Detection of drug safety signals from clinical trials data: Role of SUSARs

Ca, Perez; Olivier‐Abbal, Pascale; Lortal, Barbara; Duranton, Sophie; Montastruc, Jean‐Louis; Colin, Anne-Laurène; Toulza, Emilie; Becker, Madlyne; Hamy, Laura; Crépin, Sabrina; Roussillon, Caroline; Gimbert, Anne; Petitpain, Nadine; Salvo, Francesco

doi:10.1016/j.phrs.2018.02.010

Cited by 11 publications

(6 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Safety report management in drug clinical trials is essential to the comprehensive and objective evaluation of a trial drug [4] . In comparison with GCP-2003, there has been a significant adjustment in safety report management in GCP-2020.…”

Section: Optimization Of Safety Managementmentioning

confidence: 99%

The new Good Clinical Practice-2020 in China: Views from ethical perspective

Yang

Heng

et al. 2021

The Lancet Regional Health - Western Pacific

View full text Add to dashboard Cite

Section: Optimization Of Safety Managementmentioning

confidence: 99%

The new Good Clinical Practice-2020 in China: Views from ethical perspective

Yang

Heng

et al. 2021

The Lancet Regional Health - Western Pacific

View full text Add to dashboard Cite

“…Determining whether an adverse reaction is a SUSAR is a matter to clinical pharmacologists, who should combine medical considerations (e.g., alternative causes) with pharmacological assessment (e.g., plausibility in terms of time to onset and relevant mechanism). A recent French experience pooled data from academic sponsors and proposed SUSARs as a source of signals, especially for anticancer drugs (25). In this perspective, the information arising from SUSARs, if communicated in real time to clinicians, could help in preventing and mitigating drug-related risks, or in monitoring the risk of adverse reactions for drug(s) with similar mechanism of action.…”

Section: Pharmacovigilance As a Real-world Real-time Aid To Clinical Practice: The Case Of Immune Checkpoint Inhibitorsmentioning

confidence: 99%

Pharmacovigilance, drug interactions, pharmacogenetics and therapeutic drug monitoring of anticancer agents: a valuable support for clinical practice

Raschi¹,

Re²,

Conti³

et al. 2021

Pharm Adv

View full text Add to dashboard Cite

Clinical pharmacology is an integral part of oncology, especially in the modern era of precision medicine.The innovations introduced in drug development (conditional accelerated tumor-agnostic approvals through adaptive trials) and clinical practice (liquid biopsy, tumor molecular board) underline the pressing need for clinical pharmacologists, who play a catalyst and translational role in a synchronized multidisciplinary team. This review describes the latest advancements and challenges in actually implementing the precision medicine approach in oncology: pharmacovigilance, drug interactions, pharmacogenetics and therapeutic drug monitoring are often overlooked valuable tools for the understanding, detection, assessment, and prevention of adverse drug reactions, thus supporting safe prescribing in oncology.

show abstract

“…Inadvertent expenses for study participants due to conduct of a trial during the COVID-19 pandemic must be reimbursed by the sponsor according to applicable local policies. [12]…”

Section: Informed Consentmentioning

confidence: 99%

Clinical research during coronavirus disease pandemic: Challenges and way forward

Stockler

Gulia

2020

IJMS

View full text Add to dashboard Cite

With the novel coronavirus disease (COVID-19) being declared a global pandemic by the World Health Organization, the Indian health-care sector is at the forefront to deliver optimal care but with constrained resources and several challenges. The pandemic has also brought about a state of urgency to develop suitable management principles for COVID-19 with the help of suitably designed clinical trials. However, the pandemic along with the lockdown and other restrictions has affected the conduct of clinical trials in terms of restrictions on travelling, trial site staff availability, investigational product availability, and medical oversight among others. This article provides structured recommendations for sponsors, investigators, clinical trial personnel to adapt to the situation by identifying potential risks and challenges and mitigating them to conduct clinical trials well within the ambit of local regulatory guidelines and requirements during the COVID-19 pandemic.

show abstract

Detection of drug safety signals from clinical trials data: Role of SUSARs

Cited by 11 publications

References 17 publications

The new Good Clinical Practice-2020 in China: Views from ethical perspective

The new Good Clinical Practice-2020 in China: Views from ethical perspective

Pharmacovigilance, drug interactions, pharmacogenetics and therapeutic drug monitoring of anticancer agents: a valuable support for clinical practice

Clinical research during coronavirus disease pandemic: Challenges and way forward

Contact Info

Product

Resources

About