Improving R&D Outcomes: Standards, Technique and Rigour

Analyses across the life sciences have repeatedly found that a substantial share of published preclinical findings cannot be independently reproduced. The causes are rarely dramatic. They are procedural, cumulative and — importantly — correctable.

Know what is actually in the flask

Cell line misidentification and cross-contamination have corrupted a documented body of literature spanning decades. The remedy is unglamorous: short tandem repeat profiling to authenticate identity, routine mycoplasma testing, and passage-number discipline, since primary cells drift phenotypically with extended culture.

For primary stromal cells the standard is explicit. The ISCT minimal criteria — plastic adherence, a defined surface-marker profile, tri-lineage differentiation — exist so that a paper describing 'MSCs' describes something another laboratory can recognise.

Design before you pipette

Three decisions made before an experiment begins determine whether its result will survive scrutiny. Power the study — an underpowered experiment cannot distinguish a real effect from chance, and a positive result from one is unreliable. Randomise and blind wherever assessment involves judgement. Pre-specify the primary endpoint and the analysis, because a hypothesis chosen after seeing the data is not a hypothesis.

The distinction between biological and technical replicates deserves specific attention. Three wells from one donor are not three samples. Treating them as such inflates apparent significance and is among the most common errors in the regenerative literature.

Report what you actually did

Reproducibility depends on disclosure. Domain-specific frameworks exist for this reason: MISEV for extracellular vesicle studies, ARRIVE for animal research, MIQE for quantitative PCR. Each specifies the methodological detail that must be reported for a result to be interpretable.

Isolation method, characterisation approach, donor number, passage number and storage history all change what a preparation is. Omitting them does not make a paper cleaner. It makes it unusable.

Publish the negative result

Publication bias distorts the field's collective knowledge more than any individual flawed study. Work that fails to demonstrate an effect is informative — it narrows the search space, and it prevents other groups from spending years rediscovering the same dead end. A research culture that only rewards positive findings will produce a literature that overstates them.