The current climate for drug and device development promotes an ever increasing need for companies to launch new products onto the global market as quickly as possible. The medical writer performs a key role in facilitating this process.
A medical writer who understands the process of drug or device development and regulatory strategy is an invaluable member of the project team.
So what are the main medical writing considerations for regulatory submissions?
The key function of the medical writer is to transform the large quantities of clinical data produced during clinical trials into accurate, understandable and compliant documents for submission to the relevant regulatory authorities as part of the marketing application. Data should be presented clearly and concisely, but with the appropriate level of detail in order to support the submission process.
If possible the medical writer should utilise standard templates to ensure the harmonisation of wording and the appearance of documents across the component parts of the submission.
Clinical Study Reports are the foundation of the majority of regulatory submissions. The International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (E6) states that the clinical trial reports in marketing applications must meet the standards of the ICH Guideline for Structure and Content of Clinical Study Reports (E3). Although the ICH E3 Guidance is the gold standard for writing clinical study reports, it is not designed as a rigid template and some degree of interpretation to enhance the presentation of the data is permitted.
Once all of the clinical study reports required for the marketing application have been written and approved, the medical writer can progress to writing the summaries for the Common Technical Document (CTD) submission. Summaries of the pharmacokinetic, efficacy and safety data from all of the individual studies are required for Module 2.5 (Clinical Overview) and Module 2.7 (Clinical Summaries) of the CTD. The medical writer may also be required to prepare integrated summaries of safety and efficacy (ISS/ISE). Of note, the ISS/ISE are actually integrated analyses of the data from the clinical studies and are generally much larger documents than the efficacy and safety summaries presented in Modules 273 and 274.
Allowing sufficient time for the medical writer, in conjunction with other members of the project team, to plan, write and review documents is ultimately cost effective. Documents that are rushed will inevitably contain errors and omissions which will result in questions and requests for clarification further down the line. This can lead to costly delays. Taking time to ensure that a document is well written and of high quality will ultimately pay dividends during the submission process.
Compliance with local regulatory requirements should be addressed at the start of the writing process to ensure that any country specific requirements are adequately met. For example, sign-off and appendix requirements can vary between countries.
Writing should be a collaborative process. The bulk of the work can be effectively managed by an external consultant if necessary. Input from the sponsor in terms of the strategic understanding of the product and the therapeutic area under evaluation is key to overall success.
The document review process can be difficult to control, not least because time is scarce and documents complex. Review timelines should be achievable and agreed beforehand. Document review meetings are an invaluable way to adjudicate comments to ensure that all issues raised are discussed and adequately addressed.
Further down the line, responding to questions raised by the regulatory assessors requires a similarly pragmatic approach. Responses should be well constructed, concise and focus on the key points. Additional information should be provided where relevant, but the provision of huge amounts of extra data should be avoided as this will only serve to cloud the issues.
In summary, approval hinges on the quality and content of the submission documents, so it is worth taking the time to ensure that the highest standards are met.
CROS NT provides expert medical writing services in both drug development (Phase I-IV) and the medical device sectors. Collaboration between our medical writers and statisticians ensures a high level of accuracy.
CROS NT can provide medical writing as part of an overall centralized biometrics package where the Medical Writer works on the same data team as the Statistician, Programmer and Clinical Data Manager. We also provide Medical Writing services under the Functional Service Provision model providing FTEs or scalable teams of resources to meet specific Sponsor requirements.