Clinical investigations, commonly referred to as clinical trials, play a pivotal role both in developing new treatments and in detecting, diagnosing, and reducing the progression of disease conditions. The main purpose of a clinical trial in the field of medical devices is to assess the safety and performance of a device and to generate clinical evidence to conduct a clinical evaluation according to the European regulatory requirements.
These studies follow strict scientific standards that protect patients and produce high-quality data for healthcare needs. The results obtained from clinical trials may affect the treatment options and the life of patients worldwide. Therefore, patients have the right to receive information about the results from clinical trials.
It is important to register and publish data from clinical trials at the beginning of the study, during the conduct of the study to update the clinical community about the research progress, and at the end of the investigation to present the results and conclusion.
The importance of public disclosure of clinical trials not only applies to patients but also to other groups, including clinicians and the research community. For example, registering and publishing clinical trials can demonstrate that ethical obligations towards participants and the research community have been fulfilled, and that publication and outcome reporting biases are absent. Moreover, a transparent reporting can promote a more efficient allocation of research funds and help institutional review boards (IRBs) or Ethics Committees (ECs) determine the suitability of a research study.
The registration and posting of clinical trials in public databases is a widespread requirement in international standards such as the ISO 14155, and national and federal regulations such as the FDA and the MDR.
International standard ISO 14155:2020
ISO standard for Good clinical practices (GCP) for the design, conduct, recording and reporting of clinical studies with medical devices (ISO 14155:2020 (Section 5.4)) states that clinical investigations “shall be registered in a publicly accessible database before the start of recruitment activities and the content shall be updated throughout the conduct of the clinical investigation and the results entered at the completion of the clinical investigation.”
In addition to ISO 14155:2020, in the U.S.A, FDA (Food and drug administration) regulates the registration and results submission to clinicaltrials.gov database. All the necessary requirements for result registration results submission are available in Section 801 of the Food and Drug Administration Amendments Act of 2007, called FDAAA801. Moreover, the Final Rule for Clinical Trials and Results Information Submission (42 CFR Part 11) describes and clarifies regulatory requisites and procedures in a more detailed and precise manner.
In Europe, the registration and submission of clinical studies were not covered by any legislation until 2017. Now, this is regulated under the new EU Medical Devices Regulation (MDR) 2017/745. MDR 2017/745 Annex XV (Chapter II) specifically describes the importance of publication of results according to legal requirements and ethical principles.
The registration of clinical studies with medical devices has been made mandatory as reported in MDR 2017/745 Article 73 of the European databank called EUDAMED, which will be used as a system for registration, collaboration, notification, and dissemination.
Due to the COVID-19 pandemic, implementing the European database on medical devices has been delayed. Without a fully function EUDAMED, clinical investigation sponsors can wait for EUDAMED’s available and register the trial retrospectively.
Sponsors can also choose to prospectively register the investigation in existing clinical trial registries such as the World Health Organization’s (WHO) International Clinical Trials Registry Platform (ICTRP), the European Clinical Trial Register, or ClinicalTrials.gov. Although the second option is not mandatory (yet) under MDR, most member states require registration in public clinical trial registries.
ClinicalTrials.gov is a worldwide public web that allows easy access to information related to clinical trials of numerous diseases and conditions.
This clinical study registry and results database is maintained by the National Library of Medicine at the National Institutes of Health (NIH).
ClinicalTrials.gov was launched on February 29, 2000. Since then, it has broadened in terms of scope, features, and targeted audiences in response to the evolving disclosure requirements and laws promoting clinical trials registration. Currently, there are 369,503 studies registered in ClinicalTrials.gov from 50 different States and 219 other countries.
Additionally, in March 2020, ClinicalTrials.gov registered almost 3.5 million visits monthly. This means that it has made significant progress on registration and results reporting becoming in such a way the world’s largest clinical trials database. Specifically, there are 37,591 studies registered for medical devices, taking into account that not all the studies’ results should be submitted, such as observational studies or trials studies completed before 2008.
The transition to modernize ClinicalTrials.gov is an extraordinary chance to create a principal trial-finding site that can strengthen and expand public knowledge of various research areas. Although, the consistency and accuracy of the registry and results database rely on the diligence and integrity of trial sponsors and investigators.
AKRN Scientific Consulting can assist your company with all the clinical trial registration requirements, posting, and publication of clinical trial results compliant with the European regulation and ISO standard.