In 2021, International Clinical Trials Day celebration has a particular significance. The extra effort and work that the entire scientific and healthcare community has undertaken over the last year is unparalleled in the history of mankind, at least in peacetime. For this reason, we would like to take this day to dedicate our most sincere congratulation and admiration to those persons who have been involved in clinical trials conducted to combat COVID-19. Thank you for your dedication and commitment, seeking the common good.
We would like to focus on Research Ethics Committees, whose work, guarantee of good practice, is essential in the conduction of any clinical trial. In this interview, the Management Board of Spanish National Association of Research Ethics Committees explains how they have experienced this year of pandemic, analyse legislative novelties and make comments on the challenges they face with the digitization of clinical trials, as well as stating their vision on the work of CROs.
Happy International Clinical Trials Day!
Nowadays we cannot imagine clinical research without the participation of Ethics Committees. What is IEC’s fundamental work? Why are they a key player in clinical research?
Investigation Ethics Committees (IEC) play a fundamental role in the conduction of any research project, by endorsing the proper implementation of methodological, ethical and legal principles, as set forth by the different ethical guidelines and applicable regulations. Based on this premise, the approval by an IEC guarantees the protection of rights, safety and well-being of those participating in a biomedical research project.
The pandemic has directly impacted all areas of life, but IEC’s have had a direct impact. What has changed in your way of working with the arrival of Covid19?
The outbreak of the COVID-19 pandemic entailed a real social and healthcare challenge. Clinical research has played a fundamental role in the understanding of this disease. In order to facilitate its implementation, adaptation and coordination have been necessary by the different parties involved.
IEC’s activity has been characterized by flexibility and simplification of requirements, shortening the assessment deadlines, but maintaining the rigor in the Project review.
The healthcare burden, from many of the Committee members with clinical responsibilities, resulted in the elimination of the need of quorum to consider decisions valid. During the pandemic, IECs had to adapt their operation, due to the significant increase in the number of studies derived from this pandemic and the need to give priority to those related to COVID-19. Among the changes implemented we can highlight:
- Adaptation of procedures related to obtaining the informed consent, the personal data protection and the processing of biological samples.
- Increase in the meeting frequency (from monthly to biweekly, even weekly at critical pandemic times), to respond within 24-72 hours to the studies submitted for assessment.
- Holding meetings telematically, dispensing with face-to-face meetings.
- Prioritization of the assessment activity over the Committee’s follow-up activity.
On the other hand, Committees’ advice to investigators in methodological, ethical and legal aspects has been much more relevant and frequent, mainly due to the urgency required in the projects start-up.
It is true that many of the measures implemented in times of pandemic have come to stay; for instance, integrating the use of technology in the meetings of the committees or the telematic access to computing platforms.
We know there are new regulations coming up, such as the new Royal Decree which regulates observational studies with medicinal products, the Regulation EU 2017/745 on medical devices, which will come into force this year, and the Regulation EU 2014/536 on clinical trials. Will these new regulations bring many changes to IECs? Which are the most relevant ones?
The new royal decree on observational studies simplifies to a large extent the administrative procedures for this type of studies, by means of a single opinion by an IEC. It requires a single decision on the suitability and quality of the protocol throughout Spain, regardless of the subsequent assessment of feasibility and relevance of its conduction in the participating sites.
For its part, the entry into force of the Regulation EU 2014/536 on clinical trials is going to imply a very significant workload to IECs, due to both the management of the application, which will have to be enabled, and to the shortening of deadlines to issue a single European opinion. In this regard, it will be necessary to adequately provide the technical secretariats of committees with human and material resources in order to reply quickly and efficiently to the requirements of this regulation.
Finally, the Regulation on medical devices will reinforce clinical assessment, including a series of ethical considerations in line with those reflected in the legislation on clinical trials with medicinal products. It is noteworthy the coordinated assessment procedure, which will initially be voluntary, but will become compulsory as of the 26th of May 2027.
What challenges do IECs have to face with the digitization of clinical trials? What impact do you see on patients?
Society’s digital transformation is already a reality, both at a social and economic level. In this regard, digitization greatly facilitates the management of documentation by committees, especially with regard to its processing, assessment and filing. Furthermore, it can lead to a more exhaustive follow-up of the conditions in which studies are conducted, which is a committee’s primary function.
It may be expected that digitization will facilitate aspects such as patient recruitment, obtaining informed consents and the follow-up of the conditions in which clinical trials are conducted.
Undoubtedly, technology has enabled to establish better communication channels between patients and healthcare professionals. Access to the electronic medical record by patients facilitates information awareness and the generation of indicators with greater impact on the safety of patients.
However, it is essential to guarantee citizens’ digital rights; thus, it is noteworthy the compliance with Organic Law 3/2018, of 5 December 2018, on Personal Data Protection and Guarantee of Digital Rights, which ensures them. Hence, among other issues, it establishes that users have the right to safety of communications transmitted and received on the Internet.
In addition, it is also important to take into account the Addendum (amendment) E6 (R2) of the ICH, which ensures the protection of the rights of participants, considering the potential risks of technology in the clinical trials start-up.
CRO (contract research organizations), like SermesCRO, have been a common player within the clinical research scene for a long time now. What do you think the participation in a clinical trial of a CRO like ours can contribute?
CROs play a preponderant role in the compliance of good clinical research practice standards. They perform an important function in a clinical trial start-up and in the proper monitoring of its conditions for conducting, in order to verify that the rights, safety and well-being of participating subjects are protected, that notified data are reliable and robust, and that the clinical trial is conducted in compliance with all requirements legally established.
The Management Board of ANCEI is composed of:
- Icíar Alfonso Farnós, Chairwoman
- Marina Soro, Vice chairwoman
- María González Hinjos, Secretary
- Olga Díaz de Rada Pardo, Treasurer
- Rosa Conde, Member
- Milagros Alonso, Member
- María C. de la Cruz, Member