Qualifying for a Clinical Trial

Understanding the Why Behind Inclusion and Exclusion Criteria
In this video, a patient advocate in biotechnology discusses inclusion criteria and why finding appropriate candidates for a trial is important to a safe, successful trial and how it often results in a more rapid acceleration of approved treatments. She talks about the heartbreaking reality that in choosing candidates the focus has to be on the greater good of the entire community over the individual.
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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)
