Medpace experts discuss how to overcome oncology recruitment challenges for clinical trials for specific populations, indications, and challenging studies.

1. CLICK TO EDIT
TITLE
Click to edit subtitle
[Insert Sponsor logo or delete]
Clinical Operations – ask the Design Assistant for assistance inserting
Oncology Trial
Recruitment:
Challenging Indications
and Challenging Studies
Presented by:
Lyon Gleich, MD
Vice President of Medical Affairs
Jennifer Cutter, PhD
Director of Clinical Trial Management
Ross Ezzati, MBA
Director of Clinical Trial Management

2. Challenging Indications,
Challenging Studies
2 Physician Led | Therapeutically Focused
o Oncology field with continued changes in drug
development
 Immuno-oncology
 Targeted Agents, Antibodies
 ADCs (Antibody Drug Conjugates)
 Biosimilars
o Fast Track, Sub-Part H, Breakthrough
o Basket trials to extra-specific targeted populations
o Genetically targeted studies
o Protocol, country, and site selection

3. The Oncology Protocol
3 Physician Led | Therapeutically Focused
o Regulatory considerations coupled with safety
and activity can dictate the target population
 Define indication and target label early in
development and modify as needed
 Initiate any companion diagnostics early
o Phase 1 design is crucial
 Adaptive design can limit low dose exposure of
subjects
 Defining the MTD, RP2D, justification of the
regimen, safety profile
 Can be used, particularly through expansions, to
select populations for Phase 2 and registration

4. The Oncology Protocol
4 Physician Led | Therapeutically Focused
o Phase 2/3 – registrational trials
o Depending on specifity of indication, may be possible
to have a single arm Phase 2 as registrational trial if
unmet need and clear benefits can be demonstrated
 Leads often to trials in very specific subpopulations with
potential recruitment challenges
• Many sites for few patients at each site
o If a randomized design required, Phase 2 often best
performed first to be sure of activity and powering of
the larger Phase 3
o Trial design should aim to broaden the population
within reason and consider the burden on subjects
and sites to support recruitment
 In later phases avoid intensive PK and unneeded study
visits in later phases

5. Country and Site Selection
5 Physician Led | Therapeutically Focused
o If the oncologic indication is ubiquitous, considerations
can be driven by regulatory goals, patient availability,
and competitive environment
o If the oncologic indication is known to have
geographic “hotspots,” those areas must be targeted
o Genetic testing requirements and sample
shipments/testing may influence options for some
programs
o If failure of prior therapies required, an assessment if
other regions have the same SOC
 Similarly if SOC comparators are used or any
background therapy, must be consistent across study

6. Country and Site Selection
6 Physician Led | Therapeutically Focused
o Consider if program will be US only or involve other regions
(or even not involve the US)
o In US, can target large academic centers or community
centers or both
o Western Europe in general with similar disease rates and
recruitment potential
 Excellent large centers and high quality
o Eastern Europe can add significant recruitment potential;
may need closer monitoring
o Asia Pacific – developed countries similar to Western
Europe; developing countries have less competition, but
SOC may be a concern
 China has large potential but start-up hurdles
o Latin America – recruitment potential, but start-up hurdles

7. Recruitment – The Sites
7 Physician Led | Therapeutically Focused
o Only a small minority of oncology patients participate in
clinical trials
o Early involvement of PIs
 Protocol review, Committee participation
o Training of site staff
 Instill excitement about the science and drug potential
o Communicate findings/issues with the sites
 Positives and negatives to keep engagement
o Keep the sites engaged in the development
 Work with sites to fully engage their regional referral networks
o Financial support for site efforts
o Recruitment supports
 PI/CRC teleconferences, Newsletters, Signage/Pamphlets,
Brochures, Bring successful site practices to laggards

8. Recruitment – The Patients
8 Physician Led | Therapeutically Focused
o Patient outreach
 Advocacy groups
 Trial websites
 Disease websites
• May need to create a disease specific website
 Clinicaltrials.gov
 Twitter and electronic outreach; site websites
o If genetic testing required, consider the testing
separate from the parent protocol so patients can
consider the trial earlier
o Travel and caregiver support
o Patient education on the disease, drug, and the
procedures

9. CLICK TO EDIT
TITLE
Click to edit subtitle
[Insert Sponsor logo or delete]
Clinical Operations – ask the Design Assistant for assistance inserting
Oncology Trial
Recruitment:
Challenging Indications
and Challenging Studies
Presented by:
Lyon Gleich, MD
Vice President of Medical Affairs
Jennifer Cutter, PhD
Director of Clinical Trial Management
Ross Ezzati, MBA
Director of Clinical Trial Management
Questions?
Thank You