Sunday, January 26, 2020

ADVERTISEMENT OF CLINICAL TRIAL, IS IT LEGAL ? TO WHAT EXTENT ?

Have you ever seen any pamphlet or   hoarding sign board on public places requesting to participate for any Clinical study ? Do you think asking publicly to participate in trial of drugs for some pharmaceutical company is legal ? answer is YES. It's absolutely OK asking publicly to participate in any study being conducted  on drug for patients of particular disease. In fact, public request is less likely to have conflict of interest than asking personally in clinic or sending mail. 

Patient recruitment is the integral part  of study, which should be completed within time range defined by protocol, recruited one should be fit for study based upon inclusion and exclusion criteria  and most importantly needed to be retained throughout the study period for the sake of quality data and reproducible outcome. Every  Clinical Study and their investigators finds it hard to get enough patient and retain them throughout. Study findings says that about 50 % of studies conducted  in Unites states faces higher the cost than expected because of delay in patient Recruitment. Hence, Advertisement of study is the most commonly employed method of subjects recruitment which is endorsed by FDA also. 


Criteria to be filled for Advertisement by any hospital or site


Objective: Advertisement, content used for this purpose  should only be oriented to recruiting subject for the study. 
Approval: any content going to be publicized should be  reviewed and approved by Ethics committee of the  institution. 
Claims: there should not be any claims of curing disease or prolonging life span of participants or any fanciful commitment for that matter. Moreover study drug should not be declared as superior than any available or established treatment. 
Safety: Since there is paucity of enough evidence regarding  the safety of new drug or combinations of existing drugs being studied, advertisement should not claim any products to be safe, effective , equivalent or superior than any other treatment .


Commonly employed Methods of Advertisement


Different recruitment models can be employed in the form of advertisement in different country in the as  per the social and environmental circumstances, these are the common methods employed: 
  • Broadcasting through Local Radio or television  channel
  • Giving pamphlets on social places or people gathering in huge numbers
  • Advertisement on Local or National newspaper
  • Database search of relevant patients and sending personal mails
  • Organizing health camps and gathering patients  intended to treat
  • Peripheral referring from hospitals, polyclinics and other Hospital to Research site by informing the patient
  • Mouth publicity 
                                                                                                     Thank You !!!

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