Attn: Seniors: Where are you? Re: Ancillary care in Clinical Trials: one more scanario

[Guest guest]

Dear all,

I am deeply missing the response from our seniors?

They are in a better condition to guide us on this topic.

Regards,

Dr Kiran Chaudhari (MD)

Lecturer,

Dept of Pharmacology,

Govt. Medical College,

Nagpur-44003

From: kiran chaudhari <kiranchaudhari7@...>Subject: Ancillary care in Clinical Trials: one more scanario"netrum group" <netrum >Date: Tuesday, 14 October, 2008, 7:50 AM

Dear all, One more scenario: we were given at Bioethics Workshop at Pune. A lot of debate was there on this one. Hope we will see similar response here too. I would like to invite comments especially from our senior members on this one. A Phase III trial was conducted for a newer INSULIN preparation.

The company claimed that this Insulin is better (PK and PD) than all other available Insulins currently.

The subjects recruited were having DM and they were on Insulin therapy previously. After a wash out period the newer preparation was started to the subjects.

At the end of the trial, the company’s claim is found true. This newer preparation of Insulin is better than older ones.

What next? Don’t you think the people who participated in the trial deserve better Insulin? Is it obligatory to the company to give this newer preparation to the entire study participants free of cost or in subsidized rate for whole of their life? (THE COMPANY WILL EARN MILLIONS OF DOLLARS by selling its preparation) Suppose some subject who responded well to newer preparation were not better controlled by older preparations? What shall be done in such cases? They participated in the trial taking a risky job. (Think of various risks to the diabetic patient if he is not getting proper drug). If it is Cross Over design shifting of Insulin is also risky. Regards, Dr Kiran Chaudhari (MD) Lecturer, Dept of Pharmacology, Govt Medical College , Nagpur-440003

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