Clinical trials are a crucial element in medicine and health care to help develop drugs that will treat or possibly cure certain diseases. Researchers use clinical trials to test if a drug works, how well it works, how safe it is and how it compares to any currently available treatments.
Before a drug can be tested on human patients, it is tested for years in labs. Clinical trials are among the final steps of the drug development process. When drugs are brought to clinical trials, pharmaceutical companies must find enough patients to participate in the research in order to get solid results. The rarer the condition, the more difficult it can be to find the number of patients needed for a trial.
If you have been diagnosed with Sjögren’s and are thinking about participating in a clinical trial, there are several factors you should consider. You can learn about trials taking place in your area on the Sjögren’s Foundation’s website by clicking here. When researching details of potential trials that might work for you, find out the risks and benefits of each trial, ask if there are any costs that you may be responsible for associated with participation, and most importantly, talk to your doctor about whether or not the trial is right for you.
One specific consideration for participating in a Sjögren’s study is your diagnosis. In some cases, the diagnostic criteria in the study protocol may be different than the criteria your doctor used in your diagnosis.
Clinical trials can help patients gain access to new drugs and expert medical care, while contributing to important medical research benefiting the larger community. However, patients should not enter a clinical trial without considering the risks and costs to themselves as well – the medication might not work, or might have unpleasant side effects; the time and travel to the study site, time for study visits and absences from work might be costly; and once the trial is complete, the treatment may still need to undergo months of approvals before you can have regular access to it. Additionally, as a patient in a clinical trial, you may receive a placebo drug or therapy instead of the new treatment being studied. Even if you are a patient receiving a placebo, you will still receive basic standard of care and medical oversight for your condition.
Clinical trials vary greatly depending on the type of study and the treatment being tested. Each trial is usually funded, or sponsored, by a pharmaceutical company, academic research center, or federal agencies such as the National Institutes of Health (NIH). Studies take place across the U.S. and even globally, at hospitals, physician offices, clinics and more – one study might have researchers conducting the trial in many different locations.
Prior to enrolling, you should know how long the study is expected to last, where you will need to go and what you will need to do in order to participate, how your participation will be compensated for – or if you will be compensated for your participation and more. These questions can be answered during discussions with the doctor or staff running the study. If you are still interested in participating, the study staff will usually schedule a screening visit. The details of screening appointments varies from study to study, but all screening appointments are used to determine your eligibility for the trial. Depending on the therapy being studied, screening appointments might look to learn your medical history; run blood, urine or tissue samples; and learn what medications you are currently taking.
Following the screening, the team running the study will contact you to let you know if you qualify for the trial or not. If you do qualify, you will be scheduled for your first study visit, which will help establish the baseline of your participation in the study. Again, the specifics will vary in each trial, but the doctor might run tests or draw labs, as well as give you the drug being studied and instructions for dosing and any reporting you may need to do. This first visit will also give you a chance to schedule future visits.
Throughout the duration of the study, you will need to attend appointments at various intervals. Some studies require regular visits or even hospital stays, while others can be done less frequently. As a study progresses, you may need to be seen less frequently. At each visit, the doctor may re-run tests or labs to compare against the baseline. You also may be given more medication at each visit.
When the study comes to an end, you will need to turn in any unused medication and reporting documents. The doctor will perform tests, labs or procedures similar to what was done during your screening or baseline appointments to see if the drug has made an impact on your health. The doctor may be able to tell you what treatment you received during the study once the study is complete. Once the clinical trial is completed, you will need to revert to your previous physician, if different, and treatment schedule.
Deciding to join a clinical trial can be a difficult decision, but taking part can help researchers learn more about potential treatments for your condition. If you carefully consider the risks and rewards, and arm yourself with information before committing to a study, participating can be a very rewarding experience.