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Mariia V Maksimova1, Rosan L Lechner2, Johannes J M van Delden3

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Individualized therapies for ultra-rare diseases require a dynamic approach to the right to withdraw. This evolving dialogue balances patient autonomy with scientific progress in personalized medicine.

Keywords:
AutonomyResearch ethicsRight to withdrawTherapy developmentUltra-rare diseases

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Area of Science:

  • Medical Ethics
  • Personalized Medicine
  • Rare Disease Research

Background:

  • Individualized therapies for ultra-rare diseases merge clinical care and research.
  • This blurs ethical lines and complicates the right to withdraw.
  • Current guidelines view withdrawal as absolute, potentially causing scientific and societal loss.

Purpose of the Study:

  • To propose a dynamic model for the right to withdraw in personalized therapy development.
  • To re-evaluate withdrawal not as a final decision but an ongoing dialogue.
  • To balance patient autonomy with the value of individualized therapies.

Main Methods:

  • Reconstruction of the patient journey through therapy development.
  • Analysis of evolving factors: bodily involvement, uncertainty, dependence, and resource intensity.
  • Examination of how these factors influence the meaning of withdrawal.

Main Results:

  • The right to withdraw evolves in meaning throughout therapy development.
  • A dynamic approach acknowledges varying patient perspectives and motivations.
  • This model facilitates patient engagement and early concern resolution.

Conclusions:

  • Shifting to a dynamic right to withdraw is crucial for personalized therapies.
  • This approach respects patient autonomy while preserving scientific and societal gains.
  • It transforms withdrawal from a point of conflict into an opportunity for engagement.