Patient Recruitment and
Retention
1 AN EXAMPLE
Recruitment for ‘Stroke Trial X: some practical aspects
- Knowing the disorder and the protocol
- Having access to sufficient patients
- Believing in the protocol
- Sensibilizing and/or educating colleagues and members of your multidisciplinary team
- Organizing your stroke unit - assigning tasks (for in- and outpatients)
- Screening (put up a practical routine system)
- Convince the patients
o Overtuigen door kwaliteit van de studie, maar overdrijf hier niet in!
Some concerns raised by investigators (on this specific study)
- The fact that patients may be enrolled to the Telmisartan (Micardis ) add-on arm:
Telmisartan is a member of the class of angiotensin II receptor blockers (ARBs) and could be
contraindicated according to some investigators in patients with carotid artery stenosis
- Reply: scientific data do not support this thesis or concern (see also the post hoc analyses of
Progress Study …)
Some additional concerns by investigators
- The patient was already on one of the study medications and did a stroke - so it is unethical
to include the patient
- Reply: this is of course unscientific thinking. Antiaggregants do not fully protect against new
events but reduce the risk of new events
- The follow-up period is long and patients have to take a lot of pills
- Reply:
o it needs to be clarified to the patients that their follow-up should anyhow be life-long
o It should be stated that there are placebo pills at well and that sometimes there is
much more drug in small than in large pills
2 PATIENT RECRUITMENT
- Generally higher the in US or Western Europe:
o Qualified Investigators eager to participate in clinical trials: professional prestige,
material incentives
o Highly motivated patients (free access to modern treatment, sometimes the only
hope, close medical supervision, cultural reliability on doctor’s opinion)
o Centralized Health Care System
o Poor Health Insurance System
, 2.1 WHY SPRI CLINICAL TRIALS ? WE DELIVER PATIENTS
2.1.1 Patient Recruitment
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
- Patients on clinical studies consistently receive better treatment than patients not on clinical
studies
- The development of New Chemical Entities (Medicines) in certain indications is markedly
delayed due to poor accrual of treatment naïve patients.
- SPRI’s strategy targets locales and sites with few competing trials and large numbers of naïve
patients
The Leaky Pipe Analogy
Patient Recruitment
‘Patient Life’
- Highest level of comfort
Retention
1 AN EXAMPLE
Recruitment for ‘Stroke Trial X: some practical aspects
- Knowing the disorder and the protocol
- Having access to sufficient patients
- Believing in the protocol
- Sensibilizing and/or educating colleagues and members of your multidisciplinary team
- Organizing your stroke unit - assigning tasks (for in- and outpatients)
- Screening (put up a practical routine system)
- Convince the patients
o Overtuigen door kwaliteit van de studie, maar overdrijf hier niet in!
Some concerns raised by investigators (on this specific study)
- The fact that patients may be enrolled to the Telmisartan (Micardis ) add-on arm:
Telmisartan is a member of the class of angiotensin II receptor blockers (ARBs) and could be
contraindicated according to some investigators in patients with carotid artery stenosis
- Reply: scientific data do not support this thesis or concern (see also the post hoc analyses of
Progress Study …)
Some additional concerns by investigators
- The patient was already on one of the study medications and did a stroke - so it is unethical
to include the patient
- Reply: this is of course unscientific thinking. Antiaggregants do not fully protect against new
events but reduce the risk of new events
- The follow-up period is long and patients have to take a lot of pills
- Reply:
o it needs to be clarified to the patients that their follow-up should anyhow be life-long
o It should be stated that there are placebo pills at well and that sometimes there is
much more drug in small than in large pills
2 PATIENT RECRUITMENT
- Generally higher the in US or Western Europe:
o Qualified Investigators eager to participate in clinical trials: professional prestige,
material incentives
o Highly motivated patients (free access to modern treatment, sometimes the only
hope, close medical supervision, cultural reliability on doctor’s opinion)
o Centralized Health Care System
o Poor Health Insurance System
, 2.1 WHY SPRI CLINICAL TRIALS ? WE DELIVER PATIENTS
2.1.1 Patient Recruitment
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
- Patients on clinical studies consistently receive better treatment than patients not on clinical
studies
- The development of New Chemical Entities (Medicines) in certain indications is markedly
delayed due to poor accrual of treatment naïve patients.
- SPRI’s strategy targets locales and sites with few competing trials and large numbers of naïve
patients
The Leaky Pipe Analogy
Patient Recruitment
‘Patient Life’
- Highest level of comfort
