Project Management_DM Presentation
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This document introduces the team and project for Media4Patient. The project aims to improve clinical trial enrollment through a new digital platform using social media and mobile technologies. It outlines challenges with patient recruitment such as many trials not reaching full enrollment and patients being unaware of clinical trial options. It then discusses stakeholders in clinical trials and viewpoints from different groups. Finally, it performs a PESTEL analysis to examine political, economic, technological, legal, environmental and socio-cultural factors affecting the project.
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Project Management_DM Presentation
- 1. Team Introduc.on • Project Manager Daniela Margio6a • Team Members ü Pierre Mateo (IT) ü Chrysanthi Samara (Clinical Research Associate) ü Nikola Bucalovic (Sale Marke.ng) ü Isabel RuEmann (HR) MEDIA4PATIENT Project Descrip.on Media 4 Pa)ents is a new pla0orm aimed to target, discover and iden)fy new pa)ents by using Digital Pla0orms, Social Media, and Mobile Technologies in order to Improve Clinical Trial Enrollment. 1 in 4 clinical trials never reach full enrollment 8 5 % P a . e n t s unaware that clinical trials are treatment op.ons Help us change this sta/s/c!
- 2. Drug Development Process/Overall .meline • 12-‐15 years to bring one drug to market from discovery in a laboratory to the pa.ent. • It costs about $802 million* (in year 2000 dollars) • For each medicine that reaches the marketable, between 10,000-‐30,000 compounds must be screened. • A Phase III study include ~800 subjects ~700 days (2 years) Costs ~$25 million or ~ $36,000/day *Ref: DiMasi JA, Hansen RW, Grabowski HG. The price of innova)on; new es)mates of drug development costs. J Health Econ2003;22:151-‐85.
- 3. 9Months Pa.ent recruitment is challenging and costly $ 600K– 8M+ It’s reported that 29% of .me is dedicated to pa.ent recruitment/enrollment ac.vi.es making it the most /me-‐intensive ac/vity Typical phase-‐III clinical trials can cost $86 million and last from two to four years, implying that close to 9 months alone is a6ributed to pa.ent recruitment/ enrollment process Each day trial comple.on is delayed represents an opportunity cost of $600K-‐$8M+ to the sponsor 29%
- 4. Stakeholders 1. Pa.ents 2. Clinicians (in Primary, Secondary and Ter.ary Care seEngs) 3. Clinical Inves.gators 4. Contract Research Organiza.ons (CROs) 5. Pharmaceu.cal Industry 6. Hospital Administrators 7. Academia 8. EHR Systems Vendors 9. Trusted Third Par.es (TTPs) and Trusted Services Providers (TSPs) 10. Health Authori.es 11. Health Care Planners 12. Regulators Who can influence? … the one who … pays / invests ? regulates ? knows?
- 5. 69% Said they have not par.cipated in c l i n i c a l t r i a l because they were not made aware of any trials. 28% Said that inclusion/ exclusion criteria have the single biggest impact on p a . e n t r e c r u i t m e n t success. Viewpoints Clinical trials involve 5 main groups, each with different views and mo/va/ons. Here is what they are saying about clinical trial Pa.ents 76% S a i d t h e y a r e involved in the right amount, or too many clinical trials. 70% Said the hardest part of pa.ent recruitment is finding the right inves.gators. 233% I n c r e a s e i n pa.ents required per NDA from 1500 in the 1970s to more than 5000 today. Site Coordinators Inves.gators Sponsors Food and Drug Administra.on
- 6. PESTEL-‐analysis: Poli/cal factors Economic Factors Technological factors Legal Factors Environmental factors Socio-‐cultural factors -‐ The world is online but some countries do not allow direct-‐to-‐pa.ent solicita.on via any medium. (These include Russia, Poland, and Hungary.) -‐ Poli.cal decision being cost-‐oriented-‐ -‐ Changes in legisla.on (new GCP EU direc.ve). -‐ N e e d t o i n v o l v e relevant stakeholders as early as possible to deploy specific lobbying efforts. -‐ Pharma industry facing mul.ple drug patent expires. -‐ Interest to a6ract long term R&D investments in EU -‐ Studies have shown that member demographics in online pa.ent communi.es are representa.ve of pa.ents in general. -‐ Growing interests in public health research. -‐Access to innova.ve medicine increasingly delayed /restricted -‐Design/concept must be culturally acceptable -‐ Digital media and social plaoorms are actually less expensive compared to mass media. There are an array of op.ons available, and they can target groups very precisely. -‐ Any ini.a.ve that can be managed via tradi.onal media can be accomplished online. -‐ It must meet strict legal/ ethical/ regulatory/ privacy protec.on requirements. -‐ In some countries par.cipants are paid, in Switzerland they are not paid. -‐ M e s s a g e m u s t b e translated in all the languages. -‐Pa.ents facing required for local law -‐ Clinical trials take place all over the world but developing countries open serve as cost effec.ve loca.ons . -‐ India 2003, 8 test subjects died during the tes.ng of the an.-‐ cloEng drug Streptokinase. The worst part, though, was that the subjects did not even know that they were part of a trial.
- 7. Find target Media Develop the crea/ve concept Organize events • Increase number of pa.ents enrolled in clinical trial. • Create a full accessible plaoorm/database with a diversified pa.ents pool. • Inform pa.ents for the best available treatment op.on. PURPOSE 10 months 1-‐10 months 1-‐2 months 8 months
- 8. IN OUT Facebook Twi6er Social Media Pharmaceu.cal Industries Pa.ents Hospital Administrators Academia Trusted Third Par.es Health Authori.es Health Care Planners Regulators TV Radio Newspaper Unconscious people
- 9. Jun Jul Aug Sep Oct Nov Dec Jan Apr 2015 IDENTIFIED 30 TARGET MEDIA Wed July 1 Fri Sep27 Design prototype Wed Sep1 Created Ads Mon Sep6 Informed doctors Mon Oct 1 Planned events Fri Nov 11 Organized events Fri Jan21 KicK off Mee.ng INITIATING PROCESS Pestel SWOT Finance Stakeholders Tested ads 1. Increase number of pa.ents enrolled in clinical trial. 2. Create a full accessible plaoorm/database with a diversified pa.ents pool. 3. Inform pa.ents for the best available treatment op.on. FINAL GOAL EXECUTION PROCESS CLOSING PROCESS PLANNING PROCESS CONTROLLING PROCESS Milestones plan
- 10. STRENGHTS OPPORTUNITIES WEAKENESS THREATS Environment analysis: SWOT INTERNAL Controllable factors EXTERNAL Uncontrollable factors • Pa.ent safety: informed consent. • Data collec.on, Sta.s.cal Analysis. • Ability to recruit more from the global market. • Reduc.on of .me to “hire”. • Be6er management of informa.on. • Using the organiza.on's reputa.on, product image. • Based on best available informa.o.n • Transparent, dynamic, itera.ve. • Responsive to change. • Allow sponsor to reach pa.ents with more speed and precision. • Create value. • Educa.ng community. • Takes human and cultural factors into account. • Study popula.on. • Full Database. • 50% of people over 50 and 1/3 over 65 frequent social network sites. • Acceptance of outside support. • Look of Media4pa.ents vendors representa.on. • Interoperability challenge between available clinical database. • Clinical trial process is not very well understood in many parts of the world. • Many company assume that there are regula.on prohibi.ng the e-‐ recruitment of pa.ents. • Complexity. • Country specific & privacy protec.on. • Level of acceptance of Pharma re-‐ using the database for clinical research may vary amongst stakeholder.
- 11. Stakeholders analysis Name function Area of interest Expectation Contribution Strategy CEO Pharma Company Dr. Patricia Vega Par.cipant Ms. Formey Aurely Physician Dr. FiascheE Giulio Finance Mountains Art Gallery R&D Service tester Travel R&D Marke.ng Increase N of drugs on the market Power Responsible R&D Football Science Feel be6er Have hope Reach sufficient number of pa.ents to start the clinical trial Stop the project $$$ Stop/Speed the process (N of person) Delay/Speed the project $$$ Feedback Quality Feedback Tester Scien.fic research Publica.on Product Owner Clinical Research Associate Specialist Update info about costs management every week Email web link every 2 weeks and face to face mee.ng Scien.fic Report Every month
- 12. Iden.fy specific media RECRUITMENT REQUISITION/ TOOL CLINICAL TRIAL PROJECT MANAGER Design specific ads Adver.se for a specific trial PROJECT TEAM External STAKEHOLDER Process & Workflow Receive clinical applica.on forms Do we have > 200 par.cipants? YES NO
- 13. Risks and Constraints Iden.fying Risks: < 200 pa.ents for each clinical trial Impact: No clinical trial Probability = 5.25 Detec.on = 4 Severity = 10 Cri.cality = P x D x S = 210 >125 Trivial Trivial Significant Major Catatstrophic IMPACT Not Like Possible Quite Possible Likely Very Likely LIKEHOOD < 200 pa/ents x 1 clincal trial
- 14. 1 expert 3h/day x 1month 5000 CHF HIRE ON LINE EXPERT TOT 13000 CHF 3 conference in 1 month 6000 CHF 1 expert 2000 CHF 10 months 1 month MITIGATION PLAN Mi.ga.on Plan REACH 8 DOCTORS CREATE ONLINE SELF HELP GROUP Probability = 3.5 Detec.on = 2.25 Severity = 10 Cri.cality = 78.75 <125
- 15. Trivial Trivial Significant Major Catatstrophic IMPACT Not Like Possible Quite Possible Likely Very Likely LIKEHOOD Iden.fying Risks: Pa.ents Sca6ered all over the world Impact: Difficul.es to recruit pa.ents for clinical trial (cost demanding) Pa/ents sca]ered all over the world Probability = 4 Detec.on = 5 Severity = 5 Cri.cality = PxDxS = 100 <125 Risks and Constraints
- 16. 1 expert 3h/day x 1month 5000 CHF TARGET COMPANY WITH INTERNATIONAL SITES TOT 6000 Chf I T expert sopware license 1 week 1000 CHF 10 months 1 month delay CONTINGENCY PLAN Con.ngency Plan OFFER STATISTICAL SUPPORT ? Probability = 3.5 Detec.on = 2.25 Severity = 10 Cri.cality = 78.75 <125
- 17. Work Breakdown Structure Research Market 1.1.1 Research Users interests 1.2.1 1.1 1.2 Informed Doctors1.3 1.4 e-Recruitment for clinical trial 1.0 Iden/fied 30 web sites Designed ads Tested ads effec/veness Planned Events 1.5 Shared value 1.6 Milestones 1.2.1.1 1.2.1.2 1.2.1.3 Work Package Ac2vi2es Study market Design prototype Realize innovative graphic concept Set up a survey 1.2.2 Email random list of recipients 1.2.2.1 1.2.2.2 1.2.2.3 Check if there are more subscription Meeting to discuss about like dislike List available doctors 1.2.3 Write and adapt “message” 1.2.3.1 1.2.3.2 Discuss with doctors Visit doctors 1.2.3.3 Feedback 1.2.3.4 Write invitation 1.2.4 1.2.4.1 1.2.4.2 1.2.4.3 1.2.4.4 1.2.5 1.2.5.1 1.2.5.2 Link banner or pop up ads 1.2.2.4 Deliver brochure 1.2.3.5 Organize Concert Contact sponsor Search for available place Send invitation Meet with patients Contact patients Invite patients
- 18. Gan6 Ac.vi.es and Resources eRecruiting for clinical trial MILESTONE Name: Identify 30 specific web sites Activity M T W T F M T W T F M T W T F Precedent Resource (Who- person/title) Cost of resource (Who- person/title) Resource (What- material) Cost of resource (What- material) Budget Monitor on line discussion Web Research expert (3h x day) 3000 Wifi connection 200 3200 Create specific account 1 IT expert (3h x day) 400 Wifi connection 0 400 Contact blogger 1,2 IT Expert 600 Wifi connection Telephone line 200 800 Write specific survey 1 Clinical Trial Expert 600 Wifi connection 0 600 Up load a survey 4 IT (3h x day) 200 Wifi connection 0 200 Analyze data 5 Clinical Research Assistant 600 Wifi connection Software License 0 600 Total 5400 400 5800 Period:18 June 2015 - 9 July 2015 Timeline: M/T/W/T/F Resources executing activities
- 19. Overall budget Task Task Description DAYS Cost Equip/Mat. Cost Travel Cost Task Total Cost Task 1.1 Monitor social media sites 3h#x#day 3000 200 0 3200 Task 1.2 identify key opinion eleader 3#d 600 0 0 600 Task 1.3 Create specific accounts 3#h#x#day 400 0 0 400 Task 1.4 Write specific survey 2#days 600 0 0 600 Task 1.5 upload survey 3h#x#day 200 500 0 700 Task 1.6 analyze data 2#days 600 500 0 1100 Subtotal Milestone 1 0 5400 1200 0 6600 Task 2.1 Study users market 5#days 3000 0 0 3000 Task 2.2 Design prototype 30#days 10000 500 0 10500 Subtotal Milestone 2 0 13000 500 0 13500 Task 3.1 Write specific survey 2 400 0 0 400 Task 3.2 upload survey 3h#x#day 200 0 0 200 Task 3.3 analyze data 2 600 500 1100 Subtotal Milestone 3 4 1200 500 0 1700 Task 4.1 Contact doctors 30 1000 200 0 1200 Task 4.2 Create ads brochure doctor oriented 30 6000 1000 0 7000 Task 4.3 attend medical conference 180 6000 5000 10000 21000 Task 4.4 Install billboard in the waiting room 30 3000 4000 10000 17000 Subtotal Milestone 4 270 16000 10200 20000 46200 Task 5.1 create a database with all the events 14 3000 250 0 3250 Task 5.2 Identify suitable day 7 1000 0 0 1000 task 5.3 Name people "ready to go" 5 600 0 0 600 Task 5.1 Invite TESTIMONIAL 3 60 5000 0 15000 20000 Task 5.2 organize concert for charity 3 90 10000 20000 20000 50000 Subtotal Milestone 5 26 4600 250 0 4850 Other Cost 1 30 5000 1000 5000 11000 Other Cost 2 30 1000 1000 5000 7000 360 46200 14650 30000 90850 6000 1000 6000 13000 360 52200 15650 36000 103850 e-Recruiting for clinical trial Project Manager Daniela Margiotta Budget by Project Task Milestone 6 organize events Subtotals MITIGATION PLAN Total Milestone 4 Inform Doctors Milestone 1* IDENTIFY 20 TARGET MEDIA Milestone 2 Design ads Milestone 5 Plan events Milestone 3 Test Ads MEDIA4PATIENT
- 20. ROI/ Break-‐even $ x Number of Par.cipants 50 chf x 50 p x 60 d = 150000 ROI = (150000 – Tot costs 17000) *100 = 7.8% Tot cost 17000 ROI > 1 Contribu.on Margin = Revenue – VC = 150000 – 5000 = 145000 EBIT = CM – FC = 145000 -‐ 12000 = 133000 CM ra.o = CM/ Revenue = 145000 / 150000 = 0.966 BE = FC/CM ra.o = 12000 / 0.966 = 12422.3602 Break-‐even = 12422.3602
- 21. $ Number of plaoorm sold ROI/ Break-‐even ROI = (150000 – Tot costs 17000) *100 = 7.8% Tot cost 17000 ROI > 1 Contribu.on Margin = Revenue – VC = 150000 – 5000 = 145000 EBIT = CM – FC = 145000 -‐ 12000 = 133000 CM ra.o = CM/ Revenue = 145000 / 150000 = 0.966 BE = FC/CM ra.o = 12000 / 0.966 = 12422.3602 Break-‐even = 12422.3602 500 chf x 5 p x 60 d = 150000
- 22. Website Google adverts Faceboo k adverts Search engine op.misa .on YouTube Offline ac.vi.es Old New The road map to successful par2cipant engagement with social media means developing a strategy, a personality, and inves2ng 2me, resources, and value crea2on in a social media presence.
- 23. 1 in 4 clinical trials n e v e r r e a c h f u l l enrollment 8 5 % P a . e n t s unaware that clinical trials are treatment op.ons Help us change this sta/s/c! Thank you!
- 27. Recruitment process Tradi.onal recruitment E-‐recruitment A6rac.ng candidates Using sources that are not technology supported, like adver.sements, flyers, spokespersons, to draw as many applicants as possible to contact Using the organisa.on’s reputa.on, product image, online technology and other methods to draw as many poten.al applicants as possible to the organisa.on’s website. There Implementa.on of e-‐recruitment 19 the organisa.on. organisa.ons can present themselves Sor.ng applicants Using a paper-‐based test for applicants to create a manageable applicant pool Employing sophis.cated, standardised online tests to screen candidates, and to winnow the applicant pool to a manageable number Making contact Contac.ng the sorted applicants by phone or mail and having face to face conversa.ons Using automated hiring management systems to contact the most desirable candidates very quickly, before they are snapped up by another company Closing the deal Making the phone call, seEng up Making the phone call, seEng up the the mee.ng and shaking hands mee.ng and shaking hands Organisa.ons make use of e-‐recruitment because of several reasons (Chapman & Webster, 2003; Jones et al, 2002; Lee, 2005; Parry, 2006; Singh & Finn, 2003). These include: cost savings ease of use for candidates larger candidate pool ease of use for the organisa.on increasing the speed to hire success in finding candidates keeping ahead of compe.tors
- 28. Examples of benefits Academic perspec/ve Provide tools and services to be6er plan and conduct academic trials (inves.gator-‐ini.ated trials) Facilitate compara.ve effec.veness research Pharmaceu/cal perspec/ve Improve speed and quality of the pa.ent recruitment process and study design by accurate understanding of real pa.ent popula.ons Support to conduct observa.onal and outcomes research studies in real-‐world seEngs General Healthcare perspec/ve Significant facilita.on of the re-‐use of EHR data to allow more efficient management of public health issues Closer co-‐ordina.on between care providers and pa.ents, resul.ng in safer and more evidence-‐based diagnosis and tratment E-‐Pa.ents are 60% more likely than the general popula.on to have par.cipated in clinical research