A Q&A with Sara, founder of Ticking Off Breast Cancer and Ancora.ai’s CEO, Danielle
In August 2020, Ticking Off Breast Cancer and Ancora.ai went LIVE together on Instagram to discuss all things clinical trials and answer questions from the community. This is a recap of the Q&A discussion.
You can also watch the recording of the Instagram Live on Ancora.ai’s YouTube channel, and make sure to follow Ancora.ai on social media so you don’t miss any of our future content and upcoming events:
Q: What is a clinical trial?
A: The goal of trials is to test the safety and efficacy of new treatments, especially as compared to existing treatments. This is how we get new treatments approved and into current best practice guidelines
Q: What are the risks and benefits of participating in a trial?
BENEFITS: When you participate in a clinical trial you can access new treatments before they are on the market and take advantage of new scientific advances. You also will also gain access to doctors, healthcare professionals and lots of treatment information. Treatment is typically free and you will also be contributing to research that could benefit future patients.
RISKS: There are also a few risks. You might not respond to the treatment, and you could suffer side effects. You also might not be received to the treatment group that you would prefer. You might spend more time in appointments and receive extra tests. When you enroll in a trial these risks will be outlined to you so that you are fully aware of the risks.
Q: What does informed consent mean? Does it mean I can’t leave the trial?
A: When you join a trial you will sign an informed consent document. This is a document saying that the trial organizers have explained all the details of the trial, including risks and benefits, and that you understand these details and accept them. It’s important to know that you can leave the trial at any time and for any reason.
Q: If clinical trials are such a great option, why has none of my doctors ever mentioned them to me?
A: For a doctor who isn’t directly involved in trials, it is a big effort to stay abreast of all recent developments, especially as the number and complexity of trials is continuously increasing. This is why we developed Ancora.ai.
Q: Who can participate in a trial?
A: Each trial has eligibility criteria published in the listing based on medical history, diagnosis, and other factors. Ancora will show you potential trial matches based on your profile details and the trial’s eligibility criteria.
Q: How can I find out more about trials?
A: You can use Ancora.ai. There’s lots of background info and resources on the site and you can interact with our chat function or email us with further questions. Registering and filling out the questionnaire will allow you to opt in to updates that will let you know about any new trials or changes in trials without any effort.
Q: Will I get a placebo? How do I know whether I will be in the placebo/control group?
A: True placebo groups are extremely rare in cancer. You’ll always get what is called the standard of care, which is a treatment in line with current guidelines for your condition. Most trials are randomized and double-blinded, meaning that you will be assigned at random and that neither you nor the researchers will know which group you have been assigned to until the end. This is important to reduce any bias, as to ensure that the true effects of a new treatment can be assessed.
Q: Do I have risks if I enroll as a healthy volunteer? I see lots of ads for trials.
A: There’s always some level of risk, but know that before enrolling patients, trials are vetted to maximize safety for patients on trial. Trials are strictly regulated by law and by research ethics to protect your safety as much as possible.
Q: Why should I look for trials unless everything else has failed?
A: Of course, if your current treatment is working well for you, you might not want to look for something else. Trials aren’t right for everyone. However, do keep in mind that medicine is progressing at a fast pace, so trials can give you access to treatments that are even more effective, have fewer side-effects or even improve your quality of life (e.g. by requiring less visits). It can be good to consider your options before making a decision to start a standard treatment.
Q: Are there any trials for cancer patients in the middle of progression, i.e. neither very early nor metastatic?
A:Yes, there are. The definition of those middle stages is just less clear-cut, hence they might be harder to identify. It’s a misconception that trials are only for late stage. With Ancora.ai we standardize the staging in the trials so you can more easily find relevant options.
Q: Will having had several previous treatments exclude me from participating in trials?
A: There is no general answer to this, as there are both trials for first line treatment and later lines. The later the stage of the cancer, the less previous treatments are a decision factor. There are lots of trials out there, although some previous treatments can exclude you from certain trials. There are many cases of people participating in multiple trials (sequentially).
Q: If I participate in a trial now, will this exclude me from participating in another (potentially more beneficial) trial further down the line?
A: You can definitely participate in multiple trials, generally not at the same time. However, it is possible that some previous treatments might exclude you from some trials. A reason can be that the treatment that they are investigating is similar or targets the same pathway, and so likely won’t work again (i.e. checkpoint inhibitors- atezolizumab then pembrolizumab likely won’t work)
Q: When it comes to rarer cancers, are there any international efforts to recruit patients from anywhere in the world to ensure the numbers in the trial make a statistical significance? As a patient how can I advocate for something like this to become a reality?
A: Many later stage trials are international or have many sites, especially for rarer cancers, in order to recruit more patients. There might not be many trials specific to a rarer cancer, however, with the recent trend in precision medicine, now you can find more and more trials focused on specific mutations, rather than specific cancer. They might note they are for all solid tumors, or are tumor agnostic, so this is worth looking into. You can also join a rare disease group or registry. We’d be happy to help point you to the right place if you want to do this.
Q: How safe are trials, e.g. how large is the risk of unknown long-term side effects?
A: Clinical trial sponsors are required to inform patients about the risks and benefits of a trial. You will receive an informed consent document with detailed information about the trial, including any potential risks. You can ask questions at any time and you can also stop participating in the trial at any time and for any reason. The question list on tickingoffbreastcancer.com is a great starter. Trials are strictly regulated by law and by research ethics to protect your safety as much as possible. Trials are broken down in phases that progress and they only move into later phases if safety / efficacy data is looking good. Long term effects may take longer to discover and these are tracked through Phase IV, and these are probably the biggest risk and unknown when joining a trial.
Q: Are trials as diverse as the population?
A: Unfortunately not. This has improved a bit over the last few years, but trial populations are still far from being representative. That’s why improving access to trials for everyone, not just people with the right doctor, is so important for us. Diversity is really important because some medications behave differently in different populations so to bring safe and effective drugs to market we need data across a variety of types of patients. Diversity is at the core of our mission at Ancora.ai.
Q: Why should I enrol into a trial if my current medication is working well for me?
A: Trials are not for everyone, but we think it’s valuable to know your options so you don’t miss out on something that could benefit you.
Q: What’s the difference between the different trial phases and which one should I go for?
A: Later phase trials will have more safety and efficacy data behind them. We have some resources on Ancora.ai explaining each phase in detail and what the study looks like, how many patients, and why it is conducted. For a treatment to move to later stages it must be successful in earlier stages.
Q: What happens with my personal information and medical history if I register on a site such as yours?
A: We obviously can’t speak for other companies. As Ancora.ai we follow all applicable data privacy laws, such as GDPR, and only use the data for helping patients finding trials. More on this can be found in our privacy policy.
Q: Why are there so few trials for brain cancers or metastases?
A: The main reason is the blood-brain barrier, which makes it much more difficult to get treatments into the brain vs. other organs/tissues. So many effective treatments won’t work, meaning that treatments targeting the brain have to be developed with that objective in mind from the beginning (which will be seen in a trial’s eligibility criteria and listing details).
Q: How does it work with my normal doctors if I join a trial? Will I still see them?
A: It depends on the trial; some may require working with their team for the trial but most of the time your doctor is involved for standard check ups. Typically trial sites will work with your regular physician through out the trial process.
Q: Is it true that I will have to stop taking my current medication for a prolonged period of time before I can join a trial?
A: It depends on the specific trial, but often you have to stop taking a previous medication for 3 to 4 weeks before starting the trial to ensure that there is no impact on the treatment to be tested or drug-drug interactions.
Q: Is it true that trials take years to complete?
A: That depends on the phase of the trial, the condition, and the trial objectives. Moreover, as recruitment is a challenge, trials might be much longer overall than for a single patient who is enrolled.
Q: Trials seem to have very specific criteria for participation – is it worth the effort to try to look for one?
A: The trial eligibility criteria can definitely be overwhelming, but that’s why there are tools such as Ancora.ai that help you search more efficiently.
Q: Can I find out about the results of previous trials?
A: Yes, in most countries this is mandatory, although compliance varies somewhat based on our research. However, results might not be immediately available and will not be prepared for a lay audience. This is something you can ask about and should ask when discussing the trial with the sponsors.
Q: Will I be informed of the results of the trial I participate in? How soon?
A: Yes, you would be able to get the results of the trial. Unfortunately, there is no defined timing and it might require a proactive request from you. Note it could take months or years to get the results, depending on the trial and phase.
Q: Will the trial be able to consider my specific needs?
A: It is essential for a trial and the potential approval of a treatment that all patients are treated according to a standard fixed protocol. However, there might be some flexibility on some logistic aspects of the trial.
Q: Can I be disqualified from remaining on a trial?
A; As long as you participate in all aspects of the trial as planned, this won’t be the case. However, if you show major side effects, your participation will likely be stopped. Also, keep in mind that you can decide to leave the trial for any reason at any time of your own accord.
Q: What are the reasons why a trial might be stopped?
A: Trials can be stopped for many different reasons, e.g. lack of positive results, patients dropping out, lack of funding, etc.
Q: Will my insurance/NHS/cancer fund coverage change if I participate in a trial? Will I have to pay for anything?
A: Typically trials are free for patients to participate in, but this is something that can vary and is important to discuss. Sponsors will “sponsor” or pay for the investigational treatment. All direct costs of trials (treatment, diagnostics, care) are usually covered. However, any standard treatments or checkups that will continue, will still have to be covered as before by your normal insurance. Travel & accommodation costs might be covered, but that depends on the specific trial. If they are not paid for by the trial, there are many organizations that can help. There are HOPE lodges in the US for lodging and even internet/phone access support in the UK from SimPal, for example.
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