Authors: Philip D Houck
Rare diseases such as peripartum myocardial infarction are difficult to study using double blind randomized controlled clinical trials. There have been no new advancements in the conduct of clinical trials since 1947. As a result, rare diseases have not been effectively studied despite a gradual gain in knowledge of potential mechanisms. This paper suggests a method of study that can be applied to rare disorders by an older method suggested by James Lind – the controlled clinical trial. Open source models similarly developed by software engineers will allow free access to multiple protocols and allows the physician to choose the protocol that seems most promising. Free access of clinical data will be available to help the physician decide which protocol is successful. Results will be updated continuously by a biostatistician compared with historical control and other competing protocols. Open Source - as a philosophy that promotes a universal access via free license to a product’s design or blueprint, and b) universal redistribution of that design or blueprint, including subsequent improvements to it by anyone. Open-source model includes the concept of concurrent, yet different agendas and differing approaches in production. The components of Open source research consist of a WEB site, governing body, data partner, biostatistician, tissue, genetic, proteomic specimen analysis, and funding. The site will be a center for literature review, protocol and protocol rational, consent forms, data collection center, case material, data analysis, and provide on line future publications generated by this open data source. Open source research is different from a registry in that the protocols are based on a biologic model and selected by the physician. Open source allows multiple models to be tested. A successful protocol suggests the model of disease is correct. Results are recorded similarly to a registry and can be used to assess the real time efficacy each protocol used. This method allows an iterative adjustment of treatments until the most effective therapy is found. Submit Your Manu Script at: https://symbiosisonlinepublishing.com/submitManuscript.php
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[v1] 2017-08-24 01:40:14
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