In order to ensure that all relevant research, whether published or not, is available for inclusion in the final report, submissions were invited from drug manufacturers, professional societies and other interested groups. We asked that these groups identify any evidence relevant to the review that is known to them, including clinical trials, follow-up studies and evidence from disease registries. This also included relevant evidence that is unpublished. Contents of all submissions were made available to the public upon request and therefore materials considered confidential could not be used by the ODPRN (see Privacy Policy).
Guidelines for Evidence Submission
Who could submit an “Evidence Submission Package”?
Anyone with an interest in the specific drug class review was invited to submit an “Evidence Submission Package”. This included (but not limited to): patient advocacy groups, public, individual patients, healthcare providers including physicians and pharmacists, policy makers, and drug manufacturers.
How to submit an “Evidence Submission Package”:
Comments were submitted electronically via email or hard copy to ODPRN headquarters.
How packages were used:
The ODPRN used the information provided to ensure that all applicable studies were included in the final report.
For manufacturers and other groups interested in submitting information for the Drug Class Review, the following was requested:
- Full citation for all published studies (clinical trials, follow-up studies, evidence from disease registries) for the drug and the specific indication under review,
- Full text of any unpublished work that might be relevant to the review.
All Evidence Submission Packages received were reviewed and considered by the ODPRN.