Narrative Writing in Clinical Research
Categories Medical Writing

Narrative Writing in Clinical Research: Guidelines for a Medical Writer

Narrative writing or writing patient safety narratives is an integral part of any clinical study report writing. Before dwelling into its guidelines, let us first understand what it is and what importance it carries in clinical research.

In simple terms, a narrative is a brief summary of the adverse events experienced by the patients during a clinical trial of a drug. It is submitted along with the clinical study report to establish any causal relationship between the events experienced by the patient and the drug under investigation. This also helps in establishing the drug safety profile.

Patient narratives are generally written for deaths, serious adverse events, any adverse event of special clinical interest, and events leading to permanent discontinuation of the patient from the trial.

Components of a patient narrative

As per International Conference on Harmonisation (ICH) E3 guidelines, a patient narrative must contain the following:

  • Nature, intensity, and outcome of the event
  • Clinical course of the event
  • Timing of study drug administration
  • Relevant laboratory measures
  • How the event was treated
  • Action taken with respect to the study drug
  • Post mortem findings (in case of death of the patient)
  • Investigator’s and sponsor’s (one who sponsors the clinical study) opinion on causality
  • Patient identifier
  • His age, sex, and general clinical condition
  • Disease being treated
  • Medical history of the patient
  • Medications taken in the past or taking currently
  • Any ongoing medical condition

What do you need to know before drafting a patient narrative?

1.Thorough knowledge and understanding of the therapeutic area of the drug under investigation

2.Knowledge of the regulatory requirements

Patient narratives are usually submitted to the regulatory authorities along with the clinical study report, included either as a text in Section 12.3.2 if the number of narratives is less (6–10) or provided in Section 14.3.3 as an appendix.

3.Understanding of the role and expectations of the regulatory authorities

As narratives are reviewed by the regulatory authorities, their objectives must be borne in mind before drafting a narrative. These objectives are:

  • Identification and close examination of adverse events that require further monitoring
  • Identification of frequency and severity of unexpected adverse events
  • Identification of the factors affecting the occurrence of adverse drug reactions like patient’s age, gender, ethnicity, race, associated illness, abnormalities of renal or hepatic function, and genetic characteristics or drug-related factors such as dose, plasma concentration, duration of exposure, and concomitant medications.
  • Evaluating and analyzing the data for any limitations and safety analysis of the drug.

4.Sources of data

You can use various sources of information while preparing a patient narrative. These include:

  • Primary source which is the clinical database listings
  • Secondary source which include Council for International Organizations of Medical Sciences (CIOMS) forms, Case Report Forms (CRFs), MedWatch forms, and Data Clarification Forms (DCFs)

5.The number of patient narratives to be prepared

Challenges in narrative writing process

The most common challenges observed while drafting a patient narrative are:

  • Large number of resources required for the project
  • Maintaining consistency in the narratives
  • Timely delivery of high quality narratives
  • Lack of standardized data sources or patient profiles
  • High variability in template finalization before and after sample narratives due to differences in opinion of reviewers
  • Change in reviewers in intermediate or later stages of the project
  • Delay in review cycles
  • Delay in receiving consensus on comments and queries from the clinical team

How to overcome these challenges?

    1. Hold a meeting with all the stakeholders of the project and finalize a template for the sample narrative, in consensus with the clinical team.
    2. Review your clinical database listings for all the necessary information as per the agreed narrative template.
    3. Use standardized data sources throughout the process. Also use a resource utilization tracker that lists down all the ongoing studies, percent utilization and free capacity of the resources in each project.
    4. Use a standardized narrative tracking sheet to record details like the list of patients requiring narrative, their criteria for narrative, author, reviews, and dates.
    5. Standardize the review process and have proactive communication with all the stakeholders including the clinical team for finalizing the sample narrative.
    6. Finalize the sample narrative before dispatching future batches.
    7. Use an automation tool for narrative writing. This is particularly helpful in case of large volumes of narratives to ensure consistency, quality, and timely delivery of narratives. However, medical and scientific review, data quality control, and quality calibration must be performed regularly even if the narratives are generated using an automation tool. Quality can be checked and maintained by using a quality tracker to calculate any major or minor errors in the narrative.

Tips for writing an effective patient narrative

    • Always use hard space and hard hyphens for days, dates, and laboratory values to avoid splitting on the next page or next line except at the beginning of a sentence (hard hyphen: ctrl + shift + hyphen; hard space: ctrl + shift + space)
    • Be consistent while using the patient throughout the narrative.
    • Tag the narrative template against the information available in data sources to help the reviewer track the information easily.
    • Always use generic names for the patient’s concomitant medications or treatment medications for adverse events. However, for combination drugs, generic drug name should be provided along with the trade name in brackets; for example, lisinopril-hydrochlorothiazide (Zestoretic)
    • For describing the adverse event and medical history or ongoing condition of the patient, always use the preferred terms like pain in extremity should be reported as pain in hands or pain in legs.
    • Quick check your narrative before submitting it to the scientific reviewer.

Quality control (QC) is an important step in the delivery of a narrative project. If time is not a constraint, QC must be performed during the review and final delivery stages. However, if that is not feasible, a thorough and independent final QC should suffice.

Cognibrain healthcare technologies are the best provider of medical writing and healthcare communication services. Our Medical writing services include clinical and regulatory writing which encompasses clinical study reports, clinical study protocol, investigator brochures and pharmacovigilance writing like patient safety narratives, periodic safety update reports. Our non clinical or non regulatory medical writing services include medical manuscript writing service for journal submission, publication support for medical journals, medical abstract writing and poster presentation for medical conference, systemic review and meta analysis. We also provide healthcare communication services like medico marketing writing, product monographs, medical content writing for therapeutic products, medical devices, nutraceutical products and treatment procedures and medical websites.

How to Publish a Medical Manuscript in a High-Impact Journal
Categories Scientific Communication

How to Publish a Medical Manuscript in a High-Impact Journal?

There is nothing more satisfying than seeing your research being published and visible to the outside world. After all, scientific publications connote an ongoing progress in the medical domain, and being its part is everyone’s dream.

Medical publications are the means to let the readers know about the advances in the knowledge of human anatomy, physiology, and medicine. Therefore, the knowledge they provide must be accurate, valid, trustworthy, and clinically useful. In other words, medical journals must exist primarily for their readers; to inform and instruct them about the new advances in the medical field and not only advertise about one’s work.

However, to get your medical manuscript published in a high-impact journal, you need to have the basic knowledge of the principles of scientific research and publishing, which is the mainstay of this blog.

Let’s highlight the essential steps to follow in order to publish your medical manuscript in a high-impact medical journal.

I. Do a good research

What makes up a good medical research?

One which is based on some logical rationale, addresses a real problem, has a clear-cut goal, is carried out in a  systematic and unbiased manner, and is replicable, verifiable, and incremental in nature.

5 Quick Steps For Good Research Are:

A. Choose a good research unit with a good mentor
If you are new to the field of scientific research, you need a good mentor from high-impact units to guide you      through the pitfalls and scientific follies associated with the research study.

B. Formulate your research question

which must stem out from a clinically important disease having a significant burden on the society. Go through the previous works and literature on your research topic to know what has been done and what more you can do.

C. Articulate the goal of your research
The ultimate goal of any medical research is to provide verified and valid information about the advances in the    medical field that could be used for the benefit of the suffering humanity. Ensure that your research study will    be able to fulfill this goal. Furthermore, having a clear view of your goal keeps you focused and systematic in conducting your research.

D. Collaborate with national or international groups having expertise in the area of your research. Such studies are more valid and have a higher impact than the ones carried out at one centre.

E. Have a sound study design
Designing your research study, what volunteers you will choose, what age and sex, how will you measure the    results etc. must be clearly defined from the beginning. Choose healthy volunteers as the control group.            Involve  a statistician to calculate and analyse the results right from the start. A double-blind randomized        placebo-controlled parallel group trial design is the most sound.

II. Writing your medical manuscript

Writing a medical manuscript can be compared to writing a story of your research that has a beginning, middle, and an end with a “take home” message.
While writing your manuscript:

  • Use simple language with attention to grammar, punctuation, spelling, and linguistic style.
  • Include content that is relevant to the topic of your paper and provides value to the reader. Keep it plagiarism free.
  • Strictly adhere to the format and word count laid down for the scientific manuscripts: Title, Abstract, Methods, Results, Discussion, Acknowledgements, References, Tables, and Figures.
  • The title must be catchy, concise, and descriptive, highlighting the contents and the importance of your research study. It should neither be too long nor too short. Write down a few possible titles and shortlist the best one.
  • An abstract is a crisp introduction to the contents of your manuscript. Make it comprehensive and interesting by answering the questions like: What was done? Why did you do it? What did you find and how are these findings useful and important? And what is the “take home” message?
  • Proofread your document carefully or get it reviewed by a colleague for any careless and grammatical mistakes. If you have any queries about writing manuscript please contact our medical manuscript writing service experts.

III. Getting your manuscript published

Check the details of the editorial committee, scope, and remit of your target journal in advance to avoid the possibility of future rejection or conflicts with the editorial staff.

Submit your completed manuscript by writing a cover letter to the editor-in-chief that should:
• Address the editor-in-chief (EIC) by name.
• Highlight the novelty of your work, its importance and compatibility with the journal’s remit and scope.
• Contain previous reviews of your work if any.
• Carry an approval of the manuscript by all its authors and its non-publication by any other journal.

Never submit your manuscript to two journals simultaneously.
After submission, your manuscript will be scrutinized by the editorial assistant, EIC, and the associate editor before it is either rejected or passed on for external peer review.

Now, your manuscript may get rejected or receive a major or minor revision or get accepted.

In case it gets rejected, which is likely in cases of lack of novelty, poor study design, lack of a clear message, and confusing charts, figures or tables, do not react in a rage. Even if you receive a major or minor revision, acknowledge the comments and queries placed by the editorial staff with honesty. Do not view them as your critics, but your supporters and assure them about your capability to rectify the loopholes in the manuscript, even if it requires an additional work on your part. If this is not possible, consider submitting your manuscript to another journal after making the changes as per the previous editor’s reviews. If you disagree with their comments, state your opinion firmly but politely.

And if your manuscript gets accepted, you can celebrate your achievement. But complete few tasks beforehand like completing the copyright assignment, conflicts of interest disclosure forms, editing of the typeset version, and updating your bibliography section.

Your manuscript is now scheduled for “online first” publication and will be provided a digital object identifier (DOI) number, a character string that is used to uniquely identify an object such as an electronic manuscript.

If at any time you have questions about our medical manuscript writing service , don’t hesitate to reach out and ask us.

Good luck with your publication!