Clinical Research (Trial Design) | Report

Running head: CLINICAL RESEARCH (TRIAL DESIGN) 1
Clinical Research (Trial Design)
Student’s Name
Protocol Number: PRP-125
Protocol Version: 1.0
Protocol Date: (Assignment Due Date)

CLINICAL RESEARCH (TRIAL DESIGN) 2
Clinical Research (Trial Design)
Section A: Description of Changes to Clinical Trial Protocol
Tittle of Protocol Section: Objectives (Secondary Objective)
Previous Text:
1. To evaluate safety and tolerability
2. To compare overall survival
3. To evaluate the associated quality of life
Revised Text:
1. To evaluate safety and tolerability
2. To compare overall survival
3. To evaluate the associated quality of life
4. To evaluate health economics
Rationale:
A secondary objective encompassing health economics has to be incorporated in the
protocol. The need of this economic evaluation is to quantify the comparative costs of the
standard care therapy and the experimental therapy. Cost effectiveness is a significant goal to be
incorporated in the protocol.
Tittle of Protocol Section: Trial Design
Previous Text:

CLINICAL RESEARCH (TRIAL DESIGN) 3
A multi-centre, phase III, randomized controlled trial evaluating the efficacy of Drug
AB56 to standard of care chemotherapy in patients presenting with breast cancer. A total of 250
eligible, consenting women with histogitically confirmed breast cancer will be randomized to
receive either study DrugAB56 or standard of care chemotherapy. Randomized patients will
receive treatment with DrugAB56 administered orally at the dose of 500mg daily for period of 3
months or receive standard of care chemotherapy administered intravenously every month (i.e
every thirty days) for 3 cycles for a period of 3 months. Once treatment is completed, study
participants will be assessed in clinic every 6 months and then annually for 5 years for disease
progression, toxicity, survival and quality of life.
Revised Text:
A multi-centre, phase III, randomized controlled trial evaluating the efficacy of Drug AB56 to
standard of care chemotherapy in patients presenting with breast cancer. A total of 250 eligible,
consenting women with histogitically confirmed breast cancer will be randomized to receive
either study DrugAB56 or standard of care chemotherapy. Randomized patients will receive
treatment with DrugAB56 administered orally at the dose of 500mg daily for period of 3 months
or receive standard of care chemotherapy administered intravenously every month (i.e every
thirty days) for 3 cycles for a period of 3 months. Once treatment is completed, quality of life
assessment shall be completed by study participants at the final treatment visit to assess the
quality of life at the end of the treatment. Also, study participants will be assessed in clinic every
6 months and then annually for 5 years for disease progression, toxicity, survival and quality of
life.
Rationale: