Estimated Reading Time: 8 min AI key Risk Factors
The risks from using AI in MW are not limited to awkward wording. They affect evidence integrity, confidentiality, transparency, and ultimately trust.
AI can produce plausible but incorrect statements, omit important context, misrepresent a source, or generate a false citation.
Patient-level, personal, proprietary, or unpublished information must not be entered into a tool without an approved legal, privacy, security, and contractual basis.
Teams need to know which sources, instructions, tool versions, and review steps contributed to an output, particularly where content supports regulated activities.
Outputs can reproduce bias in training data or flatten clinically meaningful distinctions among populations, endpoints, benefit-risk considerations, and levels of evidence.
AI cannot be accountable as an author. Journal and organisational policies may require disclosure of AI-assisted work, and authors remain responsible for accuracy, attribution, confidentiality, and originality.
Junior writers need strong foundations in evidence appraisal and document development so they can recognise subtle errors rather than defer to confident-sounding output.
Skilled Medical Writers are needed to thoroughly check every AI-generated output, not offering any time or cost efficiencies.
Frequently asked questions
Artificial intelligence (AI) supports medical writing by helping professionals organise scientific information, structure initial drafts, review documents and analyse medical literature. In clinical research, AI-assisted tools can support the preparation of clinical study reports (CSRs), study protocols, investigator’s brochures, regulatory submissions and scientific publications. AI can also help identify inconsistencies across documents, check terminology and streamline repetitive tasks. However, AI-generated content requires careful verification by qualified medical writers to ensure scientific accuracy, regulatory compliance and reliable communication of clinical evidence.
AI offers potential benefits in medical writing, including faster document preparation, improved information organisation, more efficient literature reviews and greater consistency across clinical and regulatory documents. However, these advantages come with important risks. AI-generated content may contain inaccurate scientific statements, fabricated references, biased interpretations or missing clinical context. Data confidentiality, source traceability and regulatory compliance are also significant concerns. To manage these risks, pharmaceutical companies and Contract Research Organisations (CROs) should combine AI-assisted workflows with robust quality controls, verified scientific sources and expert human oversight.
AI cannot replace qualified medical writers because clinical and regulatory documentation requires scientific judgement, critical analysis and accountability that automated systems cannot independently provide. Although AI can assist with drafting, literature screening and document consistency checks, experienced medical writers remain essential for interpreting clinical trial results, evaluating scientific evidence and ensuring regulatory accuracy. Their expertise is particularly important when preparing clinical study reports, safety narratives, regulatory submissions and scientific publications. The most effective approach combines AI-supported efficiency with human expertise to protect scientific integrity, maintain compliance and communicate complex medical information accurately.
Excelya supports pharmaceutical, biotechnology and medical device organisations with clinical, regulatory and medical communications writing services, combining scientific expertise with a human-led approach to quality and accountability. Its medical writing scope includes clinical study reports (CSRs), study protocols, investigator’s brochures, regulatory documents, manuscripts and trial transparency deliverables. Where AI-assisted methods are appropriate, Excelya emphasises clear objectives, reliable and traceable source material, fit-for-purpose processes and rigorous review by experienced medical writers. Working alongside clinical, biometrics, regulatory, safety and quality specialists, its teams help sponsors maintain scientific accuracy, document consistency and submission readiness without compromising expert judgement.
