Trial Evaluation

Accept/Reject Trials

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Trial Evaluation


As mentioned throughout the website, about 30% of the sites involved in industry-sponsored clinical trials do not recruit a single participant. The reason for this is that the investigator has not performed a proper feasibility study of the suitability of the trial for his/her site.

It is a large commitment for a clinical investigator to embark on an industry-sponsored clinical trial. The investigator must critically review the final trial protocol and the Investigator’s Brochure to understand if a certain trial is suitable or not. The following sections list essential elements of a trial that should be considered in the review process. After the review, the investigator should be able to make a decision based on questions such as:

  1. Do I have access to the study population?
  2. Will the study be interesting or boring?
  3. Is the study easy or difficult?
  4. Does the study come with a financial profit or loss?

Study population: The key to success for a study site is to have access to the targeted study population. If not, do not even think about trial participation. And never trust that subjects will be easily recruited through other colleagues, by the sponsor, or from the general public. The only way to ensure that a site has access to the pre-set targeted number of trial participants is to undertake a feasibility study. The study can be performed among the clinic’s patients by applying the study inclusion/exclusion criteria to approximately 10-20 patients.  There is a large variation in the mean number of subjects per site, and this is dependent on trial phase and therapeutic area/disease as elaborated in the right column. It is important to find out the target number of subjects per site from the sponsor and to avoid participating in a trial if a site would have difficulty achieving this number.

Study attractiveness: The investigator will soon understand if a specific trial is attractive from a scientific viewpoint. That is, if the medicinal test product is novel, will allow the investigator to increase his/her scientific knowledge, and with potential benefits for the subjects/patients.

Study design issues: There are several study design issues that determine the suitability of a trial, i.e. how easy/difficult a trial will be to conduct, and the subject recruitment and retention rates. For instance, a prevention trial to test a vaccine is comparably easier to conduct than a treatment trial, if the subject recruitment requirements and follow up schedule are collectively taken into consideration. On the other hand, the revenue per subject/visit will also be comparatively less. The revenue in relation to the study phase and therapeutic area are elaborated in the right column. Other issues that must be considered are inclusion of a placebo group, primary outcome measures and how and when they are met, trial duration and post-treatment follow up period, number of site visits per subject, the type and number of clinical investigations procedures, the number of monitoring visits, the usage of electronic data capture, and if risk-based monitoring will be used (requires extra work by the site).

Test product: The investigator is recommended to contact the clinical scientist responsible for the trial (through the sponsor) to discuss the details such as mode of action of the test compound and its safety profile and proven efficacy. It is also important to clearly understand the planned post-trial treatment of the participating subjects so that they fully understand what will happen when the trial has been completed.

Profitability: Finally, many investigators fail to estimate the cost for conducting a trial and may make a loss by participating. It is highly recommended that an investigator make a realistic cost estimation, and not solely relying on the trial budget provided by the sponsor. In an optimal scenario, the budget estimation should be made by someone experienced who can itemize all the potential trial-induced activities and provide an alternative cost estimation as a base for negotiation.

Understand the facts


In order to make strategic decisions, a study site must know the facts. For instance, both the number of subjects and the cost per subject/visit will vary between trials and diseases as elaborated shortly below.

Number of sites and subjects per trial

The following table gives the number of sites and subjects per trial and the number of subjects per site for the leading diseases. The data has been compiled from clinicaltrials.org, and represent industry-sponsored phase II and II interventional treatment trials.

DiseasePhase II: sites/trial (n)Phase II: subjects/trial (n)Phase II: subjects/site (n)Phase III: sites/trial (n)Phase III: subjects/trial (n)Phase III: subjects/site (n)
ALLERGY ALLERGY 24 171 007 038 0462 012
ALLERGY ASTHMA 11 131 012 042 0384 009
ALLERGY CONJUNCTIVITIS 07 181 028 007 0254 035
ALLERGY ECZEMA/DERMATITIS 11 097 009 016 0293 019
ALLERGY RHINITIS 04 232 065 010 0417 041
ANEST ANALGESIC 04 065 017 006 0171 028
ANEST PAIN 15 125 008 021 0269 013
ANEST PAIN ACUTE 05 105 023 009 0292 034
ANEST PAIN CHRONIC 14 181 013 023 0176 008
CARDIO ANEURYSM 10 101 010 029 0263 009
CARDIO ANGINA 10 098 010 013 0354 027
CARDIO ARRHYT/FIBRILL 19 200 011 057 0657 011
CARDIO CARDIOMYOP/FAILURE 23 140 006 092 1010 011
CARDIO CHOLESTEROL/LIPIDS 18 151 008 038 0782 021
CARDIO CORONARY/ISCHEMIC 20 343 017 095 2565 027
CARDIO HYPERTENSION 14 229 016 026 0580 023
CARDIO HYPERTENSION PULM 19 050 003 046 0179 004
CARDIO INFARCT 15 191 012 041 2364 057
CARDIO PERIPH VASC 12 136 011 043 1221 028
CARDIO RAYNAUD/RESTLESS 09 115 013 023 0226 010
CARDIO STROKE 18 125 007 052 0446 009
CARDIO THROMB/COAG 18 124 007 051 0602 012
CARDIO VALVE 07 149 020 024 1220 050
DENTAL PERIODONTITIS 03 104 030 003 0106 037
DENTAL TOOTHACHE 01 176 119 002 0252 126
DERM ACNE 12 180 015 021 0759 037
DERM ANGIOEDEMA 14 055 004 026 0088 003
DERM BURNS 05 045 010 011 0098 009
DERM KERATOSIS 07 086 013 014 0321 023
DERM PSORIASIS 12 101 008 037 0465 012
DERM ROSACEA 07 136 020 019 0512 026
DERM SCAR/INJURY 04 053 015 004 0131 034
DERM SKIN DISEASE 07 069 010 006 0255 046
DERM WOUND/ULCER 06 088 015 019 0195 010
DERM WRINKLES 03 116 035 005 0307 065
ENDO ACROMEGALY 13 035 003 022 0090 004
ENDO DIABETES 23 181 008 051 0598 012
ENDO DIABETES FOOT 14 098 007 018 0224 012
ENDO FABRY 07 014 002 021 0064 003
ENDO GROWTH DISORDER 02 048 020 009 0107 012
ENDO GROWTH HORMONE 12 053 004 023 0117 005
ENDO HYPERPARATHYROIDISM 11 076 007 064 0788 012
ENDO MALE HYPOGONADISM 06 061 011 017 0190 011
ENDO METAB/NUTR 09 117 013 018 0414 023
ENDO OBESITY 10 227 023 015 1080 070
ENDO OSTEOPOROSIS 08 296 036 026 1073 042
GI CONSTIPATION 25 172 007 056 0519 009
GI CROHN 36 102 003 073 0299 004
GI DYSPEPSIA 14 136 010 006 0196 033
GI ESOPHAGITIS/REFLUX 28 150 005 041 0388 009
GI GASTRIC ULCER/BLEEDING 05 112 023 016 0324 021
GI IRRITABLE BOWEL 33 239 007 083 0620 007
GI LIVER CIRRHOSIS 11 063 006 024 0170 007
GI LIVER FATTY 20 094 005 025 0148 006
GI ULCERATIVE COLITIS 35 152 004 072 0408 006
HEALTHY/PHARM 07 120 018 005 0243 049
HEM ANEMIA 19 094 005 039 0302 008
HEM ANEMIA IRON 18 094 005 003 0488 166
HEM ANEMIA SICKLE CELL 19 089 005 022 0226 010
HEM HAEMOPHILIA A/B 31 052 002 023 0054 002
HEM MYELOFIBROSIS 13 076 006 084 0253 003
IMMUNE GRAFT VS. HOST 09 031 004 020 0150 007
IMMUNE IMMUNODEFICIENCY 08 053 006 008 0041 005
INFECT BACTERIAL 08 102 012 024 0320 013
INFECT CANDIDIA 08 094 012 026 0237 009
INFECT CONJUNCTIVITIS 12 250 021 005 0529 107
INFECT ENTERITIS 19 100 005 031 0286 009
INFECT FUNGAL 07 106 015 021 0145 007
INFECT HEPATITIS B 13 118 009 030 0244 008
INFECT HEPATITIS C 20 140 007 038 0330 009
INFECT HERPES SIMPLEX 12 318 026 018 0610 034
INFECT HIV/AIDS 20 095 005 053 0364 007
INFECT INFLUENZA/FLU 27 200 007 045 0471 010
INFECT MALARIA 04 178 043 005 0293 065
INFECT OTITIS 05 143 027 008 0428 056
INFECT PNEUMONIA 20 134 007 049 0440 009
INFECT SEPSIS 54 330 006 070 0631 009
INFECT SINUSIT 18 328 019 016 0321 020
INFECT SKIN/SOFT TISSUE 14 126 009 025 0391 016
INFECT TINEA 04 107 030 013 0385 031
INFECT TOENAILS 11 153 014 033 0722 022
INFECT URINARY 27 160 006 025 0405 016
INFECT VAGINA 09 264 030 021 0361 017
NEUR ALS 15 179 012 021 0284 013
NEUR ALZHEIMER/DEMENT 25 199 008 059 0670 011
NEUR EPILEPSY/SEIZURE 16 082 005 045 0252 006
NEUR FIBROMYALGIA 20 153 008 051 0409 008
NEUR HEAD INJURY/TRAUMA 04 064 016 043 0233 005
NEUR MIGRAINE/H-ACHE 14 326 024 018 0507 028
NEUR MULTIPLE SCLEROSIS 27 180 007 081 0691 009
NEUR MUSCULAR DYSTROPHY 10 043 004 032 0141 004
NEUR NEURALGIA 19 126 007 035 0285 008
NEUR NEUROPATHY 24 190 008 026 0202 008
NEUR PARKINSON 14 095 007 034 0286 008
NEUR SPASTICITY/PALSY 10 088 009 025 0220 009
O&G CONTRACEPTION 06 186 033 020 0909 046
O&G ENDOMETRIOSIS 30 151 005 089 0406 005
O&G INFERTILITY 05 155 029 007 0429 059
O&G MENOPAUSE & POST 24 160 007 040 0550 014
O&G MENSTRUAL DISEASE 16 191 012 008 0122 016
O&G SEXUAL DYSFUNCT 17 140 008 058 0781 013
ONC BREAST 22 104 005 137 1146 008
ONC CNS: BRAIN 08 049 006 100 0273 003
ONC CNS: GLIOMA 12 082 007 050 0295 006
ONC DERM: MELANOMA 16 089 006 094 0533 006
ONC ENDO: NEUROENDO 10 047 005 056 0197 004
ONC ENDO: THYROID 12 057 005 060 0266 004
ONC ENT: NPC 18 082 005 046 0383 008
ONC GI: COLORECTAL 18 108 006 075 0656 009
ONC GI: ESOPHAGEAL/GASTRIC 14 089 006 059 0465 008
ONC GI: GASTROINTESTINAL 07 047 007 038 0217 006
ONC GI: LIVER 15 069 005 075 0507 007
ONC GI: PANCREAS 15 086 006 057 0363 006
ONC HEM: LEUKEMIA 20 077 004 080 0350 004
ONC HEM: LYMPHOMA 18 060 003 086 0332 004
ONC HEM: MYELODYSPLASTIC 21 070 003 037 0112 003
ONC HEM: MYELOMA 14 065 005 082 0428 005
ONC O&G: OVARY 15 095 006 112 0547 005
ONC O&G: UTERUS 17 075 004 023 0221 010
ONC ORTH: SARCOMA 11 086 008 077 0437 006
ONC RESP: LUNG 20 102 005 094 0555 006
ONC RESP: PLEURA 16 143 009 015 0284 019
ONC SOLID TUMOR/CANCER 16 103 006 056 0346 006
ONC UROLOGY: BLADDER 20 080 004 057 0404 007
ONC UROLOGY: KIDNEY 19 090 005 118 0597 005
ONC UROLOGY: PROSTATE 15 085 006 080 0558 007
OPHTHAL CATARACT 05 328 072 003 0310 092
OPHTHAL DIABETIC 18 181 010 020 0314 015
OPHTHAL DRY EYE 04 175 048 011 0362 032
OPHTHAL EYE DISEASE 04 047 012 015 0209 014
OPHTHAL EYELASHES/LID 10 132 014 007 0246 038
OPHTHAL GLAUCOMA 05 117 023 007 0320 045
OPHTHAL MACULAR DEGENERATION 14 109 008 040 0456 011
OPHTHAL MACULAR EDEMA 12 097 008 023 0272 012
OPHTHAL UVEITIS 08 068 009 046 0179 004
ORTH BACK PAIN 25 235 010 031 0340 011
ORTH DISC DEGENARATIVE 06 071 013 016 0284 018
ORTH FRACTURE 30 183 006 031 0159 005
ORTH JOINT DISEASE 06 070 011 011 0216 019
ORTH MUSCULAR DISEASE 09 102 011 016 0143 009
ORTH TENDO DISEASE 08 111 014 010 0276 027
PSYCH ABUSE ALCOHOL 08 178 021 018 0435 024
PSYCH ABUSE OPIOD/HEROIN 03 091 033 028 0302 011
PSYCH ABUSE TOBACCO 05 190 041 013 0642 050
PSYCH ADHD 10 136 013 020 0236 012
PSYCH ANXIETY 16 158 010 031 0281 009
PSYCH AUTISM 35 202 006 017 0125 007
PSYCH BIPOLAR 21 153 007 026 0253 010
PSYCH DEPRESSION 23 278 012 037 0459 012
PSYCH INSOMNIA/SLEEP 15 153 010 015 0424 029
PSYCH SCHIZOPHRENIA 18 179 010 031 0342 011
RESP COPD 19 170 009 082 0848 010
RESP CYSTIC FIBROSIS 17 081 005 043 0211 005
RESP EMPHYSEMA 11 076 007 031 0193 006
RESP PULMONARY FIBROSIS 33 114 003 054 0564 010
RESP SLEEP APNEA 03 051 016 013 0242 019
RHEUM ARTHRITIS/GOUT 27 199 007 049 0474 010
RHEUM INFLAMMATION 17 096 006 001 0199 174
RHEUM LUPUS ERYTHEM. 38 183 005 071 0418 006
RHEUM SPONDYLITIS 32 144 005 045 0284 006
SURG COMPLICATION 06 088 014 015 0223 015
UROLOGY ERECTILE 08 167 021 023 0443 019
UROLOGY INCONTINENCE 23 256 011 049 0628 013
UROLOGY KIDNEY DISEASE 14 084 006 010 0508 052
UROLOGY KIDNEY FAILURE 13 094 007 029 0306 011
UROLOGY KIDNEY NEPHRITIS 25 108 004 109 0766 007
UROLOGY KIDNEY TRANSPLANT 16 110 007 022 0246 011
UROLOGY PROSTATE HYPERPLASIA 15 246 016 026 0535 020

Cost per visit versus cost per subject

It is more appropriate to make a comparison for per visit cost, rather than per patient cost, since there is a large variation in the number of visits per subject within and between therapeutic areas/disease.

Below are a few examples based on a comparison between phase III trials. The highest site visit cost is found for ADHD (100.0%), while vaccine trials have the lowest site visit cost (4.3% of the cost for ADHD).

Examples of high cost per site visit: ADHD (100.0%), SCHIZOPHRENIA (62.3%), BREAST CANCER (56.9%), RENAL CANCER (55.5%), SLE (55.2%), NEPHRITIS (54.5%), and OSTEOPOROSIS (43.1%).

Examples of low cost per site visit: LIPIDS/CHOLESTEROL (11.7%), HYPERTENSION (11.1%), PNEUMONIA (10.4%), IMPOTENCE (10.2%), ISCHEMIC (8.8%), HEPATITIS (7.5%), and VACCINE (4.3%).

Details about the cost variation between diseases and trial phases cannot be provided, because they are affected by factors such as inflation and site location. Most of the information is not made publically available. The sponsor or CRO will usually not provide the details about the cost at other sites due to confidentiality and business reasons. The best way to learn more about the cost at other sites is to ask other investigators, for example during investigators meetings.

Clinical-Trial-Magnifier-Trial-Evaluation-On-Land

 

 

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