A pharmaceuticals manufacturer is testing a drug developed to treat cancer. Duri
ID: 467420 • Letter: A
Question
A pharmaceuticals manufacturer is testing a drug developed to treat cancer. During the final stages of development the drug’s effectiveness is being tested on individuals for different (1) dosage conditions and (2) age groups. One of the problems is patient mortality during experimentation. Justify your design recommendations through a comparison of alternatives and in terms of external and internal validity.
a) Recommend the appropriate design for the experiment.
b) Explain the use of control groups, blinds, and double blinds if you recommend them.
Explanation / Answer
Appearance of a successfull drug reflects millions of people hope and health which also maximises the range of business market.
Case Details
Type Of Company : Pharmaceuticals manufacturer
Subject : Research on developping new drug ( To treat cancer patients )
Research Design : Pre - test and Post - test experimental design
Coming to the content of the case
About the Dosage and Age Groups
Dosage of drug might be different for the cancer effected patients according to the level of the disease or the stage of it. For the patients of initial stage the drug dosage may not same as to the final stage of them.
Also need to take care of different group of ages because children may not require the drug dose as same as elders or middle age groups.
a) About the Research Design
I recommend the pre - test and post - test design for given case which is more suitable to it.
The pre test and post test design tends to assign the subject to groups by random procedure and works effective through its clarity of design. Notifying the health conditions before drug testing and after on several people results shows cleanly how the drug works.
for instance phases of research like
Phase 1
Phase1 is pre test of drug on people of required . analyzing the patients health conditions and dosage conditions before drug testing
Number of People :20 to 120 volunteers of healthy condition or with people with diseased condition
Period of research : Few months
Purpose of the study : Analysis of safety and dosage
From this phase let 70 percent of the people were moved to the next phase.
Phase 2
After analyzing the health conditions of the patients the team begins the research on people as per requirement.
Number of People : Hundreds of people with the condition of having disease
Period of research : Increacing months to years
Purpose of the study : Analyzing of side effects and efficiency of the drug
From this phase let nearly 35 percentage of the people moved to the next phase
Phase 3
Number of People : Increacing the amount of people with the condition of having disease
Period of research : maximising to 3 to 4 years
Purpose of the study : Observing the reactions and notifications of efficacy.
From this phase probably 25 percentage of the people move to the next stage.
Phase 4
About Control Groups, Blinds And Double Blinds
Control Groups
Control groups are the people who stay beside the research and does not influence the results
Here research team compares the control group to actually treated group to distinguish the results
Blinds and Double Blinds
A blind experiment is easy to researchers but they must aware of all the consequences before starting the experiment as per rules
A blind experiment gives less evidence if the research fails
It reduces the effect of bias during the experiment.
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