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Improving Patient Recruitment in Biosimilar Trials

  • ID: 2236661
  • Report
  • 147 Pages
  • Industry Standard Research (ISR)
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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.


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
Note: Product cover images may vary from those shown
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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

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
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
Note: Product cover images may vary from those shown
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