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| | Team formation |
| □ | Form team; include representatives from assay development, clinical therapeutic area, program management, regulatory affairs and clinical statistics |
| □ | Establish regular team meetings |
| | Sample collection considerations |
| □ | Determine source tissue for biomarker analysis |
| □ | Minimize amount of specimen required; use non-invasive techniques if possible |
| □ | Allow 1–3 months if sample collection method does not exist |
| □ | Train personnel at clinical site, if needed; create visual aids for training |
| □ | Retain extra specimens for potential bridging studies |
| □ | If utilizing a bridging strategy, initiate sample stability studies |
| □ | If using FFPE specimens, establish minimum percent tumor specification |
| □ | Select clinical sites with licensed pathologist able to mark slides and perform macrodissection |
| □ | Collect extra sections before and after sections being analyzed for H&E staining |
| □ | Perform sample collection experiment to qualify each clinical site, if necessary |
| | Assay considerations |
| □ | Clearly define and document assay intended use, how positive and negative calls are made and how results determine patient eligibility |
| □ | Select assay technology platform, consider assay output, establish clear requirements |
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□ | Develop validation strategy, validating each sample type or collection method |
| □ | Allow several months to complete vendor agreement |
| □ | Allow time for vendor qualification, if new vendor |
| □ | Obtain clinical specimens for analytical validation and decision-point threshold |
| □ | Allow 1–6 months for assay development for a CTA; at least 24 months for a IVD |
| | Sample analysis considerations |
| □ | Document anticipated turn around time from patients’ perspective |
| □ | Document sample logistics from acquisition to patient test report |
| □ | Request hour-by-hour workflow of assay from vendor |
| □ | Have clinical site send specimen directly to testing lab if possible |
| □ | Ask vendor to accept Saturday shipments, to work weekends or to work longer days |
| □ | Avoid the use of local labs |
| □ | Reduce cost by batching samples, for example, biweekly sample analysis |
| □ | Explore alternate control strategies to reduce cost of running process controls |
| □ | Consider performing assays sequentially if using multiple predictive markers |
| □ | Calculate and document anticipated screen failure rate |
| | Regulatory considerations |
| □ | Identify CLIA lab with appropriate state licenses or allow 1–6 months for lab to obtain necessary licenses |
| □ | Discuss high complexity assays with FDA before implementing in clinical trials |
| □ | Set up pre-submission meeting with FDA in advance of clinical trial |
| □ | For companion diagnostic development, work closely with partner on timelines |
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