Clinical trials lay the foundation for the biomedical research enterprise. They not only assess the applicability of innovative laboratory findings in humans, but also generate robust evidence on treatments and/or preventive interventions in routine clinical care. Clinical trials also directly engage human participants, who trust the investigators to maintain utmost scientific as well as ethical knowledge. Although clinical trials continue to evolve and produce advanced evidence on diagnosis and treatment, the industry is posed with quite some challenges. As a result, significant changes are essential in order to reflect improved efficiency, accountability, and transparency in clinical research. (1)
Clinical Trial Disclosure is a complicated challenge faced by nearly all the clinical trial sponsors worldwide. Along with the intricate task of managing vigorous clinical trial data and working with ever-changing global regulatory requirements, the sheer quantity of trials being conducted today only amplifies the difficulty of this task. Moreover, clinical trial transparency has gained importance to have a premeditated and operational impact on a sponsor organization, and eventually healthcare providers and patients. (2)
Regardless of countless efforts to address the issues like inconsistent or selective reporting of biases, about half of all clinical trials conducted and completed during past few decades have reportedly never had their results published. This lack of transparency can certainly lead to serious implications for patients, providers, and health systems. Despite failed efforts, latest initiatives in the United States as well as other developed countries offer new prospects to address unresolved issues. The recent past has witnessed an explosion of trial disclosure requirements and expectations around the world. (3)
Additionally, these requirements to maintain clinical trial transparency continue to evolve and expand. Consequently, these ever-changing requirements invite new challenges, generating added opportunities for knowledge-sharing and requiring more interaction with peers. (4) To cite an example, regulatory authorities along with researchers and the AllTrials clinical trial data transparency campaign (among others) are pressurizing the life sciences industry to willingly provide access to patient-level data and results from clinical trials to base the regulatory decisions on. Although data sharing is gaining momentum, if ignored, regulatory authorities may require complete public disclosure of the information from clinical trials information; which, in a way, provides wide access to researchers conducting valid scientific inquiry. Such instances pose a concern of disclosure of proprietary information to competitors. Clinical trial data transparency enables qualified researchers to validate clinical trial results, improve the effectiveness of clinical trials and make progress in the medical knowledge. Furthermore, data sharing can potentially improve public health, while also increasing public trust in clinical research and the healthcare industry. (5)
Having said that, the aspect of clinical trial disclosure is gaining importance owing to the risks associated with non-compliance. It goes without saying that non-compliance will have serious consequences, such as penalties in the form of withheld grants, public warnings as well as fines issued by the FDA, rejection of manuscripts by the ICJME, and so on. Transparency is certainly an important effort, which has calculated and functioning impact on a sponsor organization. Therefore, sponsors as well as the related stakeholders must pledge to monitor emerging regulations and registry requirements consistently by allocating resources, recognising roles and responsibilities, and developing training and communication programs that are in line with their disclosure and compliance objectives. A well-coordinated approach will typically require the implementation of technologies along with process changes; particularly those that help manage the resources, tasks, and content within one environment to help in order to centralize and optimize the disclosure processes. These measures can curtail the risk of non-compliance, thus ensuring consistency of publicly-available data as well as reducing the resource requirements for managing and tracking disclosure information. Ultimately, it will mainly impact healthcare providers and patients in the sense that new information will be available that might impact their care. Organizations must always acknowledge the public need for access to clinical trial information.2
- Hudson KL, Lauer MS, Collins FS. Toward a New Era of Trust and Transparency in Clinical Trials. Jama 2016; 316(13):1353-1354.
- Wicks T. Clinical Trial Transparency: The Stepping Stones To Disclosure. June, 2015.
- Richardson E. Transparency in clinical research. January, 2016.
- Drug Information Association- DIA.
- SAS. Increase Transparency for Clinical Trials to Improve Public Trust.