ehealth (Telemedicine) and concepts of virtual clinical trials Prof. Dr. med. Siegfried Jedamzik Berlin, 09. November 2017

Transcription

1 ehealth (Telemedicine) and concepts of virtual clinical trials Prof. Dr. med. Siegfried Jedamzik Berlin, 09. November 2017

2 Agenda Number Titel 1.0 Introduction Bayerische TelemedAllianz (BTA) 2.0 Telemedicine and Mobile Healthcare 3.0 The Digitalisation of Clinical Trials 4.0 Looking Ahead Zeit für mehr Gesundheit - Leben sichern! 2

3 1.0 Introduction Bayerische TelemedAllianz (BTA) Zeit für mehr Gesundheit - Leben sichern! 3

4 The Bayerische TelemedAllianz (BTA) The Bavarian TelemedAlliance (BTA) was founded in July 2012 in Ingolstadt and since then we are known as the primary Bavarian Telemedicine Institute, supported by the Bavarian State Ministry of Health and Care. Our vision is to comprehensively optimise medical supply and health care in Bavaria through the targeted use of telemedicine and ehealth Zeit für mehr Gesundheit - Leben sichern! 4

5 Center of Expertise and Networking (ehealth) The BTA offers: Consulting Project management Public relations Congress and conventions Academic courses Workshops Webinars Education and training Zeit für mehr Gesundheit - Leben sichern! 5

6 What do we offer? At a glance: Consultations and support for concepting and planning Development and co-development of projects in the field of telemedicine Connection of cooperation partners and networking Information about funds in Bavaria, Germany and the European Union Support for setting up funding requests Zeit für mehr Gesundheit - Leben sichern! 6

7 2.0 Telemedicine and Mobile Healthcare Zeit für mehr Gesundheit - Leben sichern! 7

8 Definitions Zeit für mehr Gesundheit - Leben sichern! 8

9 Healthtelematics Is the use of information and telecommunication technologies (ITT) in the healthcare sector To increase the quality, to minimise costs and to enhance the communication in the areas of: Patient care Knowledge transfer Administrative processes Allows communication between different sectors and spatial areas Focus is on technique and structure Zeit für mehr Gesundheit - Leben sichern! 9

10 Telemedicine Is a subarea of Healthtelematics and ehealth Medical services via ITT But: It is no replacement for the doctor and patient relationship Aims: To optimise diagnose, therapy and prevention meassures To overcome spatial distances To reduce or prevent medical errors To minimise costs And to reduce time Zeit für mehr Gesundheit - Leben sichern! 10

11 Mobile Healthcare Is also called mhealth Is Telemedicine in a vivid environment Focuses on the collection of patients clinical data en route Zeit für mehr Gesundheit - Leben sichern! 11

12 3.0 The Digitalisation of Clinical Trials Zeit für mehr Gesundheit - Leben sichern! 12

13 Digital Transformation in Germany Quelle: ec.europa.eu

14 Health The Digital Revolution in Healthcare The market for digital products will grow by 20%/pa to $20 biilion by 2020 The easy access to information and the tranparency of information in the age of Health 4.0 will enable patients to be nearly on one informationlevel with their Docs..

15 Emerging Market Digital Health Representative population survey from and (March 2017) Survey Population: 1003 German, age >14, with 798 internet user and 698 smartphone user Results: 50%+ : using internet for health related information 25%+ : using a fittness app 65% : would use electronic health files 75% : wants to control who can access their data Majority: wants direct access to own data & the electronic health insurance card Conclusion Telemedicine and ehealth are future topics

16 Health 4.0 means: Transparent, digital and easily accessible information enables patients to be nearly on one level of knowledge with their doctors Patients can monitor their health in using apps and mobile devices Patients can participate in prevention, diagnosis and therapy Assumption "Digitization allows for more efficient healthcare, lower health costs, increased customer service and, above all, innovative, disruptive business models." (Quote: Matthias Mettler, Digital Business Builder and Digital Health Advisor)

17 Health Professionals Public Status Quo While medical professionals are still using paper documentation,,the general public already uses digital services, like health apps Zeit für mehr Gesundheit - Leben sichern! 17

18 Why Digitalisation in the Pharmaceutical Industry etc.? 2008: A study conducted by Tufts University in Massachusetts. The study revealed an alarming trend for clinical research: That the costs and timelines for clinical trials are rising. While at the same time recruitment and retention of patients in clinical studies are declining. Table: Various aspects of clinical trial conduct Source: Hassan Kadhim, Remote Trials to Drive Patient Centricity Zeit für mehr Gesundheit - Leben sichern! 18

19 Comparison between Traditional and Virtual Clinical Trials Table: Comparison between the remote trial model and the traditional trial model in clinical research Source: Hassan Kadhim, Remote Trials to Drive Patient Centricity Zeit für mehr Gesundheit - Leben sichern! 19

20 Effects on Cost, Efficiency and Patient Convenience (1/2) Table: Analysis and comparison of the costs, productivity and patient convenience between the traditional and remote clinical trial model (1/2) Source: Hassan Kadhim, Remote Trials to Drive Patient Centricity Zeit für mehr Gesundheit - Leben sichern! 20

21 Effects on Cost, Efficiency and Patient Convenience (2/2) Table: Analysis and comparison of the costs, productivity and patient convenience between the traditional and remote clinical trial model (2/2) Source: Hassan Kadhim, Remote Trials to Drive Patient Centricity Zeit für mehr Gesundheit - Leben sichern! 21

22 The Pharmaceutical Industry and its steps towards Patient Centricity Fully digital health ecosystem results from: - Mass digitisation of patient records. - Steadily increasing number of technologies (e.g. smartphones, wearables, sensors). - Social networking platforms Facilitating the collection and access to clinical data. Achieving higher patient engagement. Refund policies in healthcare systems: Emphasises on outcome-based reimbursements. More pressure among clinicians and their partners (e.g. pharmaceutical industry) to generate more efficient and specific medicines. New ways for the pharmaceutical industry: Innovations in the field of clinical research to adequately react to this changes. Focus on patient centricity in clinical research through digital technologies that are already present to innovate and to improve certain aspects of clinical trials Zeit für mehr Gesundheit - Leben sichern! 22

23 Components of Virtual Clinical Trials (1/2) Virtual clinical trials and its components: 1) Patient recruitment: Over the study website. Study sponsors should be able to benefit from internet advertising in social media, e.g. Google, Facebook and Instagram and specialized social networks, e.g. MyHealthTeams, SmartPatients and PatientsLikeMe. Recruitment is based on electronic health records as well as on health insurance databases. 2) Patient retention: Constant communication facilitated by modern technologies, e.g. mobile messaging. A well-educated patient about the study, informed about treatment details and potential risks and benefits, is usually a better engaged patient. 3) Electronic Informed Consent (econsent): Use of multimedia via an electronic device (e.g. laptop or tablet) to present the complete information and to obtain informed consent prior to patient study enrolment. Not expected to eliminate the patient-investigator interaction but rather to support it Zeit für mehr Gesundheit - Leben sichern! 23

24 Components of Virtual Clinical Trials (2/2) 4) Collection and monitoring of clinical data: esource/epro: Eliminates the need to transcribe data from paper forms to an electronic system, since the data is already in electronic form at the source (e.g. records). Wearable Devices: Sensors that can quantify various biometric measures (e.g. physical activity, heart rate and blood pressure) and can be worn at specific locations on the human body. 5) Data quality and patient engagement: Telemedicine: To enable video conference sessions and to obtain medical device data. Monitoring: A shift from a reactive activity happening after the events, to a proactive activity, identifying all events of the study conduct in real-time. Adherence: Text messaging to send patients daily alerts to promote treatment adherence or sensors implanted in the medication container (= smart bottles ) registering a timestamp at the opening. Thereby regulatory, legal, clinical and technological contexts must be considered Zeit für mehr Gesundheit - Leben sichern! 24

25 Summary: Benefits of Telemedicine and mhealth in Virtual Clinical Trials Visits between the principal investigator, the clinical team and the patient can take place conformately from the patients home environment: Telemedicine platforms can be used to gain medical devices data to measure blood pressure or to examine heartrate even when the patients are not at home Zeit für mehr Gesundheit - Leben sichern! 25

26 Concepts of Virtual Clinical Trials 1) Remote Clinical Trial Model One central coordinator site is responsible for the study. Reduction of contribution of clinical research sites. Taking advantage of mobile and digital health technologies. Implementation becomes more effective. 2) Hybrid Model Several clinical sites are responsible for the study. A combination of traditional visits to the clinical site and e-visits take place. Advantages of the use of modern technologies and face-to-face interactions are combined Zeit für mehr Gesundheit - Leben sichern! 26

27 Remote Clinical Trial Model Figure: Integral representation of the remote clinical trial model, with one central coordinating site Source: Hassan Kadhim, Remote Trials to Drive Patient Centricity Zeit für mehr Gesundheit - Leben sichern! 27

28 Hybrid Model Figure: Integral representation of the hybrid model, with the presence of multiple sites Source: Hassan Kadhim, Remote Trials to Drive Patient Centricity Zeit für mehr Gesundheit - Leben sichern! 28

29 Benefits of Virtual Trials For Patients Virtual methodology: Less time and effort for patient recruitment and enrollment (nowadays almost 80% of trials fail to meet initial targets). Electronic health records can help to identify targeted trial subjects and online patient support networks. Keeps patients engaged with the study, because of no need for frequent travel to study sites and automated data collection. For Everyone Investors, physicians, government agencies, patient advocacy groups and even the patients themselves have more opportunities to play an active role in the study. Better data quality & shorter timelines. Faster process of drug development, improving patient safety and reducing expenditure on failed trials Zeit für mehr Gesundheit - Leben sichern! 29

30 Pioneers in Virtual Trials 1) Pfizer in 2011 Research on Electronic Monitoring of Overactive Bladder Treatment Experience (REMOTE). First randomised clinical trial using web- and smartphone-based patient recruitment, enrollment and collection of study data without requiring patients to visit a physical site. Main goal: To compare the virtual approach to a conventional Phase IV clinical study in order to determine if the virtual trial design would be a feasible way to conduct future trials. Challenge: The issue of patient recruitment (most members were older, so the use of a technology-based trial was mostly unknown). 2) Sanofi in 2016 Supported a virtual diabetes trail (VERKKO) to be conducted remotely in Europe. Key differences compared to Pfizer s REMOTE study: Did not test a drug. Focused on a wireless glucose meter. Conclusion: It is the first clinical trial using an electronic informed consent approved by European regulatory agencies Zeit für mehr Gesundheit - Leben sichern! 30

31 4.0 Looking Ahead Zeit für mehr Gesundheit - Leben sichern! 31

32 Conclusion Concepts of virtual clinical trials should cover the entire process from the recruitment and enrollment of patients, to the collection and monitoring of clinical data. Thereby the regulatory, legal, clinical and technological context is important. The steadily increasing number of technologies, e.g. smartphones, wearables, sensors and social networking platforms, create new opportunities for the collection of clinical data and patient engagement in virtual clinical trials. Virtual clinical trials can benefit from telemedicine because virtual visits can take place from the comfort of the patients homes. Besides, the telemedicine platform can be used to gain medical device data, e.g. to measure blood pressure Zeit für mehr Gesundheit - Leben sichern! 32

33 Future Prospects The new reality will require a change of mind about patient privacy and protection. Careful monitoring and thoughtful mitigation strategies are necessary to succeed in recruitment and retention of patients with lower computer literacy. It is possible that virtual studies will coexist with traditional study practices rather than replace them. Perhaps virtual clinical trials are used in rescue studies, where traditional models have failed (e.g. for geographically dispersed groups or rare disease populations). Virtual studies may be suitable for sensors and diagnostics, which will continue to increase in importance as the technology evolves. Hybrid models are likely to gain importance as sponsors become more and more interested in testing the new model. It is not an easy road, but it is one likely to offer significant benefits for certain studies and select patient populations Zeit für mehr Gesundheit - Leben sichern! 33

34 Virtual clinical trials can benefit from telemedicine, because new opportunities for the collection of clinical data and patient engagement are provided. Prof. Dr. med. Siegfried Jedamzik Bayerische TelemedAllianz (BTA) Oberer Grasweg 50a Ingolstadt Tel: 0841/ Zeit für mehr Gesundheit - Leben sichern! 34