Note: This is a edited version of my submission to the U.S. Department of Health and Human Services (HHS) call for public comment on changes to the Common Rule, which governs research on human subjects in the US

In April of 2015, at the age of 29, I was diagnosed with advanced EGFR+ lung cancer. Although this condition is rare in a person like me, younger, athletic, never smoker, I am tragically not alone. Hundreds of young adults like me will be diagnosed with incurable advanced lung cancer in the US. Many multiples of that number will be diagnosed with diseases like mine that are not very treatable and fatal.

Recently, my cancer has recurred on first line EGFR inhibitor therapy. As I consider the next available treatments, it is clear that none are particularly good options. A next generation EGFR inhibitor will probably only buy me another 7 months to a year. There are no targeted therapies in line after that. Traditional chemotherapy is not only very toxic, but not very effective for lung cancer. To my oncologist and me, the best treatment option would be a combination of targeted therapies, a new treatment that no patient has ever received before.

For me, research on clinical subjects are not an abstract quest for greater understanding. The advancement of science is my only hope to stay alive. For me, research and science are treatment for my deadly disease.

Thus I have a few major concerns about the Common Rule:

Speed up the IRB review process so that patients can access lifesaving clinical trials

A primary tenant of the Common Rule is an Institutional Review Board (IRB) weighing that the risk and benefit to a participant of a research study are proportionate. Yet how qualified is a committee to make this decision? Are they more qualified to assess benefit than my doctor, who has devoted an entire career to studying a disease, and has become a world expert? Is the committee more qualified to assess risk than me, someone who has studied my disease literally like my life depends on it, and will have to live or die with the consequences of enrolling in a clinical trial?

Is it the responsibility of the committee to consider the potential risk and benefit for every individual participant? Does the committee consider the benefit, in terms of life years gained, of discovering a durable treatment for someone who is 30 with advanced cancer is greater than someone who is 70, the average age of a lung cancer patient? That the body of a 30 year old is more able to withstand drug induced toxicities, lowering the risk? That cancer in younger adults tends to be more aggressive, but aggressive cancers also tend to be the most responsive to treatment? And that younger lung cancer patients are far more likely to have molecularly targetable mutations in their tumor?

The IRB cannot and does not take these considerations into account. Committees in general tend to be conservative. In reality, these committees try to reduce the risk of the study doing harm to the participant to zero. They often overlook that the benefit to the participant and society is also minimal to none.

The only way to reduce the treatment risk to zero, is to provide no treatment at all. This is what is occurring in clinical research. The focus is so much on protecting the patient from the study, that protecting the patient from the disease, and protecting society from the disease, is completely disregarded. This drive to reduce the risk to the participant has led to the vast expansion of scientific understanding of the molecular basis cancer with very little translated to the clinic, and very little change in clinical outcomes.

We do not lack the knowledge. We do not lack drugs. We do not lack the courage or the will. We lack the permission.

In many top research institutions, labs are right next door to the clinic. The intention is that new findings in the labs can be immediately translated to the clinic. The fathers and mothers of these great institutions must have never envisioned the clinical research process today. If they had, they might have put an IRB conference room in between the clinic and the lab.

Every new study that is released reveals that cancer is a far more heterogeneous disease than it was ever considered as in the past. Research for the new age of cancer treatments will require clinical trials that are as diverse as the disease itself. How would the Common Rule have to look to support studying cancer as if every new patient had a ultra rare disease specific to that patient? That is what science is telling us about cancer. We need to listen and adjust how we study this disease accordingly. How can we possibly test personalized therapies for cancer when the disease moves faster than the scientific process to create the treatment?

Please consider changes to the common rule that aim to protect me from my cancer, not just from physicians and scientists trying to help me. I strongly urge the committee to add an exclusion to the lengthy IRB review process for diseases which are expected to be fatal within one year. At the very least, to provide transparent, expedited review process which is visible to the public and guarantees response with some reasonably short timeframe, such as 48 hours.

My cancer will not wait for IRB review. My treatment should not wait either.

Open access to research data

Although nearly 600,000 Americans will die from cancer this year, it receives a fraction of the research funding that defense does. This is our political reality. Every dollar spent on cancer research needs to be stretched. Since the age of the printing press, we have known that we can multiply scientific impact by sharing our research. With the internet, we can share not only the distilled research results and conclusions, we can share the raw data. All publically funded research should be available in both research paper and raw data format for free on the internet. Researchers around the world can mine this raw data for new research. Researchers should be able to freely combine the data from several studies and draw much stronger conclusions.

Patient access to their own health data

The findings of research should also be given back to the participants. The wording of the common rule should not discourage data sharing.

In 2015, I had the opportunity to participate in the Profile research project at Dana Farber Cancer Institute where I contributed my tumor for next generation sequencing of 275 cancer related genes. Five months later, the sequencing data was ready. In the meantime I had switched oncologists, and hospitals, across town to Massachusetts General Hospital.

There was one problem - the data was not allowed to be given to me! In order to pass IRB review, the study could not share the results of the testing with the patient, for fear that simply having the data could harm the participant. Of course, they were assuring that I could in no way benefit from the research either.

Realizing the absurdity of the situation, my oncologist at Dana Farber, within the protocol of the study, but through a loophole, was able give me the data verbally over the phone. I immediately made an electronic document shared the results with my current oncologist. We are using this information to guide my future treatment plans.

This is a winnable war

Although I have a fatal disease, I remain as I was: a science and technology optimist. Everything I learn about cancer reinforces my belief that this is a winnable war. The question is how long it will take, and how many lives will be lost. Today, we need aggressive, diverse, optimistic clinical research to translate our lab findings into the clinic. The shackles have to be taken off our investigators. Patients as participants have to be entrusted to understand the risks and the benefit. We have to share our research findings with the world freely online. And we need to empower patients to act as partners by allowing them to act as the custodians of the health data they rightfully own.

Thanks to Amy Li who proofread this post