recruitment into clinical trials Dr. Karen M. Barlow Associate - PowerPoint PPT Presentation

Lessons learned from Marketing Theory to improve recruitment into clinical trials Dr. Karen M. Barlow Associate Professor, University of Calgary

Objectives • Outline trends in trial recruitment • Review marketing strategies • Discuss the relevant literature about how we can use marketing to improve recruitment • Share our ideas

Recruitment and Retention • One of the most important aspects of any Qualit ity clinical trial – Delays in recruitment costs money – Leads to uncertainty about relevancy of the trial – Decreased external validity – Time marches on Budge get – Drop out after randomization and loss to follow up Time ► decreased internal validity – Loss of backing from funding bodies The “Golden T riangle” Of Project ct Management gement

So how are we doing? • Multicentre trials between 1994 and 2002 – McDonald AM et al. Trials . 2006;7:9 – only 31% achieved original recruitment targets and – 53% requested grant extensions • More recently – Sully BG, et al Trials. 2013;14:166. – recruitment has improved – 45 45% of trials als strugg ggle to r recruit uit their r sample e size and – ~1/3 needed d grant t extensio sions ns

Who here is running a clinical trial? • How’s recruitment? • How’s retention?

Barriers to participation To name a f e a few Children ldren • Public awareness • Risk vs. benefit • Children need to be protected • Cultural / language • Understanding • Industry / Economic • Negative publicity • Clinician (e.g. time, buy-in) • Informed assent • Parental (time, best tx) • Parental decision makers • Language of clinical trials • Teenagers (randomization, equipoise) • Consent process

Ma Mark rketing ting – th the e Definition Definition • Process: – defining markets – quantifying the needs of the customer – determining the value – communicating these value propositions to “stakeholders” » (A value proposition is a bundle of benefits offered that impels a customer to want to buy) – delivering – monitoring McDonald M, Wilson H. The new marketing: transforming the corporate future . Oxford: Butterworth-Heinemann; 2002

5 stages of “marketing” a clinical trial Gain the Who? Convey the 'value To learn, To maintain buy-in and What do proposition' to through doing, momentum by devise they need to patients, develop more renewing or systems for sign up? medical effective upgrading 'the marketing Develop a personnel, practices. offer’, sustain 'value agencies, interest of proposition' advocacy groups agencies etc Francis D, Roberts I, Elbourne DR et al. Trials . 2007: 8:37

The he Reference erence Mo Model del • Signaling worthiness: – Buy-in likely when participants realize, and identify with, the potential benefits gained by the trial’s success • Simple processes: – Simple processes reduces the costs (time effort money) of participation • Strategies for overcoming resistance • Adopting an explicit marketing plan: – will need to be revised frequently – probably every quarter. Separate plans for – The Uninformed – The Unconvinced – The Laggards (Enroll, facilitate and target), – The Steady Performers (Reward, renew, upgrade and recognise) and – The Stars (Honour, learn from, and nourish). Francis D, Roberts I, Elbourne DR et al. Trials . 2007: 8:37

CRASH-2 Trial • – using ng the model to develop op trial al process esses es – CRASH-2 trial collaborators. Lancet . 2010;376:23-32 • Txt2stop p Tri rial al – using ng the model as a diagn gnos osti tic c tool – all the new interventions fitted into the marketing framework tool and recruitment increased markedly – Free C, et al. Lancet . 2011;378(9785):49- 55 • LIFE FELAX LAX Trial – using ng the model as an aud udit it tool – Speed C, et al. Health Technol Assess . 2010;14(52):1-251 Play Game Trial al (diag iagno nostic stic tool) •

Recruitment ecruitment Op Opti timisa misation tion Mo Model del Galli i L, Knight ht R, Rober ertson tson S, et et al. Trials ls . 2014;15: 5:182 182

Determine nature of problems: 7 P’s • Product (trial) • Price (costs/time/barriers) • Promotion/communication (e.g. mass media) • Place (convenient, preferable) • People – research staff shape expectations, build trust and commitment between the trial and its participants • Processes – actions required of participants to participate in the trial, ease of use is key. E.g. nature of the consent process • Physical environment – participants will have greater confidence in a trial conducted in a well-cared for facility

What barriers have you encountered?

Recruitment ecruitment Op Opti timisa misation tion Mo Model del • Strengths – Iterative and dynamic – Focuses on multiple learning events as emergent and on- going processes – Experiential • Weaknesses – New – ?Only used in Txt2Stop

Ma Mark rketing ting an and In Informat ormation ion Tec echnolo nology gy • MARKIT model – IT, marketing, and clinical research – a single framework – to maximize recruitment, enrollment, engagement, and retention • Benefits – ? reach larger and more diverse community of participants – help maximize limited resources – more cost-effective and efficient clinical trial management • Limitations – ? tech savvy ? Generalizability – specialized staff with expertise in marketing and IT systems – Fewer face-to-face interactions ? Less engagement Gupta a A, Calfas KJ, J, Mar arsh shal all l SJ, , et et al. Cont ntem empo porar rary y Clinical ical Tria ials . . 2015;42 ;42:1 :185-195

Gupta a A, Calfas KJ, J, Mar arsh shal all l SJ, , et et al. Cont ntem empo porar rary y Clinical ical Tria ials . . 2015;42 ;42:1 :185-195

Q-QA QAT – qu quan anti ti-quali qualitativ tative e ap appo point intment ment ti timing ing • A A simple le tec echn hnique ue to iden entify tify key y rec ecrui ruitme tment nt issues ues in RCT? CT? • Methods: – quantification of time spent discussing RCT and its treatments • using transcripts of audio-recorded recruitment appointments, – targeted qualitative research to understand the obstacles to recruitment – feedback to recruiters on opportunities for improvement Paramasivan S, Strong S, Wilson C, et al. Trials . 2015(16:88)

What strategies have you employed to increase recruitment? • Stakeholder – patients, physicians, nurses, parents • Recruitment? • Retention?

www.playgametrial.ca

• Building our brand – Two large cohort studies – Product development – “the need” – Focus groups, online questionnaires, clinic patients – Stakeho holde lder r meets ets • Legitimacy – Conference presentations – Cohort study of treatment response – Professional expertise – Tri-council funding • But issues with “product” and “buy in” from professionals initially and over the counter availability

• Recrui ruitment ent - Simple ple process? ocess? – No. – Initially hard for families in ED to envision enrollment one month later – Other study ”competition” – Research in clinical environments eg FP office • Strategies to overcome problems – Increased ED recruitment – reiterative – Paper to electronic, Consent to contact – Personal contact • Explicit recruitment plan – ED, FP, sport societies – Webpages, twitter, FB – Product – plus MRI and cognitive testing

• Making the sale – Advocates – Media (Radio, TV, internet, newspaper) – Sports meeting – Recurring events – Safety – Participant spokeskids at events • Maintaining engagement – Xmas cards – Thank you gifts – Newsletters – Focus groups – Pictures and info for school projects – Clinic appointments – Recurrent meets with stakeholders (e.g. ED, TMS, MRI, CIHR, ACHF, ICRP)

Potential problems: 7 Ps • Product (trial) • A safe treatment but over-the-counter, initially credibility • Once a day t x ; Trial -time consuming; • Price (costs/time/barriers) inv x offer reassurance • Where are the clients? Liaison with • Promotion/communication (e.g. mass ethics, Increasingly positive reviews media) on Websites (need more promotion), • Place (convenient, preferable) TV, ACHF, News, Treatment is at home • People • Excellent staff • Processes • Complex initially, reassurances of • Physical environment weekly and medical follow-up • The fabulous Children’s Hospital

Summary • Recruitment to clinical trials is a major issue • Strategies should be planned in the development phase • Marketing strategies can be employed • Problems should be identified early on • Continual evaluation • Used our own examples to illustrate