Why clinical trials improve quality of life in patients is an important question that can’t be overlooked when talking about clinical research. For International Clinical Trials Day, on 20 May, Farmaindustria shared a three-minute video that not only highlighted the value of clinical trials in fighting all sorts of diseases. But also explained the basics on how they are conducted, the requirements and who can participate. Because in Spain alone, roughly 4,000 new clinical trials are authorised each year, involving the sponsoring pharmaceutical company, authorities, researchers, hospital centres and, above all, patients.
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Clinical trials benefits for patients
Clinical trials, which in the vast majority of cases (up to eight out of ten in Spain) are promoted by the pharmaceutical industry, are the final step in research and development (R&D) for new drugs.
“It starts when a promising new compound is identified, in the pre-clinical phase, and culminates 10-12 years later when, if all goes well, the new drug is made available to patients,” explains Farmaindustria.
Over this time, the drug’s safety is tested on a small group of volunteers, healthy individuals and patients (phase 1). Then, its efficacy is determined for a specific condition (phase 2). More subjects are used to confirm the previous results (phase 3), and the new drug’s behaviour is analysed once it is on the market (phase 4). All participants are volunteers and can only join after going through the informed consent process.
Although it all starts in the lab, patients are the reason for this process, as the Farmaindustria video explains. Thanks to clinical trials, patients can get early access to the most innovative treatments, not yet authorised, which for some serious conditions and when other treatments have failed can be the difference between life and death. Plus, patients contribute to scientific and medical knowledge that will help others in the future and get free diagnostic tests and physical examinations.
Towards leadership in clinical trails for cancer research
Spain is no stranger to the driving force of clinical trials. Last year, the Spanish Agency of Medicines and Medical Products (AEMPS) green lit 629 promising laboratory trials from the 800 applications. These are in addition to the over 70 trials that have started in Spain, in two months, focusing on the coronavirus, giving this country the fourth most Covid-19 trials in the world.
In fact, for many companies, Spain is the second favourite country for trials, after the United States.
Beyond the current clinical trials focusing on the coronavirus, there is one research area that is pre-eminent in Spain. The latest data from the BEST Project, promoted by Farmaindustria with 50 pharmaceutical companies.
54 hospital centres, 13 autonomous communities and 6 independent research groups participating, reveals that cancer research is the area with the most studies (50%). This shows the hard work the healthcare sector is putting into curing cancer. It is followed by immunology, haematology, neuroscience, respiratory and cardiovascular diseases.
Oncology is predominant in clinical research
Why clinical trials improve quality of life and healthcare system?
Clinical trials are the backbone of therapeutic innovation and a unique opportunity for patients, as they can benefit from early access to new drugs (highlight).
In addition to the benefits for patients, data shows that conducting studies in hospitals has a very positive effect on the healthcare system. Trials bring in investment in the centres; on professionals, because they can boost their reputation and experience by combining their work caring for patients with research tasks; and on the pharmaceutical industry, because they get to work with healthcare professionals and clinical facilities that help promote their research and drug-development activities.
All in all, clinical research over the past six decades has added nearly 10 years to average life expectancy in the EU. Studies that have helped reduce the mortality rate of HIV/Aids by 80% since the 80s and have made hepatitis C curable in the majority of cases.