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1、WhitepaperAccelerating clinical development through DHTsICON clinical development through DHTsContentsIntroduction:The digital revolution in clinical research 03What are DHTs and what can they measure?04The adoption of digital endpoints and digital biomarkers 07Framework for selection,validation and

2、 fit-for-purpose assessment 10Implementing DHTs:A roadmap 13A business case built on ROI and competitive differentiation 14A partner for implementation success:The ICON advantage 16Conclusion:The digital imperative 18Further reading 19Authors 20References 21Accelerating clinical development through

3、DHTs3This necessity is reflected in a growing wave of global regulatory guidance.Agencies including the U.S.Food and Drug Administration(FDA),the European Medicines Agency(EMA),Chinas National Medical Products Administration(NMPA)and others have issued clear directives that clinical trials must be t

4、echnologically enabled and patient-centred.The FDAs Center for Drug Evaluation and Research(CDER)has even established a Center for Clinical Trial Innovation(C3TI)to improve the efficiency and effectiveness of clinical trials.2Introduction:The digital revolution in clinical researchThe landscape of c

5、linical research is at an inflection point.Drug development has become increasingly expensive,complex,and time-consuming.In fact,average timelines to bring a drug to market can range from 10-15 years and cost between$200 million to nearly a billion dollars.1 As scientific innovation continues unabat

6、ed,clinical trials must keep pace and across the industryfrom sponsors to regulators,investigators,and patientsstakeholders are aligned on the needvto modernise how evidence is generated,evaluated,and applied.In response to these imperatives,digital health technologies(DHTs)have become a growing pla