Why We Need Clinical Trials for BPH

Why We Need Clinical Trials for BPH

Clinical trials are extremely important scientific studies that are used to assess new medical treatments, including treatments for diseases like benign prostatic hyperplasia (BPH). This article explores the reasons why clinical trials are necessary, what exactly they are, and how men with BPH might benefit from clinical trials for new therapies.

Improved BPH Care and Disease Management

Researchers agree that the vast majority of men will, at some point in their lives, develop some degree of BPH.

According to the NIH’s BPH health guide “Benign Prostatic Hyperplasia: An Overview,” the onset of the condition begins ” . . . at approximately 40 years of age. In fact, the histologic prevalence of BPH, which has been examined in several autopsy studies around the world, is approximately 10% for men in their 30s, 20% for men in their 40s, reaches 50% to 60% for men in their 60s, and is 80% to 90% for men in their 70s and 80s.”

The wide range of therapeutic approaches for BPH, which includes lifestyle changes, alpha-blockers and 5-alpha-reductase inhibitors, were developed by researchers primarily through clinical studies. Every therapeutic used to treat the disease must be rigorously tested in actual BPH patients, and be proven for safety and efficacy before being approved by the U.S. Food and Drug Administration (FDA).

Continued Need for New Treatments

Despite successes in treatment, BPH still remains a pervasive condition that can dramatically impact quality of life for middle-aged and older men. Although current treatments have improved management of BPH and the symptoms associated with it, better treatments are still greatly needed and wanted. Clinical trials are a necessary and required mechanism for testing and approving new therapies, so that they can be available for those who need them – they are essential to advance BPH research and treatment.

Clinical Trials for BPH Explained

What exactly are clinical trials? Clinical trials are well-designed studies that collect information about new treatments for diseases and disorders. Most of the time, the trials are for medications, but clinical trials also test other approaches, such as stem cell therapies, surgical techniques, tests for diagnosis, or medical devices. In particular, clinical trials focus on administering an experimental therapy in humans, as opposed to animals. Animal testing — or the testing on cells in a dish (in vitro) — is conducted first in the lab and is typically referred to as “pre-clinical research,” because it is research that occurs before the clinical trial that involves human patients.

Clinical Trials Are Required for the Approval of New Treatments

Can’t doctors just start using a medication based on a study showing it is effective? The answer – “no.” Clinical trials are necessary for medical treatments to be approved by government regulatory agencies, such as the U.S. Food and Drug Administration (FDA). Without carefully designed and performed clinical trials, doctors, nurse practitioners or physician’s assistants cannot prescribe medications or recommend other medical treatments. Studies must take place in order to understand two important types of information: 1) that the treatment is effective (efficacious) because it works; 2) that the treatment is safe for use in humans.

Clinical Trials Advance Scientific Knowledge, Assure Efficacy & Safety

In addition to helping patients by making the best possible treatments available, clinical trials also advance the scientific understanding of a disease or disorder.

It is important to make sure that a new drug is more effective than existing treatments, that it actually works in a disease, and that it is safe. Decisions to give drugs or other medical treatments to a patient in need must come from scientific data – not from the opinion or hope of a healthcare provider, patient, or other individual.

Despite successes in the treatment of BPH, new treatments – and new studies – are still needed. Clinical trials are necessary mechanisms that advance research, and they are a legally required step for new treatments to become approved for use by physicians and patients.

Be sure to stay tuned to BPH News’ exclusive, ongoing series of articles on clinical trials for BPH. Our next article will explore how BPH clinical trials work, and what you need to know about how they are managed and what they seek to accomplish.

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Mike has a proven background in digital publishing in the biotech and life sciences sphere. He works with Mr. Comish and the rest of the editorial staff to source article topics and ensure that news content is accurate and informative for the reader.

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