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Post-trial access to treatment for patients participating in clinical trials

Dinesh Chandra Doval1, Rashmi Shirali1, Rupal Sinha2

  • 1Department of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India.

Perspectives in Clinical Research
|April 17, 2015
PubMed

Insights

Patients in clinical trials often lack access to beneficial treatments after study completion. This case study explores compassionate use and personalized medicine to justify continued treatment post-trial.

Area of Science:

  • Clinical Pharmacology
  • Medical Ethics

Background:

  • Clinical trials are crucial for developing new drugs.
  • Patients often lose access to investigational treatments upon study conclusion.
  • The ethics of post-trial treatment access remain debated.

Purpose of the Study:

  • To evaluate the applicability of post-trial treatment access for clinical trial participants.
  • To examine the role of compassionate use in patient care after trials.
  • To assess the impact of personalized medicine on post-trial access.

Main Methods:

  • Case study analysis.
  • Review of ethical considerations for post-trial access.
  • Exploration of compassionate use principles.

Main Results:

  • Post-trial access is a complex issue with no definitive consensus.
  • Compassionate use is justifiable for patients benefiting significantly from trial drugs.
  • Personalized medicine and genetic testing support the rationale for continued treatment.

Conclusions:

  • Post-trial access to treatment warrants consideration, particularly on humanitarian grounds.
  • Compassionate use is a key ethical consideration for drugs offering substantial patient benefit.
  • Integrating genetic insights strengthens the argument for continued access in personalized medicine.
Keywords:
Clinical trialsmedicationpost-trial access

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