A clinical trial is a health-related or biomedical research study that is conducted on human beings. Clinical trials are important because they build upon the knowledge acquired from applied and basic research in a laboratory setting that takes the form of treatments and drugs administered in a hospital or clinical setting.
By participating in a clinical trial, patients are given the opportunity to play a more active role in their health care. Clinical trials are also a way for patients to have access to new treatments, therapies, and drugs before they are made mainstream. This early access is essential to patients with mesothelioma as this type of cancer tends to have lower survival rates than others. Patients who participate in clinical trials are not only helping themselves, but also other patients who have yet to be diagnosed, by assisting in medical research and helping experts better understand the specifics of certain diseases and illnesses.
Finding Your Trial
Locating a clinical trial can be a confusing and tedious process. Mesothelioma Resource Online has assembled a step-by-step guide modeled after information provided by the National Cancer Institute, in the hopes of easing the patient’s experience. This step-by-step guide takes the patient through all of the stages necessary to locate and select a clinical trial specific to their type of mesothelioma.
Understanding Clinical Trials
Patients can familiarize themselves with clinical trial terminology in order to better understand what the components of a clinical trial are. A clinical trial is defined by the U.S. National Institutes of Health as biomedical or health-related research studies in human beings that follow a pre-defined protocol.
Consulting a Physician
The best resource for patients initially considering a clinical trial for treatment is their doctor or member of their health care team. These specialists may be able to help them find one. It is also important to note that most clinical trials provide short-term treatments directly related to a designated illness or disease, but they do not provide primary health care.
Noting Specifics Concerning Diagnosis
In order to begin the search for a clinical trial the patient must know the specifics concerning their diagnosis. This information will then need to be compared to the eligibility criteria of any trial of interest. Eligibility criteria can also be referred to as entry criteria or enrollment criteria and is the set of guidelines dictating who can and cannot take part in each individual study.
Search For a Trial
The U.S. National Institutes of Health, through its National Library of Medicine, maintains a public database of clinical trials:ClinicalTrials.gov. The National Cancer Institute, a part of the U.S. Federal government also manages an extensive list of available clinical trials, as well as information and results from past trials, available through their website.
Make a List of Potential Trials
Patients should have collected summaries for all of the trials that initially interested them. They should then start the task of comparing their diagnostic information to the inclusion and exclusion criteria. Inclusion criteria are those details which would allow the patient access to the trial, while exclusion criteria are the features of their diagnosis that would keep them from being eligible.
Contact the Clinical Trial Team
This can be achieved through one of three ways. Patients can contact the trial directly, a doctor representing the patient can contact the team for them, or the patient can fill out a contact form, in which case the trial team would then contact the patient. Contact information for the trial team is generally located in the trial’s summary. It is always best to ask to speak to the trial coordinator specifically.
A comprehensive list of questions to ask the trial coordinator, as well as explanations for those questions is available from the National Cancer Institute.
Discuss the Options
A doctor can help the patient understand the full extent of the study’s risks and benefits and compare those to the risks and benefits of standard treatment for their type of mesothelioma; after which the patient can determine if the clinical trial is the course of action they wish to take.
Schedule an Appointment
Should a trial interest a patient, and their criteria match that of the study, it is best to schedule a meeting with the trial coordinator. Prior to the beginning of the trial, participants will be provided the key facts concerning the study through a process known as informed consent. This paperwork assists patients in finalizing their decision to be involved. It is not contractual and patients can leave a study at any time.
Some examples of what might be studied during a clinical trial are:
- New applications for medications that have already been approved by the United States Food and Drug Administration (FDA). For example, a drug may already be approved for use on one type of cancer and researchers are testing it for use on other cancers.
- As a means of testing alternative medicines and therapies
- Testing drugs and treatments that have yet to be approved by the FDA in order to determine proper dosage amounts and record any side effects.
- For the assessment of new diagnostic tests
- To determine the effectiveness of palliative medicines and procedures, documenting how they affect life expectancy and the patient’s quality of life.
- New methods for administering drugs that have already been approved, such as injecting chemotherapy during surgery rather than administering it orally.
Types of Clinical Trials
Clinical trials are divided into two main categories, interventional and observational.
Interventional–this type of trial involves research subjects who are assigned to a treatment or other intervention by the trial’s investigator, who then records the results.
Observational–research subjects are observed and their outcomes are measured by trial investigators. During an observational clinical trial the investigator does not interfere in the patient’s natural progression by assigning them drugs or treatment.
Trial types can be further divided as a means of explaining what the trial intends to do:
- Treatment trials–these aim to test experimental drugs and treatments, a new combination of drugs, or new surgical approaches.
- Prevention trials–work to improve disease prevention either in people who have never had a particular disease or in an attempt to prevent a disease from returning. Methods used can include medication, vaccines, herbal or other natural methods, or lifestyle changes.
- Diagnostic trials–help to determine more proficient tests and procedures for diagnosing a specific disease or illness.
- Screening trials–determine better ways of detecting certain diseases and health conditions.
- Quality of life trials–these clinical trials can also be referred to as supportive care trials, which explore ways to improve comfort and patient quality of life for those with a chronic illness.
All clinical trials are conducted in phases, which are arranged in ascending order. At each phase trials have a different purpose than during others and help to answer different sets of questions.
Phase I–this is usually the first phase in which the drug or treatment is tested on humans, prior to laboratory or animal research. In this phase doctors begin by giving very low doses and gradually increase them, looking for side effects or positive treatment results from the patient. The purpose of phase I trials is not only to assist the patients, but to also test the safety of the drug. If after phase I study the drug or treatment is found to be reasonably safe it will continue on to phase II studies. During this phase the number of people studied is generally a small group, (between 20-80 people).
Phase II–in phase II trials the experimental drug or treatment is given to a larger group of people (usually between 100-300) in order to further evaluate its safety and effectiveness.
Phase III–when a study reaches phase III the trial is often randomized and large numbers of patients are chosen (1,000 to 3,000 people). There is normally a control group, as well as the treatment groups, and the decision as to which group the patient is a part of is not up to the patient or doctor, but rather the researchers and trial coordinators. Phase III trials are usually necessary for FDA approval.
Phase IV–drugs and treatments can only enter phase IV study after they have been approved by the FDA. At this time tests are done in even larger groups of people than phase III as a means of learnin more about the treatment’s safety, or any short and long-term side effects. Phase IV can also help doctors determine if there are any rare side effects, or if the treatment could be used in conjunction with other methods and therapies.
It should be noted that because the number of people annually diagnosed with mesothelioma tends to be lower than other cancers, the number of people available to participate in any given trial may be far less than the average numbers stated above.
Benefits and Risks
Clinical trials located through trusted sources and executed at reputable clinics and hospitals are a good way for patients to:
- Be active in their health care
- Access new research, methods, and treatments before they are made widely available
- Attain expert medical care at leading health care centers while participating in the trial
- Contribute to medical research which will assist other patients with the same disease, or those who have not yet been diagnosed
However, clinical trials are not without risk and patients should be fully aware of any complications that could arise from participating in a clinical trial. These risks range in severity and include:
- Patients could experience unpleasant, serious, or even life-threatening side effects
- The drugs or treatments used in the study could be ineffective for that particular patient
- The study’s protocol could require time, travel, or attention that the patient is unable to do, such as trips to the study site, hospital stays, or complex dosage requirements.
Qualifying for a Clinical Trial
Any clinical trial, regardless of the disease or illness being studied, will have set guidelines for those being studied. Trial coordinators determine whether or not a patient meets these guidelines using inclusion and exclusion criteria. By having this criteria, studies are better able to produce reliable results and identify the appropriate participants, thereby keeping them safe. This list of specifics also ensures that the study will accurately answer the questions researchers plan to investigate.
Inclusion and exclusion criteria are the medical and social standards which will determine if a person can enter a specific clinical trial or not. The criteria is normally based on factors such as age, gender, the type and stage of cancer or disease, previous treatment history, and the patient’s other medical conditions and overall health.
Locating a Clinical Trial
The National Cancer Institute, the American Cancer Society, and the U.S. National Institutes of Health all keep lists of new and ongoing clinical trials for various treatments. However, these organizations all recommend first speaking to a doctor or other health care provider concerning patient options and whether a clinical trial would be appropriate for them or not. Mesothelioma Resource Online is committed to providing patients with access and support concerning their disease. In order to provide the most information possible Mesothelioma Resource Online has put together a step-by-step guide for those unfamiliar with how to choose a clinical trial, which can be viewed here.