Today, more and more clinical trials are conducted worldwide. Clinical trials is research conducted in people with an aim to discover whether new treatments, like new drugs, medical devices or combinations of both are safe and effective. Jigna Parekh, PharmD., MS., a Senior Clinical Trial Manager at Incyte Corporation, USA has been working in the clinical research field for over 14 years. Dr. Parekh has worked on various therapeutic areas such as oncology, respiratory, endocrinology and neurology in the past and currently working in rare disease indications. She notes some of the facts of clinical trials that can aid an individual’s understanding and participation of clinical trials.
“It’s all starts in the laboratory”, says Dr. Parekh. “After series of testing the new treatments or techniques in the laboratory and in different animal models, the most promising treatment moves to the next stage of testing called clinical research. Clinical trial, clinical research and clinical studies are often used interchangeably.. The goal of clinical trials is to find scientific answers, whether it maybe to prevent, diagnose, or treat disease. These trials are performed to find out whether the treatment is a hit or a miss.
What happens in Clinical Trials?
Clinical trials follow a pre-designed protocol that has set entry criteria for potential participants. People interested in participating must meet these criteria. The treatment that is studied is an investigational drug or device that may or may not yet been approved for human use. Since people safety is the top priority, these trials need approval from regulators and ethics committees before execution. Pharmaceutical companies, who usually fund these trials, work with doctors and hospitals to recruit patients. Of course, the patients are given the option of the standard available treatment prior to the possibility of enrolling in a clinical trial. However, sometimes due to the type of disease or limited treatment options, participating in a clinical trial is the best option, says Dr. Parekh.
Participation in clinical trial is always voluntary; there is no form of coercion allowed. Patients can also withdraw their participation at any point during the study. However, once a patient commits to participate in a trial, they must adhere to the protocol requirements such as; taking the treatment on time as directed, report any discomfort during their participation, go for regular clinic visits and be compliant. All of this data will be collected and be utilized to test the effectiveness of the treatment. The greater the compliance by the patient to the study procedures, the more precise the data will be, and this will help make appropriate scientific decision about the new treatment.
Throughout the clinical trial participation, patients are always identified by a unique number, which is assigned at the start of the study. Their personal information always remains masked, and not available publicly. Hence, patient privacy is maintained.
Why do people participate?
People take part in clinical trials for a variety of reasons. Some say they participate because they feel empowered by contributing to science and research that could bring new treatments one-step closer to patients in need. People with a certain disease or illness also participate to help researchers better understand that disease and contribute to the possibility of finding a treatment or even a cure. Participating in a clinical trials may also give access to new treatment options along with additional medical care. Moreover, many times in rare diseases, there is no treatment available or what is available is not as effective and participating in such clinical trials could even be the one that leads to a cure says, Dr. Parekh.
How to know which clinical trial is best for you
“Not every clinical trial is a fit for you and you must be aware of it”, says Dr. Parekh. “One can begin by gathering as much information about the trial as they can. Clinical trials are designed with a specific aim to answer scientific hypothesis. The trial outcome depends on what phase is being studied. Phase 1 clinical trials are conducted in a small group of people (usually healthy volunteers) designed to see if new treatment safe, identify a safe dosage range, and identify the most frequent side effects. Phase 2 trials are conducted in slightly larger groups of people with the target disease to test the efficacy and collect additional safety data. In Phase 3 trials a larger group of people with the disease are given the treatment to confirm the effectiveness, monitor side effects, and could be compared against currently used treatments. Lastly Phase 4 trials, in which the treatment is already approved and marketed, is performed to collect additional information on drug efficacy and safety.
One must carefully read clinical trial information and be assured that the trials’ goals and design matches the medical need and expectations. They should ask any question they may have to the clinical site (hospitals, clinic) conducting the trial. Being aware of trial details such as clinical trial procedures, if a new treatment is a drug or a medical device, how is the new treatment taken – orally or injection, if fasting is required, number and frequency of clinic visits, length of each clinic visit, potential risks of new treatment and if there is any payment such stipend or reimbursement to participate. There should be no assumptions about the trial conduct without knowing all the information.
Once the patient makes the decision to participate, he/she should be able to commit to the trial procedures, go for clinic visits per the protocol. Participation in clinical trials is voluntary and the participant can withdraw participation at any time during the study.
How to find a trial near me?
The first place to find about the clinical trials will be to ask your doctor. Your doctors and nurses may be aware of an appropriate clinical trial that can fit your medical needs. The other sources to find active clinical trials are on websites namely; www.clinicaltrial.gov, www.centerwatch.com, and Clinical trial registry-India (CTRI). You can use the search filters to find clinical trial for you. There are also patient and disease advocacy groups that have lists of clinical trials near you.
Every patient that participates in clinical trials is important. Participants of different backgrounds, age, race, and gender are needed for the success of clinical trials and eventually finding a cure. “Ask as many questions as possible to the healthcare providers until you are confident thatthis clinical trial is right for you”, says Dr. Parekh.