Grants:IdeaLab/Management of most public documentation for clinical research
What is the problem you're trying to solve?
The sector of science employing the most researchers is clinical research, which is pharmaceutical human subject research. This sector is unusual as compared to other science sectors as it requires a human volunteer, typically a medical patient, to volunteer for a clinical trial in which they participate in a test with an experimental drug or procedure.
Before joining a trial, research participants must give informed consent, which means that they must be told that they are getting an experimental procedure instead of normal treatment and they must agree to accept the experimental treatment. Historically informed consent has happened only on paper and verbally, but aspects of it are moving to online documentation. For example, in the United States ClinicalTrials.gov is a registry of many clinical trials in many countries and provides public access to some data about each trial.
ClinicalTrials.gov is lacking a lot of information to which the public needs access. For example, every trial registered in that database will produce academic papers describing the outcome of the trial, but that database is not set up to match citations to research publications with the trial itself. Furthermore, because of the nature of the US government in the pharma sector, neither this website nor any other registry effort is likely to be further designed to be either human or machine readable, remixable, translatable (despite being inherently multilingual), or a place in where other databases to be converged. It should be.
The problem I am addressing is the lack of connection between this database of trials and other documents, like research papers published in journals.
What is your solution?
- Develop an automated process, probably off-wiki to start, for making stub Wikipedia articles about a few clinical trials. The company Eli Lilly has a nice structured database or the Clinical Trials Transformation Initiative has a database which could provide basic info about a trial
- Wikipedia's criteria for including a topic in the encyclopedia say that covered topics must be backed by citations to published sources with some independence of the article's subject. Academic journals articles would meet this and for any trial there are several or many of these. ClinicalTrials.gov assigns unique registry numbers to trials. The journal database PubMed can be sorted somewhat to find these numbers in papers. A tool will be designed which finds PubMed papers for a given trial, generates citations of these papers, and stages them for integration into the trial's Wikipedia article.
- On a small scale to start, the basic human readable trial data is matched with a PubMed citation list and some clinical trial articles are moved into Wikipedia.
- Get comments from community
- If this seems cool then scale it up
- Once citations to academic journals are matched to trial articles lots of other things in every language that does clinical research can also be. Practically every drug which goes to market does so in three countries with multiple languages, so very quickly this begins to touch every health condition in every culture and language
- Wikimedia projects assume responsibility of documentation management of the public face of pharma research. There likely is no competition for this anytime soon, as no government or pharma company would ever want to manage themselves the increase of public access to this information for a range of reasons. Still, every company and government would state support of this effort.
- Example (in this case not using the structured Lilly data, which would make this easier)
- Consider some trial, perhaps "Dose-ranging Study to Evaluate the Safety & Immunogenicity of a HIV Vaccine 732461 in Healthy HIV Seronegative Volunteers"
- Note that its ClinicalTrials.gov ID is NCT00434512
- Search PubMed for that ID, find four published papers on the trial
- Note that "Dose-ranging Study to Evaluate the Safety & Immunogenicity of a HIV Vaccine 732461 in Healthy HIV Seronegative Volunteers" is a candidate for making a Wikipedia article, as articles have been published on this trial
- Off-Wikipedia, adapt data at ClinicalTrials.gov into a few sentences through an automated process. Five sentences would be great. Italicized text is to be inserted by a bot.
- "Dose-ranging Study to Evaluate the Safety & Immunogenicity of a HIV Vaccine 732461 in Healthy HIV Seronegative Volunteers is a clinical trial sponsored by GSK. Its enrollment was 180 participants. It started February 2007, the study ended June 2008, and its primary completion date was June 2008. The study sponsor described this study by saying "This is a single center, observer-blind, randomized, dose-escalating, staggered study with 6 groups: 3 groups of 50 subjects receiving the adjuvanted candidate vaccine, at 3 different doses and 3 groups of 10 subjects receiving the non-adjuvanted candidate vaccine in water for injection, at 3 different doses. The vaccination schedule will be 0-1 month. Blood samples will be collected at 8 visits. The duration of the study will be approximately 14 months for each subject. Rationale for Protocol Posting Amendment: The third vaccination will be cancelled and the visit at Month 7 will be postponed to Month 9. The Protocol Posting has also been updated in order to comply with the FDA Amendment Act, Sep 2007."
- Off-Wikipedia, append the references found at PubMed to the summary made of this clinical trial.
- Now that some content and some references have been combined, this content meets inclusion criteria for being a Wikipedia article, and can be uploaded as an article with a Wikipedia bot from a database.
- Upload to Wikipedia
- Data can now be remixed and developed. For trials which get other media coverage, those sources can be added by volunteers. Setting up these articles also makes a base from which clinical research participants can request more information, as now there is a public repository for clinical trials information.
The majority actions of taken by the the global pharmaceutical sector should pass through Wikipedia. I would like for this to result in Wikimedia becoming a stakeholder in all pharma research documentation and for all other stakeholders in this to begin recognizing that the public needs free online access to the entirety of all health information and that it needs to be translated into every language. It would greatly obligate industry and government to respond if anyone even provided a modest platform for providing information to the public about medical research. Nothing like this has ever been done and pharma is a highly discussed topic in business ethics, and that talk should include Wikipedia.
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