With the advent of new technologies, how clinical trail could be in the future

1. Clinical trials & trial data in
future
Moovendhan Devaraj

2. Is it gonnu change?
• Do we need patients/Subjects for Clinical
trials?

3. Stem Cells from Skin Cells

4. Organ Chips

5. Organ printing

6. Extra cellular structure extraction

7. What would be the change in clinical
trials?
• Phase 1 trials will be majorly lab based…
• larger samples of data even for very rare
disease occurrences…
• Number of subjects in phase 2 clinical trials
would be reduced…
• Better Safety, better results…

8. What would be the change in CDM?
• Phase 1 would have more of LABs data…
• eCRF will not be needed for Phase 1…
• Very less amendments/CRs…
• We might have to design the eCRF based on
the data base structure…
• Will have much more standardized the data
and validation/analysis will be much simpler
and easier…

9. References
• http://www.independent.co.uk/news/science/exclusive-the-miracle-cure--
scientists-turn-human-skin-into-stem-cells-9117102.html
• http://9lives.co.za/organs-on-chips-stop-animal-testing/
• http://www.worldpharmanews.com/research/2767-bone-marrow-on-a-chip-
unveiled
• http://www.worldpharmanews.com/research/2771-patient-stem-cells-used-to-
make-heart-disease-on-a-chip
• http://www.ted.com/talks/anthony_atala_printing_a_human_kidney
• http://www.nytimes.com/2012/09/16/health/research/scientists-make-progress-
in-tailor-made-organs.html?pagewanted=all&_r=0

10. Thanks
Battilamous Hasta La Victoria Siempre...
(Battle till the ever lasting victory - Che)