5 Important Things to Know Before Beginning a Mesothelioma Clinical Trial
West Virginia Mesothelioma Lawyer
Individuals diagnosed with mesothelioma may have the opportunity to partake in a mesothelioma clinical trial, which can be an exciting and frightening experience. Clinical trials are research studies designed to test new ways of preventing, diagnosing and treating diseases, including cancer. All new prevention and/or treatments have to go through a clinical trial procedure before FDA approval for mainstream market use is obtained.
By enrolling, participants are given the opportunity to receive the best available treatment. These treatments may also help future patients who are on a similar journey. However, taking part in a clinical trial is not the same as taking part in a regular visit to your doctor – such trials require some preparation and research prior to enrollment.
For additional information regarding clinical trials, contact a West Virginia Mesothelioma Lawyer at Goldberg, Persky, and White, P.C. today!
1.Review Requirements for Eligibility
The belief that a physician grants their patients access to a clinical trial by chance or preference is a myth. In reality, all clinical research studies have guidelines on who may participate.
Each clinical research study has an extensive list of requirements that make use of inclusion and exclusion criteria. This is an important principle of medical research that helps to generate reliable data. That being said, a patient must meet all requirements in both categories in order to qualify.
These guidelines, which take into consideration the patient’s medical and treatment history, determine a patient’s eligibility. It is therefore essential to have access to various medical records – all of which should be up to date.
Necessary items to be included among medical records include…
- General medical history
- Medication list
- Previous cancer diagnoses
- Surgical history
- Treatment history
If you or your loved one are considering enrolling in a clinical trial, consult your doctor or research staff for a copy of the eligibility requirements. Do not hesitate to ask questions about any uncertain clinical trial requirements.
2.Begin Preparations for the Screening Process
After a patient discusses the clinical trial thoroughly with their medical team and family members and confirms that all criteria for inclusion and exclusion have been met, screening process preparations may begin.
It is custom for patient’s to be asked to sign an informed consent. Though this document may be lengthy, the patient is generally provided with a copy of the consent form to be reviewed in advance, so that they may ask questions prior to signing.
Common questions to ask a research team before signing a consent form:
- What are the costs of the clinical trial?
- What are the risks of participating?
- What type of long-term follow-up care can a patient expect?
- What are the odds of receiving a placebo in this trial?
The research team of the patient and their physician will lead them through consent procedures and then enroll them in the next step, which is the screening process.
A preliminary series of blood tests and imaging scans will be performed before the patient has the opportunity to receive the experimental medication. These tests will ensure that the clinical trial does not place the patient at an increased risk of serious and/or permanent damage.
The screening period usually lasts between two and four weeks after signing the consent. During this time, the patient will be asked to return to their treatment center for blood work and imaging – such as CT scans or MRI tests.
At this point, the patient has been enrolled in the clinical trial and therefore any exams or tests that are not considered conventional treatment (tests that would normally be prescribed by a doctor) are likely to be covered.
Randomization in Clinical Trials
Once all screening activities have been completed, the patient will be randomized to the treatment arm. If the risk is considered high or ineligible for the trial during the screening period, alternative conventional treatments will be discussed by the patient’s physician.
For most trials, the term randomization implies the assignment of a treatment that either includes or does not include an experimental drug in addition to conventional therapies.
The patient’s physician and/or research team have the ability to provide details on the number of treatment arms available for their study, as well as the chance of being randomized to each.
3.Expect to Plan for Additional Tests and Doctors Visits
Many patients with serious illnesses are familiar to frequent visits to their doctors, however, those who participate in clinical trials should prepare to maintain frequent visits – especially during a trial’s early stage.
A schedule of activities that clearly outlines how many visits are expected and what will be conducted at each visit may be provided. A change during the course of the study is unlikely, however, if it does, the medical team will inform the patient in advance and ask them to sign an updated consent form.
In addition, be prepared for any unexpected visits. Participation in a clinical trial involves a variety of unknown risks, so any change in the state of the patient’s health may require a scheduled visit by the physician.
Ensure adequate transportation and discuss any possible reimbursement with the research team before enrolling in a trial. As these trials are testing the latest medicines and/or treatments, they will be closely monitored by the patient’s doctor during the first few months of the trial.
4.Monitor Your Progress
Each patient experiences clinical research trials differently. For this reason, patients usually wonder how their cancer reacts to experimental drugs. While data may not be available on the overall clinical trial, a physician will examine the progress of a patient in a variety of ways, including:
- Size of the tumor measured by imaging scans
- Performance status based on the level of daily activity
- Overall health following a physical examination
- Organ function monitored through blood work
By keeping up with progress during a clinical trial, a patient and their physician will be able to make informed choices as to whether to continue a research study or to pursue another treatment.
5.Expect A Lengthy Follow-Up
After showing promise in a clinical trial that has managed cancer over a long period of time, a patient may be curious to know how and when the trial will end.
A trial’s follow-up period will vary depending upon the study’s protocol and structure. If a second-line therapy is being tested in the study, a doctor may continue their patient on the experimental medication indefinitely until they experience disease progression.
If an additive drug that is used alongside the standard of care in first-line therapy is tested throughout the study, users may only complete a specific amount of chemotherapy or radiation cycles followed by a re-evaluation period.
Follow-up activities usually replicate the tests and examinations that were completed during the screening process. This data helps the evaluation team to collect data on a patient’s overall health and benefit after completion of the treatment. A patient will then officially enter the final phase of the study – a long-term or survival follow-up.
Throughout a long-term follow-up, someone from the research team is likely to call every couple of months to determine the status of the patient’s cancer and whether or not they need additional treatment.
There are many unknowns during clinical trial; this may be a frightening factor that hinders patient’s consideration prior to enrollment. However, with the right knowledge and preparation, you or a loved one can find the best fitting clinical research trial. Enrollment in a trial is an exciting opportunity as patients can seek out new therapies for themselves and help researchers to pursue new cancer treatments that could help many others.
For more information regarding clinical trials, contact a West Virginia Mesothelioma Lawyer at Goldberg, Persky, and White, P.C. today!