An untreatable illness finally finds its therapeutic match; an approved drug at last gets a competing equal with less side effects and a patient, who could temporarily not afford treatment, can have peace. These are the continuous victories provided by clinical research trials. Clinical Trials not only involve the administration of new investigational therapies, but also seek medical advancements and contribute to diversity and creativity in the field of medicine. It could be argued that Clinical Trials stimulate a competitive field for pharmaceutical innovation and create a platform for equal opportunity in accessing top therapeutic advancements for a wide range of patients. Consequently, embracing Clinical Research promotes a non-stagnant, safe, and ever evolving environment within the medical field.
Historically, Clinical Research has been used in the development of new investigational products in a wide number of diseases. Each study design responds to a different necessity and addresses a different population. In some cases, said population is not covered by insurance and would have no access to treatment otherwise, essentially turning a treatable disease into a detrimental factor in all aspects of a patient’s life. The key to a therapeutic strategy integrated in a Clinical Research setting lies in identifying how a given study design, that is specific in nature, can be incorporated into a patient’s routine.
In Clinical Trials, patients become committed to the advances in medicine as much as they become committed to their own health. Most studies require patients to follow a planned schedule of activities, which serves both to reduce uncertainty in patients and to improve the accuracy of collected data. Additionally, in Clinical Research patients are encouraged to be curious and aware of their condition’s progression or the course of their illness. Since monitoring adverse events is fundamental in Clinical Research, subjects often become aware of undesirable changes if their condition aggravates. Becoming aware of their own symptoms soon transforms into a habit for patients participating in a Clinical Trial, which translates into a long-term benefit that often extends in time further than trial participation.
A priority of Clinical Research is the generation of novel treatments and the improvement of existing ones. As the medical field evolves, there is a better understanding of patient’s individual response to therapies frequently associated with distinct needs in patients affected by the same condition. Whether it is due to an individual reaction or a genetic predisposition, in some cases approved and available medication cannot be used to treat a specific illness. Then, Clinical Trials provide data to support and encourage exploration of new methods with potentially fewer side effects, or the enhancement of current therapies.
Sometimes, approved therapies are not available or are a few months away from being available. For some patients this can make all the difference, especially when they are dealing with a severe or chronic illness. In some cases, it is in the best interest of the patient to have early access to a certain therapy before it gets authorized for marketing. Moreover, some therapies do not become commercially available immediately after being market authorized.
Clinical research not only presents an opportunity for patients to access these therapies but also allows them to actively engage in the improvement of medicine that will benefit other patients in a non-distant future. Studies that are allowed and make novel not-authorized products available for patients with serious, rapid progressing or life-threatening diseases often demonstrate how Clinical Research is done with compassion. During such studies, patients benefit not only from free-of-charge medicinal products but also from continued care within and beyond the Clinical Trial duration.
There are currently thousands of Clinical Trials in the United States. As more potential subjects for Clinical Trial participation are identified, new challenges in Research arise and new ways to cope and overcome such challenges are constantly evolving. New developments in Clinical Research include new ways of monitoring potential adverse events and combining these new developments with high-quality care to enhance clinical outcomes.
Clinical Research studies are gaining momentum to become an important option for patients with conditions that have no available treatment, or those whose standard of care treatment has been unsuccessful in treating their illness. Over the past years, new knowledge about Clinical Trials and their positive impact on patients has thrived. Clinical staff alongside clinicians are hopeful that Clinical Research will play a key role in the future of available treatment development and continuing care.
By Kamoly Dorneles and Maria Torrez
Clinical Research Coordinators