Drugs

Clinical Researchers Oppose ‘Right-to-Try’ Legislation

David McFarland

— 1 min read
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The Association of Clinical Research Organizations has issued a policy statement detailing its opposition to legislation that would give terminally ill patients access to unapproved treatments, known as “right-to-try” bills. “As the organization representing the world’s leading clinical research organizations that each year conduct more than 7,000 clinical trials involving 1.3 million patients in more than 100 countries, ACRO is deeply committed to ensuring treatments are made available to patients in need, to the full extent possible, through the established clinical trials process in order to effectively monitor safety and efficacy,” the statement says.

ACRO says “right-to-try” legislation is “deeply flawed” because it: 

  •          contains insufficient patient protections;
  •          compromises the clinical trial process; and
  •          undermines FDA’s authority to assess safety and effectiveness.

The group describes FDA’s Expanded Access (Compassionate Use) program as an acceptable alternative, noting that unlike under “right-to-try” legislation, expanded access patients must meet certain conditions to participate.

The policy statement expresses concern that if right-to-try were available, patients could start taking an investigational therapy without ever pursuing the traditional trial route, increasing the current difficulty in meeting clinical trial enrollment needs.

“Given FDA’s implementation of its current Compassionate Use policy, it is unclear that ‘right-to-try’ legislation would provide any added benefit for individual patients in terms of access,” the statement says. “Such legislation would, however, create potentially significant concerns for patient safety. This legislation could also lead to ethical challenges for future clinical research, weakening the informed consent process by diminishing the safety and risk/benefit data that should be available to every patient. By circumventing FDA, ‘right-to-try’ eliminates utilizing the agency’s objectivity, expertise, and knowledge of treatments in various stages of development, in presenting the best options to the patient. Conversely, under Expanded Access FDA review can require changes to treatment plans that are most beneficial to patients.”

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