The Enduring Problem of Under-Reporting

In 2012 I wrote about the issue of under reporting of clinical studies – at a time when we were writing over 100 clinical study reports and manuscripts a year [1]. Clinical trials form the empirical foundation of modern medicine. Treatment guidelines, regulatory approvals, reimbursement decisions, and everyday clinical practice are all shaped by the outcomes of controlled investigations involving human participants. Embedded within every clinical study is an implicit social contract: participants accept inconvenience and risk in exchange for the advancement of knowledge that may benefit future patients. When trial findings are not reported, that contract is weakened. The resulting gaps in the scientific record distort evidence synthesis, misdirect clinical decision-making, and erode public trust in research.

For decades, the dominant explanation for under-reporting has been publication bias,the tendency for positive or statistically significant results to be published more frequently and more rapidly than neutral or negative findings. While this bias is real and well documented, it represents only one dimension of a broader and more complex problem. A substantial proportion of clinical trials remain unpublished or inadequately reported for reasons unrelated to outcome direction. These include lack of writing expertise, insufficient time, financial constraints, competing academic priorities, and uncertainty about how to access professional reporting support.

Historical Emergence of the Problem

Recognition of selective publication dates back to the 1980s, when studies with statistically significant findings were reported to be considerably more likely to appear in journals than those with null results [2]. This discovery highlighted a systematic distortion of the medical literature. Subsequent investigations across multiple therapeutic areas confirmed that the published evidence base frequently overstated treatment efficacy while understating risks.

Regulatory and editorial reforms followed. In 2004, the International Committee of Medical Journal Editors (ICMJE) announced that member journals would only consider trials for publication if they had been prospectively registered in a public registry [3]. The US Food and Drug Administration Amendments Act of 2007 (FDAAA) legally mandated results reporting for certain trials on ClinicalTrials.gov within 12 months of completion [4]. In Europe, Regulation (EU) No. 536/2014 established similar obligations for summary results reporting. Advocacy campaigns such as AllTrials brought the issue into mainstream scientific and political discourse, reinforcing the ethical imperative for transparency.

Despite these measures, compliance has remained uneven [1]. Analyses of registry data and journal publications repeatedly show that many completed trials are never fully disseminated. The persistence of the problem suggests that structural and cultural obstacles extend beyond regulatory gaps alone.

The Extent of Under-Reporting

Recent large-scale analyses indicate that under-reporting continues at a significant level. A comprehensive Cochrane review synthesising over 160,000 trials found that approximately 47% of clinical trial results were ‘unpublished’ in peer-reviewed journals, and the median time to publication exceeded 2 years after completion [5]. Although registry postings partially address visibility, registry data often lack narrative interpretation, contextual analysis, and methodological detail, limiting their practical utility for clinicians and systematic reviewers.

Notably, the issue is not confined to industry-sponsored research. Investigator-initiated and academic studies frequently demonstrate equal or greater delays, indicating that operational and resource-related factors are central contributors [6].

Causes of Non-Reporting

• Limited Writing Expertise: Many principal investigators are highly trained in clinical science yet receive little formal instruction in scientific or regulatory writing. Preparing a clinical study report (CSR), manuscript, and/or registry summary requires distinct skills in narrative construction, statistical interpretation, compliance with reporting guidelines, and editorial precision (see our guide [6]). Without structured training, investigators can find the reporting phase daunting, leading to prolonged drafting cycles or the abandonment of reporting altogether.
• Time Constraints and Competing Priorities: Academic and clinical environments often reward the initiation of new research more than the completion and publication of existing work. Grant deadlines, patient care responsibilities, and teaching commitments displace writing tasks, which are perceived as secondary. As time passes, datasets age, team members disperse, and motivation diminishes.
• Financial and Administrative Barriers: Professional writing support is sometimes viewed as an optional or luxury expenditure rather than a core research cost. Misconceptions about expense, uncertainty regarding procurement processes, and limited awareness of available service models deter investigators from seeking assistance. Ironically, the absence of early budgeting for reporting results in greater downstream costs due to prolonged timelines and non-compliance risks.
• Cultural and Cognitive Biases: Negative or inconclusive results are still occasionally perceived as ‘failures’ rather than scientifically informative outcomes. This perception reduces enthusiasm for dissemination, even when the findings have substantial value in preventing redundant or unsafe research directions.

Why Report Writing Takes So Long

Clinical reporting is intrinsically complex. A full CSR may encompass hundreds of pages of safety tables, protocol deviations, statistical appendices, and regulatory narratives. Journal manuscripts require iterative revisions, co-author coordination, and peer-review responses. Delays often arise from fragmented data verification, multiple review layers, unclear authorship responsibilities, and the absence of dedicated writing time. These factors create a cycle in which reports stall, momentum dissipates, and eventual non-publication becomes increasingly probable.

The Role and Benefits of Professional Medical Writers

One of the most practical and evidence-supported solutions to under-reporting is the engagement of professional medical writers. A growing body of literature demonstrates that manuscripts and reports developed with professional writing support are associated with improved adherence to reporting guidelines, clearer methodological description, and shorter time to publication [8][9][10]. Professional writers contribute specialised expertise in structuring complex data, maintaining consistency across documents, and ensuring compliance with regulatory and editorial standards.

Importantly, professional medical writers do not replace scientific authorship; rather, they support investigators by translating technical findings into coherent, accurate narratives while preserving author accountability. Their involvement has been associated with higher reporting quality, improved transparency, and reduced administrative burden on research teams [8]. Furthermore, writers are often trained in ethical publication practices, helping to mitigate inadvertent omissions or inconsistencies that would otherwise delay or compromise dissemination.

Integrating Writing Costs into Research Budgets

Given the clear value of professional writing support, incorporating these costs into original research budgeting should be considered best practice rather than an afterthought. Funding applications frequently include allocations for statistical analysis, data management, and study monitoring; reporting deserves similar recognition as an essential phase of the research lifecycle. Early budgeting enables timely engagement of writers, predictable expenditure, and avoidance of last-minute financial constraints that commonly delay publication. Unlike the clinical aspects of trials, estimates given for report writing at Niche are relatively predictable, long before study delivery.

From an economic perspective, the cost of professional writing is modest relative to the overall expense of conducting clinical trials. When viewed against the ethical obligation to participants and the potential consequences of non-reporting, regulatory penalties, reputational damage, and wasted research investment, the inclusion of writing services in your planning is both fiscally and scientifically responsible. Integrating dissemination planning at the proposal stage (rather than relying on the diktat of a publication plan installed by you Medical Affairs team) also reinforces a cultural shift in which reporting is recognised as integral, not optional. You can also benefit from the same person working on your CSR and you manuscript.

Consequences of Continued Under-Reporting

Failure to disseminate trial findings carries substantial implications. Meta-analyses and systematic reviews become skewed, clinicians may adopt interventions based on incomplete evidence, and redundant studies expose new participants to avoidable risk. High-profile examples in psychiatry and other therapeutic areas have demonstrated how selective publication can inflate perceived efficacy and obscure safety concerns [11]. Beyond methodological distortion, under-reporting undermines public trust in research institutions and weakens the ethical foundation of participant consent.

Toward Sustainable Transparency

Addressing under-reporting requires coordinated action across multiple domains. Education in scientific writing should be embedded within research training programmes. Academic promotion criteria must evolve to value dissemination alongside discovery. Funding bodies and institutions should normalise the inclusion of professional writing costs, while journals and regulators continue to enforce reporting standards. Technological tools, including structured templates and responsibly governed AI-assisted drafting systems, may further reduce logistical barriers. When all else fails you can partner with the Niche Medical Writing Team.

Ultimately, transparency is not solely a regulatory obligation but a cultural commitment. Every completed trial, positive, negative, or inconclusive, adds a necessary piece to the collective understanding of health and disease. Ensuring that these pieces are visible requires recognising dissemination as a skilled, resource-dependent, and ethically indispensable component of scientific work.

References

1. Hardman TC (2012). Under-Reporting of Clinical Studies [accessed 13 Feb 2026].
2. Dickersin K, Chan S, Chalmers TC, Sacks HS, Smith H. Publication bias and clinical trials. Control Clin Trials. 1987;8(4):343-53.
3. De Angelis C, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med. 2004;351(12):1250-1.
4. Food and Drug Administration Amendments Act of 2007, Pub L No. 110-85, 121 Stat 823.
5. Showell MG, et al. Time to publication for results of clinical trials. Cochrane Database Syst Rev. 2024.
6. Chen R, Desai NR, Ross JS, et al. Publication and reporting of clinical trial results across academic medical centers. BMJ. 2016;352:i637.
7. Niche Science & Technology Ltd., (2026). An Insider’s Insight into Clinical Study Reports. V4 [accessed 13 Feb 2026].
8. Gattrell WT, et al. Professional medical writing support and the quality of randomised controlled trial reporting. BMJ Open. 2016;6:e010880.
9. Evuarherhe O, Gattrell W, White R, Winchester CC. Professional medical writing support and the quality, ethics and timeliness of clinical trial reporting: a systematic review. Res Integr Peer Rev. 2019;4:14.
10. Jacobs A. Adherence to CONSORT guidelines with professional medical writing support. Med Writ. 2010;19(3):182-5.
11. Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med. 2008;358(3):252-60.