;
- endorse a policy by which respondents are informed at the start of the research that any mention of product dissatisfaction will require that the organization to submit an AE report on their behalf if one has not already been filed;
- fully waive, and indemnify the market research organization against, any and all legal liabilities arising as a result of its AE reporting responsibilities.
CASRO says that while it believes these terms extend some measure of legal protection to member organizations and help to safeguard the ethical integrity of the research process, they do not overcome its overriding concerns about the impracticality and inadvisability of requiring routine market research studies to serve as a direct instrument of the 'pharmacovigilance' process.
However, CASRO recognizes that the industry's extensive contact with patients and physicians puts research agencies in a unique position to encourage and facilitate AE reporting by those who experience them and the medical professionals who observe them. It recommends that research organizations play an indirect role, by reminding respondents of the importance of AE reporting and providing them with information to help them do so.
The association is online at
www.casro.org .
All articles 2006-23 written and edited by Mel Crowther and/or Nick Thomas, 2024- by Nick Thomas, unless otherwise stated.
