View Open source clinical trials
Open source clinical trials are trials studying the effects of therapies that do not rely on traditional funding and management, but instead are open source. For instance, curetogether.com is a website where individuals who want to test out alternative therapies for their conditions can sign up and quantitatively track symptoms such as pain, in an attempt to gauge the effectiveness of, and provide extensive data about, various therapies.
Open source clinical trials are one aspect of open science, along with open source software and the core components of open science: open access to scientific journals, open data, and transparent research methodologies.
Strengths and Weaknesses of Open Source Clinical Trials
Like all study designs, open source trial designs have strengths and weaknesses. The costs of open source trials can be distributed amongst many participants and people, making larger sample sizes feasible. Furthermore, open source trials do not require the approval of a government or drug company. On the other hand, open source study designs can be challenging to randomize or adequately control.
Open-source trials are capable of bypassing Institutional Review Boards (IRBs) and other bureaucracy, avoiding delays in getting promising treatments to those who need them, albeit with less guarantee of their efficacy and safety. This option is particularly appealing to cancer patients or others with terminal illnesses, who have little to lose by experimentation. IEET Board of Directors member Giulio Prisco has written:
” Nobody has any right to prevent dying patients to experiment on their own health at their own cost and without damaging others. Not so much ‘ethics’ please, and some more compassion and especially common sense.”
Open source trials allow much easier study of a greater number of people. Whereas a regular scientific longitudinal study would incur large financial overhead for each person it followed, an open source trial can be designed where each participant is responsible for tracking themselves. The open nature of these trials allows for far more participants, and greater numbers of participants can add power to a study. However, it matters little how large a sample size is if a study places too much importance on unreliable and subjective self reporting.
While open source designs have promise for opening up access to promising drugs that the FDA refuses to approve because of the risk of negative press if there are unforeseen side effects, they have several methodological issues that need to be overcome and pitfalls that must be avoided in order to remain firmly science-based.
IEET Links:
DIY Cancer Therapy: Should dying people be allowed to experiment?
Sources:
Tim Ferriss and Kevin Rose on Open Source Clinical Trials
p2pfoundation Category:Science
Curetogether.com
External Links:
Open Source Medicine
DIY H+
The open science registry