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Physical examinations in clinical trials, do we really need them?

Physical examinations in clinical trials, do we really need them?

Discipline: Medicine Startdate: As soon as possible
Year of study: Year 3 Language: English
Level: Research internship Location: UMC Utrecht
Duration: 6 months (24 weeks) Contact: J.Kopanz@umcutrecht.nl

In clinical trials physical examinations are standard practice. They are mostly used to assess the health status of participants and/or to evaluate in- and exclusion criteria. Thereby the definition of exams vary and often it is not clearly stated what exactly is performed as part of the physical exam. With the changing clinical trial landscape, including the move towards decentralized clinical trials (centering trial activities around patients rather than clinical sites) the question arises what the added value is of physical examinations in clinical trials. Do we really need a physical examination in all clinical trials? This project is seen as a first step to get a better understanding of the current situation and will analyze what the physical examination entails in current clinical trials. This project is embedded in a large international consortium project around the topic of decentralized clinical trials (www.trialsathome.com) taking into account the future role of physical examinations.

Within this project we will investigate in detail how physical examinations are defined, what typical elements they include and what purpose they serve, by assessing current study protocols for type 2 diabetes. The database clinicaltrials.gov will be searched for published study protocols regarding interventional clinical phase 3 and phase 4 drug trials. The identified protocols will be assessed using an evaluation form and data will be collected and analyzed accordingly.

We are looking for a master student who is interested in this topic as part of her/his research internship. The main tasks will include the extraction of the protocols, the subsequent assessment of the study protocols (data collection) and analysis as well as the interpretation of the results, whereby the assessment is expected to take up the largest part of the work. The internship will preferably start as soon as possible and would last three months.

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