Qualifying for a Clinical Trial
1 / 16

Understanding the Why Behind Inclusion and Exclusion Criteria

Clinical Trials: Recruitment and Pre-Screening

Clinical Trials: Two children screened, one qualifies – antibodies exclude the other.

Informed consent. Take it seriously.

Clinical Trials: Informed Consent defined. Parents and providers together making the best decision based on the limited information available

The Screening Visit: You Will Be Asked to Sign the Informed Consent Form, the most important document.

Clinical Trials: A mom: Don’t feel rushed, don’t feel desperate – read the Informed Consent

Clinical Trials: Prioritizing therapies to meet the eligibility criteria

Clinical Trials: Restrictions in the Informed Consent and participation can be isolating

Clinical Trials: Excitement to participate can blind you to the details

Clinical Trials: Mom finds out about a trial on Facebook, learns about the trial design & the screening process

Clinical Trials: A Rare Disease Mom-Just Tell Me, What Do I Need to Do?????

Clinical Trials: Assent to Participate: My son is old enough to decide for himself.

Clinical Trials: Our son and family’s road to the trial. No man’s land. (CLN2 / Batten)

Clinical Trials: We really felt like we had the golden ticket. (CLN2/Batten)
