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Getting involved in clinical trials

After years of being excluded from virtually all clinical trials, today nearly 20 percent of participants are over the age of 65 and more than half of the drugs now being evaluated are aimed at treating conditions associated with aging. Consumer attorney and “Today” contributor Alan Kopit offers a look at the risks and benefits of participating.
/ Source: TODAY

After years of being excluded from virtually all clinical trials, older Americans are finally finding their way into these trials. Nearly 20 percent of participants are over the age of 65 and more than half of the drugs now being evaluated in clinical trials are aimed at treating conditions associated with aging.

The National Institutes of Health, along with the non-profit Friends of Cancer Research and five drug makers, recently announced that nearly $6 million in grants to six institutions across the country will be earmarked for studies that include the elderly in clinical trials. And with good reason — a recent study conducted at Duke University found that older people tend to be more willing than younger people to participate in clinical trials because they have fewer time constraints and a greater desire to help the next generation by advancing medical research.

Joining a clinical trial could give you access to advanced treatments not generally available to the public, but before you volunteer it's important to understand the risks.

WHAT IS A CLINICAL TRIAL?

A clinical trial is a research study using human volunteers to answer specific health questions. Clinical trials are one of the final stages of what can be a long and detailed research process to develop new drugs, treatments or procedures to help people live longer, healthier lives. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people to improve health.

Clinical trials test new types of medical care, like how well a new cancer drug might work. They may also be used to compare different treatments for the same condition to see which treatment is better, or to test new uses for treatments already in use. That is why it is important to include the elderly in clinical research.

The only way researchers know whether particular medications, drugs or treatments are useful in this age group is by testing it on that age group since the body may respond differently depending on age. Interestingly, although medical researchers have long pointed to age-related differences in how drugs are absorbed, metabolized and excreted, it wasn’t until 1989 that the FDA published guidelines for including older patients in clinical trials. Today, according to the FDA about 15 to 20 percent of the participants in drug trials are over age 65.

CLINICAL TRIALS ARE CAREFULLY DEVELOPED

All trials are based on a set of rules called a “protocol,” which is a research and study plan. The plan is carefully designed to safeguard the health of the participants as well as to answer specific research questions. A protocol describes what types of people may participate in the trial, the schedule of tests, procedures, medications and dosages, and the length of the study. While in a clinical trial, participants will be regularly evaluated by research staff to monitor their health and the effectiveness of the treatment under study.

All clinical trials have guidelines about who can participate called “inclusion/exclusion criteria.” These criteria are an important principal of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that disallow someone from participating are called “exclusion criteria.” These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

THE RISKS AND BENEFITS OF PARTICIPATING IN A CLINICAL TRIAL

Participating in a clinical trial is not without risk. Some of the risks are:

-There may be unpleasant, serious or even life-threatening side effects of the treatment.

-The treatment may not be effective for the participant.

-The protocol may require more of a participant’s time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

There are also benefits to participating in clinical trials. Clinical trials that are well-designed and well-executed allow eligible participants to:

-Play an active role in their own healthcare.

-Gain access to a new research treatment before it is widely available.

-Obtain expert medical care at leading healthcare facilities during the trial.

-Help others by contributing to medical research.

Only after becoming fully informed and weighing the risks and benefits should someone consent to participating in a clinical trial.

TIPS FOR EVALUATING A CLINICAL TRIAL

As noted above, you should not participate in a clinical trial unless you or a family member are willing and able to become thoroughly informed about the process. Here are a few questions to ask:

What is the purpose of the clinical trial?

Remember that a trial does not result in a cure. You need to consider whether the trial you are considering is best for your situation. Learn why researchers believe the new drug or treatment being tested may be effective. Note that many clinical trials test new drugs or treatments where effective drugs and treatments already exist. As a result, the clinical trial may offer commercial benefit to a drug manufacturer, but little added benefit to patients.

Who is paying for the study?

Before getting involved in a clinical trial, find out whether your doctor or the investigator have a financial stake in the outcome.

Is the experimental treatment being compared with a standard treatment?

Clinical trials are often compared to standard treatments or “placebos.” If this is the case, you personally may not be getting any treatment at all, although your participation will aid the research.

What if something goes wrong during or after the trial and you need extra medical care?

It is important to know going into the trial who is going to pay for this additional care. In addition, find out where this medical care will be given.

Can you stay on the treatment after the study is completed?

If you can, it is important to know who will pay for the treatment, and again, where will it be given. In addition, learn whether long-term follow up care is part of the study.

In all cases, be sure that you are an informed participant before getting involved in a clinical trial.

RECENT PROBLEMS

A recent study suggests that clinical trials are coming under attack by regulators and Congress because of well-publicized deaths of some participants. Within the last three years, researchers say legal claims including class-action lawsuits have begun targeting universities and research institutions that recruit millions of people for clinical trials of new drugs and other medical treatments. These cases question the design of the clinical trial, the protocols that were developed, and whether the protocols were followed. A team of legal experts at the Harvard School of Public Health said the cost of clinical trials will likely rise as court judgments increase and trial procedures are subjected to tough regulation to minimize legal exposure.

MORE HELP IS AVAILABLE

The NIH Clinical Center in Bethesda, Maryland is the research hospital of the National Institutes of Health. The Center’s Web site guides potential participants, their families and physicians about participating in clinical trials. Contact the NIH Clinical Center at www.cc.nih.gov.

The National Cancer Institute is the U.S. government’s focal point for clinical trials on cancer. Contact the NCI at www.nci.nih.gov.

The National Cancer Institute also provides information on understanding cancer trials. Contact the NCI at www.cancer.gov/clinical_trials.

MEDLINEplus is a web-based information service from the National Library of Medicine. Contact MEDLINEplus at www.nlm.nih.gov/medlineplus/clinicaltrials.html.

Copyright 2003 by Alan S. Kopit. All rights reserved. Alan Kopit is a consumer attorney with the firm Hahn Loeser and Parks LLP in Cleveland, Ohio and a regular contributor to “Today.”