What disclosure changes about a writer's work
Disclosure changes the job before it changes any single document: the scope of what a writer prepares, the skills the work needs, the readers a regulatory document reaches, what the writer's task comes down to, the way source documents are drafted, the balance between disclosure and data protection, and who staffs the work.
The scope of the work
The medical communication environment will be strongly influenced by ongoing campaigns for individuals and organisations to be transparent and to maintain ethical practices in publishing data. Proposals for revised EU legal frameworks for clinical trials and for medical devices and in vitro diagnostics also supported wider data transparency.
Within healthcare there were different interpretations of what meaningful data transparency entails, and the processes for making detailed information available to interested parties remained to be defined. Wider accessibility to data will need to be managed with the intended audience in mind, so that the information is disseminated in a format that audience can understand and use. It is important to start considering the implications of wider data transparency, as it will profoundly influence the future medical communications environment.
New guidelines and recommendations that emerge from initiatives on clinical trial data and transparency will have a noticeable impact on medical writers, because the scope of their work will change. Writers are likely to be involved in preparing more extensive trial information for publication than is available from accessible sources. The expanded scope of work will need to be accounted for in budgets, resourcing, timelines and qualifications. Writers' training on guidelines and standards will need to be kept up to date, with its completion formally documented and the records maintained so that they can be independently verified.
With requirements in the US and abroad growing more stringent for publicly disclosing the results of applicable trials through central data banks and summaries in prescribed formats, medical writers in the biopharmaceutical industry were being called upon to take part in or lead the effort. As a result, medical writers were building processes with their regulatory, biometrics, compliance and clinical colleagues for effective, timely, clear and efficient communication of key study results.
The skills the work asks for
As many companies grappled with these requirements, results disclosure gave writers a new way to apply their medical and regulatory writing skills, whether for the companies they work for or for the clients they serve as independent contractors. It required them to become comfortable working with technically challenging data-entry tools, to convey dense information in restrictive formats, and to understand the needs of a lay audience.
A basic knowledge of disclosure regulations and support for trial transparency are part of a regulatory writer's job.
The wider audience for regulatory documents
Historically the primary audience for clinical study protocols and clinical study reports was investigators, industry insiders and regulators. The Pharmaceutical Research and Manufacturers of America and the European Federation of Pharmaceutical Industries and Associations jointly developed Principles for Responsible Clinical Trial Data Sharing, implemented on 1 January 2014. The EU's disclosure and transparency policy, an EMA policy effective 1 January 2015, increases the traditional audience for these documents: academic and research groups can request access to data sets to attempt to reproduce study results, or may perform their own analyses. In anticipation of this change, many pharmaceutical companies created websites for requesting clinical study data and established independent adjudication panels to assess the requests and ensure appropriate disclosure.
Science and medicine are evidence-based disciplines in which peer-reviewed publication is held in high regard, and cited publications support fact and develop and inform scientific discussion. Professionals with internet, library and financial resources rarely have difficulty obtaining a publication from a bibliographic reference. To aid transparency and avoid excluding people without institutional resources, the wider audience for protocols and reports must have access to the literature at little or no cost.
In the first year of Policy 0070, less than a fifth of all users of the published information were registered for academic and other non-commercial research purposes, in line with the experience of the EMA's Policy 0043, under which more than half of the document requests came from the pharmaceutical industry and law firms.
Of the parties seen to access shared report content, the largest audience had been other pharmaceutical companies, whose main driver for accessing the reports was to understand how their peers were approaching document anonymisation. As an educational resource on anonymisation, the published reports were not great examples of high-quality anonymisation combined with accurate risk metrics, and there was plenty to improve upon.
Practitioners preparing their own packages under EMA Policy 0070 were looking at the documents published there to see what other people were doing. In the future, others might look at the trial designs published there to see whether they are on the right lines, or a new trial design put up there might inform how to proceed.
The EMA had not been very clear about the target audience for externally published report content. If the intended reader is the general public, interested patients among them, they are unlikely to understand the detail and the language of a clinical study report, so the value of publishing it is questionable. If the intended reader is other researchers, a summary with the efficacy and adverse event detail could be argued to suffice.
Several clinical documents, clinical study reports among them, are published in the public domain, for example under EMA Policy 0070 and Health Canada's public release of clinical information, but they contain scientific jargon that can be impenetrable to a non-scientific audience.
The transparency requirements
Rapidly evolving regulatory requirements for transparency have increased the information that will be published. A multitude of transparency regulations now applies from the start of a trial through to the marketing authorisation application, and there is little harmonisation across regional regulations or transparency platforms. That multitude makes the regulatory framework governing transparency ever more challenging to navigate, and the scope of transparency is increasing. Medical writers play an important role in generating the information transparency requires, so they need to be familiar with the relevant requirements. They can play a key role in driving compliance with applicable regulations.
The requirements fall broadly into three categories:
- clinical trial registries, which provide information on planned, ongoing and completed trials, usually through a searchable interface
- data and document sharing, which publishes trial documents and data suitably anonymised to protect personal and company confidential information
- plain language writing, which presents clinical research information in language accessible to those without a scientific or medical background
Registries initially provided limited information, and transparency has evolved to give direct access to certain clinical study documents and data sets, which adds complexity because they may contain personal data or commercially confidential information that must be redacted before publication.
The requirements are becoming more widespread and more complex, and medical writers are often at the vanguard of making clinical information more widely available. Effective, compliant disclosure requires them to stay informed about the relevant regulations and to seek ways to make transparency processes more efficient and consistent.
The writer's role in disclosure
One practitioner holds that writers have a very important role in disclosure, and that the medical writing task is basically to minimise the risks it brings. In that account the task comes down to protecting patients' privacy responsibly; finding the balance between disclosure and data protection, and between data protection and scientific utility; thinking about proactive medical writing and proactive anonymisation; and streamlining the disclosure process to avoid additional work and increased costs in healthcare.
Writers' roles and responsibilities have evolved with the new disclosure requirements. Writers used to be bound to trade secrecy and data confidentiality; they have become protectors of patients' personal data, stewards of data and document utility, and advocates of plain language communication, and their texts have become leaner and more focused, written with public disclosure in mind.
Transparency in clinical research is emerging as more than a regulatory requirement: it is a cornerstone of public trust and ethical responsibility. With new regulations, evolving expectations and the ever-present need to protect sensitive information, it can feel like another string writers must add to their bow. The revised transparency rules for the EU's trial information system are a reminder that the work was never about ticking boxes but about the balance between openness and protection: making clinical trial data available to the public while safeguarding the personal data of the people who take part in a trial and commercially confidential information. What exactly counts as either can sometimes be a grey area, and navigating those decisions with care is the writer's job. For trials moving from EudraCT to the new system, the data have to transfer smoothly and be presented meticulously. The goal is transparency, but never at the expense of privacy or commercial sensitivity, and writers are uniquely placed to drive best practice.
In the push to make trial results more accessible to the public, especially to patients, one document gaining momentum is the plain language summary. Patients should have a say in how plain language summaries are written, because they can provide insights that professionals might miss. AI may help craft clearer, more concise summaries that resonate with a broader audience. Working globally, writers have to be not only compliant but consistent across regions that each have their own rules and expectations. The digital tools that reach people where they are add to the responsibility to ensure that the information provided is accurate, accessible and meaningful. Staying up to date requires continuous learning.
Transparency has emerged as not merely a regulatory requirement but a critical ethical and scientific imperative. It means making clinical trial information available, in the format useful to them, to all the stakeholders who need it, could use it or might want it: regulators, researchers, sponsors and the public. It spans the registration of trials, the reporting of outcomes, the sharing of data and the publication of summaries, including plain language ones, and it aims to reduce duplication, improve data reuse and uphold the integrity of scientific communication. Transparency is being redefined not just as a compliance checkbox but as a value-driven commitment to public trust, data utility and meaningful engagement. Doing it well is far from simple.
The focus should be not only on meeting legal obligations but on delivering genuine value to stakeholders, whether through readable summaries, reusable data or ethical openness, and sponsors are urged to ask not only what they must do but what they can do better. Transparency done well is not just good science but good stewardship.
As clinical trial transparency becomes embedded in scientific culture, the role of medical writers, sponsors and regulators will only grow more nuanced, and with AI tools evolving and regulation tightening, collaboration, clarity and strategic thinking are more crucial than ever. Transparency is no longer a challenge to manage but an opportunity to lead.
Considerations for disclosure-ready documents
Five considerations can help medical writers prepare disclosure-ready clinical documents, meet regulatory requirements and ensure transparency while maintaining data privacy, confidentiality and the integrity of data. They are these, each with its practical application and the effect expected of it:
- Know the transparency requirements: understand what must and what must not be disclosed, and prepare documents with disclosure timelines in mind, which achieves compliance with regulations.
- Collaborate across functions: facilitate agreement between, and train, the diverse stakeholders in transparency processes, such as legal, regulatory and medical teams, for greater consistency and reduced timelines.
- Write lean and consistently: include commercially confidential information and personal data only when necessary, create lean document templates and maintain a glossary of commercially confidential information for each product, which reduces the redaction required and avoids variation across documents.
- Develop plain language skills: learn to write in plain language, use infographics and engage patients directly in creating documents, for more efficient and engaging plain language summaries.
- Embrace technological advances: be aware of how new tools, such as the CORE Reference secondary-use clinical study report, TransCelerate templates and generative AI, can support clinical trial transparency processes, for more efficient writing.
AI in transparency work
AI tools were being developed to help anonymise data sets and clinical study reports for safe sharing on regulatory and data-sharing portals, and AI was proving valuable in managing the variability of document formatting and structured-data terminology, such as the many ways of referring to a patient identifier. Generative AI was a promising means of drafting plain language summaries of trial results and protocol synopses, but while it can deliver first drafts efficiently, human experts have to be kept in the loop to ensure the accuracy of complex clinical data, the right reading tone for the intended audience and the absence of hallucinations. AI should assist, not replace, expert judgement. Whether summarising protocols for ClinicalTrials.gov or aligning with regulatory expectations, AI-driven tools should work under expert supervision. Responsible use of AI in writing plain language summaries needs critical evaluation and strategic oversight from human experts to ensure quality and compliance.
Source documents written with disclosure in mind
The Clinical Trial Regulation requires clinical documents to be disclosed at regular intervals during a trial, and that raises points for medical writers to consider. Writing disclosure-ready documents, beginning with the end in mind, is imperative in making disclosure efficient. Lean, concise writing ensures that redaction or anonymisation is needed only in limited sections. To meet the new disclosure obligations, sponsors need redaction and anonymisation processes that are consistent across documents and performed proactively, and documents have to be prepared so that anonymising them takes minimal work. Writers should assess the personal data and commercially confidential information in the documents and prepare consistent anonymisation. Sponsors also have to identify in-scope documents prepared in local languages, which need redaction before upload to the Clinical Trials Information System and may need back-translation into English first so that the redaction can be done efficiently. Some sponsors were considering a secondary-use clinical study report built from the anonymised data set, which removes the need to anonymise the report for public disclosure. CORE Reference suggests preparing primary-use and secondary-use reports separately.
To support disclosure, a protocol "disclosure template" can be created to hold the main registration data, including the trial identification number, the public and scientific titles, the brief description and the eligibility criteria. A good starting point is the registration data set developed by the World Health Organization, with the protocol registration information from clinicaltrials.gov or EudraCT, where available, passed to local affiliates, partners and contract research organisations as their source data for local registries. The disclosure considerations for study endpoints include explaining how each endpoint aligns with the objectives; documenting how each will be measured; explaining scales and giving their best and worst scores; including the measurement objective; classifying endpoints as primary, secondary or exploratory and structuring them; making sure each objective has one or more endpoints; defining study processes such as study dates and enrolment; and summarising all nonserious adverse events.
When preparing source documents such as the protocol or the clinical study report, writers should consider the information needs of patients and potential trial participants. The information relevant to them should be written in plain language as part of the protocol: the study title and a brief description, the description of the health condition, the product description, the key inclusion and exclusion criteria, the description of study procedures and assessments, the primary and possibly key secondary outcome measures, context on the age range and sex of the participants, and the length of participation. Submitting these elements to trial registries improves communication with patients and benefits users such as recruiters and patient advocates. Plain language elements should be integrated into the protocol, the clinical study report and even the informed consent form, which is often not as clear as it could be. A plain language abstract can be added to the study synopsis, especially where the sponsor plans no separate plain language summary, and a plain language glossary and templates are handy tools.
Because the clinical trial results summary is needed twelve months from the intermediate data analysis date, it is important to finalise the interim analysis report so that this obligation can be met. The clinical study report, as the main source document for the plain language summary, would need to be written as soon as possible after the trial completes. For paediatric trials the timeline for results disclosure is even stricter, six months from the global end of the trial, so to meet the timelines the availability of source documents for disclosure preparation is key. During the first phase of the Regulation's implementation, the format required for the results summary of intermediate and end-of-trial analyses was likely to resemble a clinical study synopsis or a disclosure synopsis. In that case the effort of preparing results summaries in EudraCT would be reduced, because the requirement for full data sets may phase out. This may change as new functions are added to the EU portal.
To increase efficiency, medical writers may also consider finalising the sections of the plain language summary that do not depend on the data at the shell stage of the clinical study report, leaving only the data-dependent sections to be completed when the report is finalised.
Medical writers should keep abreast of updates to the EMA's guidance and policies while preparing clinical documents. Because the COVID-19 crisis affected site monitoring, patient visits and data collection, amendments to protocols, informed consents among them, and to trial conduct were inevitable, and these changes need to be properly addressed when the results are disclosed.
Trials are conducted almost everywhere and disclosure requirements keep expanding, with an average of two new trial registries going live every year, and this global expansion can lead to inconsistent public disclosure of protocols, trial results and associated documents. The inconsistency becomes apparent when the information is disclosed through several registries, company trial websites and publications and then assessed by recruiters, industry and financial analysts and patient advocacy groups. Regulators in several countries had started to include disclosure compliance in their inspections, while industry critics and transparency advocates continued their detailed assessments of transparency practice. Beyond these, sponsors face additional risks if disclosure decisions are not well harmonised. Sponsors also need to keep the information they disclose publicly consistent, for scientific integrity.
Disclosure and data protection
Public access to protocols and reports requires above all that individual participants cannot be identified from published information. Developing targeted treatments, which focus research on genetically suitable populations, in effect personalised medicine, will present challenges, because patients with rare conditions enrolled in small numbers at a particular site may be relatively easy to identify from their data. Disclosure of an individual's pre-existing conditions could preclude their eligibility for health insurance cover in some countries, and clinical trial data could potentially be used to influence reimbursement decisions in countries with healthcare free at the point of access, or to exclude entire populations from health insurance coverage or state medical aid on the basis of genetic predisposition.
Because writing teams are tasked with work under Policy 0043, Policy 0070 and data disclosure generally, writers need to understand both the policies' requirements and the General Data Protection Regulation. Policy 0070 provides for the disclosure of anonymised clinical documents while protecting the personal data of trial participants, and requires marketing authorisation holders to anonymise personal data by a mix of strategies followed by a thorough assessment of the risk of re-identification. The data protection regulation came into force on 25 May 2018 in place of the EU Data Protection Directive, and it applies to the EU, the EEA and any data controller or processor located outside the EU. To remain compliant with it, disclosed data should be rendered completely anonymous, and failure to comply may lead to monetary penalties and reputational damage. Writers should evaluate collected data for potential risks, categorise information as direct identifiers or quasi-identifiers and understand the anonymisation rules, and organisations should make their staff aware of the data protection requirements so as to adhere to privacy policies and address accidental breaches.
Policy 0070 and the Clinical Trial Regulation significantly enhance public access to evidence-based clinical information while the data protection regulation requires personal data to be adequately protected. The conflict between them leads to under-reporting of data (redaction against transformation techniques), data abuse, privacy risks and compromised commercially confidential information. Redaction alone decreases the data's utility, so other anonymisation strategies have to be considered. The risk of re-identification should be assessed either against three criteria, whether it is still possible to single out an individual, to link records for an individual or to infer information about an individual, or by a quantitative risk assessment, as the Article 29 Working Party recommended. The movement of clinical data across borders makes the regulation's effect on data usage, processing and storage evident, and pharmaceutical organisations must adapt their processes and systems to remain compliant with it.
Regulatory writers prepare clinical documents for public disclosure and can separately have a role in preparing clinical trial data sets for data sharing, and the methods for managing the risk of re-identifying individuals in the two processes have much in common.
A disclosure function staffed by medical writers
Any research group that registers a trial must comply with the same disclosure regulations as pharmaceutical companies. One writer at a contract research organisation holds that these regulations have had a considerable but positive impact on that writer's day-to-day work. That organisation's regulatory affairs group had supported clients' transparency efforts since 2008 and the US Food and Drug Administration Amendments Act (FDAAA 801), but requests to prepare results postings were intermittent and fluctuated in number. When posting to the EMA's European Clinical Trials Database, EudraCT, became mandatory for interventional trials that ended on or after 21 July 2014, the impact was almost immediate, and requests from current and new clients rose sharply.
A dedicated disclosure group was established in the UK by the end of 2014, with a new role of disclosure specialist; its first two members were medical writers by trade, and they worked hard to learn the regulations, taking advantage of the training resources freely available through ClinicalTrials.gov and EudraCT. The group grew by enticing other medical writers who were perhaps looking for variety or for part-time work or reduced hours. Preparing a results posting takes much less time than, for example, preparing a clinical study report, and the effort can be moulded to suit part-time employees. The aim was a couple of specialists who could prepare the postings while supporting each other on their days out of the office. Alongside the disclosure specialists, a bank of medical writers was trained to prepare results postings. A contract research organisation sees a wide variety of trial results data in phase and therapeutic area, so no two studies are the same, and combined with the challenges of working in regulated databases with restrictions, character limits and required verification steps, this makes preparing results postings anything but routine. The landscape keeps moving, and the group continually monitors industry and agency changes by signing up to the agencies' notifications and blogs, attending the webinars they host and using their online training. It shares lessons learned within the group and in the broader field of disclosure through forums such as the Drug Information Association.
Medical writers are ideally suited to working in results disclosure: they already have the skills to summarise trial data and present the results to address a study's objectives, and they are known for attention to detail. They have the skills to complete the tabulated data postings in EudraCT and ClinicalTrials.gov competently: they can understand the design of a study and why it was performed, what its objectives were and what its endpoint results show; extract the data that belong in a posting; and summarise text within the character limits the databases set. The disclosure specialists also worked with the organisation's medical writers to change the protocol and clinical study report templates to take account of data transparency. Building the function also meant managerial work: hiring staff, establishing processes and standard operating procedures, and developing job descriptions and job grades. Disclosure offers a writer the opportunity to become an expert in requirements and regulations that keep evolving, and to use practical experience of trial data to help clients understand and meet their obligations.