We don’t often think about where lifesaving drugs and medical treatments come from; in fact, we don’t tend to think of them at all until we’re beyond the point of needing them. When we’re injured or fall ill enough to be hospitalized, medical professionals spring to—seemingly—automatic action in order to implement a series of tried and true processes which give us the best shot possible at getting better.
Sometimes this involves eliminating possibilities to narrow down treatment options and, sometimes, it involves administering aggressive drugs just in the nick of time to fight off a potentially fatal infection.
Nearly everything that modern doctors and professional medical caregivers do to save our lives when we need them most was once the subject of a clinical trial. Clinical trials are important because they allow for controlled experimentation on willing subjects who could potentially benefit from the medicine or procedure under observation.
While class action attorneys can tell you that participating in clinical trials is sometimes a risky move, they, nonetheless, serve an irreplaceable purpose in a modern medical survey.
How Do Clinical Trials Work?
Clinical trials are regulated studies conducted by hospitals, universities, pharmaceutical companies, and other entities within the medical industry which aim to find new ways to prevent, diagnose, and treat a particular disease or ailment.
Sometimes, clinical trials are conducted to guarantee the safety of a newly developed drug and cast a wide net seeking healthy and sick people in order to study side effects and recognize potential problems before releasing the drug to the general public.
Other times, they’re much more targeted; albuterol inhalers, for example, were developed and eventually approved thanks to clinical trials seeking new methods of administering lifesaving oral steroids to asthmatics.
Clinical trials seek to answer questions by providing a cross-section of sound data derived from willing participants. Maybe there’s already a well-established treatment for a particular disease, but the drugs involved come with prohibitive side effects which dampen the quality of life for the patient; pharmaceutical companies might hold trials on similar but improved medicines which seek to minimize the side effects and create a markedly more desirable and lucrative course of treatment.
Typically, a clinical trial will take place over the course of four phases:
- Phase I studies are usually conducted on a small number of volunteers, usually between six and ten people. Alternatively, these early trials may include patients whose prognosis is particularly grim and lacking treatment options. Subjects are monitored very closely for any adverse or unforeseen effects related to the administration of the drug or treatment.
- Phase II studies take place once the drug or treatment in question has been deemed reasonably safe and helpful in Phase I. Phase II studies are carried out on large groups of up to three hundred participants and are designed to allow professionals to closely observe the impacts of the drug or treatment on a larger sample of the population.
- Phase III studies are conducted on large groups of people—as many as three thousand volunteers—and aim to demonstrate the safety, efficacy, and overall benefit of the treatment in question, often in direct comparison or juxtaposition to a more common or prevalent medical option. Phase III data is what doctors and other practitioners will use to determine howh the new drug or treatment should be prescribed and to whom.
- Phase IV studies are conducted after the new medicine has been approved by regulatory bodies in the United States, such as the FDA, and has been marketed to the general public. Phase IV, or post-marketing surveillance trials, evaluate long-term benefits, effects, costs, and unforeseen issues associated with the new drug or treatment method. Previously unanticipated long-term problems discovered at this stage may lead to costly recalls and involve lawyers that handle pharmaceutical multidistrict litigation and sue the drug manufacturers. The FDA is generally immune from any legal liability to injured consumers.
Saving Lives Through Trial (and, Occasionally, Error)
For a handy modern example of the effectiveness of clinical trials and research, look no further than the statistics surrounding coronary heart disease in the United States. In the space of twenty years, between 1980 and 2000, the number of lives claimed by the disease was fully halved.
While some of this decrease can be attributed to increased awareness in the general public surrounding cholesterol, blood pressure, and smoking, a significant portion can be credited to medical therapies and processes established and validated during the process of clinical trials.
Another great example is the polio vaccine. A trial of over half a million school-aged children led to the approval of the first preventative treatment. Subsequent advancements upon this have since functionally eradicated the disease in the United States. Without the Salk trials and the data gained through careful, studious medical research, it’s impossible to guess what role polio would play in our lives today.
While clinical trials are absolutely necessary, it’s uncommon for doctors to recommend their patients for experimental procedures unless standardized treatments are ruled ineffective. No doctor would send a patient to a trial before establishing that known, tested, and approved courses of action are not helpful in diagnosis or treatment.
In cases of terminal cancer patients, for instance, Phase I clinical trials are often put on the table when a patient’s outlook is poor, based on established results with traditional, approved procedures. If nothing else is working, and time is running out, an early clinical trial offering some element of relief or possibility of recovery is worth the risk in a medical scenario.
Indeed, many patients hear about clinical trials for the first time when they’re suddenly faced with an unexpected, potentially life-threatening illness for which there exists no approved, widely marketed treatment.
As such, clinical trials in the common parlance tend to be viewed as a sort of last resort, an acknowledgment by the patient’s doctors that they are utterly stumped. However, this is not always the case, and experts like Ken Getz, chairman of the Center for Information and Study on Clinical Research Participation, predict that “… it will be more common for clinical trials to be discussed during routine visits with the doctor as electronic health records and clinical research converge.”1
Of course, as with any experimental paradigm, clinical trials sometimes don’t always turn out as predicted or expected. Unfortunately, this is usually in the form of detrimental or potentially life-threatening side effects or complications which afflict volunteers and, occasionally, cause greater damage than the disease or condition being studied for treatment.
Know Your Rights and Weigh the Risks
If you’re considering participating in a clinical trial, you do so facing down the slim but ever-present possibility of negative repercussions; whether this is a bad reaction to a trial medication or an allergic response to a new synthetic application material, there’s always the chance that you could leave the trial worse off than when you went in.
This is why conferring with legal counsel is important; for example, if you’re undergoing an experimental hip replacement procedure, a hip recall attorney can show you stats and case files that might sway you in the other direction or al least inform you of the risks..
Class action attorneys and multidistrict litigation lawyers are attorneys who have experience in medical malpractice and personal injury. These lawyers sometimes are the only one who have the ability to discover the truth as to whether drug and device manufacturers are looking out for patients or are putting their own corporate profits ahead of patient safety.
Our legal system allows these lawyers to subpoena internal documents from these companies and to take sworn testimony from company executives to find out the truth.
Clinical trials are a crucial part of the scientific process of bringing new medicine and broader, more inclusive treatment options to the general public. However, some clinical trials have been found to be manipulated for the financial benefit of the manufacturer.
Some clinical trials are bogus marketing ploys. For example, I was on the Federal court steering committee for the Zicam cold medicine lawsuits and discovered that the advertisements touting that: “clinical studies show that Zicam shortens colds” was based on a fake medical study put together by the Zicam marketing department.
Academic epidemiologists have scientific standards for valid clinical trials. But advertising companies can call anything a clinical trial or clinical study like Zicam did. The class action and multidistrict lawyers in the Zicam litigation hired scientists to analyze the study that Zicam called a clinical trial and concluded that the study did not follow accepted scientific standards. It was just a bogus sales pitch.
Further, drug and device manufacturers can mislead the FDA and the general public by not disclosing the results of clinical trials that do not come out in ways that financial benefit the company. Federal regulations do not require that manufacturers disclose the results of all clinical trials.
If your doctor suggests that a clinical trial might be a good path for you, make sure to seek a second opinion from another medical professional and talk to your lawyer. Saunders & Walker Consumer Justice Attorneys are here to listen to your concerns, provide you with the necessary data and statistics, and show you options you might not know you had.