Cancer Drug Development & Clinical Trials: What Patients Need to Know
Featuring: Kevin Freiert, Owner and CEO of Salem Oaks
In short
Cancer drug development is complex and fast-moving, and patients who understand how it works are better equipped to evaluate clinical trials, ask the right questions, and advocate for themselves. Kevin Freiert, a 30-year Pfizer veteran and rare cancer survivor, walks through the real barriers patients face — from information overload and trial eligibility confusion to limited time with their oncologist — and explains what education can help.
- •Before joining a clinical trial, ask whether it will limit your future treatment options and what happens if you need to withdraw.
- •Clinical trials are not automatically riskier than standard care — understanding the phase of a trial (and what that phase is testing) helps you weigh the real trade-offs.
- •If you don't meet a trial's eligibility criteria, you can still ask questions and advocate for access; knowing the prerequisites changes your decision-making.
- •FDA pathways like expanded access, compassionate use, and right-to-try exist for situations where standard options aren't enough — ask your care team whether any apply to you.
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Brad Power May 8, 2024 “When I left Pfizer I started Salem Oaks to teach patients how pharmaceutical R&D really works, so that they can have a greater impact as they approach companies, academic researchers, or the FDA.
Meeting Summary
About 70% of cancer patients and caregivers are educating themselves about their disease and engaging in their medical decisions, but they are confronted with many challenges as they try to navigate their care, including their consideration of clinical trials:
•An increasingly complex cancer landscape : With a 94% increase in the number of cancer treatments available over the last five years, it is becoming more difficult for both patients and providers to stay up-to-date on rapidly evolving guidelines. The continuous approval of new tests and therapies means that what you know becomes obsolete every six months or so.
•Preconceptions about clinical trials : Many patients and caregivers consider clinical trials to be higher risk than standard treatments. They don't want to be lab rats in an unproven experiment.
•Difficulties in understanding the process of clinical trials : Drug discovery and development consists of multiple layers filled with dependencies, hidden risks, and changing policies. It's like a transportation system with land, sea, and air routes for various activities.
•Information overload : Patients and families have unprecedented access to information (97% of patients use Google), yet are overwhelmed due to the lack of information curation and medical education to interpret complex test results, treatment options, and molecular biology
•Limited time with doctors : Cancer patients have on average only 23 minutes with their oncologist, and healthcare providers are seeing an increased number of cancer patients. Tools for shared-decision making are essential to make that limited time as efficient as possible. Kevin Freiert, Owner and CEO of Salem Oaks, a healthcare education services company, is uniquely qualified to lead a discussion about the challenges and solutions for educating patients and caregivers about clinical trials. During his 30-year career with Pfizer, Kevin acquired a broad and deep understanding of the drug discovery and development process. He is a recovered rare cancer patient. He educated colleagues and others about pharmaceutical R&D, including establishing and running Pfizer Research University. Salem Oaks builds educational resources about pharmaceutical research and development tailored to the specific needs of patients. They have mapped out all the on ramps, roundabouts, express routes and service stations along the drug discovery and development journey. Kevin is the host of three podcasts: Raising Rare, LEMS Aware, and Improbable Developments. He has many educational sessions in his development roadmap. He wanted to learn about the biggest educational content gaps that patients and caregivers experience. What information gaps about drug development can hinder you from selecting your best treatment options? Evaluating Treatment Options
•Finding credible sources to evaluate treatments, assessing the credibility of research literature and claims about treatments, and quickly skimming literature and evaluating a treatment’s potential value. For example, reviewing information about the background to a clinical trial, such as the research on an animal model that led to the trial.
•Comparison of standard of care treatments versus treatments available through clinical trials
•Potential trade-offs that come with clinical trials, such as treatment limitations and consequences, or more frequent scans and blood tests. For example, if I join this clinical trial, will it limit me in my future treatments? Am I locked into this? What are the consequences if I drop out of the trial or do something different? Might I be prevented from pursuing other courses? Accessing Treatments
•Navigating the FDA regulatory process, especially for access, such as expanded access, compassionate use, and right to try
•Reviewing eligibility criteria to see whether you can qualify for clinical trials; knowing what the prerequisites are can change your decision tree
•How to access drugs off-label, e.g., drugs indicated by genomics rather than the cancer setting (tissue of origin)
•Assessing the timing of the availability of a drug through a clinical trial and weighing that against the likelihood of disease progression in the meantime Behaviors
•How to ask tough questions, how to advocate for yourself, e.g., how to make your voice heard if you don't meet the eligibility criteria for a clinical trial
•Examples of patient journeys, such as how a patient successfully advocated for themselves What resources should be available to educate patients and caregivers about cancer and drug development?
•Content available through multiple media: video, audio, written
•Bite-sized learning modules
•Online discussion board: a place to ask questions, lasting records of discussions
•Flexible and self-paced learning opportunities, tailored to individual pathways and needs
•Include examples to illustrate concepts What can you do to educate yourself about drug development?
•Explore Salem Oaks’ Atlas platform and provide feedback The information and opinions expressed on this website or platform, or during discussions and presentations (both verbal and written) are not intended as health care recommendations or medical advice by Cancer Patient Lab, its principals, presenters, participants, or representatives for any medical treatment, product, or course of action. You should always consult a doctor about your specific situation before pursuing any health care program, treatment, product or other course of action that might affect your health. Meeting Notes KEYWORDS question, clinical trials, cancer, drug discovery, drugs, patients, trial, put, work, courses, biotechs, cancer patient, oncology, treatments, information, kevin, process, company, access, pfizer SPEAKERS Kevin Freiert (69%), Brad Power (13%), Brian McCloskey (7%), David Plunkett (4%), Robert Gurmankin (3%), Sherrie Arsenault (2%), Cheryl Middleton (1%), Roger Royse (0%) SUMMARY Kevin Freiert discussed the challenges of navigating clinical trials and drug development for rare cancers and his personal experience. He explored the differences between clinical trials and standard of care, highlighting their potential benefits and drawbacks. Drug discovery has evolved and personalized medicine has increased, especially the importance of genomics in redefining diseases and fast-tracking drug approvals. There are many challenges in providing education in drug discovery and development, especially the need for personalized education tailored to individual learners' needs and pathways. OUTLINE Patient education on drug development and clinical trials.
•Kevin Freiert has a problem: prioritizing education materials for rare disease patients.
•He explains his experience in drug discovery and development, offering a subscription service with courses for those interested.
•Participants discuss their experiences with clinical trials and drug discovery, sharing sources of information such as Cancer Patient Lab and clinical trials.gov.
•Patients and caregivers should know where drugs come from to make informed decisions about clinical trials. Drug development challenges and personalized learning solutions.
•Kevin Freiert discusses challenges in developing educational content for rare disease organizations due to lack of funding.
•He identifies knowledge gaps and information overload in drug discovery and development.
•Solution proposed: bite-sized learning modules tailored to individual pathways and needs.
•He describes a subscription-based online learning platform with various features, including written resources, discussion board, and bi-weekly office hours.
•The platform aims to provide flexible and self-paced learning opportunities for members, with a focus on practical applications and lasting records of discussions.
•He outlines complex processes for drug discovery and development, emphasizing interdependencies and complexity.
•He explains the drug development process, including FDA regulations and company acquisitions. Cancer clinical trials and eligibility criteria.
•Patients should ask about potential treatment limitations and consequences before joining a clinical trial.
•Kevin Freiert discusses eligibility criteria for clinical trials, emphasizing the importance of making your voice heard if you don't meet criteria.
•He showcases the courses available on their website, offering exclusive content for members and a subscription program for access to more courses.
•He describes drug discovery and development, highlighting key concepts, such as phase 2 trials confirm drug efficacy and safety, while phase 3 expands on safety database.
•He shares personal experiences and insights from his career in the pharmaceutical industry, including the importance of understanding the regulatory view and clinical pharmacology. Cancer treatment options, including clinical trials and standard of care, with a focus on the advantages and disadvantages of each.
•Patients face a decision between standard of care and clinical trials, with pros and cons of each.
•Patients seek to understand trade-offs, such as more frequent scans and blood tests with clinical trials.
•Kevin Freiert discusses drug discovery and development in oncology, highlighting the importance of building on existing knowledge and using examples to illustrate key points.
•He discusses the use of artificial intelligence in drug discovery, highlighting its potential to analyze complex genomic data and identify specific cancer mutations.
•He believes pharmaceutical companies will adopt AI in clinical settings gradually, allowing the technology to mature first, and their current projects have been in development for years. Cancer drug development, patient education, and literacy.
•Kevin Freiert discussed the importance of evaluating research papers and understanding their methods and conclusions.
•He emphasized the need for patients to be able to quickly skim literature and evaluate its credibility.
•He highlights the complexity of cancer, with over 16,000 different diseases to consider.
•The group discusses the importance of asking tough questions and seeking credible sources of information.
Full transcript
Brad Power This is the Cancer Patient Lab. We're pleased today to have Kevin Freiert of Salem Oaks to talk with us. I ran into Kevin at a recent conference here in Boston which he was attending. He focuses on rare diseases. It was a rare disease conference. We've known each other for several years.
I got to know Kevin as someone who'd come out of Pfizer and the clinical trials process, and through a set of circumstances got into the business of helping patients understand how the clinical trials process works. He told me that the challenge he's facing is that he could develop 50 different modules of education materials for patients, but doesn't know where to prioritize, where to start.
I sometimes call our community “focus group as a service”, that we are a ready-made market research forum that can give feedback to startups, as we've done many times, or to someone like Kevin, who's got these kinds of questions. This is for information purposes only, it is not medical advice. Consult your doctor. We're trying to help arm patients with information they can bring to their doctors and their medical teams.
Cancer Patient Lab is a patient-led nonprofit learning community. We depend on the kindness of people who make donations of time and money. This is just a reminder that we would appreciate any donations that you can make. Kevin Freiert 2:33 Thank you for the opportunity to speak today with you. Brad mentioned to me that you were a group of people who know what's going on.
It was clear just from hearing one of the patient’s introductions before we started recording. I heard you're really tuned into your healthcare, your cancer, and the treatments you go through. I am a recovered rare cancer patient. I had a liposarcoma that was removed in 1998. That seems like a long time ago.
The only liposarcoma patients I've talked to since then were in much worse situations than I was, and I haven't been able to follow up with them. I think that we're primarily terminal. I spent 30 years at Pfizer, and a lot of that time was spent teaching people how drug discovery and development works. My scope is larger than clinical trials. My thing at Pfizer was I knew how the whole puzzle fit together.
I helped people understand how they depended on each other to get things done. It's a lot easier to win the game if you know how the game is played. That's what I set out to do. I'm trying to get some feedback from you, and also offer to you a service that we put together. I want to give you a little bit of background on it. We call it “The Atlas”. The long name is “The Biopharmaceutical Atlas of Discovery and Development”.
It's a subscription service where we're offering courses to people at the pace that they need it. I will just dive in and ask you guys some questions first. The first question I have for you is in general, how well do you guys already understand drug development, drug discovery, and development? For example, how many of you have been in clinical trials?
Have any of you met with the FDA or any other regulatory authorities talking about your situation, your diagnosis, or the treatments available? How about meeting with academic researchers? Anybody tried to get people starting to look at treatments that may not exist yet? Do any of you invest in the biopharmaceutical market? Roger Royse 6:33 I'll just offer that I'm currently part of an FDA expanded access application.
It's not a clinical trial, but it is a clinical research study. I'm getting a vaccine under that program. Kevin Freiert 6:50 Knowing what expanded access is knowing what the difference is between a study and a trial. Where have you learned about drug discovery and development before? Where do you get your information? Cheryl Middleton 7:18 I get most of my information from this and other organizations.
My brother has prostate cancer, and our father died of it. I've had breast cancer, and I'm being watched for multiple myeloma. So I sign up for information from those sites. But that's about it. Brad Power 7:40 At Cancer Patient lab, we use Massive Bio, which is a free service. If you give them consent to give them access to your medical records, they will tell you about clinical trials.
gov, and you define a geography that you're willing to travel. Then they give you the best clinical trials for you. We get similar services from Cancer Commons.
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