How to conduct sponsored clinical trial ethically.

[Guest guest]

Respected Chetna madam and Netrumians,

Current discussion topic " how to conduct sponsored clinical trial

ethically? " Though require prior knowledge in background to

understand, it is valuable discussion topic because, I think in

future the proportion of such trial may exceed due to evaluation of

newer and newer chemical entity or devices.

Performance of high quality research requires considerable

investment of time and money necessitating procurement of

substantial funding. It is possible that principle investigator (PI)

and sponser involved in such clinical trial may have variation in

goals and perspective. The productive, ethical relationship as well

as atmosphere of honesty matters more.

The central dogma of sponsored trial should be based on sound

scientific principles and it should answer an investigative question

rather than representing specific industry product.

All the rights of human subjects should be carefully protected

throughout the research and patient privacy, confidentiality should

be respected. Both sponsor and PI should have firm commitment

towards every phase of clinical trial.

Regarding data management- PI should give sufficient input in data

collection and interpretation and also whenever amendments occurring

during clinical trial period.

Coming to publication of results- There should be clear

understanding to publish study results regardless of the findings

along with full discloser of financial support.

It is the prime responsibility of PI to ensure an accurate, honest,

and complete representation of findings of the trial. These are my

some viewpoints regarding the discussion topic.

Thank you.

With Regards,

Dr.Deepali Tehare

JR-II, Pharmacology,

G.M.C.

Nagpur.