Between 1pm - 2pm, Rachel Minnick from CISCRP and Benjamin Donovan from Encore Research Group will be here on the community to answer your questions about clinical trials.
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Quick background about me: I work as the Senior Manager of Marketing and Patient Engagement Alliances at CISCRP and I am also a patient enrolled in a clinical trial for breast cancer. I was diagnosed with breast cancer back in 2013 and that is when I enrolled in the trial. I was placed in the control group (meaning I received the standard treatment but not the test drug) and have been in the trial ever since. I have check ups for the trial every 6 months. I am still fighting the cancer, as it spread to my bones earlier this year, but I am on a great (approved, not trial) medication that seems to be working well. I am also looking for new clinical trials to benefit my condition. I am passionate about clinical trial participation because I would not have access to the medication I do without clinical trials. Looking forward to chatting with the community today!
First question we received from nozha13 : As a Canadian who is willing to join a clinical trial in another country, what are the costs involved in the clinical trial itself? Also how long does a pharmaceutical company continue to provide the drug to the patient after the trial is over?
In most cases, you will not pay any medical costs to participate in a clinical trial; the sponsor of the clinical trial will typically cover all of the costs associated with the trial, including medications, tests, scans, bloodwork, etc. However, this is a question you should absolutely ask the study staff before you enroll in the trial so that you are clear about the obligations. Also good to note, that there may be other costs associated with participation such as travel to and from the trial site, childcare while you are at your appointments, time lost at work, etc. But many trials will actually provide some compensation for those costs as well. This varies, but this is a great question to ask the study staff before you enroll in a study.
As for your second question, this varies from trial to trial but in general access to the study drug ends when the clinical trial ends. However, there can be exceptions - study volunteers with serious or life-threatening illnesses who have completed a study may be granted access to continue to receive the medication for free until the FDA approves it or for a fixed time period. But again, this really varies from study to study and patient to patient.
Hi Rachel, hi Ben! I asked this question on other thread but thought I would post again!
How does it work with balancing care with your current doctor and the clinical trial doctor? Do you still have to see your current doctor for some medications or do they do it all?
Great question! In my experience, my clinical trial doctor and current doctor (primary care doctor) work very closely to monitor my care. With electronic health records, it makes it very easy to ensure that both doctors have copies of all scans, updates, list of medications, etc. It's definitely something that I, as the patient, make sure to facilitate, but the doctors are all willing and happy to work together. If I have a medical issue that is not related to my clinical trial, I usually go to my primary care doctor, but sometimes I ask my clinical trial doctor first and wait to see what their recommendation is. I think it depends on the trial you are in as well. My trial is for cancer, so if there is anything unusual (like a headache or pain) it could be related to my condition or treatment and therefore I usually go to my clinical trial doctor first. If there is a medication that you need related to the trial, the clinical trial doctor will usually take care of it. If it is something that is completely unrelated, they may recommend that you see your primary care doctor first. Hope that answers your question, but let me know if you had any other question
Thanks Rachel. That makes sense. Is it still the same with specialists? So if your original oncologist wasn't part of the trial, would you still see them as well as the clinical trial doctor?
Yes I would. Also, it's really important that all of your doctors (trial doc and specialists) know what medications and treatments you are receiving in a clinical trial so that there are no issues with prescribing meds that might interact poorly with your trial drug.
This is a hard question to answer because it seems like there is an exciting breakthrough around every corner in research. Two exciting areas for me right now are Alzheimer's Disease and Lipid studies. Biogen's Engage study for Alzheimer's disease looks very promising and is in stage III. Also, doctors have traditionally treated heart disease by lowering LDL, but that has not ended cardiac events. Many companies are now looking into other cholesterol components such as Lp(a). Hopefully by doing more research into all aspects of cholesterol we will be able to continue to reduce the frequency of cardiac events.
In Phase I trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Let me know if you have any other questions about the phases of clinical research.
I would not say 'all' but most are in order to protect the integrity of the data. However, after participating in a phase III study you may be eligible for a open-label extension in which everyone receives drug.
In an open label extension they already know the drug works and are measuring long term safety. Therefore they do not need to show the drug is statistically more effective than placebo.
This is a great question! Phase I studies are first in human studies. They are usually just for testing safety. Phase II studies are typically used to find out the optimal drug dose. Finally, phase III studies are testing efficacy of the drug to see if it is more effective than what is currently available.
The simple answer is that they are supposed to. Unfortunately, only around 30% of trials are reported in the mandated time frame and the FDA has failed to penalize them sufficiently so that they are motivated to do so. As one can imagine pharmaceutical companies can be reluctant to publish data on failed trials.
Thanks for the answer. I would've thought pharma would be happy to publish data on failed trials - it would help justify why they need to make so much money.
Ha! Well it would also save money by reducing the number of repeat trials, but unfortunately in the highly competitive pharmaceutical industry all data comes at a premium.
Hi newdad2013, thanks for your question. This is a really important one! In the US, there is a federal requirement that pharma companies post the results of clinical trials (that have been completed) online. However, these results are written in very scientific/medically advanced terminology. At CISCRP, we endorse the practice of pharma companies sharing the results of a clinical trial, with the patients who participated in it, written in lay language that patients can understand. This practice is not required at this time, but we are definitely seeing a trend in the industry where more and more pharma companies are sharing the lay language summaries with patients in an effort to truly engage with the study volunteers.
My family was really supportive of being in a clinical trial. Since my condition is cancer, there is a lot of support from my family to do anything and everything to find a treatment that works for me. I am on a standard treatment now that seems to be working well, but we will always look for new and better treatments with clinical trials.
Question previously asked by FMundo : If one participates in a Clinical Trial and the results of the trial demonstrate the efficacy of the drug or therapy, what sort of commitment is offered by those people who underwrite the Clinical Trial to continue to offer the drug to trial participants after the trial is completed?
BDonovan touched on this a bit in one of the questions above: If you participate in a phase III clinical trial, you may be eligible for a open-label extension that will allow you to continue taking the drug for free until it is approved by the FDA or for a set period of time. This varies from study to study.
Most patients will not continue to receive drug after the trial. The most common way to continue to receive treatment is in an open-label extension after the study ends (if available). However, there are some cases in which the company approves the patient to continue the drug because of the clear benefit to the patient and the hardship that discontinuing the drug would cause. Unfortunately, these cases are rare and as previously stated you will most likely not continue to receive the medication.
Question previously asked: Why are clinical trial protocols so complicated? I have tried to take part in a couple of trials but have been rejected from both due to small issues, blood test results and previous side effects, but a clincal trial could possible save my life.
This can be very frustrating and I am sorry you're having trouble finding a trial that you qualify for. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study. But of course when it comes to finding a study that could save your life, it's hard not to take it personally. I would recommend that you continue to look for trials. CISCRP has a wonderful free service called Search Clinical Trials (searchclinicaltrials.org) where we have people dedicated to finding clinical trials to fit your needs. You can submit a form online or you can call us and a live person will assist you. I hope this will help you to locate a trial that will meet your needs.
I'm so pleased to hear that you're interested in participating, this is a wonderful gift. I would recommend that you take a look at our free Search Clinical Trials service: searchclinicaltrials.org where you can submit a form online or speak to a live person and we will assist you in finding relevant clinical trials to suite your needs. They can look at any city/state in the US and for any condition. Thank you again for being willing to participate!
Thanks for all your replies so far! This has been super interesting. One from me...how is it decided how many clinical trials are needed to get a drug approved?
Hi HBrand1 - this really depends. The sponsor companies will propose a certain number of patients for the study that they feel will show safety and/or efficacy (depending on phase). This will need to be reviewed and approved by both the regulatory agency (FDA) and an IRB (institutional review board) before moving forward.
Question asked by Holc71 : What is the average cost to get clinical trials done on a new product for a start up company and and what is the time frame to get it started?? How much money down and is their a ballon payment at the end??
This is an interesting question and I do not know the answer! It is not clear to me whether you are asking as a Sponsor or a CRO. I imagine it would cost the sponsor a fortune because of drug development costs and hiring the IRB's and CRO's. The CRO negotiates the budget with the sponsor up front so a start up would be a lot more feasible, but still cost hundreds of thousands of dollars at a minimum because of the overhead, equipment and personnel required.
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