The Swissmedic position paper on DCTs second version was published on 15th December 2022. The Swiss Agency prepared it for Therapeutic Products (Swissmedic). In this blog, we will discuss some of the most critical aspects of this document.
What is a decentralized clinical trial?
A decentralized clinical trial (DCT) is a research study in which patients are studied at multiple sites rather than just one through some digital connection. This means there are no direct connections between these sites, but they rely on various communication mechanisms to ensure that data sets are shared. It also allows for more flexibility regarding how trials can be organized, as well as their duration and location.
Why are DCTs important?
The main reason doctors would choose to perform DCTs over traditional methods such as surveys or questionnaires lies because it provides them with more accurate information about their patients’ health status compared with conventional methods, which require face-to-face interactions with doctors who might not always be aware of all relevant details about each patient’s situation (e.g., whether someone has been diagnosed with cancer) since most people prefer talking directly about sensitive topics like this over other mediums, such as e-mailing or any digital means.
Objectives of the position paper
This position paper provides a basic overview of decentralized clinical trials, the legal framework for decentralized clinical trials in Switzerland, and an overview of the ethical aspects related to the regional implementation of decentralized clinical trials with medicinal products. The purpose of this position paper is not to provide legal advice, but to provide information on how competent authorities can address these topics.
Legal framework for decentralized clinical trials.
In decentralized clinical trials, Swiss medic has issued a position paper on this topic. This document focuses on the legal framework for decentralized clinical trials with medicinal products in Switzerland.
Swiss medic is the Swiss authority for the authorization and supervision of medicinal products (e.g., regulations on manufacturing, testing, and marketing). The position paper summarizes current rules related to DCTs and other innovative methods used by pharmaceutical companies, such as pharmacovigilance or bioequivalence studies, and their impact on these types of projects.
As presented in this position paper, the central aspect of decentralized clinical trials with medicinal products is the use of DCTs. Besides their direct effect on patient care and health, DCTs have a far-reaching impact on how we conduct clinical research and develop new medicines. They can also be essential for improving transparency and accountability within drug development processes at all levels (from preclinical research through regulatory submission).
This paper describes how such an approach could work in Switzerland, where there are currently no national regulations concerning decentralized clinical trials (DCTs).
Regulatory aspects regarding the regional implementation of decentralized clinical trials with medicinal products.
The regulatory framework for clinical trials with medicinal products mainly focuses on cGMPs, a generic set of quality requirements that apply to all clinical research. In Switzerland, the Swiss Federal Act on Human Research Act has been implemented as a national legal framework regulating centralized and decentralized clinical trials. Other countries have adopted different approaches regarding decentralized clinical trials with medicinal products. In some countries; centralized protocols are still used. In contrast, other countries, such as the US and some in Europe, have moved towards the decentralization of DCTs by creating independent national regulations.
The primary aim behind creating these position papers was to ensure that patients are treated equally regardless of their country of residence; however, there are also some concerns regarding possible inconsistencies between national laws and regulations within Europe because of differences in interpretation among member states regarding whether specific activities make up “medical products” within EU law.
Ethical aspects regarding the regional implementation of decentralized clinical trials with medicinal products.
In Switzerland, all clinical trials must be carried out following the Swiss Federal Law on Clinical Trials (The Clinical Trials Ordinance – ClinO). All ethics committees must be consulted before starting any research project. In addition, the ethical review should take place at least once after conducting each stage of a trial and before finalizing results.
As part of their role as an independent third party, ethics committees have also been given additional responsibilities under this law: they are now responsible for monitoring whether doctors and nurses involved in DCTs adhere to these regulations; they may also force them to make changes if necessary.
Additional aspects related to regional decentralized clinical trials which may require further consideration in the future.
Regional implementation of decentralized clinical trials with medicinal products may affect the availability of medicinal products. In this context, it is essential to consider whether any new regulatory requirements would apply in each region. For example, suppose a product has been granted marketing authorization for sale within an area. In that case, some countries may require further data from clinical trials before approving its use in the national market. Similarly, suppose a country only allows importation under specific circumstances (e.g., research purposes). In that case, imports from other countries could become more difficult after regional implementation of DCTs with medicinal products takes place.
The Swiss medic paper on DCTs
It discusses the current legal and ethical framework for such practices and some practical considerations that may affect your organization’s decision-making process. Read the position paper in detail by following the link.
Swiss medic’s position paper on DCTs with medicinal products is a good starting point for further discussion and debate. It contains valuable information on the legal framework in Switzerland, as well as the regulatory aspects of decentralized clinical trials. Let us know if we can help you with clinical studies.