New Drugs For Safety And Efficacy

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Contract research organizations run hundreds of clinical trials per year to evaluate new drugs for safety and efficacy. The phase 1 of these trials consists of testing the safety of a drug; therefore, it does not require the individual being tested to have the disease the drug is aiming to cure. However, it is important that an individual takes part of a single trial at one particular moment in time and that he refrains from participating in another trial prior to a washout period determined by his current trial participation. Unfortunately, people do not always follow the rules. In phase 1 trials, some people are lured by the monetary compensation offered in return for their participation. These people attempt to participate in more than…show more content…
The criterion that our protocol verifies is the eligibility date: is the participant eligible to participate in our trial at a specific date? The participant should not be concurrently enrolled in another trial at that date and should not have participated in a previous trial within a specified time period of that date for the criterion to be satisfied. We designed the protocol for a healthcare setting taking into consideration that healthcare sites have limited computational power and that participant privacy is their highest concern. The limited computational power criterion is especially important because the healthcare setting is currently adopting mobile devices to manage patients and information. We named the protocol TRACK because our end goal is to track the existence of an individual in different databases. 3.1. Requirements In order to introduce the requirements for a well thought privacy-preserving solution to our problem, we take into consideration the attacks described in the literature, the advice of security experts in the EHIL laboratory and professors at the School of Electrical Engineering and Computer Science at the University of Ottawa and the considerations of real-world feasibility and practicality. We present the following requirements pertaining to tracking a participant in phase 1
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