Scientific Information Packet Guidelines

For those submitting scientific information packets, the information requested is:

1. A current product label.
2. Randomized controlled trials, published or unpublished.
3. Observational studies, published or unpublished.

For published studies, please provide only a list of citations and reprints when available.

For unpublished studies, please provide a summary that includes the following elements:

• Study number.
• Study period.
• Design.
• Methodology.
• Indication and diagnosis.
• Drug dose and duration.
• Inclusion and exclusion criteria.
• Primary and secondary outcomes.
• Baseline characteristics.
• Number of patients:
  1. Screened.
  2. Eligible.
  3. Enrolled.
  4. Withdrawn.
  5. Lost to follow-up.
  6. Analyzed.
• Effectiveness/efficacy.
• Safety results.

We will not be considering any marketing or pharmacoeconomic information, or information on indications not included in the review. The contents of all submissions will be available to the public upon request. Materials submitted must be publicly available or materials that can be made public. Materials that are considered private cannot be used by the Effective Health Care Program. Submission of information is voluntary. All costs for complying with this request must be borne by the submitter.