Patient centric approach for clinical trials: Current trend and new opportunities

Sharma, Neha

doi:10.4103/2229-3485.159936

Cited by 54 publications

(41 citation statements)

References 2 publications

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“…While recent studies have reported improved trends in the overall conduct of CTs, sponsors continue to experience significant challenges in meeting overall CT timeline demands [11][12][13][14].…”

Section: Discussionmentioning

confidence: 99%

Streamlining and Cycle Time Reduction of the Start-up Phase of Clinical Trials

Abu-Shaheen

Al‐Badr

AlFayyad

et al. 2019

Preprint

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Objective: The start-up phase of a clinical trial (CT) plays a vital role in execution of novel drug development. Hence, this study aims to identify the factors responsible for delaying the CT start-up phase. Further, it focuses on streamlining and reducing the cycle time of the start-up phase of newly sponsored CTs. Methodology: Thirteen sponsored CTs conducted (between 2016 and 2017) in clinical research 3 Conclusion: Varied factors are responsible for delay of the start-up phase of CTs and understanding the impact of each factor allows for optimization and faster execution of the start-up phase of CTs.

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Section: Discussionmentioning

confidence: 99%

Streamlining and Cycle Time Reduction of the Start-up Phase of Clinical Trials

Abu-Shaheen

Al‐Badr

AlFayyad

et al. 2019

Preprint

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“…Clinical research eligibility criteria have been criticized for their vagueness, ambiguity [5], complexity [6], overly restrictive nature, lack of patient-centeredness [7], and lack of computational capability and interoperability across studies or with other data sources [8]. Unfortunately, few resources exist for helping clinical investigators discover potential patient selection problems and make better eligibility criteria choices.…”

Section: What Is Wrong With the Current Practice For Eligibility Critmentioning

confidence: 99%

“…Moreover, eligibility criteria are often defined through trial and error, a process that requires many protocol amendments. There is an unmet need for early protocol feasibility assessment and cost-effectiveness analysis of individual eligibility criteria [7]. …”

Section: What Is Wrong With the Current Practice For Eligibility Critmentioning

confidence: 99%

Optimizing Clinical Research Participant Selection with Informatics

Weng

2015

Trends in Pharmacological Sciences

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Clinical research participants are often not reflective of the real-world patients due to overly restrictive eligibility criteria. Meanwhile, unselected participants introduce confounding factors and reduce research efficiency. Biomedical Informatics, especially Big Data increasingly made available from electronic health records, offers promising aids to optimize research participant selection through data-driven transparency.

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“…In addition, the need to carefully consider patients as active collaborators rather than subjects is increasingly acknowledged (89). Acknowledging the limited number of paediatric use marketing authorisations (PUMAs), it is commonly agreed that the Regulation may need to be changed in order to promote paediatric trials in off-patent drugs, whereas other limitations have been observed as well.…”

Section: Paediatric Regulation: Progress and Future Perspectivesmentioning

confidence: 99%

Paediatric Drug Development and Formulation Design—a European Perspective

Riet‐Nales

Kozarewicz²,

Aylward

et al. 2016

AAPS PharmSciTech

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Abstract.The availability of licensed paediatric drugs is lagging behind those for adults, and there is a lack of safe formulations in suitable doses that children are able and willing to take. As a consequence, children are commonly treated with off-label or unlicensed drugs. As off-label and unlicensed drug use are associated with a greater risk for harm than on-label drug use, a range of global initiatives have been developed to realize Bbetter^medicines for children. This review describes the challenges and achievements of the European Union to realize this goal, with a focus on paediatric drug development and formulation design. In 2007, a European Paediatric Regulation was installed enforcing companies to consider children in the early development of drugs with a new drug substance, for a new indication or with a new route of administration. The Regulation, e.g. requires companies to develop a paediatric investigation plan discussing the proposed clinical trials in children of different ages and the formulations for future marketing. Since 2013, the pharmaceutical design of any newly marketed paediatric drug should comply with the BGuideline on the Pharmaceutical Development of Medicines for Paediatric Use.^Companies should, e.g. justify the route of administration, dosage form, formulation characteristics, safety of excipients, dosing frequency, container closure system, administration device, patient acceptability and user information. In this review, the guideline's key aspects are discussed with a focus on novel formulations such as mini-tablets and orodispersible films, excipients with a potential risk for harm such as azo dyes and adequate user instructions.

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Patient centric approach for clinical trials: Current trend and new opportunities

Cited by 54 publications

References 2 publications

Streamlining and Cycle Time Reduction of the Start-up Phase of Clinical Trials

Streamlining and Cycle Time Reduction of the Start-up Phase of Clinical Trials

Optimizing Clinical Research Participant Selection with Informatics

Paediatric Drug Development and Formulation Design—a European Perspective

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