This program was co-hosted by GRYT Health and Ancora.ai
We were joined by Emily Jordan, PhD, from Ancora.ai and GRYT Health’s Chief Medical Officer, Dan Platt, MD. This program focuses on understanding the process and benefits of clinical trial participation, their importance in advancing cancer care, barriers to trial access and implications for health equity, how you can find clinical trials and common misconceptions about them.
This article is a text summary of the program that took place in July 2021. Below you can find the hour-long program, if you would rather watch.
As always, this program is meant to help educate and not replace any medical advice. If you have any medical questions, please talk to your healthcare team.
- What is a cancer clinical trial?
- What are the pros and cons of participating in cancer clinical trials?
- When should I be looking for clinical trials?
- Why don’t more people participate in clinical trials?
- How do comorbidities affect communities of color’s participation in clinical trials?
- Why does diversity matter in clinical trials?
- How can you find trial options?
1. What is a clinical trial?
Clinical trials are run to test the safety and efficacy of new treatments, especially compared to existing treatments. They facilitate the discovery and development of new therapeutics. Trials are how we get new treatments approved for use outside of research settings and into current best practice guidelines. There are 3 clinical trial phases: phase 1, phase 2 and phase 3. Each carries their own levels of risks and benefits.
Clinical trials are additive, meaning they are testing new therapies against the best existing therapy and, often, with the best existing therapy. The new drugs are used in combination. By joining a trial you will not be denied the standard course of treatment. This is the way medicine moves forward; it provides a clearer understanding of what treatment works and in what context. This impacts people of different ethnicities, races, and genetics. Genetics are now a huge part of how trials are done and move forward our understanding of the genotype of the cancer.
Additionally, clinical trials don't just look at drugs.They also look at behavioral changes. For instance, if you're in remission, there will be trials that look at potential ways to keep you in remission and prevent the cancer from coming back. Those may be drug trials, but they also may be trials of exercise and its impact.
2. What are the pros and cons of participating in cancer clinical trials?
- You could be one of the first to gain access to new drugs or therapy types
- Your care will include close monitoring by the clinical trial health team
- Your participation could benefit other cancer patients
In clinical trials you will have a high quality medical team who will be watching you very closely. It is a level of attention you might not get otherwise and could include extra tests, extra scans, extra diagnostics. Also clinical trials look beyond just efficacy, they also look at quality of life issues and what is more tolerable. For example, there might be new treatment schedules where instead of having an infusion every week, you could do an injection at home.
Beyond the above reasons, your experience improves science and benefits those who come after you. It is one other way to give back to the community.
- The treatment may not be effective or inferior to standard treatment
- You could have an adverse reaction or unpleasant side effects
- Clinical trials could include additional travel, appointments and other potential inconveniences
While clinical trials are highly regulated, there is still a chance the treatment received in clinical trials might not be better than the standard of care. Depending on the design of the clinical trial, you may not know which group you are assigned until after the trial. So if you wanted to try the experimental treatment, you may instead get the standard of care and you would not know until after the trial which one you received. Since the treatment is in the trial phase, there may be some adverse side effects that are discovered during the trial. Additionally, these trials may be inconvenient for some. They may require time off of work, additional travel and scheduling additional care for any dependents you care for.
Pharmaceutical companies are understanding the inconveniences placed on patients in clinical trials and are working to lessen the burden by offering financial compensation. This could be paying for travel, hotel rooms, child care, etc. Additionally, many advocacy organizations offer grants to help with travel or other ways to help differ costs. Finally, COVID’s impact has put pressure on pharmaceutical companies to use technology, such as telehealth, to make clinical trials easier for those who participate.
3. When should I be looking for clinical trials?
There is a perception that clinical trials are for late stage patients or when you've exhausted all of your other options. That is not the case, in fact there is a 95% chance, no matter where you are in your health journey and no matter what treatments you've received, that you will likely fit into some form of clinical trial or into patient experience research. Patient experience research is a growing field that focuses on understanding what the patient has been through in order to tailor drug design and drug trials better. The patient experience matters and is being listened to in order to move forward medical solutions. This is research GRYT Health currently focuses on.
Currently only 5% of cancer patients actually make it into a trial and it is important to emphasize that pretty much everyone has a potential to find a trial that might either work for you in the sense of getting a new therapy or work for you to better understand your experience and your cancer so that other patients diagnosed with your type of cancer can benefit.
4. Why don’t more people participate in clinical trials?
While clinical trials are essential to any development in cancer research and treatment, there are so many problems that make it challenging to participate:
Patients often have a hard time finding clinical trials and understanding the science behind them. Placing the burden on patients also means not many people hear about trial opportunities.
Physicians are often overloaded with paperwork, leaving them with little-to-no time to research all the existing trials, and are not affiliated with research hospitals, so they are not told about existing or new trials.
Both problems above lead to trial sites struggling to recruit eligible patients, resulting in delayed results and slower innovation for patients who need it.
There are online resources like clinicaltrials.gov, which is a very thorough database because the government mandates that all clinical trials have to be entered into this list. However this was designed for people in the field who are knowledgeable and understanding the technical language. It is not designed for patients to find trials. That is what is so helpful with Ancora.ai because it is conducive to making the information patients need easy to find.
5. How do comorbidities affect communities of color’s participation in clinical trials?
Due to clinical trials having very strict eligibility criteria, comorbidities and metastasis become a big blocker to diversifying trials. Populations that are more likely to have comorbidities are then unfairly excluded. More companies are becoming aware of this and are working to relax eligibility criteria.
The reason this happens is because pharma’s goal is to get a medication through clinical trials and to the market as quickly as possible. They want to make the treatment available more quickly for patients and need to recoup their expenses for running the trial. It is easier for them to get a drug to trial if they only test it in relatively healthy patients. Comorbidities and other things, like a brain metastasis, will introduce something that has to be accounted for. For example, patients with brain metastases will die at higher rates and the drug won't show its true benefit. So there is a need to convince pharma to let more people participate. While it will take longer and the process becomes more complicated, it is important to understand how particular drugs impact people who are in different places in their treatment. In 2017, the FDA recommended using subgroups with sub analyses to handle comorbidities, but it was a recommendation and not a mandate. It is a battle that we have to fight as advocates in order to get pharma to accept everyone into trials.
6. Why does diversity matter in clinical trials?
Right now about 5% of people diagnosed with cancer participate in trials. That rate is lower in certain groups: African-Americans constitute 5% or less of trial participants, Hispanics less than 5%, Asian around 3%. Participation in certain racial and ethnic groups are disproportionately low compared to their representation in the general population. If we don't study the medicine or new treatment in the population where it's going to be used, then some unintended consequences can happen. It is important to have a comprehensive understanding of treatment plans on the population who will be using the treatment.
This is a key reason why Ancora.ai is excited to change this and help more people find out about trials. One example of how this change is Ancora.ai’s collaboration with Tigerlily Foundation. With an integrated search portal on their website, their target population, young black women with breast cancer, can find clinical trials directly. Maybe they hadn’t thought of a clinical trial, but as they are looking on the page for information or for a support group, they will now get access to trials.
Most importantly, this change won’t happen until there is some socioeconomic change and changes in systemic racism. The ability to be in a trial requires money, time and wherewithal to find and have access. The lack of medical access is a huge reason why a lot of African-Americans in this country do not get the care they need. They are not getting screened early enough. When they do develop cancer, it is not getting caught until a later, more aggressive stage. A lot of that has to do with the system, and getting patients into a part of the system where they can get access to care earlier, where they can get screened earlier and access to elements of education. We don't have a great history in this country of how we have treated people of color in clinical trials and in research. Overcoming those trust issues is going to be a significant part of making trials more representative. Bringing patients, physicians and advocates together can hopefully move the needle on this.
7. How can you find trial options?
Ask your healthcare team! Ask early and often. Just because your medical team has not mentioned it doesn’t mean clinical trials are a bad idea. Oftentimes primary care physicians have limited time and don’t know all the trials that are out there. Nurse navigators and oncology social workers are amazing resources as well.
Empower yourself. Look at trial options on Ancora.ai, clinicaltrials.gov and other databases. Set alerts so you are notified if a new trial starts. Identify a short list of trials that are feasible for you and share them with your primary care team. Think about what fits your needs beyond eligibility criteria and the drugs offered. Prepare questions to ask your healthcare team. Finally, learn more about trials and novel treatments.
Thanks for reading! What should you do next?
- Want to connect with others? Our GRYT Health platform is a safe place for real conversations where you can connect with others who are going through what you are. Bonus! This is where you get to text with me, Vivibot, a mental health chatbot that gives a daily dose (~5 minutes) of guidance through positive psychology exercises proven to improve a human's anxiety after a month of use 💬
- View upcoming online programs and support group events. Our events page shows dates for online programs we have on the calendar made specifically from input by people like you! We <3 our community and listen to bring programs to life that they're asking for 💞
- Read cancer patient stories. Read powerful stories and experiences from our community members who have found their voice. Advocacy starts at finding and using your voice 📢