Nice to meet? Meeting unmet medical needs: a social innovation to facilitate early access to investigational drugs

Samenvatting

Although national healthcare systems allow for compassionate use of investigational pharmaceuticals outside of the context of clinical trials, such legal pathways are not routinely used. The online platform myTomorrows connects drug developers to patients and their physicians worldwide to facilitate access to unauthorised early-phase investigational drugs. In order to determine the ethical and social conditions for a responsible design of (commercial) services to facilitate early access to investigational drugs, it is vital to understand what patients themselves want, need and value. Further, as the prescription of investigational drugs will ultimately remain the responsibility of treating physicians, inquiry into physicians? assessment and decision-making processes regarding patients? requests is urgently needed. Little is known about the assessment criteria employed by doctors, or whether their heuristics align with patients? interests and preferences or with ethical guidelines. Furthermore, myTomorrows operates in a context of shifting societal, regulatory, institutional and financial arrangements for the research, development and registration of new pharmaceuticals, in the Netherlands and abroad. This empirical-ethical comparative research project will help fill the gaps in the qualitative evidence on patients? perspectives and on medical decision-making concerning patients with unmet medical needs in three countries - the Netherlands, France and the United States. Moreover, it will enable informed ethical analysis of key issues in the domain of innovative therapies, including shifting responsibilities, societal impact (including issues of reimbursement and equitable access) and healthcare system implications. Finally, it will critically evaluate and help shape an ethical design and set-up of the services envisioned by myTomorrows.

Output

Wetenschappelijk artikel

Publicatie bedoeld voor een breed publiek

  • N Aarts, R Brus, EM Bunnik(2017): Recht op experimentele medicijnen. pp. 73 - 75

Publieksinformatie

  • EM Bunnik(2016): 'Medicijnen'
  • EM Bunnik(2016): Arts helpt patiĆ«nten aan experimentele pillen.
  • S van de Vathorst, N Aarts, EM Bunnik(2016): Balance between individual rights versus societal needs in expanded access.
  • N Aarts, EMB Bunnik(2016): Ethical issues in efforts to expand access to investigational drugs.
  • N Aarts, S van de Vathorst, EM Bunnik(2016): Views and experiences of physicians in expanded access to investigational drugs.
  • EM Bunnik, N Aarts, S van de Vathorst(2017): Views and experiences of physicians in expanded access to investigational drugs.
  • N Aarts, EM Bunnik, S van de Vathorst(2017): Comparative analysis of regulatory systems for expanded access to investigational drugs in three countries: The Netherlands, Turkey and the United States of America.

Kenmerken

Projectnummer

313-99-311

Hoofdaanvrager

Prof. dr. S. van de Vathorst

Verbonden aan

Erasmus Universiteit Rotterdam, Erasmus MC, Medische Ethiek en Filosofie van de Geneeskunde

Uitvoerders

Dr. N. Aarts, Dr. N. Aarts, Dr. E.M. Bunnik

Looptijd

01/08/2015 tot 22/02/2018