The pandemic has paved the way to consolidate decentralized health research, allowing people to participate in research at home, and researchers can use technology to communicate with volunteers.
In 2011, we can’t imagine ten years later coronavirus It 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 Participate at home.They registered via the Internet, sent test drugs to their homes and filled out questionnaires online And a diary about its development. 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.
Generally speaking, Clinical Trials Products produced 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 modified”, he told SINC. Lina Perez, Who is Vaccine Research Area From FISABIO Foundation, Located 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
This Dispersion test It can be very convenient in the following situations Can not move Citizenship, and the need to reduce 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 included remote procedures (such as follow-up calls).” In addition, it also emphasized: “Spanish medicines And Health Products 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.”
With the scientists Vallivana Rodrigo ÿ Jaime Fons, Lina Pérez manages European projects Try @家 In FISABIO.32 institutions from Europe and the United Kingdom participated in the plan to design and implement a Experimental Research Pan-European tests the feasibility of decentralized tests and compares them with conventional tests.
They decided to study its application in Valencia at the Valencia Center. diabetes Because of its high incidence and “patients have A certain degree of autonomy Regarding disease monitoring and treatment”, Rodrigo instructed SINC. The study includes three modes: one is traditional, one is completely remote, and the other is hybrid. All participants will receive the same drugs, Because the goal is to evaluate the method and not the effect of the drug.
Volunteers will have to fill out a questionnaire online Check 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 passed Electronic equipment.
Remote testing can increase your Accessibility ÿ range And they avoid obstacles in distance or visiting schedule. 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.They receive a more convenient Video call At home, you must go to the facilities of a company, hospital, research center or university from time to time.For the latter, the method may involve Economic savings And a faster recruitment process.
We usually ask sick patients to go to the research center to participate in the research, but this must be another way
the study Parkinson and zoledronic acid test The purpose of (TOPAZ) is to test the effectiveness of zoledronic acid used to treat osteoporosis in preventing fractures in patients with osteoporosis Neurodegenerative Parkinson’s Disease.Volunteers (over 65) will participate at home Telemedicine. 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.”
“This Cell phone, sensor The American researcher said.Technology makes everything Monitoring and follow-up Remote participants. And it is foreseeable that new tools will be developed to collect more information. However, despite any other measures, 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.
In addition, the problems they will have to face Number division 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.
If the study includes Surgical intervention Or by route vein, For example, this method will 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
“Most importantly, we met Regulatory barriersA scientist who recognizes FISABIO. They pointed out that although most of the investigations have been partially investigated by telephone or the Internet, “the law is not yet ready and a completely decentralized trial is not considered.” In addition, the laws of EU countries are different, and they still do not Know how Brexit will affect the “Trials @ Home” project.
One of the main obstacles they encountered was Electronic signature The General Data Protection Regulation and European and national standards for clinical trials of drugs. “Participants must sign a consent document on the paper They explained.
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 despite the widespread use of technology, “due to the lack of infrastructure and personnel and their training, some medical centers and hospitals are not yet ready to implement a fully decentralized system.”
El “Real World Data”
Use real-world evidence Real world data), the information obtained Outside the laboratory control environmentProved to be 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.
“Historically, one thing that has been questioned about clinical trials is that through restrictions A very specific population of the population, The results are biased”, he explained to SINC Ricard MartinezHead of the Department of Privacy and Digital Transformation at the University of Valencia. 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, “not only to ensure the right to data protection, but also to ensure the right to data protection, this is the key. privacy, to Own image however Inviolability Martinez pointed out.
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, in Platform development Allow encryption of information to ensure its security privacy.On the other hand, in training professional Researchers in health as well as researchers in digital skills and data protection.
These experts predict that even though there are still obstacles, This kind of dress rehearsal is the future This will be consolidated thanks to experience and technological advancements and what we will see in the newsletter in the coming years.