Reference no: EM132408178

Project -

The study - 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.

Your manuscript must include the following sections:

1. Introduction

You don't have a lot of information to write a long Introduction as a regular cancer research paper, but you should have a short paragraph about the type of your study, the basic research purposes of your study.

2. Statistical Analyses

This should be regarded as an essential part in the Materials and Method in a regular cancer research paper. For each statistical analysis you did (both descriptive statistics and inferential statistics), you should provide the details on the test, such as what type of descriptive statistics (such as mean/standard deviation or median/IQR for continuous variables), two-tailed tests or one-tailed tests, paired comparisons or unpaired comparisons, what was the significance level. At last, you should provide which statistics software was used in your analyses.

Of note, since the data set is relatively big, and nonparametric tests in Excel are a bit challenging, you can analyze the continuous data using Student's t tests, not rank sum tests, assuming that these continuous data were approximately normally distributed.

3. Results

3a. Demographic and baseline characteristics

Like in most of cancer research reports, you should provide analyses on the basic information of the patients, and the best way to present is a table including summary statistics and the p values for the comparisons between two groups. You should also write a text paragraph to talk about these demographic and baseline data to show: i) the overall information about your patient population (such as how many patients included, how many groups in your study, each group had how many patients); ii) the descriptive statistics of each group; iii) the comparisons between two groups. The purpose to compare the demographic and baseline data between two groups was to check if these two groups were "balanced" in these demographic and baseline characteristics.

Demographic and baseline characteristics should include (not limited to): Age, Race, Gender, Risk, AE, and Index0.

Since it's a manuscript, you should present your results in a test well. For example, instead of saying there is no significant difference in gender between two groups (I assume! I could be wrong), I would rather say: there were 56% and 49% of female in these two groups, respectively. There is no statistically significant difference in gender between these two groups (p = 0.85).

3b. Reduction in cancer Index [Of note, you can change the subtitle, but should include the right information]

Reduction in cancer index was regarded to present the short-term efficacy of the new drug. You should compare the reduction here. Again, instead of saying that the difference between this two groups is or is not statistically significant, you could provide the mean/sd values of the Index10-Index0 for each group. You could also talk about whether there is any difference between these two groups at the baseline index (Index0), which helps you interpret the data.

While the comparisons between treatment groups in cancer index are required, you could expand your analyses as you like (as long as it's reasonable and statistically right). For example, you may check any potential correlation between the cancer index reduction and age (whether old patients had bigger or smaller reduction in cancer index) upon treatment, between cancer index reduction and gender, etc.). I am not going to limited your options but if you use some advanced statistical procedures, such as generalized linear regression, you should provide such information in "Statistical Analysis" section and in your test here.

3c. Efficacy in extend progression-free survival [Change this subtitle as you like]

I will provide outputs from K-M analyses (including the K-M curves, median progression-free survival time, log rank comparison results) and Cox proportional hazard regression for your convenience. Besides Treatment, other factors statistically associated with progression-free survival has also been provided for your convenience. You need to combine all information you have to develop your research story (i.e. your paper!)

3d. The safety of your new drug

Results on the comparison of the AE incidence and your interpretation.

4. Conclusions/ Discussions

Make your own conclusions on the efficacy and safety of the new drug based on your analyses. You can discuss from the perspectives of both statistics and clinics. Since I made up this data set based on a real data set, your discussion from the clinical side should be reasonable.

Attachment:- Assignment & Data Files.rar