For task no. 5, how do you define the time to approval? Do you mean the time span from start to completion or do you expect us to acquire external data to answer that question?
V. Chausays
For the ‘Study_Results’ column, can you elaborate on what is meant when it says ‘no results available’ and ‘has results’? What results is it referring to? Is this in the provided Excel data file? Thank you.
Clay Lloydsays
The term “success” is left to us to be defined in our analysis. However, for clarity: must a drug be shown to be effective in addressing a disease in order to advance to Phase 3?
In other words, have every trial listed shown to be effective in Phase 2?
Is it a pre-requisite before entering a Phase 3 trial?
Laurel Millersays
Yes the phases of a clinical trial are in order. They must progress sequentially.
Each phase has slightly different purposes.
If a drug fails at Phase I, it is much less costly for a company than failing at Phase III for example.
We also highly encourage students to watch the 5 minute video we provided a link to, to give background on the trials.
Dennissays
Is there a way for us to see whether a trial is in Phase I, II or III? I do not see a column that says the phase that a trial belongs to.
Laurel Millersays
Not in this dataset but you are encourages to pull other data or do other research to find the information you need in order to complete the analysis.
emily gindelesays
In the excel sheet, the row status has several values. One of them is completed. Does this mean the trials were/are successful? Also what is the difference between withdrawn and terminated?
Laurel Millersays
Clinical trials have different touchpoints. A student can see an NCT record more than once because there was a an update made. We suggest students use the most recently updated NCT (there is a column that tells the latest update).
This does not mean a trial was “successful.” “Successful” is a measurement students can come up with and it can be based upon whether a trial was completed/not completed. “Success” could also be about how good the clinical data was or the ROI of the drug developed.
Withdrawn = no participants ever in trial
Terminated = trial had participants, but the trial prematurely ended
Javier Ballestesays
Hi,
We have a lot of data in which the start date is after the completion date.
Is this data okay to work with?
We look forward to hearing from you soon.
Thank you.
Laurel Millersays
For the trials where it “appears” the trial date ended before it started; this is not the case.
Some of the trials have their dates formatted giving a Month, Day, and Year. Other trials only give a Month and Year.
Therefore, what students are looking at is 2 different date formats.
Older trials — those before 2000 are probably autoformatting for students to be correct.
Those after 2000 are actually registering the month as a year.
We will provide a hint in the coming days to assist in cleaning this data. We will add the excel code shortly.
This is a frequent problem in date data — date data is very tricky.
Thorsten Krause says
Hi,
For task no. 5, how do you define the time to approval? Do you mean the time span from start to completion or do you expect us to acquire external data to answer that question?
V. Chau says
For the ‘Study_Results’ column, can you elaborate on what is meant when it says ‘no results available’ and ‘has results’? What results is it referring to? Is this in the provided Excel data file? Thank you.
Clay Lloyd says
The term “success” is left to us to be defined in our analysis. However, for clarity: must a drug be shown to be effective in addressing a disease in order to advance to Phase 3?
In other words, have every trial listed shown to be effective in Phase 2?
Is it a pre-requisite before entering a Phase 3 trial?
Laurel Miller says
Yes the phases of a clinical trial are in order. They must progress sequentially.
Each phase has slightly different purposes.
If a drug fails at Phase I, it is much less costly for a company than failing at Phase III for example.
We also highly encourage students to watch the 5 minute video we provided a link to, to give background on the trials.
Dennis says
Is there a way for us to see whether a trial is in Phase I, II or III? I do not see a column that says the phase that a trial belongs to.
Laurel Miller says
Not in this dataset but you are encourages to pull other data or do other research to find the information you need in order to complete the analysis.
emily gindele says
In the excel sheet, the row status has several values. One of them is completed. Does this mean the trials were/are successful? Also what is the difference between withdrawn and terminated?
Laurel Miller says
Clinical trials have different touchpoints. A student can see an NCT record more than once because there was a an update made. We suggest students use the most recently updated NCT (there is a column that tells the latest update).
This does not mean a trial was “successful.” “Successful” is a measurement students can come up with and it can be based upon whether a trial was completed/not completed. “Success” could also be about how good the clinical data was or the ROI of the drug developed.
Withdrawn = no participants ever in trial
Terminated = trial had participants, but the trial prematurely ended
Javier Balleste says
Hi,
We have a lot of data in which the start date is after the completion date.
Is this data okay to work with?
We look forward to hearing from you soon.
Thank you.
Laurel Miller says
For the trials where it “appears” the trial date ended before it started; this is not the case.
Some of the trials have their dates formatted giving a Month, Day, and Year. Other trials only give a Month and Year.
Therefore, what students are looking at is 2 different date formats.
Older trials — those before 2000 are probably autoformatting for students to be correct.
Those after 2000 are actually registering the month as a year.
We will provide a hint in the coming days to assist in cleaning this data. We will add the excel code shortly.
This is a frequent problem in date data — date data is very tricky.