From ACRO – Decentralizing Clinical Trials A New Quality-by-Design, Risk-Based Framework

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Clinical trials play a vital role in the development of new therapies, with positive trial outcomes helping pave the way for regulatory approval and market entry. Traditionally, trial activities have been centered around trial sites, locations where patients receive treatment or an investigational medical product (IMP) and are evaluated to determine the safety and efficacy of the intervention. Such “conventional” or “traditional” clinical trials require patient travel, which may be time-consuming, inconvenient, or costly

and could restrict access for individuals who live far away from a trial site, have limited mobility, or cannot spare the time away from work.

Any unnecessary burden on patients could make it difficult to enroll and retain a sufficient number of participants in the trial.

Innovations in clinical trial design are leveraging emerging mobile technologies and increased connectivity to transcend some limitations of conventional trials by incorporating decentralized, patient-centric approaches. Be-
cause of their expertise in clinical trial innovation and clinical trial technology, the clinical research and technology companies of the Association of Clinical Research Organizations (ACRO) (www.acrohealth.org) have paved the way in designing, executing, and refining decentralized clinical trials (DCTs).

Description

Clinical trials play a vital role in the development of new therapies, with positive trial outcomes helping pave the way for regulatory approval and market entry. Traditionally, trial activities have been centered around trial sites, locations where patients receive treatment or an investigational medical product (IMP) and are evaluated to determine the safety and efficacy of the intervention. Such “conventional” or “traditional” clinical trials require patient travel, which may be time-consuming, inconvenient, or costly and could restrict access for individuals who live far away from a trial site, have limited mobility, or cannot spare the time away from work.

Any unnecessary burden on patients could make it difficult to enroll and retain a sufficient number of participants in the trial.

Innovations in clinical trial design are leveraging emerging mobile technologies and increased connectivity to transcend some limitations of conventional trials by incorporating decentralized, patient-centric approaches. Be-
cause of their expertise in clinical trial innovation and clinical trial technology, the clinical research and technology companies of the Association of Clinical Research Organizations (ACRO) (www.acrohealth.org) have paved the way in designing, executing, and refining decentralized clinical trials (DCTs).

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