Innovation in Clinical Trials: opportunities and challenges

Transcription

1 Innovation in Clinical Trials: opportunities and challenges Enrica Andreoni Clinical Operations Country Study Manager, Roche SpA FROM - Bergamo - May 27 th, 2014

2 2 Empowered Patients Are Here

3 WHY Innovation in Clinical Research? 1. Take opportunities from new communication approaches (social media) 3

4 4 New Technologies Are Here

5 2. Take opportunities from new technologies Wearable biosensors/devices have the ability to objectively measure data that has traditionally been self reported by patients or required an office visit (e.g. sleep, activity, vital signs). Biosensors have the ability to provide an early intervention/coaching resulting in enhanced patient compliance and safety oversight in clinical trials. 5

6 Examples of opportunities from new technologies 6 but it is crucial to pay attention to data reliability and accuracy

7 7 Value Creation is Here, with the Shifting role of Government and Payers

8 8 3. Sustain new innovative medicines, developed with high quality in a timely manner and reducing costs

9 Personalized Medicine is Here 9

10 10 4. New technologies and new communication approaches could help us to reach easily and quickly our targeted patients for trials

11 Examples of Tools for Clinical Trial Innovation

12 12 Websites for Clinical Trials

13 Social Media & Patient Insights 13

14 14 Telemedicine & Mobile Home Nursing

15 15 Biosensors in Clinical Trials

16 16 Mobile Technology in Clinical Trials

17 Roche Innovation Overview Selected high impact initiatives Physician Insights Patient Insights Social Media Already available Obtain KOL insights quickly e.g. on identification of indications using online network Sermo Gain patient insights using networks such as Patients Like Me or Crohnology.com design studies which recruit faster Tools to support development of social media recruitment strategies that help accelerate recruitment Mobile Nurse Networks Sharing Trial Results to Patients Site Qualification Training Available in Q3/14 Mobile Nurses could reduce F2F trial visits and increase trial participation/ retention for patients unable to physically visit a trial site Share trial results with patients to foster trust and societal acceptance Establish mutual recognition of GCP training and site qualification between pharmaceutical companies Lean Protocol Design Decentralized Trial mhealth Experiments this year Design significantly more efficient and effective protocols - by starting with a bottoms up strategic firstprinciples approach Enable community doctors and their patients to participate in clinical trials using telemedicine Enable efficient, faster & costeffective development and deployment of mobile app solutions for study teams

18 Join efforts to improve Clinical Research: TransCelerate 18

19 19 TransCelerate Mission

20 TransCelerate ongoing Initiatives 20

21 Summary: Drug Development Needs Rethink the process increasing patients awareness and patients voice Decreasing costs Apply new technologies New communication approaches (social media) 21 Prepare the ground to accept

22 Clinical Research Innovation Challenges Tools: reliability & sensitivity Privacy law: differences country by country Regulatory aspects: EMA, FDA, country by country 22

23 Present & Future Prepare the ground to accept the changes Cultural aspects Regulatory implications Ethics/administrative implication Legal implications (i.e. privacy, advertising, ) Pilot Projects 23

24 Dream big and make possible! Innovation in clinical trials is a challenging need Innovation is helpful for patients, caregivers, physicians, pharmaceutical companies and governments Innovation could decrease drug development and health assistance costs Innovation means updating regulatory framework preserving three key important topics: 24 PATIENT S SECURITY PATIENT S PRIVACY PATIENT S QUALITY OF DATA

25 25 Thank you for your attention!

26 Doing now what patients need next 26