Home  |  About us  |  Editorial board  |  Ahead of print  | Current issue  |  Archives  |  Submit article  |  Instructions |  Search  |   Subscribe  |  Advertise  |  Contacts  |  Login 
  Users Online: 711Home Print this page Email this page Small font sizeDefault font sizeIncrease font size  
CLINICAL RESEARCH METHODOLOGY
Year : 2010  |  Volume : 1  |  Issue : 4  |  Page : 128-133

Non interventional drug studies in oncology: Why we need them?


Division of Medical and Research, Pfizer Limited Patel Estate, Off S.V. Road, Jogeshwari (West), Mumbai - 400 102, Maharashtra, India

Correspondence Address:
Divya Mishra
Pfizer Limited Patel Estate, Off S.V. Road, Jogeshwari (West), Mumbai - 400 102, Maharashtra
India
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2229-3485.71770

Rights and Permissions

Oncology is a highly researched therapeutic area with an ever expanding armamentarium of drugs entering the market. It is unique in how the heterogeneity of tumor, patient and treatment factors is critical in determining outcomes of interventions. When it comes to decision making in the clinic, the practicing physician often seeks answers in populations with obvious deviations from the ideal selected populations included in the pivotal phase III randomized controlled trials (RCTs). While the randomized nature of the RCT ensures its high internal validity by removing bias, their 'controlled' nature casts a doubt on their generalizability to the real world population. It is for this reason that trials done in a naturalistic setting post the marketing authorization of a drug are increasingly required. This article discusses the importance of non interventional drug studies in oncology as an important tool in testing the external validity of controlled trial results and its value in generation of new hypothesis. It also discusses the limitations of such studies while outlining the steps in their effective conduct.


[FULL TEXT] [PDF]*
Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)
 

 Article Access Statistics
    Viewed3381    
    Printed199    
    Emailed0    
    PDF Downloaded580    
    Comments [Add]    
    Cited by others 6    

Recommend this journal