Innovation in Clinical Trial Methodologies

Lessons Learned during the Corona Pandemic

Specificaties
Paperback, blz. | Engels
Elsevier Science | e druk, 2020
ISBN13: 9780128244906
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Elsevier Science e druk, 2020 9780128244906
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Samenvatting

Innovation in Clinical Trial Methodologies: Lessons Learned during the Corona Pandemic presents a selection of updated chapters from Re-Engineering Clinical Trials that feature innovative options and methods in clinical trials. The Coronavirus pandemic is an accelerator for digitalization in many industries, including clinical trials. This book considers best practices, alternative study concepts requiring fewer patients, studies with less patient interaction, the design of "virtualized" protocols, and moving from data to decisions. This book will be helpful to pharmacologists, physicians and clinical researchers involved in the process of clinical development and clinical trial design.

Specificaties

ISBN13:9780128244906
Taal:Engels
Bindwijze:Paperback

Inhoudsopgave

<p>Section 1 Introduction<br>1. Is the Covid pandemic an accelerator for digitalization?<br>2. Best practices for streamlined development</p> <p>Section 2 Alternative study concepts requiring fewer patients<br>3. Use of historic data<br>4. Adaptive and platform trials<br>5. A vision: Studies without patients</p> <p>Section 3 Studies with less patient interaction<br>6. Home Nursing replacing site visits<br>7. Telemedicine replacing site visits</p> <p>Section 4 Design of "virtualized" protocols<br>8. Data mining for better protocols<br>9. Patient-centric registries for population enrichment<br>10. Make a protocol "patient centric"<br>11. The use of new digital endpoints<br>12. Regulations for apps in clinical trials<br>13. The role of the site and the patient<br>14. A real virtual trial</p> <p>Section 5 From data to decisions<br>15. Data standards against data overload<br>16. Data analytics for operational excellence<br>17. Taking control of high data volume<br>18. Share the (digital) knowledge based on quality data</p> <p>Section 6 Conclusions</p>

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        Innovation in Clinical Trial Methodologies