Sol_Doc_FDA-22-RFP-1249967_Attachment 5 - Sample Studies_.xlsx
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- Clinical Study and Laboratory Support Services for FDA Office of Clinical Pharmacology (OCP).
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- FDA-22-SOL-1249967
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Sample Study 1 Provide cost for a study with 72 healthy subjects undergoing the following study. Include cost for method development/validation for two biologic drugs, pharmacokinetic (PK) concentration, and analysis of flow cytometry samples.
| Screening | Checkin / Baseline | Treatment Period | End of Study | ||||||||||||||||||||||||||||||||
| Study Week | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 13 | 18 | ||||||||||||||||||||||||
| Study Day | -2 to -21 | -1 | Pre | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 21 | 28 | 35 | 42 | 49 | 56 | 63 | 93 | 123 | |||||||||
| Hour | 0 | 0.5 | 1 | 2 | 3 | 4 | 6 | 9 | 12 | 18 | 24 | ||||||||||||||||||||||||
| Visit | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 | 23 | 24 | 25 | ||||||||||
| In House Residency | X | X | X | X | X | X | X | X | X | X | |||||||||||||||||||||||||
| Informed Consent | X | ||||||||||||||||||||||||||||||||||
| Medical History | X | X | |||||||||||||||||||||||||||||||||
| Abbreviated Physical Examination | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||||||||||||||||
| Vital Signs | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||||||||||||||||
| Height | X | ||||||||||||||||||||||||||||||||||
| Weight | X | X | X | ||||||||||||||||||||||||||||||||
| 12-Lead ECG 1 | X | X | X | X | X | X | X | ||||||||||||||||||||||||||||
| Telemetered ECG monitoring | X | X | X | X | X | X | X | X | X | X | X | ||||||||||||||||||||||||
| Clinical Chemistry/Hematology 1 | X | X | X | X | X | X | X | ||||||||||||||||||||||||||||
| Urinalysis # | X | X | X | X | X | X | |||||||||||||||||||||||||||||
| HIV Ab, HbsAg, HepC Ab | |||||||||||||||||||||||||||||||||||
| HCV Viral Load Test | X | ||||||||||||||||||||||||||||||||||
| Urine Drug and Alcohol Screen | X | X | |||||||||||||||||||||||||||||||||
| Pregnancy Test (females only) 2 | X | X | X | ||||||||||||||||||||||||||||||||
| SARS CoV-2 PCR Test | X | ||||||||||||||||||||||||||||||||||
| Study Agent Prep and Administration - IM | X | ||||||||||||||||||||||||||||||||||
| PK Sample (serum) | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||||||
| Flow Cytometry Sample | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||||||||
| Concomitant Medications | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |||||||||
| Adverse Events | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |||||||||
| 1 clinically notable results are repeated | |||||||||||||||||||||||||||||||||||
| 2 serum test |
Per Subject Cost
| Other Per Subject Charges |
| Administrative overhead |
| Clerical |
| Volunteer payment |
| Total Per Subject |
| Total per subject * 72 subjects |
| Study Drug Costs |
| Supplies |
| Alternate Stipends |
| Dry Ice and Sample Shipment |
| Data Transfers |
| Verified Clinical Trials |
| Institutional Review Board (IRB) - includes drafting ICF and compiling submission |
Total Study Cost
| Bioanalytical Costs | |||
| Item | Number | Cost Per Item | Total |
| Method Development/Validation for PK analysis of biologic drug | 2 | ||
| PK Sample analysis | 1944 | ||
| Bioanalytical report | 2 | ||
| Incurred sample reanalysis - bioanalytical (10%) | 200 | ||
| Method Development/Validation - Flow Cytometry (Eosinophils) | 1 | ||
| Flow Cytometry Sample Analysis | 1800 | ||
| Bioanalytical report - Flow cytometry | 1 | ||
| Interim Data Transfer with QC | 2 | ||
| Materials Costs | 1 | ||
| Shipping Samples to FDA | 1 |
Sample Study 2
Provide cost for a study with 20 healthy subjects undergoing the following drug interaction study. Include cost for pharmacokinetic (PK) sample collection for a small molecule drug and bioanalytical costs including method development and validation for 5 drugs and 2 metabolites.
| Screening | Check-In and Baseline | Treatment Period | Check-out | ||||||||||||||||||
| Study Day | -28 to -2 | -1 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | |
| Hour | |||||||||||||||||||||
| Visit | 1 | 2 | |||||||||||||||||||
| In House Residency | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |||
| Meals | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |||
| Informed Consent | X | ||||||||||||||||||||
| Medical History | X | X | |||||||||||||||||||
| Comprehensive Physical Exam | X | X | X | ||||||||||||||||||
| Vital signs (including pulse oximetry) | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |
| Height/Weight | X | X | X | ||||||||||||||||||
| ECG - single1 | X | X | X | X | X | X | X | X | |||||||||||||
| Telemetry | X | X | X | X | X | ||||||||||||||||
| Chemistry/hematology1 | X | X | X | ||||||||||||||||||
| Urinalysis | X | X | X | ||||||||||||||||||
| Urine drug screen + alcohol screen | X | X | X | ||||||||||||||||||
| Pregnancy test2 | X | X | X | ||||||||||||||||||
| FSH (females only) | X | X | |||||||||||||||||||
| HIV test | X | ||||||||||||||||||||
| Hepatitis test | X | ||||||||||||||||||||
| SARS CoV-2 PCR test | X | ||||||||||||||||||||
| Study Agent preparation & administration - oral | X | X | X | X | X | ||||||||||||||||
| Continuous Pulse Oximetry | X | X | X | X | X | ||||||||||||||||
| Plasma PK draw | |||||||||||||||||||||
| (See protocol for time points) | 10 | 10 | 10 | 10 | 10 | ||||||||||||||||
| Estrogen and progesterone | X | X | X | X | X | ||||||||||||||||
| Pupillometry Assessment | 14 | 14 | 14 | 14 | 14 | ||||||||||||||||
| Buffy Coat Collection3 | X | ||||||||||||||||||||
| Con Med/AE Assessment | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||
| Dosing Day | Washout Days | Dosing Day | Washout Days | Dosing Day | Washout Days | Dosing Day | Washout Days | Dosing Day | |||||||||||||
| 1 Clinically notable results are repeated | |||||||||||||||||||||
| 2 Serum test | |||||||||||||||||||||
| 3 Buffy coat samples are processed as part of a PK sample and is not a separate sample |
Per Subject Cost
| Other Per Subject Charges |
| Administrative overhead |
| Clerical |
| Volunteer payment |
| Total Per Subject |
| Total per subject * 20 subjects |
| Study Drug Costs |
| Supplies |
| Alternate Stipends |
| Dry Ice and Sample Shipment |
| Data Transfers |
| Verified Clinical Trials |
| Institutional Review Board (IRB) - includes drafting ICF and compiling submission |
Total Study Cost
| Bioanalytical Costs | |||
| Item | Number | Cost Per Item | Total |
| Method Development/Validation with Single Analyte | 5 | ||
| Method Development/Validation for Additional Analytes added on | 2 | ||
| Sample analysis for single analyte | 1000 | ||
| Sample analysis for additional analytes added on | 200 | ||
| Incurred Sample Reanalysis (~10%) | 120 | ||
| Bioanalytical report with single analyte | 3 | ||
| Bioanalytical report incremental cost for additional analytes | 2 | ||
| Interim Data Transfer with QC | 1 | ||
| Materials Costs | 1 | ||
| Shipping Samples to FDA | 1 |
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