Question

In: Biology

A long, dismal history tells of charlatans who make unfounded promises and take advantage of people...

A long, dismal history tells of charlatans who make unfounded promises and take advantage of people at the time when they are least able to care for themselves. The clinical trial process is the most objective method ever devised to assess the efficacy of a treatment. It is expensive and slow, and in need of constant refinements, and oversight, but the process is trustworthy. (Zivin, 2000, p. 75)

What do you think Zivin means when he suggests that clinical trials can be trustworthy, fast, or cheap—but that in any one trial, only two of the three are possible? How does that relate to challenges in current times to create a coronavirus vaccine?

Solutions

Expert Solution

  • The clinical trials are trustworthy or not how to look into it?? There is a proteus effect which tells when a drug is tested first it gave good results but after when it was re examined the effects were potentially decreased. After a quite a bit of research it is seen that the 1st trial is 2.67 times successful that other later trails.
  • The reasons pointed out are the earlier trial may be of short duration or there may be patient to patient difference.
  • The trials are not so cheap for new drugs as it's a very longer process till the market approval and the safety is the primary concern. The cost are mainly upon procedures, staffs and admins and site monitoring, retention and lab cost etc. So it's very hard to be cheap.
  • As the safety, efficacy, clinical benefit and long term risks are concerned so that the process is not so fast and takes much time.
  • As the 4 parts mentioned above are addressed in different phases one or two trials may not be beneficial for human concern. The drug should not be life endangering.
  • The process hardly takes close to one year. And more in other cases. In case of this pandemic we need to speed up the process but the quality of clinical trials is to be focussed on. There are several drugs waiting for approval but the long terms risks is also to be concerned along with other parameters.

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