A guide to clinical trial reporting
Clinical trials in Australia are conducted within a strong regulatory framework underpinned by Good Clinical Practice (GCP). The principles of GCP emphasise the importance of thorough, accurate, and transparent reporting in clinical trials to ensure that data generated are credible and reliable and contribute to medical and scientific advancement and that participant rights, safety and well-being are protected.
What is clinical trial reporting?
Clinical trial reporting refers to the comprehensive documentation and dissemination of clinical trial results and methodologies. This process ensures transparency, reproducibility and accountability in health and medical research.
Clinical trial reporting is crucial for several reasons:
- Transparency and accountability: It ensures that the methodology and results of clinical trials are openly available to allow for independent verification and scrutiny. This transparency helps build trust in the research process and its outcomes.
- Scientific integrity: Appropriate reporting prevents selective publication of positive results (publication bias) and ensures that all findings, including negative or inconclusive results, are accessible. This is vital for scientific integrity and rigour and for making informed decisions based on a comprehensive understanding of the evidence.
- Patient safety: Reporting adverse events and side effects encountered during trials helps identify potential risks associated with new treatments, ensures patient safety, and informs future research and clinical practice.
- Informed decision-making: Healthcare providers, health systems, and patients rely on accurate and complete trial data to make informed decisions about treatments. Comprehensive reporting provides the evidence needed to evaluate the efficacy and safety of interventions.
- Regulatory compliance: Regulatory agencies, such as the Therapeutic Goods Administration (TGA), require thorough reporting of clinical trial data as part of the approval process for new drugs and treatments. This ensures that only safe and effective treatments reach the market.
- Research progress: Detailed reporting of trial methods and results facilitates further research by providing a foundation for new studies. It helps researchers avoid duplication of effort and allows for meta-analyses and systematic reviews that aggregate data across multiple studies.
- Ethical responsibility: Participants make a significant contribution to the advancement of science through their participation in clinical trials. Reporting is an ethical obligation to the participants who contribute to the research. It ensures that their participation is meaningful and that the findings are available for public benefit.
- Funding justification: Transparent reporting is essential for justifying the investment made by sponsors and funding agencies in research. It provides evidence that the research was rigorously conducted and that the findings are reliable and useful.
Key components of clinical trial reporting
Standards and guidelines, such as the CONSORT (Consolidated Standards of Reporting Trials) statement, exist to ensure that clinical trial reports are complete, transparent, and useful to the scientific community and public.
Key components of clinical trial reporting include:
- Study protocol: A detailed document that provides a systematic approach to the trial's methodology, outlining the objectives, design, methodology and statistical considerations.
- Registration: Clinical trials must be registered in a clinical trials registry before the first participant is enrolled. A clinical trial registry is a publicly accessible database that contains details on the trial design, conduct and status, and administration information and contact details. In Australia, researchers can register their trial on the ANZCTR website.
- Results reporting: This involves the systematic presentation of the trial's outcomes, including both primary and secondary endpoints. It ensures that results are accessible to the public, healthcare professionals, and researchers.
- Publication: Clinical trial findings are often published in peer-reviewed scientific journals. These publications provide detailed information on the study's design, methods, results, and interpretations.
- Adverse events reporting: Any adverse effects experienced by participants during the trial must be thoroughly documented and reported to ensure safety and inform future research.
- Data sharing: Data sharing improves access to health research data for maximum benefit. Researchers are increasingly encouraged to share anonymised clinical trials data to enable independent verification and further analysis. In Australia, the Health Studies Australian National Data Asset (HeSANDA) program has developed a national infrastructure called Health Data Australia to allow researchers to access and share data from health studies, including clinical trials.
FAQs about clinical trial reporting
Clinical trial reporting is the comprehensive documentation and dissemination of methodologies, results and conclusions. It involves preparing detailed reports and submitting them to regulatory authorities such as the TGA, publishing findings in scientific journals, and ensuring that data is accessible to the public and scientific community.
Clinical trial reporting is essential for ensuring transparency, reproducibility, and accountability in health and medical research. It provides vital information for healthcare professionals, researchers, and policymakers, helps in the advancement of scientific knowledge, ensures ethical responsibility to trial participants, and is necessary for regulatory compliance and market approval of new treatments.
Key components of a clinical trial report include:
- title and summary
- introduction with background and rationale
- detailed methodology (trial design, participants, interventions, and statistical methods)
- results (participant flow, baseline data, outcomes, and adverse events)
- discussion and interpretation of results
- conclusions
- references and appendices (including protocols, case report forms, and statistical analysis plans)
Clinical trial reporting should follow guidelines such as the CONSORT (Consolidated Standards of Reporting Trials) statement, which provides a standard way for authors to prepare reports of trial findings, facilitating complete and transparent reporting.
Ethical considerations include ensuring participant confidentiality, accurately reporting results (including negative or inconclusive findings), and providing a truthful account of the trial's conduct and outcomes. Ethical reporting respects the contributions of trial participants and maintains public trust in health and medical research.
Trial registration is crucial for transparency and accountability. It helps prevent selective reporting and allows the public and researchers to track the progress and results of clinical trials. In Australia, clinical trials must be registered on the ANZCTR website.
The CSR is a comprehensive document that provides a detailed account of the clinical trial's methods, results and conclusions. It is submitted to the TGA as part of the drug approval process, which ensures that all aspects of the trial are thoroughly documented.
In Australian clinical trials, Serious Adverse Events (SAEs) should be reported to several key entities to ensure compliance with regulatory and ethical standards:
- Human Research Ethics Committee (HREC)
Reporting Requirement: SAEs should be reported to the HREC as soon as possible, typically within 24 hours of the investigator becoming aware of the event. Detailed follow-up reports providing additional information on the SAE and any subsequent actions taken should be submitted as soon as more information becomes available. - Trial Sponsor
Reporting Requirement: SAEs should be reported to the sponsor as soon as possible, typically within 24 hours of the investigator becoming aware of the event. Detailed follow-up reports providing additional information on the SAE and any subsequent actions taken should be submitted as soon as more information becomes available. The sponsor is responsible for assessing the events and determining the necessary actions, including further reporting if required. - Therapeutic Goods Administration (TGA)
Reporting Requirement: Sponsors are required to report SAEs related to the use of investigational products to the TGA. This includes any event that is serious, unexpected, and possibly related to the investigational product. - Institutional Review Boards (IRBs) or Institutional Safety Monitoring Boards (ISMBs)
Reporting Requirement: SAEs may need to be reported to these boards according to the specific policies of the institution where the trial is being conducted. - Principal Investigator (PI)
Reporting Requirement: The PI must report SAEs to the sponsor and HREC. They are also responsible for ensuring that the trial participants are informed about the SAE and any implications for their safety.
All reports of SAEs should be meticulously documented, including the nature of the event, its severity, the relationship to the investigational product, and any actions taken in response. Records must be maintained in compliance with GCP guidelines and regulatory requirements.
It is crucial to include a comprehensive and detailed breakdown of all the costs involved in your clinical trial budget. You should maintain records of all financial reports and supporting documentation for audit purposes. Financial reports should be accurate and kept up to date, and detailed justification should be included for any significant budget changes.
Key aspects to consider in your budget include:
- personnel costs (including principal investigator, co-investigators, study coordinators/research nurses, data managers, laboratory technicians, and administrative support)
- participant costs
- clinical procedures
- tests and assessments
- medications and supplies
- equipment costs
- facility fees
- regulatory and administrative costs
- study monitoring
- data collection
- data analysis
- database management
- consumables
- study-specific supplies(e.g. kits, forms)
- staff training
- meetings (including travel, accommodation, and meals.
- a buffer for unexpected costs
- indirect costs and overheads (e.g. institutional overhead or facilities and administrative (F&A) costs).
There are several clinical trials databases and platforms you can use to manage your clinical trial in Australia. These platforms offer various tools for trial registration, data management, participant recruitment, and regulatory compliance.
Australian New Zealand Clinical Trials Registry (ANZCTR)
ANZCTR is a primary registry recognised by the World Health Organisation (WHO). It provides a comprehensive database of clinical trials conducted in Australia and New Zealand.
ClinicalTrials.gov
Although this is a U.S.-based database, ClinicalTrials.gov includes trials conducted worldwide, including Australia. It allows researchers to register and manage trials.
Australian Clinical Trials
Australian Clinical Trials is an initiative by the Australian Government's National Health and Medical Research Council (NHMRC) to provide information about clinical trials in Australia. It includes resources for both participants and researchers.
Research Electronic Data Capture (REDCap)
REDCap is a secure web application for building and managing online surveys and databases. It is widely used for clinical trial data management and can be hosted by institutions globally, including in Australia.
OpenClinica
OpenClinica is an open-source clinical trial software that provides electronic data capture (EDC) and clinical data management system (CDMS) functionalities.
Other platforms, such as Medidata Solutions and CliniOps Medidata Solutions, provide digital and cloud-based solutions for clinical trials, including data management, trial planning, and analytics.
Data integrity is maintained through rigorous data management practices, including secure data storage, accurate and complete data entry, regular data audits, and adherence to predefined protocols. Good Clinical Practice (GCP) guidelines provide standards for maintaining data integrity.
Publication in peer-reviewed journals ensures that the trial findings are scrutinised by independent experts, which helps validate the results and enhances credibility. It also disseminates the findings to the broader scientific community, contributing to the advancement of health and medical knowledge.
