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Clinical trials require strict adherence to protocol, extensive documentation, complete accuracy, compliance to ICH-GCP and other regulatory norms, an ethically sound patient recruitment strategy, and efficient site management.

 

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Life science and Pharma companies approve and fund Investigator Initiated Trials (IITs), Medico Marketing Studies (MMSs) and Post Marketing Surveillance Studies (PMSS), Collectively Post Market Studies (PMS) to meet a number of clinical objectives of a marketed drug. These Post Market Studies are generally more productive as far as the additional data generation on the marketed product is concern and also with respect to enhancing the market reach of a product in order to accomplish broader brand and company goals.

PMSs are becoming more complex and difficult to manage. Identifying the top challenges faced in these studies and learning new strategies for overcoming them would be a much needed and empowering step to capitalize the advantages of PMSs.

Having a expect team to handle these Post Market studies and support the Sponsor/Investigator in designing, organizing, conducting and reporting Multicentre Post Market studies will be the right approach towards PMSs in coming future.

 

CONCEPT

 

To design, organize, conduct and report Multicentre Post Market long term and short term studies (which includes IITs, MMSs and PMSSs) with key opinion leaders of the respective indication of study drug. Studies will be designed in a way to analyze/compare the inferiority or superiority of marketed competitive molecules in order to have a proof of concept of established parameters with deeper information and/or of new parameters, to propagate and increase the market of study drug and also to serve as strategic Medico marketing studies with amplified benefits with respect to marketing & sales and for publications.

 

PROBLEMS IN PMSs

 

  • Legal Concerns
    • Intellectual Property thefts. Solution: Good tracking system to identify potential overlaps.
  • Ethical Concerns
    • “Supported”/Dictated trail conduct and conclusions. Solution: Balancing the commitment to high Ethical standards against the desire to maximize the investment values.
  • Financial Concerns
    • Unexpected risks inherent in IITs.
      Solutions:
    • Choose to support studies that maximize the benefits and minimize the risk.
    • Look at the trial proposal in the context of the organization’s strategy.
    • Making rationale decisions regarding support of IITs requires knowing the reason for conducting them in the first place.

 

PROTECTIVE MEASURES

 

  • Establish proper Intent
  • Establish the Clinical Investigator and Trial sponsor
  • Establish Fare Marketing Value (FMV)
  • Avoid influence of sales force in PMS process
  • Limit involvement in PMS studies after study approval
  • Promote transparency and disclosure

 

DISCREPANCY IN PERCEPTION

 

  • Lack of knowledge and experience in the complex and evolving area of Clinical Trial process and regulatory aspects.
  • Lack of infrastructure (staff, equipments, premises and etc)
  • Lack of expert support (Medical writing, biostatistics, data management)
  • Time and resources constrains.

 

COMPLEXITIES

 

  • Limited Study management
  • Poor Documentation
  • Lack of Quality Control
  • Complexity increase with multicenter studies

A field report says “performing PMS according to the new requirements is nearly impossible for clinicians and academic researchers without cooperation with expensively specialized experts such as project managers, statisticians, data managers, pharmacist and monitors.

 

REQUIREMENT OF I5's TEAM IN PMSs

 

Life sciences companies should guarantee a compliant PMS process and many cases the sponsor/ investigator cannot comply with the role without professional support. Having a CRO as an integral part of the PMS to will reflect very positively and productively in the results of PMSs. However CROs involvement in PMSs is significantly low when compare to Phase studies.

Following are the advantage of having I5’s team as a part of PMSs:

  • Experts in all facets of Clinical Trials processes
  • Management of Clinical Studies is the sole core business
  • Independent Organization without conflict of Interest
  • Independent QA/QC
  • Adjusted Cost structure
  • Resource and experience
  • Study priority
  • Intensive PM
  • Extended network of investigators
  • I5’s Vision
 
 
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