Data transparency and free exchange of the research materials are crucial for effective clinical trials. The lack of publicity can lead to huge amounts of money being wasted, ineffective treatments, and loss of health and life of individuals and whole communities.
In his video “Battling Bad Science” Ben Goldacre advocates research transparency by giving examples of secrecy and incomplete disclosure leading to unclear results and inefficient treatments. The main lesson is that until the research results are fully presented to the public, nobody can be sure about their legitimacy. According to the video, currently there are cases in which up to two-thirds of all data is not disclosed. These omissions make it extremely easy to manipulate the opinions even of the professionals. Without proper mechanisms in place, there is no way to ensure that the clinical research, which can be critical to people’s lives and wellbeing, was conducted properly (Battling bad science, 2011).
AllTrials and Changes in Research
Currently, there are organizations like AllTrials working to get all data about clinical research properly reported and disclosed (AllTrials, 2013). If they succeed the medical practices will not be revolutionized but rather changed for the better. That would mean that clinical trials can actually be trusted. Currently, there are no laws or regulations that make sure the researchers are honest about their results (AllTrials, n.d.). If they are created, that would mean all research data will be openly available for review and critique. Falsification will become a lot harder, and it will be a lot easier to determine what can actually help a patient.
Precision Medicine Initiative
Precision Medicine Initiative is a unique project launched by the US government in 2015. It aims to create a cohort of more than a million research subjects to promote a personalized approach to medicine. The biggest influence it will have on data transparency and exchange is by providing a basis for precise and large-scale research. The data gathered through the project will be invaluable in checking and criticizing other research. This project will also develop an efficient system for managing huge amounts of data which will be useful in other initiatives aimed to make the information exchange easier (PMI Working Group, 2015). If the project works out as intended, it will become a public research tool allowing everyone from regular citizens to professional researchers assemble precision data and conduct research. It will have a huge positive impact on transparency by giving virtually everybody tools to verify the research data.
Health Information Exchange
Health information exchange is the key part of these initiatives. Without it, the verification of the research results and the comparison studies would be impossible. Moreover, as the tragic experience of the TGN1412 shows, incomplete data exchange can lead to loss of life among the volunteers (AllTrials, 2016). If the data exchange is incomplete or affected by politics and personal interests, there is no hope for true transparency. PMI aims to achieve just that by creating a publically available research platform. Federal Health IT Strategic Plan also emphasises the importance of effective and standardized exchange of health information as a part of the interoperability program which will ensure easy access to information by medical institutions across the country (ONC, 2015). One way or another, data exchange is a huge part of those programs.
While I have not personally been affected by the transparency issues during my practice, as Goldacre has demonstrated, you do not have to look hard to find poorly conducted research or misrepresented results. We can prevent those things from affecting the medical practice only by exposing them to public. Luckily, it seems that initiatives like AllTrials and PMI show that the issue is being taken seriously both by the governments and by private organizations.
AllTrials. (2013). What does all trials registered and reported mean? Web.
AllTrials. (2016). Lessons need to be learned from clinical trial tragedy. Web.
AllTrials. (n.d.). Myths and Objections. Web.
Ben Goldacre [TED]. (2011). Battling bad science. Web.
ONC. (2015). Federal Health IT Strategic Plan. Washington, DC: Author.
PMI Working Group. (2015). The Precision Medicine Initiative Cohort Program – Building a Research Foundation for 21st Century Medicine. Washington, DC: Author.