Bioequivalence and Bioavailability Forum

Hi Nirali,

❝ As per regulatories can a Bachloer of Pharmacy (B.Pharm-Pharmacist) graduate person perform statistical analysis of BA/BE & Clincal studies, randomization, sample size calculations and report writing using statistical softwares?

Few lines from ICH E6 Good Clinical Practice

“Section 2/ 2.8 states that - Each individual involved in conducting a trail should be qualified by education, training, and experience to perform his or her respective task(s)”

Here individual includes all the personal involved in performing clinical trail related activities.

Few lines from ICH E9 STATISTICAL PRINCIPLES FOR CLINICAL TRAILS

Section 1/1.2 states that

• Second paragraph second line
  However, it is assumed that the actual responsibility for all statistical work associated with clinical trails will lie with an appropriately qualified and experienced statistician, as indicated in ICH E6.
  
• Third paragraph
  “The trail statistician should ensure that the protocol and any amendments cover all relevant statistical issues clearly and accurately, using technical terminology as appropriate.

All the above states that a qualified, trained, experienced personnel has to perform statistical work (randomization, sample size calculations, report writing), protocol related activities and its amendments.

A qualified, trained, experienced statistician can easily judge appropriate study outcome.

Im not sure that whether that you are qualified or not to perform statistical analytical work.: confused:

How ever in rare/many cases there are statisticians who are unqualified by education (probably not from statistical back ground) but with a sound knowledge in statistical knowledge with all aspects of your question, they even sign the statistical data and do submit the same submission (audit purpose).


Regards,

RVR

Hi Nirali,

❝ As per regulatories can a Bachloer of Pharmacy (B.Pharm-Pharmacist) graduate person perform statistical analysis of BA/BE & Clincal studies, randomization, sample size calculations and report writing using statistical softwares?

I don't know of any territory enforcing a rule in this regard. The term 'statistician' is if I recall correctly not a protected title in most territories like e.g. a medical doctor or a psychologist is. In real life, I think economists and long-haired engineers have already proven that a good statistician is not necessarily one that has a math/stats degree. So I see no problem in using an experienced B.Pharm. for the task.

Dear Nirali, dear discutants,

I recommend you a look into a discussion from the early years of this great forum. Especially the answer of a well-known member HS .

BTW: Considering Helmut's first example I must admit: me too.

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Theoretical statistician. A second class mathematician who imagines that he is a first class statistician.
Applied statistician. A second class statistician who imagines that he is a first class scientist.
Medical statistician. A second class scientist without any imagination.
Guernsey McPearson's Drug Development Dictionary Part I.