Systematic Review Protocol Development
A systematic review protocol is the written plan that fixes your research question, eligibility criteria and search strategy before any screening begins. EviMeRx develops PRISMA-aligned protocols for pharmaceutical, CRO and HEOR teams.
The protocol is what separates a systematic review from a literature summary. It commits the review team to a method in advance, so the selection of studies cannot drift toward a preferred conclusion. Regulators, journals and HTA bodies increasingly expect to see one, and a weak protocol is the most common reason a review is challenged after the work is finished.
What a systematic review protocol contains
A complete protocol specifies six things before the first search is run:
- The research question, structured using PICO or an equivalent framework
- Eligibility criteria — population, interventions, comparators, outcomes, study designs, languages and date limits
- Information sources and the full search strategy for each database
- The screening process, including how many reviewers assess each record
- Data to be extracted, and the extraction template
- The planned approach to quality assessment and synthesis
Why the protocol is written before the search
Writing the method after seeing the results allows selection bias to enter unnoticed — criteria get adjusted, borderline studies get included or dropped, and the review stops being reproducible. Fixing the method in advance means any reviewer following the protocol would arrive at the same set of included studies. That reproducibility is the property that makes the evidence usable in a regulatory or market access submission.
Framing the research question
Most protocols we develop use PICO — Population, Intervention, Comparator, Outcome — with PICOS or PICOTS where study design or timing needs to be constrained explicitly. The framing determines everything downstream: a question that is too broad produces an unmanageable screening burden, while one that is too narrow risks missing the evidence that matters. We work through this with your team before committing it to the protocol.
Eligibility criteria that hold up
Eligibility criteria have to be specific enough that two independent reviewers reach the same decision on the same abstract. Vague criteria are where screening disagreements originate, and resolving them mid-review is expensive. We pilot the criteria against a sample of records before the protocol is finalised, so ambiguity is found while it is still cheap to fix.
Protocol registration
Prospective registration — most commonly on PROSPERO for health-related reviews — timestamps the method publicly before the results are known. Many journals now expect a registration number at submission. We prepare the registration record alongside the protocol so it is ready to submit.
What you receive
A complete, PRISMA-aligned protocol document; the full search strategy written out per database and ready to run; a piloted screening form with the eligibility criteria; the data extraction template; and the registration record prepared for submission.