The effect of therapy on asthma and COPD patients: from randomized trials to clinical practice.
Asthma and chronic pulmonary disease (COPD) are among the top 10 conditions negatively affecting general health and daily activities. The ability to transfer evidence from randomized trials to clinical practice remarkably still remains an obstacle i nachieving healthcare quality.
This year’s Respiratory Day gives an overview on the latest research strenghts nd weaknesses, with the objective of better appreciating their relevance to clinical practice.
Italy, Parma 28th May 2010 – The 6th annual “Respiration Day” is held in Parma in the magnificent Auditorium Paganini designed by Renzo Piano.
This is a highly renowned international scientific event which involves pulmonologists from all over the world to share the latest up to date information on chronic respiratory disease management, particularly in asthma and COPD.
“Respiration Day” was born in 2005 following collaboration between “University of Parma” and “Chiesi Foundation”.During the past five annual events many topics have been discussed, among them are the new asthma and COPD diagnosis and treatment guidelines, the approach to manage complex clinical situations due to co-morbidities and what clinical parameters are better related to treatment efficacy or to disease progression and are more relevant for an early and accurate diagnosis.This year “Respiration Day” is focused on randomized trials and on their relevance to true-life clinical practice.
Randomized trials are a central tool for the evaluation of efficacy and safety of drugs. Their introduction in 1975 was key evaluation criteria for the regulatory authorities in assessing markeet authorization for new drugs and has become a milestone in guaranteein objective judgements.
Randomized controlled clinical trials study the effects of a treatment in a group of patients compared with a group of people that do not receive the treatment or receive a “control” treatment.
Randomization guarantees that the two groups of patients are as similar as possible.
Unfortunately, altought this type of study represents the optimal modality on how to evaluate a medical product, important limitations exist in transferring the evidence produced to clinical practice.
For example, in order to ensure homogeneity in the sample, patients involved in clinical studies are selected according to strict criteria which are often difficult to apply to the general patient population.
In reality, the type of patient who usually visit the physician would not be eligible to enter a randomized controlled clinical study. Furthermore, the use of treatments during the study tends to reflect the best case scenario.
For example, a patient who takes a treatment incorrectly is excluded from the trial. Whereas, in real life the use of drugs in asthma and COPD can be rather problematic and patients’ lack of adherence to therapy can compromise efficacy.
This cannot be observed in controlled trials. One of the points of view that will be discussed during the international congress is about how to randomized trials can be complemented by real-life studies, i.e. observational studies where the clinical history of the patients and therapy administration resemble everyday experience.
Another highly debated point is related to the clinical studies evaluation parameters, the so called endpoints. The parameters most frequently used by regulatory authorities are certainly objective, reliable and reproducible, but are not necessarily the best choice regarding their ability to represent the patient real condition, their sufferance, and the disease evolution perceived by the patient.
During this day, an assessment on the parameters important to patients, also called patient reported outcomes (PRO), will be discussed.
Unfortunately, consensus among the scientific community regarding these parameters has not been reached yet.
Furthermore, these parameters are perceived differently by regulatory authorities, clinical researchers, prescribers and the patients. Therefore, Respiration Day represents an important opportunity to critically revise these parameters and propose round table discussions involving patient associations, physicians, pharmaceutical companies and regulatory authorities to facilitate innovation and the identification of more accurate and sensitive parameters.
2010 has been declared “Year of the Lung” by the Forum of International Societies (FIRS). This initiative is based on the consideration that lung health has been until now, only marginally considered by public opinion and is not actively present in the political and social agenda, dspite the fact that every year millions of people suffer and die from respiratory diseases.
Respiratory Day aims to be a further contribution to increase general public attention on the importance of chronic respiratory diseases and the need for prevention programs and care on a vast scale.
The Chiesi Foundation is a non profit organisation that aims at improving and spreading biomedical knowledge in pneumology, neonatology and rare diseases, in order to improve patients’ quality of life.
