In this episode, Libbi Rickenbacher of 4G Clinical’s Trial Trends podcast is joined by Brad Power, Founder of CancerHacker Lab, to discuss what can be done
You Need to Choose Your Best Treatment Options, Tailored Uniquely to You, Based on as Much Health Data about You as Possible
Here’s how you should decide what your best cancer treatment decision are, and the challenges with each step:
- Standard of Care Guidelines: You and your trusted physician should first look for treatments that are well understood, with lots of experience, and backed by solid evidence. Side effects are known and the protocols for dealing with them are also part of the standard. The gold standard of evidence is the prospective, double-blind, randomized clinical trial. There are two challenges with the standard of care guidelines: adherence and updating. You should rigorously and consistently follow the standard of care guidelines.
- Tumor Board + Algorithms (Clinical Trials): When there are no clear pointers to a standard treatment pathway (as above), you and your physician should look for newer treatments with some evidence of effectiveness and safety, usually within controlled research investigations in which people volunteer to test new treatments (“clinical trials”). If no clinical trials look attractive or are hard to access, evidence obtained from observing patient experiences during routine clinical practice and outside of clinical trials (“real-world evidence”) may be used to identify and select treatment options. Because such decisions are based on some evidence, but less evidence than the standard of care, decision teams are needed (“tumor boards”), enabled where possible by algorithms and tools, such as systems which match people with clinical trials. The challenge in this case where there is some evidence, but not definitive evidence, is the complexity of the decision-making. Another situation which requires a team decision (“tumor board”) is when there are many potential pathways for the patient to consider, such as sequencing or combining treatments.
- N of 1, Hackers: You should look for therapies outside the standard of care or a traditional clinical trial when your cancer is extremely rare, standard treatments have been exhausted, or the benefits of unusual approaches outweigh harms, such as the prospect that a young patient with a brain cancer will die in nine months. The U.S. Food and Drug Administration (FDA) offers an “extended access” process, made famous in helping HIV/AIDS patients get faster access to new therapies, which can enable you to effectively get a clinical trial just for you. A doctor prepares the paperwork for an investigational new drug; the FDA approves 98% of these requests; the pharmaceutical company provides the drugs; and you can’t be denied coverage. The challenge in this case is finding a possibly beneficial treatment option when all standard treatment options and clinical trials have been exhausted. Only a relative few will try unorthodox approaches, such as “off label” uses of existing drugs, cocktails of drugs, or “alternative medicines”, like mistletoe, or Vitamin C injections.