This webinar discusses the importance of declining some clinical studies in order to build a better study pipeline and ensure long-term site success. It is important to decline studies that are not a good fit and could damage relationships or drain resources. Factors to consider when declining include whether the site can successfully enroll patients, has the necessary capabilities and resources, and whether the study meets predetermined requirements. Providing detailed feedback to sponsors can improve studies and build credibility. The goal is to accept studies that contribute to the site's strategic focus areas and therapeutic expertise to become a preferred site for certain indications.

1. Importance of Feasibility Timelines and When to Accept/Decline
a Study
Moderated by:
Simonne - ClinEdge
Presented By: Doug Cavers, Associate Director of Clinical
Operations ClinEdge Network
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2. Webinar Agenda
• Why It’s Important to Decline Some
Studies
• What Factors to Consider When
Deciding to Decline
• Declining Studies to Build a Better
Pipeline
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3. Why It’s Important to Decline Some Studies
• Only a small portion of clinical trials seeking investigators at a
given time will be a good fit for your site.
• Taking on the wrong studies can:
– Damage sponsor/CRO relationships
– Drain valuable resources
• Taking on the right studies can:
– Provide revenue
– Build PI experience
– Contribute to long-term goals
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4. Why It’s Important to Decline Some Studies
• Accepting a “bad-fit” study jeopardizes your site’s relationship
with the sponsor and CRO
– Failure to recruit successfully
– Additional costs accrued for enrollment support
– Delays due to lack of necessary capabilities
• Declining studies shows sponsors and CROs your site is both
knowledgeable and trustworthy
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5. Why It’s Important to Decline Some Studies
• Some studies will divert resources away from more valuable
opportunities
– Burden on site staff
– Complex procedures/requirements
– PI time
• Don’t “lock” your patients in a bad study
– Upcoming trials may compete
– Duration of patient participation
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6. Why It’s Important to Decline Some Studies
• Some studies may not be profitable for your site financially
– Low per-patient budgets
– Few patients enrolled
• Consider the investments needed to conduct the trial
– Cost of new equipment
– Cost of new staff required
– Advertising/database outreach
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7. Polls
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8. It’s Time to Decline When…
• You are not confident that your site can
enroll enough patients
– Patient database > advertising
– Will your patients agree to participate?
– Will you be able to retain patients?
• The study does not meet your site’s
standard of patient care
– Motivated patients are your most
valuable asset!
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9. It’s Time to Decline When…
• Your site does not have the necessary resources in place
– Equipment
– Staff
– Training (rating scales)
– PI experience
• Plan ahead so you are ready for the study before feasibility
ramps up
– Sponsors will prefer ready-to-go sites
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10. It’s Time to Decline When…
• The study does not meet your site’s predetermined requirements
– Outside indications of interest
– Lower than acceptable budget
• Your site has a minimal chance of being awarded
– Lack of PI experience
– Reliance on advertising
– Competing studies
– Unresponsive sponsors/CROs
– Pre-award studies (except in key indications)
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11. Tips for Smart Declining
• Do not waste energy on dead-end studies
– Completing FQs takes a lot of time!
– Check with PI and staff when unsure
• Provide detailed feedback to sponsors and
CROs
– They want to hear this to improve their study
– Builds your site’s credibility
• Do not decline too early
– If possible, wait to see a protocol
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12. Building a Better Study Pipeline
• When evaluating a study, consider how it will
contribute to your site’s long-term goals
– Predetermine key therapeutic areas of
interest
– PI experience
– Access to patients
– Desire to participate in future trials
• For which indications should sponsors and
CROs think of you as a “go-to” site?
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13. Building a Better Study Pipeline
• Always consider the relationship with the sponsor and CRO
– Will the study showcase your site’s strengths?
– Will the sponsor have future trials in the indication?
– Can help in deciding between similar studies with different sponsors
• For CROs specifically:
– Does the CRO have a therapeutic focus?
– How often are they awarded?
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14. Breaking into New Therapeutic Areas
• When you do not have experience in a TA, some studies will be
easier to break into than others
– Registry studies
– Observational studies
– Phase 4 studies
– “Easy” in terms of recruitment and procedures
• Signs you should decline:
– Low number of sites on study
– Difficult enrollment expectations
– “Hard” in terms of procedures required
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15. Summary
• Declining some studies is key to your site’s long-term success
– Maintains trust with sponsors and CROs
– Conserves resources for more valuable opportunities
– Builds experience in a few key areas of interest
• It’s time to decline when…
– You do not have the patient population
– You do not have the necessary resources in place
– The study does not meet your predetermined requirements
– Your site has a minimal chance of being awarded
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16. Questions?
Please take this time to submit questions in
the webinar question box on the right
Contact:
Doug Cavers
Dcavers@clin-edge.com
857-496-0054, ext. 547
ClinEdge is a full-service business development and marketing firm dedicated to the success of Clinical Trials. We
represent a network of highly qualified research facilities to pharmaceutical industry professionals as well as manage
individualized marketing and patient recruitment strategies.
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