In 2011, we cannot imagine that the coronavirus in just ten years will change our lives.No medicines Pfizer.But that year, this American company did Novel article Ten years later, its implementation promoted covid-19.
This study is the first to allow volunteers to participate in the home. They registered via the Internet, sent test drugs to their homes, and filled out online questionnaires and diaries about their evolution. This epidemic has occurred just like in other fields such as work or education. It is a form of remote investigation that helps to consolidate this epidemic.
Clinical trials require participants to visit hospitals, companies, universities, and research centers multiple times.The pandemic forced the system to be modified
Usually, clinical trials conducted by hospitals, companies, universities, and research centers require participants to visit their facilities. Due to the high risk of SARS-CoV-2 infection, these exercises are not safe. This is why the “system must be reinvented”. Vaccine Research Area Head of the FISABIO Foundation in Valencia. Experts say that digitizing the process “can prevent healthy people from being exposed to the virus and ensure that those who must be quarantined remain in quarantine.”
Remote monitoring in a pandemic
Distributed experiments can be very convenient in situations where citizens have limited mobility and where it is necessary to reduce human-to-human interaction for public health reasons.Last year, the European Medicines Agency (European Medicines Agency) issued a series of Guidelines for drug development during a pandemic And its remote monitoring.
Perez commented: “In view of the necessity and urgency of research on the prevention and treatment of covid-19, many trials have adopted remote procedures, such as follow-up calls.” In addition, it emphasized: “Spanish medicines and health Product Administration [AEMPS] Remote authorization data monitoring, This is something that could not be done before”.
“In view of the necessity and urgency of research on the prevention and treatment of covid-19, the Spanish Agency for Medicines and Health Products authorized remote monitoring of data, which was not possible before.”
Lina Perez (FISABIO)
Lina Pérez manages European projects with scientists Vallivana Rodrigo and Jaime Fons Try @家 In FISABIO. This initiative involves the participation of 32 institutions in Europe and the United Kingdom. It aims to design and initiate a pan-European pilot study to test the feasibility of decentralized trials and compare them with conventional trials.
Rodrigo told SINC that at the Valencia Center, they decided to study its application in diabetes because of its high incidence and “patients have a certain degree of autonomy in disease monitoring and treatment.” This study includes three modes: one is traditional, one is fully remote, and the other is hybrid. All participants will receive the same medication because the goal is to evaluate the method, not the effect of the medication.
“Trials @ Home” attempts to design and initiate a pan-European pilot study to test the feasibility of decentralized trials and compare them with conventional trials
Volunteers will have to fill out an online questionnaire to see if they meet the requirements. In this case, as part of the informed consent, the researcher will explain the research procedure and the method of access to them in a virtual way. For example, “healthcare professionals may come to your home for medication or blood draws,” Fons explained. Health status updates will be sent via electronic devices.
Remote rehearsals can increase your accessibility and coverage, and can prevent obstacles from distance or visiting schedules. Rodrigo said that one of the areas that may be particularly useful is rare diseases or other areas with low incidence, because “potential participants are geographically dispersed.”
He told SINC: “What we usually do is to invite sick patients to the research center to participate in the terms set by the research leader.” Ray DorsayIs the director of the Center for Health and Technology at the University of Rochester and wrote about Telemedicine with Decentralized clinical trials.
Scientists believe that this should be the opposite: the trial should be centered around the patient’s preferences. For them, making video calls at home is more comfortable than visiting company facilities, hospitals, research centers or universities from time to time. For the latter, this method can save money and speed up the recruitment process.
We usually ask sick patients to go to the research center to participate in the research, but this must be another way
Ray Dorsay, Director of the Center for Health and Technology, University of Rochester
the study Parkinson and zoledronic acid test The purpose of (TOPAZ) is to test the efficacy of zoledronic acid, which is used to treat osteoporosis, in preventing fractures in patients with neurodegenerative Parkinson’s disease. With the help of telemedicine, volunteers (over 65 years old) will participate at home. According to Dorsey, so far, of the 3,500 target participants, 300 have been registered, which has been “a good sample size for clinical trials of drugs.”
American researchers said: “Mobile phones, sensors and other devices are increasingly used.” Technology makes it possible to monitor and track participants from a distance. And it is foreseeable that new tools will be developed to collect more information. However, despite many things, surveillance cannot be as exhaustive as face-to-face interviews. “Researchers will have to give up control, or at least they will have to get used to relying more on volunteers,” Dorsey said.
Surveillance in “online” trials cannot be as detailed as in face-to-face interviews: “Researchers will have to give up control, or at least trust volunteers more”
In addition, they will have to face the digital divide among participants. Although this may seem incredible, many people may not have smartphones, computers or other devices. Although decentralized testing is a possible advantage, it is not always a feasible or appropriate solution.
For example, if the study included surgery or intravenous administration, this approach would not be available. Or at least not at all stages of the research. However, it may be useful for some of it, such as volunteer recruitment or long-term follow-up, which in many cases will last for several years.
Regulatory and technical barriers
FISABIO scientists admit: “The most important thing is that we have encountered regulatory barriers.” They pointed out that although most investigations have been partially investigated by telephone or the Internet, “the law is not yet in place, and a completely decentralized trial is not considered. In addition, the laws of EU countries are different, and they still don’t know how Brexit will affect the “Trials @ Home” project.
The two main obstacles to these virtual trials are the electronic signature of informed consent and the digital divide in the health system
One of the main obstacles they encountered was the General Data Protection Regulation and European and national standards for clinical trials of drugs. They explained: “As part of the experiment, participants must sign a paper consent form.”
FISABIO researchers also mentioned the digital divide in the healthcare system. The pandemic not only highlights the importance of telemedicine, but also highlights the shortcomings in this field. Experts say that although the technology has been widely used, “due to the lack of infrastructure and personnel and their training, some medical centers and hospitals are not ready to implement a fully decentralized system.”
El “Real World Data”
Facts have proved that the use of evidence from the real world (in English as real-world data), that is, information obtained outside the controlled environment of the laboratory, is becoming more and more valuable in research.In the most recent example, Pfizer The effectiveness of the vaccine has been evaluated Using data from Israel’s largest health agency on infections, symptoms, hospitalizations, serious illnesses, and deaths, a targeted investigation of COVID-19 among 1.2 million people was conducted.
SINC Ricard Martínez, Chair of Privacy and Digital Transformation at the University of Valencia, explained: “The problem with clinical trials has always been that the type of population is restricted to very specific populations, and the results are biased.” By monitoring participants’ daily lives, we can eliminate these biases and consider a more diverse set of individuals.
In the upcoming project, Martínez will study the possible link between energy poverty and health. They will not only use data from medical records, but also data provided by sensors that measure variables such as temperature or smart meters.
Other types of research can also analyze information about geographic location or images or sounds of the home environment. Therefore, “it is necessary to ensure not only the right to data protection, but also the right to privacy, personal image and the inviolability of the house,” Martinez said.
The person in charge of the “family trial” emphasized the importance of advancing from two aspects to ensure the success of this type of decentralized experiment. On the one hand, when developing the platform, it is allowed to encrypt information to ensure its privacy. On the other hand, health professionals and researchers are being trained in digital skills and data protection.
These experts predict that although there are still obstacles, this type of experiment is the future, and it will be consolidated due to the experience, technological progress and exchanges we will see in the coming years.