Invitation Letter

Risk Evaluation and Mitigation Strategy (REMS) Programs to Promote Appropriate Medication Use and Knowledge: Physician Surveys on Experiences with REMS Programs

OMB Control Number: 0910-0847

Expiration Date: 12/31/2022

 

[FIRST NAME] [LAST NAME]

[ADDRESS]

[CITY], [STATE] [ZIP]

[MONTH] [DAY], 2021

Dear Dr. [LAST NAME]:

I am writing to ask for your participation in a study of physician experiences with Risk Evaluation and Mitigation Strategy (REMS) programs, which the Food and Drug Administration (FDA) requires for certain drugs. Your participation is extremely important. FDA has sponsored this survey,¹ which is being conducted by Luminas on behalf of a team of researchers at Brigham and Women’s Hospital/Harvard Medical School and FDA. The findings from this investigation will help clarify physician views on this topic and guide future work aimed at optimally mitigating the risk of prescription drugs.

In addition to the $20 enclosed, individuals who complete the survey will also receive an $80 Amazon gift card as a token of our appreciation. The survey is designed to take no more than 20 minutes to complete and has been approved by our Institutional Review Board.

Your participation is voluntary. Your responses will be completely anonymous and analyzed only in the aggregate. Any links between your identity and your responses will be maintained securely by Luminas and will never be released to the research team or FDA.

If you prefer, you can complete the survey online using the following Internet address: [URL]

If you have any questions about this survey, please don’t hesitate to email Dr. Roz Pierson at roz.pierson@luminasllc.com.

Please help us with this important public health objective by completing this survey!

Sincerely,

Ameet Sarpatwari, Ph.D., J.D.

Assistant Professor of Medicine at Harvard Medical School

Division of Pharmacoepidemiology and Pharmacoeconomics

Brigham and Women's Hospital

1620 Tremont St, Suite 3030

Boston MA 02120

asarpatwari@bwh.harvard.edu

1According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0910-0847. The time required to complete this information collection is estimated to average 2 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.