Oncology clinical trials in India in the last ten years has been a phenomenal increase and emerged as one of the major global destinations for clinical trials. Changed intellectual property regimen after WTO has been the principal mover of the occurrence, and maximizing profits rather than serving any considerate motives forms the main ideology of the rise of oncology clinical trial in India.
Challenges:
Regulation:
The
complexity of the guidelines in heavily regulated clinical industry,
addition of new rules and variations between different regulatory bodies
causes constraints and predictable concern among professionals in this
field. Increasingly emerging markets of clinical trials in new countries
requires thorough understanding of whole new sets of requirements.
Infrastructure:
One
of the major reasons for not being able to implement screening
programmer in India has been lack of workforce - physicians, health
workers, technical staff and pathologist to review pathological
material.
Clinical Research:
There is a need to develop proper
clinical research environment. This includes exposing graduate and
postgraduate medical students, community physicians and medical college
teachers about translation clinical research, and developing adequate
infrastructure.
Spiralling
Costs:
Tight timelines and
increasing complexity results in cost of trials to be all-time high and
puts more pressure on the resources required to implement and control
every step.
Delay
in Diagnosis:
Late presentation which in turn
is due to low level of awareness in the population and among community
physicians, lack of screening programs, lack of diagnostic facilities
locally and vast distances to travel to reach a major tertiary cancer
center, financial constraints and stigma associated with the diagnosis.
Benefits:
• Opportunity to access new drugs/treatments.
• Free treatment of cancer.
• Close supervision during treatment.
• Chance to participate in advancement of medical science.
