The effective participation of patients, essential for the success of clinical trials
Source: Farmaindustria.es
Representatives of the Spanish Agency of Medicines and Health Products, research teams, pharmaceutical industry and patient organizations agree on the opportunity and need to encourage greater participation of these in clinical research. This was stated in the meeting entitled The patient in the DNA of clinical trials, with which the Platform of Organizations of Patients (POP) opened on February 7 the forum Breakfast POP, a meeting and analysis space that was born with the goal to discuss issues that promote the effective participation of patients in the health and social field.
The meeting was attended by the head of the Department of Medicinal Products for Human Use of the Spanish Agency of Medicines and Health Products (AEMPS), César Hernández; the director of Communication of Farmaindustria, Francisco J. Fernández; the representative of the European Academy of Patients (EUPATI), Roberto Saldaña, and the researcher of the University Hospital of La Princesa, of Madrid, Ignacio de los Santos. On the part of the POP, its president, Carina Escobar, participated. The debate was moderated by the general director of the Servimedia news agency, José Manuel González Huesa.
Communication barrier
The president of the POP called for greater participation of patients in clinical trials. “In most cases, patients remain a passive subject. Despite the fundamental nature of their participation, they are not usually counted on in the design of the trial, and neither the protocols nor the information prepared is adapted to their needs. It continues to use a very technical language that represents an important barrier of knowledge and information for patients. ”
In this the Director of Communication of Farmaindustria abounded: “The participation of the patient is fundamental for us. They should be more involved, more protagonists in this process. Your contribution is very valuable because it allows us to evolve and know, among other issues, what your priorities are. ”
Another topic in which all the professionals gathered was the importance of encouraging dialogue between the patient and the reference professional at the moment in which they are informed about the possibility of being part of a clinical trial, a dialogue that gathers and resolve the doubts and uncertainties that may arise.
Needs and improvements
As Roberto Saldaña from EUPATI pointed out, “the process of the clinical trial is long, but the involvement of the patient throughout the development is fundamental. They should know what the needs are, move them and put them on the table so we can achieve an improvement. ” And that way of being present does not end in the first stages. According to Saldaña, “during the entire intermediate process, the patient can talk about safety, what worries him, the inclusion and exclusion criteria, and can also bring a lot of value in the presentation of the results and in the promotion of the clinical trial. ”
For the head of the Department of Medicines for Human Use of the AEMPS, César Hernández, this collaboration between professionals and patients is much more effective if it is a specific disease. “Specific patients participate much more in the evolution of the results,” he said. In that doctor-patient relationship, researcher Ignacio de los Santos insisted: “In the research in hospitals, the daily attention we dedicate to patients is fundamental. Thanks to there are patients there we are. When we have clinical trials under way, it is usual for us to publicize them inside the hospital itself or to talk to the patient when he comes to consultation. ”
Information and training
The role of patient entities for the correct dissemination of the importance of clinical trials was another of the main conclusions of the meeting. As pointed out by Carina Escobar, “the entities of patients have the duty to be trained in this area, in order to participate in the best possible way and articulate this knowledge so that it reaches patients”. He stressed that the Spanish Registry of Clinical Studies (Reec) is a very useful tool that is available to all citizens.
The meeting was closed highlighting the role of Spain in the field of clinical trials, with “very well prepared professionals and increasingly active patients, a pharmaceutical industry involved and a solid and fairly homogeneous health system”. In this sense, the director of Communication of Farmaindustria recalled that “Spain is already the second country best positioned in clinical trials for many large multinationals, behind the United States. The research is collaborative, multicentric and international. There is a big competition between different countries of the world. Something good we will have to be so well positioned. Spain should not miss this train. ”
From Distefar we thank those patients who participate in clinical trials, because thanks to them, we can continue to evolve.
