Answering Your Questions about Clinical Trials
Two members of the research team at EvergreenHealth will be answering common questions about clinical trials. Dr. Pinky Agarwal is a movements disorders neurologist specializing in Parkinson’s disease and Dr. Ted Brown is a rehabilitation and multiple sclerosis expert.
Let's start out by defining what is a clinical trial?
Pinky Agarwal, MD: A clinical trial is a means of trying out the safety as well as the benefits of experimental medication that is in development for clinical conditions. They are not yet in market most of the time, and we are trying to see if this is something that’s worth developing and that could help that patient population.
Sometimes, trials are also conducted for medications that have recently been launched and the FDA is trying to track how it works or how safe it is in real life situations outside of clinical trials.
Theodore Brown, MD, MPH: Trials can also be held for a repurposing of a medication that’s already approved in one condition or disease and it’s being studied in another condition.
Who can participate in clinical trials and what are some of the benefits of participation?
Dr. Brown: Participants are typically adults with a specific condition, disease or symptom that the investigators are trying to study. So, it can be anyone who would meet the enrollment criteria which are extremely important so that you make sure that you’re studying the right population.
We’ve all heard some common misconceptions about clinical trials. What are some important questions that people who are considering a clinical trial should ask themselves, and tell us about some of the misconceptions and questions you’ve received.
Dr. Agarwal: One of the common misconceptions can be people can think they are being used as a guinea pig for developing of a drug. But clinical trials can have several benefits for the participants.
One benefit is that you can get access to a drug that’s not yet available in the market. And sometimes that can be as early as three or four years before it ever comes to market.
Another benefit is that people get extensive testing while they are participating in clinical trials. They get access to EKGs, cardiac monitoring and brains scans...and typically at no cost. They also get a long time inside the clinic where they can be monitored for longer periods of time than in a typical office visit.
All of this is typically at no cost, so people can get safe access to medications not yet in market at no cost. And oftentimes, they can continue on the meds until the med comes to market.
In some studies, people can have genetic testing, which is not even available in market, to see what kind of reaction they have to these meds. Some of the trials we are doing right now are for possible neuroprotective benefit. At least for Parkinson’s disease, there are no neuroprotective meds available in the market. Some of the meds we are looking at are to see if it could possibly slow progression of Parkinson’s Disease.
Can people participate in a clinical trial while undergoing other forms of treatment?
Dr. Brown: That’s going to depend on the particular protocol. For example, in multiple sclerosis, there may be a trial which involves an immune therapy that really has significant effects on the immune system and so typically, in those studies, there will be a need to control other MS medications, usually by having the patient off of other drugs.
That will be defined in each research study, whether other medications must be continued as they are or whether medications must be discontinued prior to participation. So, it just depends on study to study. But patients generally can continue their usual care and typically this is something extra that they are doing beyond.
I want to circle back to the misconception about clinical trial participants being guinea pigs. It’s really important that people understand that they really are, and we try to keep them informed and in control. It’s voluntary. They should understand what we’re doing every step of the way and then at any time point, they have the right to decide if they still want to participate or if not; they are never trapped in the situation. It is always something that is only with their consent to go forward.
Can people continue to work with their current provider once they join a clinical trial?
Dr. Agarwal: Yes, they can continue seeing their treating doctor. The research doctors will typically stay in touch with the patient’s treating doctor.
So, if some question comes up along the way, is this medication – say a patient has an infection and they need an antibiotic and there’s a question if that’s allowed with the trial. We’ll stay in touch with the treating physician and guide them through that so that they can continue having any procedures or urgent meds that are needed so they can continue seeing their treating doctor and see the research doctor in addition.
Dr. Brown: We want continuity of care, too, because all these studies are going to end; we want them to have their care provider in place to carry on from that time.
What is informed consent? What do people have to go through to get involved in a clinical trial?
Dr. Brown: We want the patient to understand the expectations of the study, and that means reading something about what is being studied:
- what is the intervention?
- what are the risks and the potential benefits of that intervention?
- what are the requirements in terms of the visits?
- what is the timeline for the patients?
All of that is provided in the informed consent, which is a reasonable packet of information written at a grade level that an average person can understand. Anything that they don’t understand, we want them to be asking questions and make sure that they’re fully informed and understanding the study when they agree to participate.
Dr. Agarwal: Patients need to know that consent is ongoing. You don't sign a consent and then are stuck with being in the trial. At any time during the trial, the patient can withdraw consent without any negative repercussions.
You've mentioned neuroprotective and medication trials for MS and Parkinson’s at EvergreenHealth. What about cancer trials?
Dr. Agarwal: We are extremely fortunate to partner with Seattle Cancer Care Alliance for our cancer clinical trials. SCCA is one of the world’s top cancer research facilities, with a satellite right here at EvergreenHealth. That means our cancer patients can access cutting-edge clinical trials right here, close to home.
Do patients pay to participate in clinical trials?
Dr. Brown: Typically not. Usually, there is either no expense on the patient’s part to participate or there may be some payment to the patient for aspects such as transportation to and from the center. So, most studies offer no payment by the patient to participate.
Dr. Agarwal: In addition to transportation, sometimes there can be reimbursement for the patient’s time or for the caregiver’s time if there is significant added time or effort needed on their part to participate in the trial.
How does someone find a clinical trial?
Dr. Agarwal: There are numerous websites that post clinical trials available in the area. Patients can go to www.clinicaltrials.gov, put in the condition that they are interested in, and it will generate a list the clinical trials that are going on in their area. Sometimes the local advocacy groups will publish the local clinical trials. You can also tell your care provider that you're interested in clinical trials; they will often be able to connect you with either trials going on in their center or at other nearby centers.
Currently, we have some Parkinson’s trials going on in which pretty much any patient with Parkinson’s who is interested can participate provided they have consenting ability. There are numerous trials out there and a lot of them are under-enrolled. These trials are time sensitive and if patients with conditions express interest, oftentimes they can be matched up with a trial that they might be a candidate for.
Dr. Brown: There are also support groups or self-help groups, peer groups of patients where there will be someone within a group who has some knowledge about a study and they can share with each other. So, those groups are a good way for people to learn about what’s going on, what studies are out there as well.
Dr. Agarwal: Some sponsors or centers will also do social media advertising. So, if patients are part of some groups or some virtual groups say on Facebook or somewhere else; sometimes they’ll get contacted for clinical trials through social media too.
What would you like people to know about clinical trials?
Dr. Agarwal: Clinical trials are the only way new medications can be brought to market. Initially, when we do phase one trials, you can tell the patients they can volunteer to demonstrate the safety of a product. But once it comes to efficacy, meaning does it actually help the affected population, only patients with that condition can participate and help with the development of a new drug.
So, if we want newer meds to come to market, meds that are more effective, maybe safer or meds that slow disease progression, the only way that’s going to happen is if patients with that condition participate in clinical trials.
Any final thoughts on clinical trials and some of the amazing research that you are doing there at EvergreenHealth?
Dr. Brown: In addition to our disease clinical trials, we also offer trials for symptom management.
We may not treating the underlying disease, in our case, multiple sclerosis, but we’re treating symptoms related to that disease involving mobility, strength, fatigue, pain or other aspects of symptom management. So, the treatment and the research study is focused on trying to make life easier for someone...and that can make a big difference as well.
The first question people should ask before joining a clinical trial is why do I want to do this? We like people to go into it partly for altruism because, as Dr. Agarwal said, it does really make a difference. We can have a great protocol but if we can’t get patients to enroll, that study will not succeed.
And then secondly, is it the right time in their life? Are they stable? Are they stable medically and emotionally to participate? Do they have the time? Because it is a partnership between us and the patients and so we have to make a full commitment to them, but we also ask that the patients once they agree to participate, that they give it their best effort.
Dr. Agarwal: There can be a concern that in a clinical trial, would I be on a placebo. But in all the trials in which there are placebos, the patients tend to do better. So, whether the patients get active drugs or placebo, both tend to do better than when they entered the trial.
Thank you both for clearing up so many misconceptions about clinical trials and the importance of asking those questions and getting involved because that really does transform patient care.