• Search by category

  • Show all

Clinical study reports under the microscope

March 14, 2017
 - Tim Hardman

Nowhere in the pharmaceutical industry is the relationship between cost, price and value better demonstrated than in the delivery of the clinical study report (CSR). Delivery of the CSR is often viewed simply as dotting i’s and crossing t’s at the end of the clinical trial process. And yet, once the study participants have been thanked, the samples analysed and the many study documents archived, the CSR is the one single aspect of the study that remains visible for the lifetime of the product. Will it reflect the care you put into conducting the study? Will it clearly represent the study’s findings and communicate the true value of your investigational medicinal product (IMP)? Considering these challenges, you need to consider carefully who should write your study report.The requirements for clinical study reports (CSRs) and the transparency of trial data have evolved markedly over time, reflecting growing concerns over the ethical, scientific, and public health implications of undisclosed research data.

Early Regulations and Ethical Foundations

The history of clinical trial transparency began in the mid-20th century, largely as a response to ethical concerns about human experimentation. In the aftermath of the Nuremberg Trials (1947), which exposed unethical medical experiments conducted during World War II, the Nuremberg Code was established. This laid the foundation for ethical standards in human experimentation, but transparency in clinical trial results was not yet a major focus. Further ethical oversight was introduced by the Declaration of Helsinki in 1964, developed by the World Medical Association [1]. This declaration emphasised the ethical responsibility of researchers to publish both positive and negative results from clinical trials, though there were no formal requirements for publicly reporting the full details of trial data [2].

Evolution of Clinical Study Report Requirements

As the pharmaceutical industry grew in the late 20th century, concerns about selective reporting of clinical trials—especially by industry sponsors—emerged. Clinical study reports (CSRs) became a regulatory requirement to address this issue. CSRs are comprehensive documents that detail the methodology, statistical analysis, and results of clinical trials, and are required to be submitted to regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

  • 1980s and 1990s: In the U.S., the FDA began requiring sponsors to submit CSRs as part of the drug approval process under New Drug Applications (NDAs). This period marked the early stages of requiring detailed documentation of clinical trial results. However, CSRs were not routinely made public.
  • 2000s: Concerns about data suppression, especially of negative trial results, led to a stronger push for transparency. High-profile cases, such as the controversy over selective publication of trials on antidepressants (like SSRIs), highlighted the potential dangers of unpublished or incomplete trial data.

Key Milestones in Transparency

  1. ClinicalTrials.gov (2000): The U.S. launched the ClinicalTrials.gov database as part of the FDA Modernization Act of 1997. Initially, it served as a registry of clinical trials, but later expansions required sponsors to submit trial results for public access. In 2007, the FDA Amendments Act (FDAAA 801) mandated that sponsors report summary results for certain trials, even if the drug was not yet approved.
  2. EMA and EudraCT (2014): The European Medicines Agency (EMA) introduced EudraCT, a similar registry in Europe, and in 2014 it adopted a policy on the proactive release of CSRs for new medicines authorised in the European Union. This move was part of a broader push for greater transparency in Europe, following the passage of Regulation (EU) No 536/2014 on clinical trials.
  3. AllTrials Campaign (2013): The global AllTrials campaign, spearheaded by researchers and patient advocacy groups, further increased pressure on pharmaceutical companies and regulators to ensure that all clinical trials, past and present, are registered and their results are made public. The campaign argued that withholding negative results undermines medical knowledge and leads to biased treatment decisions.

Current State of Transparency

Today, trial transparency is seen as essential for ensuring the integrity of medical research and safeguarding public health. Major regulatory bodies, including the FDA, EMA, and Health Canada, now require that clinical trial results be posted on public registries. In addition to summary results, there is growing momentum for the full publication of CSRs and even patient-level data, which can be re-analyzed by independent researchers to verify findings.

  • EMA Policy 0070: In 2016, the EMA began publishing CSRs proactively as part of its transparency initiative. The policy mandates that CSRs be made available to the public, with minimal redactions, after the conclusion of the regulatory process.
  • FDA’s Clinical Data Summary Pilot: The FDA has planned to run a pilot program to enhance transparency by publishing portions of CSRs. This program is designed to make detailed trial data more accessible to the public, though the proposed scope is still somewhat limited.

Challenges and Future Directions

Despite significant progress, challenges remain. Concerns over commercial confidentiality and patient privacy continue to complicate the full public disclosure of trial data. Although the EMA and other bodies have made strides, selective publication of data remains an issue, and compliance with reporting mandates is not always uniform. Going forward, there is increasing advocacy for the routine sharing of individual participant data (IPD) and greater international harmonisation of trial transparency requirements. This would allow for more rigorous post-approval analyses, enhancing patient safety and trust in the research process. The history of clinical study report requirements and trial transparency reflects an ongoing effort to balance scientific innovation with ethical responsibility and public accountability. Significant steps were made in the early 2000s, there are calls for further regulation and international cooperation to ensure that all clinical trial data is transparently reported, accessible, and used to improve global health outcomes. However, concerns have also been raised over issues of study subject/patient data confidentiality that still need to be considered.

To ensure prompt delivery of high quality CSRs, the author needs to both understand regulatory requirements and have the ability to decode the many aspects of the project knowledgebase. If you write the CSR yourself (assuming you have the know-how), you will avoid the cost of finding, employing and instructing a third party; however, the minimum price you pay will be loss of your valuable time. Your other responsibilities – such as programme management, site negotiations and addressing IMP issues – may affect your focus, preventing you from concentrating on the next task in hand. And are you aware of the most recent regulatory requirements – for example, do you know enough about Policy 0070 to address its challenge when writing the report? You could hand the work to a colleague but the challenges remain the same.

At Niche we care about the quality of CSRs within the industry and have written over 600 CSRs in the last 18 years. Now you can share some of the insights we have gained from all that experience. Please download our introductory guide and resource in our latest Insider's Insights and avoid making the most obvious mistakes [3]. Don't forget to sign up to receive future issues of Insider's Insights. We also welcome topic suggestions for future issues of the Insider's Insights.

References

  1. Human Experimentation: code of ethics of the World Medical Association. Br Med J. 1964;2:177.
  2. Carlson RV, et al. The revision of the Declaration of Helsinki: past, present and future. Br J Clin Pharmacol. 2004 Jun;57(6):695-713.
  3. An Insider’s Guide to Clinical Study Reports. Niche Science & Technology Ltd., 2017

 

About the author

Tim Hardman
Managing Director
View profile
Dr Tim Hardman is Managing Director of Niche Science & Technology Ltd., a bespoke services CRO based in the UK. He also serves as Managing Director at Thromboserin Ltd., an early-stage biotechnology company. Dr Hardman is a keen scientist and an occasional commentator on all aspects of medicine, business and the process of drug development.

Related Articles

Get our latest news and publications

Sign up to our news letter

© 2025 Niche.org.uk     All rights reserved

HomePrivacy policy Corporate Social Responsibility