Kenneth Getz Answers FAQs About Clinical Trials.
Email
Print
How do patients find out about clinical trials?
There are a variety of ways. Most major and many local newspapers carry advertisements for clinical trials seeking volunteers. Craigslist has a growing number of listings online. Major health/disease-specific associations provide listings of trials on their Web sites and in published literature. Patients can also call health/disease-specific associations for assistance.Non-profit advocacy organization CISCRP hosts a search engine that patients can use to find clinical trials in and around their zip-code area. The search engine, called SearchClinicalTrials.org gathers listing information from almost 100 different Web sites and organizes these listings by disease, condition and Zip code where the trials are being conducted. Patients can also visit company-specific web sites for trial listings (e.g., Amgen, Lilly, Merck)
What should patients do once they find a clinical trial they may be interested in participating in?
At the outset, patients need to bring together friends, family and professionals (e.g., primary and specialty care nurse and doctor) who can be part of an active and thoughtful support network. Once a patient finds a potentially appropriate clinical trial, he or she should discuss the available information with his/her support network and list-out general questions about the trial. Next, the patient should call the research center to learn more about the trial.The patient should ask their list of questions and the center will provide more details and even a pre-screening to determine preliminary eligibility. If the patient is not appropriate or interested in that particular trial, he or she should ask the research center if they know of any other trials that might be appropriate.
What are the benefits of taking part in a clinical trial?
Most often, patients tell us that they receive a higher level of medical attention. Some patients also see their medical condition improve during a clinical trial. Others have extremely favorable responses and might even be cured of their illnesses. Patients who participate in clinical trials also receive free medical care (relevant to the trial), free study medications and often compensation for the time and effort they commit to participate in the study. Another major benefit is the sense that one's participation will advance medical knowledge and benefit future patients.
What are the risks?
There are two major risks that patients must be aware before they participate in a clinical trial.(1) Clinical trials involve investigational/experimental treatments that may cause harmful side effects and even death. Although clinical research staff monitor patient safety closely and trials are overseen by ethical committees, there is still the risk of adverse events.(2) Clinical trials may also involve procedures that are uncomfortable and even painful. One out of five clinical trials involve a placebo. In cases where there is a placebo arm, patients also face the risk of not receiving any therapy and their condition may not improve. In many cases, if an experimental drug has proven to be safe and effective, eventually all patients including those on a placebo arm will receive that study treatment. At the outset, it is extremely important that patients do their homework so that they know what their getting into.
How hard is it for patients to get into a clinical trial?
It really depends on the protocol. Some studies have very strict eligibility requirements, others relatively few. Also, over time, some protocols that were initially hard to qualify for become more inclusive, particularly when recruitment has been difficult. So again, patients shouldn't lose hope in gaining entry into a specific clinical trial, but should continue to maintain some contact with the research center if they don't first qualify for a study.
What are the financial costs involved?
Typically, there are no financial costs to the patient. All study-related costs -- including transportation and child care -- are usually covered. However, if during the course of a clinical trial an unrelated illness is identified, then the patient (and their health insurance provider) will need to cover those costs of care.
There are a variety of ways. Most major and many local newspapers carry advertisements for clinical trials seeking volunteers. Craigslist has a growing number of listings online. Major health/disease-specific associations provide listings of trials on their Web sites and in published literature. Patients can also call health/disease-specific associations for assistance.Non-profit advocacy organization CISCRP hosts a search engine that patients can use to find clinical trials in and around their zip-code area. The search engine, called SearchClinicalTrials.org gathers listing information from almost 100 different Web sites and organizes these listings by disease, condition and Zip code where the trials are being conducted. Patients can also visit company-specific web sites for trial listings (e.g., Amgen, Lilly, Merck)
What should patients do once they find a clinical trial they may be interested in participating in?
At the outset, patients need to bring together friends, family and professionals (e.g., primary and specialty care nurse and doctor) who can be part of an active and thoughtful support network. Once a patient finds a potentially appropriate clinical trial, he or she should discuss the available information with his/her support network and list-out general questions about the trial. Next, the patient should call the research center to learn more about the trial.The patient should ask their list of questions and the center will provide more details and even a pre-screening to determine preliminary eligibility. If the patient is not appropriate or interested in that particular trial, he or she should ask the research center if they know of any other trials that might be appropriate.
What are the benefits of taking part in a clinical trial?
Most often, patients tell us that they receive a higher level of medical attention. Some patients also see their medical condition improve during a clinical trial. Others have extremely favorable responses and might even be cured of their illnesses. Patients who participate in clinical trials also receive free medical care (relevant to the trial), free study medications and often compensation for the time and effort they commit to participate in the study. Another major benefit is the sense that one's participation will advance medical knowledge and benefit future patients.
What are the risks?
There are two major risks that patients must be aware before they participate in a clinical trial.(1) Clinical trials involve investigational/experimental treatments that may cause harmful side effects and even death. Although clinical research staff monitor patient safety closely and trials are overseen by ethical committees, there is still the risk of adverse events.(2) Clinical trials may also involve procedures that are uncomfortable and even painful. One out of five clinical trials involve a placebo. In cases where there is a placebo arm, patients also face the risk of not receiving any therapy and their condition may not improve. In many cases, if an experimental drug has proven to be safe and effective, eventually all patients including those on a placebo arm will receive that study treatment. At the outset, it is extremely important that patients do their homework so that they know what their getting into.
How hard is it for patients to get into a clinical trial?
It really depends on the protocol. Some studies have very strict eligibility requirements, others relatively few. Also, over time, some protocols that were initially hard to qualify for become more inclusive, particularly when recruitment has been difficult. So again, patients shouldn't lose hope in gaining entry into a specific clinical trial, but should continue to maintain some contact with the research center if they don't first qualify for a study.
What are the financial costs involved?
Typically, there are no financial costs to the patient. All study-related costs -- including transportation and child care -- are usually covered. However, if during the course of a clinical trial an unrelated illness is identified, then the patient (and their health insurance provider) will need to cover those costs of care.
Copyright 2008 by TheBostonChannel.com. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
