Research was once the domain of sterile environments, white-coated scientists, housed in the castles of academe or the battlements of great hospital complexes. It seemed remote and far away from our lives. Today it is a vital part of our lives. We cling to reporters’ words as they announce the latest medical findings and, as people whose lives are affected by Spina Bifida, we look to it with verdant hope.
You may someday be asked to be a living part of research by taking part in a clinical trial or study that could improve the treatment, prevention or quality of life for those living with Spina Bifida. You don’t need to become an expert on research, but you should know some of the basics to help you come to an informed decision.
To help in many studies, you need only supply information in the form of an interview or questionnaire. Your answers will help provide insight into the lives and history of those with Spina Bifida that no one else can provide. The National Survey questionnaire of the Spina Bifida community that is posted on SBA’s Web site is an example of this kind of research. Your participation is invaluable to researchers in reaching their conclusions.
You will often come across the phrase “clinical trial” regarding a special kind of research. A clinical trial is a research study designed to test the effectiveness of new therapies or medications and to develop better ways of using existing treatments. Carefully conducted clinical trials are the fastest and safest way to find treatments that work.
There are four basic types of clinical trials. Treatment (or Therapeutic) trials test new treatments, new combinations of drugs or new approaches to surgery. Prevention trials look for better ways to prevent disorders and diseases and may include medicines, vitamins, vaccines, minerals, or lifestyle changes. Screening (or Diagnostic) trials test the best way to detect certain health conditions or diseases. Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic condition or illness.
All clinical trials have guidelines about who can participate. Using inclusion and exclusion criteria is an important principle of medical research that helps 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 strictly enforced and may be based on such factors as age, gender, the type and stage of a disorder, previous treatment history and other medical conditions. Before joining a clinical trial, a participant must qualify for the study.
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for the participants. To help someone decide whether or not to participate, researchers must explain the details of the study. Informed consent is not a contract and the participant in the study can withdraw from the trial at any time.
By participating in a clinical trial you can play a more active role in your own health care, gain access to new research treatments before they are widely available and help others by contributing to medical research. Taking part in a clinical trial is a significant commitment and may involve some personal risk; you should always have a good understanding about the specific study and about clinical trials in general before participating. Don’t be afraid to ask questions (even if they seem silly) before make your final decision.
At some time you may be asked by one of your physicians to participate in a clinical trial. You should give thought to the proposal because in some studies you may receive direct benefit, while in others, you may not benefit directly at all. But, remember you are under no obligation to participate. Your relationship with you physician and the future care you receive will not suffer if you decide not to participate.
Participating in any kind of research can be a rewarding experience and a great gift to those who benefit from the results of the research.