Our Pledges:

Robust Participant Training

We promise to give our study participants thorough training to help them fill out forms correctly and carefully review each assessment. Participants will practice using the migraine diary three times before completing it after taking the study medication.

Reducing Placebo Response

We pledge to address the potential impact of placebo response on our study outcomes through the professional conduct of our investigative team.

Professional Conduct

To reduce the placebo effect, we promise to always act professionally when interacting with participants. We will be empathetic and informative without forming personal bonds that could affect how participants perceive and respond to the treatment.

Keeping It Professional

To reduce the placebo effect, we promise not to offer extra services, treats, or free items during visits. This ensures that participants’ experiences and responses are only influenced by the treatment itself, not by extra attention or perks.

Maintain Boundaries

To reduce the placebo effect, we promise to keep clear boundaries with participants. This means not forming friendships or relationships outside of the study. We will communicate in a friendly but professional manner and avoid topics not related to the study.

Ensuring Consistency

To reduce the placebo effect, we promise to give all participants the same level of attention and information. Consistency is key to reducing differences in placebo responses. We will train all team members in these guidelines and explain why they are important.

Ensuring Study Integrity

 To maintain the integrity of our study, we promise to follow these rules:

• No paying for referrals.
• No site staff, their friends, or family can participate.
• Family members (spouses, siblings, children, in-laws, stepfamily, and adopted family) and those living in the same household are not allowed to join to prevent bias.

Ensuring Accurate Data

To keep our study data accurate, we require that all participants can read, write, and speak English. The prescreening questionnaire must be completed in English without any translation help.

Maintaining Data Integrity

We promise to ensure accurate data by having participants complete the prescreening form in person, on-site, without using internet-connected devices like smartphones, tablets, computers, or smartwatches.

Selection of Qualified Patients

 

We promise to carefully select participants and keep enrollment open longer to ensure we choose well-qualified patients.