Towards an Automated Assistant for Clinical Investigations V. Nigam, LMU, Germany; T. Ban Kirigin, Univ. of Rijeka, Croatia; A. Scedrov, UPENN, USA; C. Talcott, SRI, USA; M. Kanovich, Univ. of London, UK; and R. Perovic, USA CLINICAL INVESTIGATIONS POLICY Regulations may be imposed by multiple governmental agencies as well as by institutional policies and protocols. • Before drugs can be made available to the Due to the complexity of both regulations and activities there is great potential for violation due to human error, general public, their effectiveness has to be misunderstanding, or even intent. experimentally validated. • Normally, at the final stages, clinical FDA Regulations Protocols investigations (CI), involving human subjects, "Any adverse experience associated with the use of the drug Protocols are elaborated by specialists are carried out. that is both serious and unexpected; Each notification shall be explaining how one should carry CIs, so that made as soon as possible and in no event later than 15 calendar the most conclusive data is collected and the days after the sponsor's initial receipt of the information." health of subjects is not compromised. KEY CONCERNS Safety of Subjects One should avoid at all costs that the health of subjects is compromised Pharmaceutical companies (Sponsor), clinical ● Deviations from procedures and violations of regulations during the tests. research organizations (CRO), health should be avoided as they may compromise both the institutions (HI) and government agencies collected data and more importantly the health of subjects. Conclusive Data Collection (FDA) collaborate in order to carry out CIs. ● CIs are rigorously regulated by FDA inspectors. CIs should be carried out in order to ● Violations may also imply heavy penalties, both financial as obtain the most conclusive results/data well as of bad PR. without compromising the health of ● HIs with record of deviations in the past may be punished subjects. ● A better approach would be to have a by the market and not being hired for carrying out future CIs. computer assistant for CIs. ● Two possible applications (see Figure to Plan Generation the left), Plan Generation and Execution Execution Monitoring. Deviations from procedures and violations of regulations Subject Monitoring ● Mathematical models do occur. ● As illustrated above, regulations and ● At each site it is common to have more than one on going policies mention time explicitly. trial, typically 5-10 trials at the same time. ● Novel models for collaborative systems ● Trials take place along with normal hospital duties. Team subject to explicit time constraints. ● Easy to lose track of the global view of the process. FDA / Sponsor / PI ● Computational complexity for the plan ● Therefore, there is great potential for violation due to generation problem. human error, misunderstanding, or even intent. Tests Archives Tool Development Whenever a subject visits a HI, the staff receives ● Ways to translate protocols into our from the computer assistant a plan (Plan mathematical formalism. Generation) with the actions that need to be ● Investigate adequate human computer Next Steps performed. interfaces. ● Define a language for specifying protocols that can be Data Management understood by protocol developers and at the same The computer assistant can help FDA inspectors, ● Formally certify that privacy policies are not time implemented in our model. Sponsor monitors and the Principal Investigators of violated. ● We expect this language to be based on existing HI to monitor the execution of the CI ● Facilitate the statistical analysis of data by standards for CIs, such as the model proposed by building bridges to existing tools. Clinical Data Interchange Standards Consortium.
Pages to are hidden for
"Towards_an_Automated_Assistant_for_Clinical_Investigations"Please download to view full document