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Clinical Research: Access to Potential Participants Pre-Enrollment: Staying One Step Ahead?

Abstract : At the World Economic Forum in Davos, the CEO of Novartis had declared that the sources of innovation were found in digital solutions, particularly those concerning clinical trial enrollment. In a world in which research is competitive, having access to patients is critical, essential and inescapable. The stakes, therefore, are high. Any organization of a clinical trial able to facilitate patient enrollment will enable faster, more reliable and probably more representative responses to the questions being studied. An undeniable advantage when it comes to addressing patient needs faster and better, and in cases of rare diseases can even be a necessity. We consider the enrollment process to have two distinct phases. One is formal and strictly supervised, at least in France, in which the investigating physician explains the research, invites the patient to take part and, if they accept, obtains their written enlighten consent. The second, which occurred first, less formal phase involves identifying a potentially eligible and interested individual, providing them with informal information about an existing protocol and, if they agree, referring them to the investigating physician. In traditional clinical research organization, this pre-enrollment phase is generally handled by the investigators themselves and the two phases under the responsibility of the same actor. With the new technologies offering patients more choice, it is our hypothesis that other players could set their sights on the upstream phase and as such influence the directions that patients take. Therefore, the key question is: in the future, how will protocols be chosen and the participants informed? At this stage in the enrollment process, we consider it essential and urgent both from a methodological and ethical point of view to continue to educate patients about what research is and means. Patient associations play and will continue to play a critical role in that – something that the pharmaceutical companies and some academic researchers have already understood and taken into account.
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https://www.hal.inserm.fr/inserm-02393894
Contributor : Nathalie Duchange <>
Submitted on : Wednesday, December 4, 2019 - 3:28:47 PM
Last modification on : Tuesday, March 17, 2020 - 2:40:44 PM
Document(s) archivé(s) le : Thursday, March 5, 2020 - 9:57:30 PM

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  • HAL Id : inserm-02393894, version 1

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François Eisinger, François Hirsch, Bernard Baertschi, Mylène Botbol-Baum, Isabelle Remy-Jouet, et al.. Clinical Research: Access to Potential Participants Pre-Enrollment: Staying One Step Ahead?. 2019. ⟨inserm-02393894⟩

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