In the pharmaceutical and life sciences industries, literature reviews are foundational. Whether conducted to support health technology assessment (HTA) submissions, global value dossiers (GVDs), real-world evidence planning, or clinical trial design, they play a crucial role in shaping strategic decisions.
Yet, despite their importance, literature reviews are often done poorly — plagued by methodological gaps, unclear objectives, and a lack of actionable insight. At best, this weakens the credibility of the output. At worst, it leads to regulatory setbacks, misinformed strategy, or HTA rejections.
In this post, we explore the most common pitfalls in literature reviews, their downstream implications, and how teams can course-correct using best practices rooted in transparency, reproducibility, and fit-for-purpose design.
Why Literature Reviews Matter More Than Ever
Let’s begin by revisiting the “why” behind literature reviews in a high-stakes context like pharma and biotech:
- They inform model assumptions in cost-effectiveness analyses.
- They shape value narratives in global value dossiers (GVDs).
- They support clinical trial protocols and regulatory strategy.
- They are often included directly in HTA submissions and reviewed by agencies.
- They help identify evidence gaps that inform RWE generation or post-marketing commitments.
In short, they are not just academic exercises — they are strategic inputs with tangible impact on product success.
🚫 Common Pitfalls in Literature Reviews – And Their Consequences
❌ 1. Unclear Research Objectives and Review Scope
One of the most frequent missteps is initiating a literature review without a clearly defined research question. Without using a structured framework like PICO (Population, Intervention, Comparator, Outcomes), reviews risk becoming directionless compilations rather than strategic syntheses.
Consequences:
- Overly broad or irrelevant results
- Difficulty in interpreting or applying findings
- Misalignment with HTA or payer expectations
Best Practice: Define a fit-for-purpose objective, grounded in the decisions the review must support (e.g., model inputs, burden of illness, unmet need). Use PICO or a similar framework to anchor the review.
❌ 2. Inadequate or Non-Reproducible Search Strategy
A flawed search strategy can derail a review before it even begins. This includes:
- Using only a single database (e.g., just PubMed)
- Vague or overly narrow search terms
- Ignoring grey literature or conference abstracts
- Omitting filters or Boolean logic
Consequences:
- Missed key studies
- Non-reproducible methods (red flag for HTA bodies)
- Accusations of cherry-picking
Best Practice: Use multiple databases (e.g., Medline, Embase, CENTRAL, EconLit), design precise search strings, and document everything — including date ranges, language filters, and inclusion/exclusion criteria.
❌ 3. Poor Documentation of Screening and Study Selection
If you can’t show how you went from 1,000+ references to 30 included studies, your review lacks transparency.
Consequences:
- HTA reviewers may reject your evidence
- Internal stakeholders may question validity
- You cannot replicate or defend your methods
Best Practice: Follow PRISMA guidelines, include a flow diagram, and maintain a screening log that details inclusion/exclusion reasons. Use tools like Covidence or Rayyan to streamline this process and ensure traceability.
❌ 4. Lack of Critical Appraisal or Risk-of-Bias Assessment
All studies are not created equal. Without evaluating methodological quality, you risk giving equal weight to a high-quality RCT and a poorly designed observational study.
Consequences:
- Misleading conclusions
- Use of low-quality data in models or submissions
- Payer pushback on evidence credibility
Best Practice: Use validated appraisal tools (e.g., GRADE, NICE checklists, ROBINS-I) and categorize studies accordingly. Summarize the quality of evidence clearly in your report.
❌ 5. Confusing “Data Compilation” with Synthesis
A literature review is not just a spreadsheet of studies. Too many reviews stop at data extraction — listing publication year, sample size, endpoints — without synthesizing trends, gaps, or implications.
Consequences:
- No actionable insight
- Stakeholders unsure how to apply findings
- Weak support for models, dossiers, or strategy
Best Practice: Go beyond tabulation. Include narrative summaries, thematic synthesis, and link findings to strategic decision-making (e.g., “X intervention shows consistent reduction in hospitalization across 3 high-quality RCTs”).
A Real-World Example
We recently worked with a global biopharma client preparing a literature review to support a value proposition in oncology. A previous vendor had delivered a 60-page report — full of references but lacking clarity, methodology, and insight.
Problems Identified:
- No PICO framing
- Unstructured searches in only two databases
- Missing PRISMA flow
- No risk-of-bias assessment
- No synthesis or conclusion — just data tables
Our Solution:
- Redesigned the scope into three focused research questions using PICO
- Conducted a comprehensive, documented search across five databases and grey literature
- Applied dual-screening with exclusion rationale and PRISMA diagram
- Used GRADE to rate confidence in key findings
- Created an executive summary and HTA-ready annex with clear, digestible conclusions
Outcome: The review was used as-is in two major HTA submissions and later adapted into a publication and internal training tool.
Strategic Implications for HEOR & Medical Affairs
If you’re in HEOR, market access, or scientific communications, literature reviews are core to your strategy — but only when executed correctly. Poorly conducted reviews can:
- Delay submissions
- Undermine payer confidence
- Require costly rework
- Cause missed opportunities in value communication
On the other hand, a well-executed review enhances efficiency, credibility, and strategic alignment across functions.
Best Practices Checklist
Here’s a quick checklist your team can use to audit your next literature review:
- Is there a clearly framed objective (PICO)?
- Were multiple databases searched with documented search terms?
- Was grey literature or conference data included, if relevant?
- Is there a PRISMA diagram with screening documentation?
- Were studies appraised for quality using validated tools?
- Does the output include both data and narrative synthesis?
- Is the report structured to align with HTA or value communication goals?
If any of these are missing, your review may not be HTA-ready — and may need to be revised or rebuilt.
Final Thoughts: Literature Reviews Are Strategic Tools
The difference between a literature review that informs and one that persuades lies in rigor, transparency, and synthesis.
In today’s environment of payer scrutiny and regulatory precision, teams can’t afford to treat literature reviews as a checkbox activity. They must be fit-for-purpose, decision-driven, and defensible.
Whether you’re supporting an HTA submission, building an economic model, or crafting a value proposition, start with evidence — but make sure it’s the right evidence, collected and interpreted the right way.
📌 Need support with a targeted, HTA-ready literature review?
At Vedara-IQ, an i-Qode company, we specialize in transforming literature reviews into strategic tools for HEOR, market access, and medical writing teams. Our expertise ensures fit-for-purpose objectives, transparent methodology, and actionable insights that meet HTA and regulatory expectations. Whether you need comprehensive search strategies, critical appraisals, or HTA-ready reports, we help you avoid pitfalls and deliver evidence that drives credibility and impact.
Contact Us at info@i-Qode.com
