Lecture 8: Clinical Trials with a human touch

Question 1

Evolving Healthcare Landscape

Answer 1

Clinical research facing serious challenges due to under-enrolling of patients, but they could have support of volunteers or would-be volunteers if they changed approaches.

Question 2

Collaboration around the patient

Answer 2

• Clinical trials awareness
• Patient-focused trial design
• Patient recruitment
• Advocacy and site collaboration

Question 3

Clinical outcome assessments (COAs): Patient reported outcome (PRO)

Answer 3

measurement based on a report that comes directly from the patient about the status of particular aspects of or events related to a patient’s health condition

Question 4

Clinical outcome assessments (COAs): Clinician reported outcome (ClinRO)

Answer 4

assessment determined by an observer with some recognized professional training that is relevant to the measurement being made

Question 5

Clinical outcome assessments (COAs): Observer reported outcome (ObsRO)

Answer 5

assessment that is determined by an observer who does not have a background or professional training relevant to the measurement being made

Question 6

Clinical outcome assessments (COAs): Performance rated outcome (PerfO)

Answer 6

based on a tasks performed by a patient according to instructions that is administered by a health care professional