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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 |
□ | 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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