Reference no: EM131745436

Final Project

A RCT Parallel was conducted to test the efficacy of a new drug in treat patients with cancer X. A standard drug was used in this trial as an active control. Data used in the FINAL analysis were listed in the attached data file. The entire trail lasted three years.

The data

Age (year)

Gender: F, female; M, male

Race: White, Black/Africa American

Risk: a clinical parameter form chromosomal abnormality and other clinical evaluation. 0, standard risk; 1, intermediate and high risk.

Treatment: 1, the standard drug (an active control); 2, the new drug;

Index0: cancer index at Day 0 (the start of this trial)

Indext10: cancer index at Day 10 (after the start of the trial)

Progression: cancer progression, YES or NO.

Relapse: another name of Progression here. 1, progression; 0, no progression.

Days1 (day): for patients with progression (Progression=YES, Relapse=1), this is the time when progression starts;

For patients with NO progression (Progression = NO, Relapse = 0), this is the "censoring" time.

AE, adverse effect, 1, YES; 0, NO.

Primary endpoints

1. Progression-free survival (PFS), i.e. the time with no progression.

2. Cancer index change upon treatment between Day 0 and Day 10, i.e. Index10-Index0.

Secondary endpoints

1. The incidence of adverse effect 9AE). [Of note, there were difference types of adverse effects. What we had here was the total AE incidence]

The purpose(s) of this trial

1. To evaluate the short-term efficacy of the new drug in comparison with the standard drug. The short-term efficacy is represented by the reduction of cancer index in the first 10 days, Index10-Index0

2. To evaluate the long-term efficacy of the new drug in improving the progression-free survival of patients, i.e. the potential to extent the time to progression

3. To roughly evaluate the safety of the new drug, i.e. comparing the incidences of AE in the new drug group and the standard drug group.

You are required to write a concise "manuscript" draft using all the information you have. All the data analyses should be done yourself except that the outputs from survival analyses are provided by your instructor as attached. Your manuscript must be in a right format and with right data analyses and interpretation. Your "manuscript" will be graded based on your analyses, interpretation/discussion and format.