Remuneratie van
proefpersonen
1 INTRODUCTORY CONSIDERATIONS
- Ethical misgivings arise when a research study is undertaken that is not able to answer the
research question of interest, e.g. by being seriously underpowered
- IRBs need to safeguard the rights, safety and well-being of research subjects
o Autonomy
o Voluntary consent
o Integrity
o Scientific research needs to be sound/valid
2 PATIENT RECRUITMENT
- In early phases of clinical trials
- Phase I en II
- Gezonde vrijwilligers
Patient accrual is the single largest driver of time to market of a new drug
- Only 6% of the clinical trials complete accrual on schedule.
- Only 3% of patients participate in clinical trials.
- Up to 90% of PIs miss their recruitment target.
- The development of New Chemical Entities (NCE) of New Investigational Drugs (NIDs) in
certain indications is markedly delayed due to poor accrual of patients.
3 PATIENTS’/VOLUNTEERS’ MOTIVATIONS AND
FACTORS INFLUENCING THEIR DECISION TO
PARTICIPATE
3.1 REASONS WHY PATIENTS PARTICIPATE
- Not adequately treated with current therapy
- Adverse reactions to current therapy
- Patients believe that their relationship with their physician would be jeopardized if they do
not enroll
- Free medical care
- Remuneration $
- To benefit society; help others
- Seek attention to alleviate loneliness
- Seek new challenges or changes in their life
- Enjoy special attention from physician and staff
, - Want to help their physician with his or her research
3.2 FACTORS REDUCING WILLINGNESS TO PARTICIPATE
3.3 WHAT MOTIVATES VOLUNTEERS ?
- Altruism
o Disease
o Society
- Curiosity
- Medical Care an or evaluation (where not available)
- Other incentives
- Money
o >90% of those surveyed said financial compensation was main motivation for
participation
e.g. Bigorra and Banos 1990; van Glederen et al 1993; Hassar et al. 1977
3.4 A CULTURE OF SAFETY
“The demand for human subjects is at all times high, and the competition for human subjects for
research participation is equally great. Investigators must take care to not respond to this
competitive environment …
proefpersonen
1 INTRODUCTORY CONSIDERATIONS
- Ethical misgivings arise when a research study is undertaken that is not able to answer the
research question of interest, e.g. by being seriously underpowered
- IRBs need to safeguard the rights, safety and well-being of research subjects
o Autonomy
o Voluntary consent
o Integrity
o Scientific research needs to be sound/valid
2 PATIENT RECRUITMENT
- In early phases of clinical trials
- Phase I en II
- Gezonde vrijwilligers
Patient accrual is the single largest driver of time to market of a new drug
- Only 6% of the clinical trials complete accrual on schedule.
- Only 3% of patients participate in clinical trials.
- Up to 90% of PIs miss their recruitment target.
- The development of New Chemical Entities (NCE) of New Investigational Drugs (NIDs) in
certain indications is markedly delayed due to poor accrual of patients.
3 PATIENTS’/VOLUNTEERS’ MOTIVATIONS AND
FACTORS INFLUENCING THEIR DECISION TO
PARTICIPATE
3.1 REASONS WHY PATIENTS PARTICIPATE
- Not adequately treated with current therapy
- Adverse reactions to current therapy
- Patients believe that their relationship with their physician would be jeopardized if they do
not enroll
- Free medical care
- Remuneration $
- To benefit society; help others
- Seek attention to alleviate loneliness
- Seek new challenges or changes in their life
- Enjoy special attention from physician and staff
, - Want to help their physician with his or her research
3.2 FACTORS REDUCING WILLINGNESS TO PARTICIPATE
3.3 WHAT MOTIVATES VOLUNTEERS ?
- Altruism
o Disease
o Society
- Curiosity
- Medical Care an or evaluation (where not available)
- Other incentives
- Money
o >90% of those surveyed said financial compensation was main motivation for
participation
e.g. Bigorra and Banos 1990; van Glederen et al 1993; Hassar et al. 1977
3.4 A CULTURE OF SAFETY
“The demand for human subjects is at all times high, and the competition for human subjects for
research participation is equally great. Investigators must take care to not respond to this
competitive environment …
