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1. Decline Wrong Studies &
Welcome the Right Ones

2. Choosing the right study is crucial
for your site's long-term success.
This will help you build a better
study pipeline.
Remember:
IT'S OKAY TO DECLINE A
STUDY THAT'S NOT THE
RIGHT FIT!
Introduction

3. The Importance of Declining
Certain Studies

4. - Spending your resources unnecessarily;
- Straining the relationship with sponsors/CROs;
- Not meeting your recruitment target;
- Extra costs for enrollment;
- Postponing the trial;
- Losing time and effort of staff and PIs;
- Locking your patients in a 'bad' study;
- Not gaining profit/Losing money;
- Spending money on new investments/staff;
Damages from Accepting the Wrong Study

5. - Gaining income;
- Increasing PI experience;
- Improving long-term site success;
- Gaining trust and respect of sponsors/CROs;
Benefits from Accepting the Right Study

6. When to Decline a Study?

7. Not being able to recruit and retain patients
If you think that you won't be able to recruit and retain the number and type of patients
required for the study, it's better to decline it.
Patient database is usually the first and biggest source of patient recruitment, so if this is not
an option for you, then don't do it.
Relying only on promotion and advertising, without your own patient database, will rarely give
you the outcome you're expecting. Even if you are able to recruit the needed number of
patients, make sure that you'll be able to retain those patients until the end of the trial.

8. Not having the required resources for the study
In order to conduct a study successfully, you must have the necessary resources such as
equipment, experienced staff, training and education, and PI experience. If your site doesn't
have all this, then it's best if you decline it.
Many times, the amount of money that your site spends on acquiring the necessary resources
will not pay off in the end.

9. Only minimal chances of obtaining the study
If it's obvious that your site's chances of getting the study are close to zero, then it's better to
direct your time and efforts elsewhere.
The reasons why your site isn't competent to conduct a study can be different: lack of PI
experience in the suggested therapeutic area, much better competition sites, unresponsive
sponsors and CROs, relying only on advertising for recruitment, etc.

10. The Study Doesn't Meet Your Site's Standards
For instance, if the study is not in your site's field of interest – decline it!
If the study has a budget that's too low and won't even cover your site's costs – decline it!
If the study doesn't match your site's patient care standards – decline it!

11. Clever Declining

12. Don't waste your time and effort
on studies that lead nowhere
Don't decline a study before you see the
protocol – declining a study too early
might ruin your chances of conducting a
perfectly good study
Give the sponsors and CROs feedback – this will
give them reasons why you refused to conduct
the study so that they know which parts to
improve, and will also give your site a sense of
professionalism and respect
Take into consideration that FQs
(feasibility questionnaires) take a lot of
time to complete, so don't do this if the
study is a dead-end
When you're not sure if to accept
or decline a study, consult with
your staff and PI and ask them for
their opinions
Tips for clever declining

13. Long-term Goals:
Improving Your Study Pipeline

14. Most important long-term goal to have in mind:
IMPROVING YOUR STUDY PIPELINE!
Answering the questions that follow will help you
decide if to accept or decline a study in order to improve
your site's study pipeline in the long-term.

15. - What are your site's therapeutic areas of expertise?
- What is your PIs experience?
- What sources do you have for accessing and recruiting patients?
- What are your desires regarding participation in future trials?
- Will this study display your site's best qualities?
- Will the sponsor/CRO have more similar studies in the future?
- What's the therapeutic area of focus of the CRO?
- Has the CRO been awarded/how often?

16. Entering New Therapeutic Areas

17. - Phase 4 trials/studies;
- Studies that have easier recruitment and procedures;
- Registry studies;
- Observational studies;
Easier options for entering new therapeutic areas:

18. - If the number of sites interested in a study is low;
- If the recruitment expectations are impossible to
meet;
- If the procedures that the study requires are
difficult;
- If the equipment needed for the new study is too
expensive for your site;
- If your staff and PIs don't have any experience in
that therapeutic area;
'Red flags' when entering new
therapeutic areas

19. Declining certain studies will help you...
✓ gain more trust and credibility with sponsors and CROs;
✓ keep your resources for more important and profitable projects;
✓ gain excellent experience in the few therapeutic areas that are
your main focus;
Checklist

20. Decline a study when...
✓ you are not able to recruit the needed number of patients;
✓ you don't have the needed resources (equipment, PI and staff
expertise, training and education);
✓ the study doesn't match your site's standards;
✓ you have only a minimal chance of obtaining the study;
Checklist

21. Clinical research sites have to carefully choose which studies to accept and which
to decline. Contrary to popular belief, accepting all studies is not the key to
success. In fact, the opposite is often true! The real key to a successful building of
your site's study pipeline is declining the studies that aren't the right fit for your
site.
Whenever you have to make this choice, always have your site's long-term success
Conclusion

22. THANK YOU FOR YOUR
ATTENTION!
Accepting the right studies for your
site will build your study pipeline
better in the long run!