{[ promptMessage ]}

Bookmark it

{[ promptMessage ]}

_Lecture notes_trialphases

_Lecture notes_trialphases - Handout 3 Basics of Clinical...

Info icon This preview shows pages 1–2. Sign up to view the full content.

View Full Document Right Arrow Icon
Handout 3: Basics of Clinical Trial Design Pre-clinical research The pre-clinical phase covers all treatment development that is not carried out in human subjects. There are two main settings: in vitro (tissue culture, infectious organisms in culture) and in vivo (animal models such as mice, rats, non-human primates). Goals of pre-clinical research: To identify compounds that show activity against infectious agents or tumor cells. To identify compounds that bind to specific cell markers. To build devices that have specific properties with tissue. To determine whether interventions are sufficiently promising in animals to warrant human testing. To determine reasonable dosages for first human studies. To refine techniques (e.g. surgery, imaging) needed for treating or monitoring in humans. Examples of statistical challenges in pre-clinical research: Models for outcomes in cell culture (bioassay). Phase I Trials A Phase I trial is designed to find the best dosage of a drug for use in human subjects. Dosage include amount of drug, route and frequency of administration, and how amount is calculated (per body weight, per surface area, different for male and female, etc.) Usually the first studies of treatment in human subjects. Sometimes you want the highest tolerated dosage (cancer chemotherapy) but other times you want the lowest dose that is active (vaccine that induces immune response.) Sample sizes are typically quite small. Patients in treatment (as opposed to prevention) studies are often very sick, desperate. New approaches try to give more patients an effective dose. Not generally randomized. Usually start with a low dose and escalate until you hit dose-limiting toxicities. For vaccine, might start high and reduce until you no longer get protection.
Image of page 1

Info icon This preview has intentionally blurred sections. Sign up to view the full version.

View Full Document Right Arrow Icon
Image of page 2
This is the end of the preview. Sign up to access the rest of the document.

{[ snackBarMessage ]}

What students are saying

  • Left Quote Icon

    As a current student on this bumpy collegiate pathway, I stumbled upon Course Hero, where I can find study resources for nearly all my courses, get online help from tutors 24/7, and even share my old projects, papers, and lecture notes with other students.

    Student Picture

    Kiran Temple University Fox School of Business ‘17, Course Hero Intern

  • Left Quote Icon

    I cannot even describe how much Course Hero helped me this summer. It’s truly become something I can always rely on and help me. In the end, I was not only able to survive summer classes, but I was able to thrive thanks to Course Hero.

    Student Picture

    Dana University of Pennsylvania ‘17, Course Hero Intern

  • Left Quote Icon

    The ability to access any university’s resources through Course Hero proved invaluable in my case. I was behind on Tulane coursework and actually used UCLA’s materials to help me move forward and get everything together on time.

    Student Picture

    Jill Tulane University ‘16, Course Hero Intern