Clinical Research Trial Initiatives
The world-wide market for clinical trials in Asia-Pacific Region (APAC) region contributed to more than 50% of trials between 2017 to 2021, amongst the United States of America (USA) and France, Germany, Italy, Spain, the United Kingdom (European 5) as reported by Globaldata. Across all regions, China has registered the largest number of new trials, followed by the USA and India. Oncology, central nervous system diseases and infectious diseases have been the main topics for research.
Access to trial registration has been driven by changes in national standards of safety and reporting clinical trials. Since 2016, the Australian Government (National Health and Medical Research Council) has increased safety monitoring reporting of clinical trials. Arrangements increased the number of onsite regulatory inspections, training Good Clinical Practice (GCP) compliance, site audits, vendor/supplier qualifications and computer data security. Good clinical research practice reporting improves good clinical practice, pharmacovigilance, compliance with ethical conduct and communication about products.
Data from APAC frequently meets the criteria for the Therapeutic Goods Administration (TGA), US Food and Drug Administration (US FDA) and European Medicines Agency (EMA) regulatory submissions. Acceptable quality information for drug approval and journal article publication is well written, sufficient in Scientific English, technically correct, complete in reporting, compliant with guidelines, conforms to style and is free of plagiarism.
Clinical trial summary and interim report writing.
Preparation of clinical trial documents (Investigator’s Brochure, clinical trial protocol and informed consent).
Patient Safety Narratives for Nuanced Reports
Clinical trial studies differ in risk, size and complexity. Responsible clinical study reporting of Adverse Events (AEs) and Adverse Reactions (ARs) is crucial in the authorisation safety monitoring of investigational medicinal products and medical devices.
Australian clinical trials complying with the National Health and Medical Research Council (2016) are aligning with European regulations under the International Organization for Standardization (ISO) 14155 standard for the ICH E3 GCP. Collection of good quality data using ethical conditions and regulatory compliance no longer requires individual reports of AEs, serious Adverse Events (SAEs), external Suspected Unexpected Serious Adverse Reaction (SUSARs) and Unanticipated Serious Adverse device Effect (USADEs). Inclusions of an annual safety report needs to be clear in summarising the safety profile of the trial.
Support can help with revising information stating descriptions, analysis, reporting and recommendations:
Relevant, new findings, measures to minimise risks and implications of data to risk-benefit ratios.
Implications for participants when accounting all safety data and results of studies in profiling safety of investigational medicinal products (IMPs) and not on Australian Register of Therapeutic Goods (ARTGs).
Major safety findings from an animal study, temporary halt/termination of a trial and case events leading to an urgent safety measures.
Recommendations from the Data Safety Monitoring Board for participant safety in specific situations.
Sources: medical notes, AE log, clinical database, Case Report Forms (CRF), safety data base, notification and the Council for International Organizations of Medical Sciences (CIOMS) Form.
APAC region has a genetically diverse population, with different health behaviours, conditions and influence from environmental aspects. Key inclusion and exclusion criteria protect participants from avoidable harm.
A Medical Writer can revise information on valid choices and balanced selections to match opportunities with participants:
Correlation analysis of information to justify flexible inclusion ranges for participant enrolment.
Explanations of inclusion, exclusion, withdrawal criteria and procedures.
Adequately capture the terminology used, describe health conditions, evaluate participant cooperation with checklists, calculate enrolment rate of studies, identify broad debate topics and use scoring measures of trial questionnaires.
Sources – protocol, eligibility checklist, pre-screening log, screening log, identification log, participants log and enrolment log.
Selecting Studies and Data Extraction
Quality studies linking systematic reviews with your primary research can be determined by assessing the process of extracting data and the choices of data. Data extraction for systemic review is time-consuming, especially with larger reviews or if quantitative analysis requires coding. A logical, thorough approach to developing a data extraction form and excel spreadsheet in screening of selection can result in less errors and repetition in extracting data.
Medical writing support can refine data collection:
Grouping categories for form development detailing study characteristics, participant characteristics, intervention, setting, contexts, methods, unit of assessment analysis, statistical techniques, analysis, results of analysis, publications, investigators, additional outcomes, costs, resources used and adverse events.
Tabling categories using the PICOT framework and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) protocol checklist.
Framing data items with close-ended question.
Sources: journal articles, conference abstracts, letters, trial registers, clinical study reports, regulatory reviews and individual participant data.
Data Analysis Before Database Lock
Translate reliable data into meaningful interpretation for safe decisions in medical research. Use your evidence from adequate data analysis and clinical endpoints to address the research question and objectives. Clear descriptions of unbiased related data analysis or statistical analysis reporting protects the clinical trial against misinterpretations.
Express numerical data in words to align objectives with endpoints:
Textual and context correctness complying with regulatory requirements of ICH guidelines.
Customised technical statistical terms in the documents to the level of the intended reader.
Clear reporting of the study objective, data generation process, effect size, evidence-based biostatistical methods and development of statistical models.
Identifiable changes in statistical methods and data analysis (if revalidation is required).
Adequate descriptions of specific choices in analysis sets.
Exclusion criteria for protocol violations and participants.
Review of tables, figures and listings to present correct and easy to understand data:
All relevant data from CRF and external data.
Presented analysis population in title, columns, row headers, field labels, data labels, units, derived variables, footnotes and legend.
Source: statistical analysis plans, statistical outputs, clinical study report and protocol.
Journal Writing Assistance, Technical Editing, Language Editing and Proofreading
Author your work with legitimate distinction from other publications with substantial new knowledge. Present the findings with relation to other articles in the journal, images in science, journal community and the industry vision.
Use the complexity level required for accepted submissions, adhere to guidelines, instructions for authors and style. Well revised manuscripts protect the credibility of work verifying publication with quality, accuracy, depth, completeness and significance.
Authors instructions and guidelines on titles change in structure requirements for length, presentation and correctness. Increase positive critic from editorial review by using techniques such as omitting abbreviations, removing taxonomical information and including the study design in the subtitle.
Improving discoverability of your publication will maximise journal visibility, citation counts and impact. Reduce ‘master lists’ to a submission list of field specific keywords representing the content for search engines and standard vocabulary terms from the Medical Subject Headings list for indexing with the American National Library of Medicine.
Studies have the opportunity to ‘stand alone’ with interesting, relevant, clear, concise, understandable and realistic representation of work. Address the study question(s) with clear description of the aim, key method, inclusion and exclusion criteria, reporting of findings and important conclusions aligning with the research purpose.
Improve clarity for readers to understand the state of the topic, current limitations in knowledge, scope and boundaries as a reference framework for the article. Explain the necessity for the study by clearly summarising the general background, specific background, knowledge gap, statement of study aim, methods and findings. Use an appropriate number of justifiable references from a literature search, to show sufficient referencing of existing literature. Brief your explanation of linking the hypothesis with the theory framework. Synthesise the information to present a unique argument for the purpose statement of the research question to be used as a foundation of the study.
Report the leading methods you used to answer your research question and build confidence in scientific merits of your study results by describing use of accurate techniques for replication. Quality methodology uses a descriptive analysis of the advantages and disadvantages to justify the methods used.
A strong study design shows good ethics, philosophy, strategies of inquiry and application of specific new methods to answer the research question with evidence. Use previous researchers’ methodological choices and their research findings to describe your decision choices to align the research question with your chosen methods. Identifying the Human Research Ethics Committee (HREC) and registration for clinical trials as oversight bodies for study approvals improves acceptance of the manuscript.
With different readers interested in understanding research from concise reports, leads to extra details of the study need to be searchable and findable for journal article acceptance. These include the Research Resource Identifiers, Consolidated Standards of Reporting Trials (CONSORT) checklist, Template for Intervention Description and Replication (TIDieR), open source web applications, platforms for repositories of resource sharing data and logs (GitHUb - Sceptre).
Detail and refine information to report the methods.
Complete and transparent reporting of quality data integrates responsible research conduct with credibility. Report your key and secondary findings to show the significance to the central research question. Present a concise summary of the results with the most important evidence from analysed data used to test each hypothesis and identify trends. Organise your findings towards a comprehensive and less complicated description.
Describe rigorous and robust data while logically answering the research question and explain the accuracy of the methods for measuring the experiment. Depending on the study, the approach with chronological order, theme/category, research question or statistical test may increase the reproducibility.
A general description of the study purpose with the approach to patient selections, recruitment, data collection actual performance of the study and interpretation needs:
Certain balance of statistics, narrative observations, tables, figures, photographs and visual representations.
Reporting of significant results (P-values with measures of effect, percentages with frequencies, confidence intervals with measures of magnitude of effect).
Data presentation with declarative titles, concise headings, adding up of numbers, labelling of X and Y-axes, legends, clearly stated units, sufficient distinguishing of series, colour contrast and concise descriptions of captions.
Referencing in subsections to datasets correspond with table or figure, all figures support the narrative, figures in logical order, important figures reference and described in the text (without the same results appearing in both text and table and in the table and figure).
Visualisations of 2D and 3D image with resolution and adequate explanations.
Summarise your results by interpretating the analysed data, logically explaining the findings and answering the research question. Discuss with appropriate references, implications from the insights in relationships, trends and discoveries. Answer the hypothesis as described in the introduction.
Achieve cohesion with logical sequencing of subsections, level of depth, connecting ideas, repetition, parallelism in sentences, transitions, synonyms, pronouns and cohesive devices.
Subsection the most important findings first with details and then for each finding:
Discuss the main results.
Compare with reference to previous research and the methodologies.
Identify abnormalities and exceptions in the data or the scientific literature.
Discuss with sound assumptions the implications of the results on policy and practice.
Identify the main contribution of findings without overstating the implications of the results.
Acknowledge the limitations of the study and present appropriate inferences.
Summarise your important conclusions supported by data and sufficient details to establish the extent for generalising insights to a larger population or to determine reasoning for further research.
Restate the aim, summarise appropriately the main research findings, describe the work in context with other existing author’s conclusions, suggest implications for the field of knowledge, state significance of the findings and contribution of the study, identify potential study limitations (including theory and application), analysis the strengths and make recommendations for further work.
References and citations
Provide a thorough listing of relevant, current and reliable citations. Show the context of your work, scope of research and acknowledge other people’s work in the field. Correct referencing protects the author from accusations of plagiarism, reduces processing time and enables online linking of journal publication from the citation or reference list to the original author. Complete author information without discrepancies in the format.
Previous Experience in Topics of Therapeutic Areas
Central Nervous System