Improving Patient Recruitment in Biosimilar Trials

Transcription

1 Brochure More information from Improving Patient Recruitment in Biosimilar Trials Description: ISR's newest report examines topics affecting recruitment for Biosimilar clinical trials. This report includes 93 charts and graphs and is a complete and quantatative assessment of Biosimilar recruitment. The report was developed based on novel data from 103 respondents with on-site patient recruitment responsibilities. ISR believes we are in the beginning stages of high-growth for Biosimilars. Teva's August, 2012 FDA approval for two of Amgen's products (Neupogen & Neulasta) signals a milestone for the development of Biosimilars. It is interesting to note that Teva chose to use the Biologics License Application (BLA) process, normally reserved for novel products, as their route to approval. While this has both regulatory and commercial implications, the clinical development implications center on the fact that if others follow this route, the magnitude of the trials needed for a Biosimilar approval increase dramatically. With increased clinical trial activity through Phase III, the ability to recruit patients into these important studies will become a key stepping stone to Biosimilar commercial success. REASONS TO BUY Readers of this report will: - Have a better understanding of how sites view Biosimilar trials today - Understand the current barriers to Biosimilar patient recruiting - Learn what the most successful techniques are for recruiting patients into Biosimilar studies - Be able to craft patient-centric messages that will resonate with them and provide a launching pad for discussions and interest in being trial participants - Conceptualize how an integrated approach is needed between early pharma trial design, sponsor/ CRO assistance for sites in patient recruiting, and developing tools/ collateral/ language/ messages for site and patient recruitment The report enables you to: - Improve targeting, techniques, and communication with sites and patients to increase likelihood of participation in Biosimilar trials - Anticipate barriers to site and patient recruitment and utilize recommendations from industry professionals - Recognize the "information gap" for key constituents and how this restricts participation in Biosimilar trials Contents: MAJOR SECTIONS Major Sections: 1. Summary and Recommendations - How pharma/cros can motivate sites - How sites can motivate patients 2. Biosimilar environment at the site 3. Barriers to Biosimilar patient recruitment 4. Recommendations for Biosimilar patient recruitment 5. Study data - Patient recruitment trends - Biosimilar recruiting - Analysis by practice type - Respondent/ site demographics

2 List of Charts and Graphs Title Page How pharma/ CRO can motivate sites 11 How sites can motivate patients 14 Biosimilar familiarity 16 Biosimilar trial interest and excitement 17 Biosimilar and generic trial activity 20 Where Biosimilar trials have been taking place 22 Patients 23 Communicating patient benefits 25 Biosimilar experienced sites 27 Misconceptions of how Biosimilar trials are different 28 History and expectations of Biosimilar recruiting difficulty 29 Ways to increase site participation rates 30 Top 3 barriers to patient recruitment 31 Influencing site participation through grants 32 Limiting force of inclusion/ exclusion criteria 34 How sponsors can help sites 37 Overall patient recruitment effectiveness 38 Most successful Biosimilar recruiting approaches 39 Attributes most impactful to recruitment success 47 Single biggest bottleneck to patient recruitment 48 Most successful recruitment methodologies/ mediums 49 Most important motivators for trial participation 51 Overall familiarity with Biosimilars 54 Interest in being a site for a Biosimilar trial 55 Rationale for interest in being a site for a Biosimilar trial 56 Trials needed to approve a Biosimilar 63 Predisposition to site participating in a Biosimilar trial 64 Mean number of chemical generic studies past 24 months 65 Mean number of Biosimilar studies past 24 months 65 Frequency of turning down a Biosimilar study 66 How Biosimilar trials are different 67 Top barriers to recruiting Biosimilar patients 73 Difficulty in recruiting based on previous/ existing therapy 81 Difficulty in accessing the reference product 82 Increasing a site's willingness to participate in a Biosimilar trial 83 Data for Biosimilar inexperienced sites 84 Best practices for communication of patient benefits 85 Medical history that help with Biosimilar recruitment 92 Are patients motivated by a Biosimilar trial? 98 What motivates patients to participate in a Biosimilar trial? 99 Increasing a patient's willingness to participate in a Biosimilar trial 107 Frequency of situations that assist in patient recruitment for Biosimilars 109 Most successful mediums for Biosimilar patient recruitment 111 Best practices/ experiences in Biosimilar patient recruitment 114 Constructing a Biosimilar recruitment program 117 Importance of the payment/ grant model in participating as a site 124 Milestone payments that encourage site participation 125 Importance of the payment/ grant amount in participating as a site 126 Difference in investigator fees (Biosimilars vs. traditional studies) 127 Influencing site participation with a 20% grant increase 128 Would you recommend being a Biosimilar patient? 129 Practice setting distribution 130 Most impact on patient recruitment 131 Biggest bottleneck in patient recruitment 132 Success of Doctor Referral programs 133 Top motivations for participating as a site 134 Familiarity with Biosimilars 135 Site types/ Practices most interested in Biosimilar trials 136 Most excited sites to participate in Biosimilar trials 137

3 Site interest if Investigator grant was 20% higher 138 Practice setting 139 Role and responsibility 140 Patient recruitment responsibility 141 Site location 142 Recent trial activity at the site 143 Number of trials conducted in past 24 months 144 Therapeutic areas of study 145 Ordering: Order Online - Order by Fax - using the form below Order by Post - print the order form below and send to Research and Markets, Guinness Centre, Taylors Lane, Dublin 8,

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