Monitoring the quality of conduct of clinical trials: a survey of current practices

Abstract

These findings underscore the necessity of research to provide an evidence base for monitoring practice.

Risk indicator taxonomy for supervision of clinical trials on medicinal products

“…Moreover, the taxonomy facilitates risk analysis because the indicators and their explanation provide further understanding of the risks, their causes and their consequences. Examples of assessment procedures of different stakeholders include monitoring procedures by trial sponsors [6][7][8]21 , identification of triggers for G.C.P. inspections by regulators 3-5,10 , and ethical review by M.R.E.C.s 5,22 .…”

“…Over the past years, regulators publically shared their viewpoints on risk-based approaches for regulatory activities with respect to clinical trials on medicinal products in guidance documents and in presentations, postulating a variety of indicators for risk assessment 3-5 . In addition, other stakeholders shared their thoughts and opinions on risk adapted approaches for clinical trials [6][7][8] . The focus of the risk indicators may depend on the perspective.…”

Solving clinical trial delays: innovative solutions

“…Recruitment projections and continuous monitoring of recruitment is important to provide rapid assessment of the recruitment strategies currently being employed and identify areas for improvement [25,26] Solving clinical trial delays Clinical Trial Perspective measures such as recruitment index has been proposed for planning the duration of recruitment period for a new study, or projecting the number of participating sites required to enrol the target number of analyzable patients within a certain period [27]. Electronic decision support tools can be utilized to help with participant eligibility assessment as its use has been justified in multicenter cancer clinical trials [28]. Drug trial regulations should also reconsider the inclusion of audio-video consenting process, given the privacy issues raised by the study participants.…”

Benefits of integrated clinical trials systems in risk based monitoring

“…What results is another level of revelation with inside and out knowledge that would never have been accomplished through a conventional audit of the crude information. 4,5 Wielding these propelled devices and rendering information in this extended limit are difficulties requiring the organization of settled visual examination speculations, advanced programming and a capable pool of developers. Yet notwithstanding the difficulties, when legitimately connected, these information combination and visual examination instruments convey genuine potential to developing ideas that would somehow or another be consigned to "wish for" status:…”