Clinical Trial: Alternative to Health Care?

Is it prudent for those without health insurance to seek care in clinical trials for dire conditions?

RESEARCH Clinical trials are generally considered to be biomedical or health-related research studies in human beings that follow a predefined protocol. [1] Without such clinical studies, many of the helpful therapies on the market today would not be available and many of the harmful ones would be absent of suffient warnings. [2]

Before joining a clinical trial, a participant have to qualify for the study. By law, participants must be informed of all of the known benefits and risks of the new treatment. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It may be necessary to have been previous diagnosed with a particular condition or evaluations might be performed by clinical investigators. Many people who take part in studies believe that doing so will benefit themselves and others now or in the future. [3]

Different Types of Clinical Trials

  • Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
  • Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.
  • Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
  • Screening trials test the best way to detect certain diseases or health conditions.
  • Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.

Not all drugs in clinical trials are experimental. Some trials use drugs that have been already approved and are on the market. The reason for these trials could be to use the drug for another condition, or to test a new dose of the medication. Some trials compare approved drugs to see which is better. [3] Before human trials are performed several iterations of trials are required, including in vitro and animal testing.

When Seriously Ill Patients Need Care

Some patients find themselves between the proverbial 'rock and a hard place.' Having a grave illness without adequate insurance or financial resources, one may contemplate enrolling in a clinical trial. Action or inaction, under such circumstances, can have dire consequences.

A potential participant must fully understand the risks of the specific study. If a patient definitely requires medical attention, is there a chance that a placebo will be received or is it a study that compares already FDA approved drugs? In a double-blind clinical trial, neither the investigator nor the patient is allowed to know which of multiple treatment therapies is being administered. Is there a clinic or non-profit organization that can provide less ambiguous treatment?

All clinical trials have risks. For that matter, FDA approved drugs also list possible complications (as reported during clinical trials). Risks can sometimes be minimized by the type of clinical trial in which one enrolls. For example, a topically applied ointment for sun protection or eczema may have the potential for doing nothing, exacerbating a rash, or improving the condition; it's less likely to be fatal or cause secondary illness. Psychopharmacological research tests drugs that can effect moods and behavior, which can affect one's ability to concentrate, operate machinery or function well at work. Some drugs are not suitable for women planning to have or who are nursing children. An experimental drug for cancer could represent a medical breakthrough or delay established treatment methods.

Patients with terminal illnesses might consider clinical trials after exhausting available FDA approved treatments. Usually, at this stage, however, the disease may have advanced to the point where limited effectiveness can be demonstrated with the trial. Ultimately, no one can make the decision to participate for another individual. An informed consent form must be signed. When the benefits outweigh the risks, one may choose to enroll in order to benefit themselves or others.

The ClinicalPosters Twitter account features daily updates on dermatological clinical trials in the recruiting stage and completed trials that hold promise to various patients. Currently, the primary focus is on skin burns, eczema and skin cancer. More exhaustive clinical trial results are available on the website, clinicalstudyresults.org.

Tags: chronic pain, diagnosis, healthcare, medicine, serious illness, sickness

References
  1. Understanding Clinical Trials. clinicaltrials.gov
  2. Drug Side Effects drugs.com
  3. Why Should I Participate in Clinical Research? pdtrials.org
  4. Should I Join a Clinical Trial? thebody.com