Please be dying, but not too quickly, part 3: the end of the journey

On disease progression, screening, getting into a trial at UCSD, why the clinical trial process is so awful, and how it can improve.

Part 1 is here: A clinical trial story. This is Part 3.

Part 2 is here: The patient’s perspective.

If you need help finding a clinical trial or you’d like to get in touch to talk more about how we can make this process better please reach out to DrBStillman@gmail.com. I’d love to talk.

Progression: Please be dying, but not too quickly.

We had a call with UCSF on Aug 11. UCSF had the same Moderna study as University of Chicago. Our initial talk with UCSF seemed promising, and it happened in mid-August, when most of these appointments occurred. Recall that Jake got CT scans on July 21, showing the new recurrences and metastases.

One of the more bizarre eligibility criteria for many of the clinical trials was “confirmed signs” (usually via CT) of “disease progression” on the current treatment regimen. But why would disease progression matter? Current treatment regimens are stopped when a patient enters a trial and HNSCC isn’t cured by chemotherapy. Jake had exhausted surgeries and radiation: he was and is going to die of HNSCC whether or not chemo gives him another few months. It makes more sense to start on a study drug and see if that could lead to something more durable than the few palliative months from chemo.

Between May 25, when Jake underwent a devastating total glossectomy that removed his entire tongue and part of his larynx—while also removing all of the visible cancer—and July 21, Jake had re-grown four new tumors in his neck, and the cancer had metastasized to his lungs. How much more progression did he have to show? How much more progression before he was dead? But, according to the study PI, since Jake had received one dose of chemotherapy (which, if you recall, had been scheduled before we even knew of the recurrence and was meant to kill off any cancer cells left over from surgery), the “progression” clock had been restarted, because even one dose of chemo was considered committing to a new line of therapy. But he needed the chemo to try to stabilize the tumors so he had time to find a trial, yet in doing so, he now had to show progression on the chemo—thus delaying his ability to get into a trial. If he hadn’t gotten that single dose of chemo, he would have been immediately eligible based on progression between the May 25 surgery and the July 21 scans, as well as the failure of Keytruda.

On August 13, Jake’s local oncologist was willing (at our request) to get a short-interval CT scan in an attempt to show “progression” from the July 21 CT scan. Usually, restaging scans are spaced at least two months apart, but it was imperative to demonstrate any tumor growth, if it was happening, as soon as possible. One month of demonstrable growth while on chemo might be Jake’s trial entry ticket. Two months of growth might mean his death or debility so severe he became ineligible for a trial. The August scan found that, in the neck, “The size has not changed significantly since 7/21/2023.” But the chest CT scan found: “Multiple bilateral lung nodules are again evident, number of nodules not clearly changed from several nodules particularly on the left side, are measurably enlarged compared to previous, most notably a 7 millimeter oblong nodule in the peripheral left base, although the slight changes in these nodules are within measurement error. Nevertheless, the appearance of growth of nodules is more conspicuous when compared to PET scan 4/26/2023.”

The finding was ambiguous but, arguably, the lung nodules had progressed.

A week after the initial UCSF call, we heard back from the oncologist we’d talked to: UCSF’s tumor board decided that Jake’s cancer hadn’t progressed enough from July 21 to August 13 to merit trial inclusion. To UCSF, Jake wasn’t dying fast enough. I call this “please be dying, but not too quickly,” because patients who are too sick are often excluded from trials. If you’re not expected to live at least twelve weeks, you’re generally out. Things like brain metastases can be used to exclude, too, as can limited mobility and ability to care for yourself.

The progression tango and the UC San Diego Medical Center: That’s progression enough for us!

On August 10, during our telemedicine appointment with UCSD, we learned that the trial for MCLA-158 / petosemtamab, which had moved to number one on our list thanks to Dr. Katherine Price’s comments, and which had been closed when I reached out in July, had re-opened! The window was small but Jake had officially established care—was it possible that he could snag a spot before they filled or closed to new patients again? Preliminary study data for petosemtamab was incredible. 37% of patients, who had already failed standard of care therapies, saw tumor reduction! One woman saw the complete resolution of her tumors. One is more than zero, and those were better odds than any other data had hinted at. This trial was the exact reason we were putting in so much effort. There had to be a way in.

And those Aug. 13 CT scan results showing minimal progression of the lung mets could be our way in.

A quick review of where the other trial sites stood: the U Chicago people decided that Jake’s progression from the time of surgery was enough, and they didn’t want to see images. MSKCC didn’t have study slots and required progression, but the oncologist at MSKCC put Jake on the waitlist for BCA-101 anyway, since he was willing to stop chemo by choice at any time (more examples of PI variation in interpreting the same patient data and eligibility). Hackensack said the Aug. 13 scans meant he was failing enough for them. Honor Health in the Phoenix area? Failing enough. The National Institutes of Health: Not failing enough.

This variability between PI’s is another reason why establishing care at multiple sites, some with the same trial you’re after, is important. It’s not enough to find one good trial and establish care at one site. Spots become available at different sites at at different times, and PI judgment plays a role. Of sites with the Moderna trial (U Chicago, UCSF, U of Colorado) where Jake established care, only the U Chicago offered Jake a spot, despite all having identical clinical information.

UCSD was convinced by the Aug. 13 results, which, to them, showed an acceptable amount of progression. I overnighted UCSD the official CD images of the Aug. 13 CT scan  and they replied: we can consent you for the trial tomorrow.

This dopamine surge was the largest yet. I was euphoric. A feeling Jake has described as “hopium” (a portmanteau of hope and opium). Our first choice. He  would consent for our first choice.

The next morning, we did the UCSD consent remotely (which, you’ll remember, some sites say they can’t do, or won’t do), signed via DocuSign, and began the process of scheduling the screening exam. I updated the other hospitals, so that their doors remained open should Jake be found ineligible on screening tests, or if he progressed on the petosemtamab and needed to pivot to a different trial.

The maddening journey so far

What it took to get to the point where Jake received the consent talk from UCSD: Without Eileen making the spreadsheet of 500 potential trials, without the 300 plus emails and phone calls to suss out information from investigators and clinical trial sites, without a PI emailing me back that the trial we wanted at UCSD was closed by would open again in a few weeks (that it opened up two days before we called was luck), without telemedicine visits that meant we didn’t decline a visit to UCSD in order to go to a site that we knew had an open slot, without knowing to ask to move up Jake’s imaging to prove early progression before the trial spots filled up—Jake wouldn’t have been offered a spot in the trial. The preceding sentence is deliberately exhausting.

In retrospect, I wish I’d started researching clinical trials before Jake’s May 25 surgery so that we could’ve been prepared for the worst, and I wish I’d started establishing care back then for the same reason.

The right hand doesn’t know what the left is doing

Before moving on to the next part of our story—the screening period—I want mention something I was surprised by: The right hand of clinical research didn’t seem to know what the left hand was doing. Researchers didn’t have their own spreadsheet or databases of active trials. They didn’t know what trials were going on down the street. Sometimes they didn’t know what trials were going on in their own (very large) departments. They were able to screen Jake for studies at their own institution but, they didn’t regularly say, “you know, we don’t have a good study for you here, but there’s one at XYZ hospital two cities over that might be better for you.”

Jake’s primary oncologist at Mayo told us there weren’t any trials applicable to his case at the Mayo Clinic. But he didn’t tell us that Honor Health, twenty minutes away, had a large clinical trial department that would be useful, and that we should establish care there. Most patients wouldn’t know that Honor Health in the Phoenix metroplex has a good clinical trial program. We wouldn’t have known that, either, except that one of the trials on our ClinicalTrials.gov NCT spreadsheet was being hosted at Honor Health, so we scheduled that early appointment. Only then did we learn that Honor Health in Arizona is a large phase 1 trial center.

For investigators, and many oncologists, the research landscape is their world, but most seemed isolated on their own research islands. There were a few trials I’d e-mailed PIs about, who were at the same institution, and who were unfamiliar with one another’s studies for the same primary cancer! Maybe this is a testament to the sheer quantity of early phase 1 trials out there, which compose the vast majority of trials. It would be hard to track them all, and mostly useless to, since the bulk don’t make it past phase 1.

But quality phase 1b expansion arms or phase 2 studies are rarer, and recommending categories of trials makes sense too. For example, “We don’t have one here, but if you come across a trial using a bispecific antibody, those have had some promising data behind them.” That kind of guidance came from Eileen, but not from the medical community, even those who knew I have a biochemistry background and that Jake is scientifically literate.

A researcher at Sarah Cannon in Denver told me that even the Denver site doesn’t know what the Nashville or Florida sites are doing. Sarah Cannon is a sort of international research chain. The McDonald’s of research centers, you’ll find them across Europe, too. The oncologist we talked to was extremely helpful. You can look the information up through judicious searches on ClinicalTrials.gov, but there’s no easy internal system between hospitals, or regions. The primary mode of sharing research information isn’t real time access to a wide variety of studies and availability across institutions, but large conferences as well as online oncologist communities, where information is shared much in the same way I approached my online physician communities to get advice.

Information siloing may be why “hospital first, trial second” seems to be common advice. When you’re at hospital A, and familiar with what your friend at hospital B is up to, you’re more likely to recommend hospital B because you have some idea of their research offerings. That’s what was happening when the physician at MSK told us that she didn’t have an available spot in the BCA-101 trial but would ask her colleague at Dana Farber to put us on the Dana Farber waitlist. She didn’t ask for us to be put on the other 12 possible waitlists, because she didn’t have connections at other sites. Similarly, we were referred to UCSD by some oncologists not because of the MCLA-158 study, which was what we were after, but because the other oncologists thought that the researchers there had a reputation for doing a good job, and tended to do more cutting edge work.

If one hospital thinks a patient would be a good fit for a study, but their study arm is closed, wouldn’t it be beneficial to the drug company to recommend other sites? Shouldn’t sites coordinate with each other? That way, the overall trial can more quickly fill a given study with  eligible patients. While the site oncologists and PIs will remind you that they’re not working FOR the drug companies, they are beholden to the drug company rules, as well as the company having the final yea or nay on trial participants. Why wouldn’t the drug company want to connect a good patient, who’s dying at just the right rate, with a different site, fulfilling their needs faster? I tried contacting various drug company trial contact directly, to see if they’d provide me with a list of all sites and openings, but, like Moderna, I was only able to get contact information. I couldn’t get real-time information about availability, not because it didn’t exist, but because no one would give it to me.  

I’m not sure why this is, but I have a few ideas—all of them are unflattering. Primarily, that the secrecy and confusion is about money, and industry secrets. Pharmaceutical companies don’t know if I was a patient calling for that information, or a competitor.

Making this information public and easily accessible would allow competing companies to track where others are in their studies, how far along they are in data-gathering, and other information which, I’ve been told, companies pay large quantities of money to try to glean. Ultimately, pharmaceutical sponsored drug trials are races to make money, even if, in the process, the product benefits patients.

Maybe by isolating the various trial sites, pharma companies prevent the researchers from sharing industry information with pharmaceutical companies supporting other studies at the same center. I doubt too many doctors are going to be bothered with engaging in industry espionage, but I also don’t know what the going rate for a physician investigator is, so couldn’t say for sure.

Screening Time

In August, Jake signed consent forms for the MCLA-158 trial at UCSD, but he wasn’t officially in the trial.

Although the earlier parts of the study-finding process felt like a battle royale, the screening process wasn’t competitive, and he was scheduled for screenings on Sept. 5 and 6 at UCSD. Jake’s spot would only be released to someone else if he didn’t make it through the screening portion. In the meantime, another patient can’t finish their screening tests faster and take the last remaining spot, at least not until someone finds a way to televise the process and let people place bets on it, but I’m getting overly dystopian here (this process will cause dystopian thoughts).

The typical screening period lasts up to 28 days, which seems standard across most studies, and the only way your spot is lost is if you don’t meet eligibility criteria based on the new labs and imaging. It’s possible that, at any point during this process, you can be told “no.”

Here’s where things get interesting, or terrifying, depending on your view: the screening period has to be completed within 28 days before the first dose of study medication. This gives the hospital time to schedule your tests and images. These tests might be performed 27 days prior to the first anticipated dose of study drug, or three days prior.

But most trials also require a “washout” period separating the patient from the last dose of some other treatment. In Jake’s case, that meant time between chemotherapy and pembrolizamab, which he’d gotten at Mayo on July 24 and August 14, and the trial drug(s). The time period is meant to “wash out” the old drugs from your system, so that they don’t interfere with the new study drug. The time period might be based on half-life of your old drugs, or, like so much else in clinical trials, it can be kind of arbitrary.

For the MCLA-158 study, the washout period initially appeared to be four weeks. Exclusion criteria for the study says that patients may be excluded based on:

 “Systemic anticancer therapy or immunotherapy within 4 weeks or 5 half-lives, whichever is shorter, of the first dose of study drug. For cytotoxic agents that have major delayed toxicity (e.g., mitomycin C, nitrosoureas), a washout period of 6 weeks is required.”

The half-life of Jake’s chemo is relatively short, and “Pembrolizumab (Keytruda) has an elimination terminal half-life of 27 days.” Moreover, the language of the exclusion criteria says “whichever is shorter.” Jake wasn’t taking any cytotoxic agents that have major delayed toxicity.

By our reading of the criteria, Jake could have his last dose of chemo and pembro (which lasts three weeks), and go one week without any treatment. But then Merus—the petosemtamab drug company—apparently increased the washout period to six weeks sometime after Jake signed consent. As of this writing, the clinicaltrials.gov language appears not to have been updated. For rapidly growing tumors, a six-week washout period seems bad because of the length of time without treatment. The oncologist at UCSD agreed and said: “We’ve explained to the drug company that this increase in time isn’t necessary, but we have to follow their rules. They don’t listen to the doctors.”

Jake was scheduled for more chemo and pembro on Sept. 5, but we cancelled that appointment and instead bet on Jake passing the UCSD MCLA-158 eligibility tests. We told other clinical trials we were likely going for the UCSD petosemtamab trial. But if Jake wasn’t accepted for some (possibly arbitrary) reason, he’d have skipped the chemo that was likely, to some limited extent, keeping his tumors in check—and we’d have to re-start the “seeking a trial” process.

For MCLA-158, Merus and UCSD wanted:

• Overall normal lab work

• An MRI of the brain proving no leptomeningeal disease, and no brain metastasis requiring radiation or steroid therapy

• An echocardiogram of the heart showing LVEF (left ventricular ejection fraction) of over 50%

• Life expectancy over twelve weeks, per investigator

Other tests included a bone scan to look for further metastases, and repeat CT scans of the neck, chest, and abdomen.

Repeat scans made me nervous. Inclusion criteria included visible disease on CT, which we knew Jake had. But what if Jake’s tumors had shrunk between Aug. 13 and Sept. 5? Would that disqualify him?

I was too afraid to ask. Fortunately, the screening went smoothly, and, once screened, we were told that the final step was the submission of Jake’s case to Merus. That was supposed to happen by Sept. 14 or 15 but didn’t until Sept. 18 or 19. On Sept. 20, we finally got word that Jake was officially a study participant. The drug went into his vein on Sept. 27. When the infusion started, I took what felt like the first full lungful of air I’d had in two months. I hadn’t even realized I was breathing shallowly, as if I could scare away Jake’s study slot just be breathing too loudly, or wanting it too badly.

Today, the tumors in Jake’s neck are visibly bigger, and his skin is edematous. It’s like he’s becoming a frog, though he won’t yet ribbit for me, and doesn’t like being perpetually damp.    The CT scans performed on Sept. 6 didn’t show new growth in Jake’s neck tumors, but I’ve seen his neck grow in the weeks since. The median time to response for MCLA-158 is 1.8 months, or seven weeks. His first restaging CT scans will be at the end of November. We’ll see if the work to get Jake into this trial will result in more months, or (when I dare to hope), more years.

Alternately, was it simply something to try and then we’re back to the Excel spreadsheet? He’s broken out in a terrible rash, something that’s been correlated with a positive response to EGFR inhibitors in colon cancer, so I’m hopeful. Or, rather, I was hopeful, until I mentioned that study to his UCSD oncologist, Dr. Sacco, who said that HNSCC doesn’t show as much correspondence between rash and effectiveness. Damn.

Why is this process so awful?

If you’ve made it this far, you may be as angry and frustrated and baffled by the process as us. You might be starting, or be in the middle of the process yourself—in which case, please refer to the guide I’ve included at the end to outline some concrete steps you can take to make things easier. 

From what I can tell, the motivations of pharma and the FDA aren’t the motivations of the patient. To understand why, we need to step back a bit. As far back as 2003, 75% of all clinical trials were sponsored by pharmaceutical companies. In 2019, the pharmaceutical industry spent 83 billion dollars on Research and Development, 10 times what it spent in the eighties.

Because so much money is at stake, drug companies compete for FDA approval and market share. Guarding not only the results of trials, but where a company is in the trial process in order to prevent other companies from making inferences about the efficacy and outcomes of a certain drug, may be the difference between nothing and billions of dollars. Even the PI hosting a trial often don’t know in real-time if a participant spot is available (for example, U Colorado requesting a spot for Jake in the Moderna trial and then finding out two days later the study was closed by Moderna to new participants). But hiding this data from competitors also means that it’s harder for researchers, physicians, and patients to access data that could help them make a trial decision.

Additionally, in the attempts to make it to the high-payout finish line that is FDA approval, drug companies look to test drugs on patients who produce the best trial results, which are the patients who are the healthiest—although this preference skews real-world data and excludes vast swaths of patients.

Dr. Gary Lyman of the Fred Hutch Cancer Center says:

“Patient participants who are extremely healthy despite a cancer diagnosis produce the best trial results. Not surprisingly, pharma prefers these patients.They want to put their best foot forward by only using low-risk patients in trials. If they have their choice, they want Olympians on their studies.”

National Cancer Institute Director Dr. Ned Sharpless says:

“We don’t need needless eligibility criteria,” said NCI Director Dr. Ned Sharpless during a recent virtual conference on modernizing cancer trials. “Even the pharmaceutical industry is starting to accept it’s bad for everybody — for patients and for progress. The eligibility has to make sense for the trial. [Eligibility criteria] are important to include, but you can’t just copy and paste them from your last trial.”

But they can, and they do. Eligibility requirements often seem arbitrary, as do washout periods.

While the patients in the clinical trials are hoping for a miracle, the clinical trial isn’t really for them. The trials are really for the patients who will be treated by the drug in the future after it comes to market, and for the FDA, who has the final say in whether a drug can come to market, and, therefore, make a pharmaceutical company a huge quantity of money. The FDA’s arbitrary behavior and standards are legendary. Ostensibly, the FDA is waiting for the safety profile to be established, but the FDA has a storied history of being slow, filling up the invisible graveyeard with patients waiting for drug approvals.

“Safety” sounds great, but the FDA is providing safetyism. There’s a process by which the FDA can fast-track a drug based on promising early-phase data, allowing the drug to come to market contingent on confirmatory trials. In exchange for accelerated approval, pharmaceutical companies will perform follow-up studies collecting additional data. The drug companies can use the drug, but they don’t always fulfill the obligations to complete additional safety testing. This kind of wild-west “give it a try” approach extended to the drug companies by the FDA isn’t extended in kind to patients who want to try certain off-label uses of established drugs of therapeutic interventions.

We ran into this problem when trying to develop an n of 1 trial for Jake

Because it seemed like there was a good chance that we wouldn’t be able to get Jake to the right trial, I wondered if we could simply build the right trial for Jake, as the only study participant (n of 1).

If Jake had been one of the 20 – 30% of R / M HNSCC patients who responded to pembrolizumab (otherwise called Keytruda—an immunotherapy), then his disease might have been controlled for years. There’s compelling early evidence suggesting that gut microbiome plays a role in whether or not a patient responds to Keytruda. Researchers at University Pittsburgh Medical center collected fecal samples from melanoma patients who responded positively to Keytruda and then performed a fecal transplant (you can do this via pill, a colonoscopy, or a special type of enema) into patients who didn’t respond to Keytruda. Nearly 40% of patients who weren’t previously responding began to respond. This is astonishing. Further studies confirmed immunologic changes associated with gut microbiome alterations.

A fecal transplant from a responder could save Jake’s life. I brought up the idea with Jake’s gastroenterologist at Mayo, Dr. Jamie Bering, who was immediately on board. But even with her enthusiastic support, we immediately ran into trouble, because the FDA had cracked down on off-label use of FMT for anything other than treatment of a bacterial overgrowth called C.diff, due to two deaths associated with FMT-related infection. 10,000 FMT procedures for C.Diff are performed annually. Because of this increased oversight requirement, the Internal Review Board at Mayo Clinic would have to okay the procedure and the process of finding a donor, despite already having the only patient’s consent, and a physician willing to perform the procedure. It wouldn’t be enough for Jake to decide he was willing to take on potential risks, the IRB would have to tell him he was allowed to consent (we are still waiting for a reply months after submitting the request). The stool donor would need to give a stool sample and undergo screening blood tests, but otherwise not undergo any dangerous, invasive procedures. Jake could, instead, undergo a fecal transplant from a general healthy donor if he pays out of pocket—as insurance wouldn’t help cover off-label use due to the FDA’s hesitancy—but then the potential benefits of gaining the microbiome of a Keytruda-responder, which is the whole point of the procedure, would be lost. But to find a donor who is PD-1 responsive, even if we offered to cover the screening costs ourselves, the hospitals’ ethics internal review board would have to okay the process and we wouldn’t be able to start looking for Keytruda responders who might just feel like helping another patient without their okay.

Luckily for Jake, the FDA and IRB will protect him from being one of the 2 in 10,000 patients who died from a fecal transplant by denying him this potentially life-saving therapy so that he could have a 99%+ chance of dying from his cancer. I feel safer. (Dr. Bering is wonderful and is still working on the process for us, so that if Jake fails MCLA-158 he may have one more chance at survival. We are currently 3 months into awaiting an IRB reply).

It's awful because doctors aren’t guiding patients and patients can’t get to doctors, anyway.

Other doctors are as confused by the clinical trials process as I was. The obfuscation of information such as study availability, early data, and ways to streamline the screening process and integrate the trial with the patient’s ongoing treatment plan leads to a lot of, well, nothing:

 In research conducted by the Tufts Center for the Study of Drug Development, it becomes clear that the problem is about communication. About 90% of physicians surveyed said they feel comfortable discussing clinical trials with their patients, while less than 0.2% actively refer them to studies. These doctors reported that they lack access to trial information (54%), do not know where to refer patients (48%), or do not have the time to learn about active trails (33%). 

We should have telemedicine legalized across state lines for clinical trials. A national medical license would solve the problem of out-of-state trials, but groups of doctors have been begging for this for years to make their lives and their patients’ lives easier—and it just won’t happen. Probably because it would involve state boards ceding a lot (a lot) of money and control, but it would be so much better for doctors and patients both, neither of whom are at the center of the healthcare system (that’s another essay for another time). The VA proves that it can be done in a 11/12/2020 ruling on the “Authority of VA Professionals to Practice Health Care” :

Specifically, this rulemaking confirms the VA's current practice of allowing VA health care professionals to deliver health care services in a State other than the health care professional's State of licensure, registration, certification, or other State requirement, thereby enhancing beneficiaries' access to critical VA health care services.

I’m no great fan of large federal institutions, as my complaints in this essay (and others) about the FDA suggest, but the VA licensing does licensing right, or at least better.

It's awful because it’s expensive and inconvenient

The NIH is doing clinical trials relatively well. The researchers there returned e-mails, I spoke with the coordinators on the phone, submitted Jake’s medical records and imagine remotely, and was pre-screened and provided a list of studies for which he would be eligible. The NIH also provides the study drug they’re researching (which all trials do), but it also covers costs of flights and hotel so the patient’s financial barrier to entering the study is decreased. If the NIH can, so can the pharmaceutical companies. 

Right now, the pharma companies only have to provide the study drug, and the cost of doctor’s appointments and testing that wouldn’t be required outside the study. Cancer patients and their families are already burdened with astronomical medical costs and decreased income (theirs and their caretakers’). Choosing the ideal clinical trial might sound good, but if you can’t afford to travel to the treatment, it might as well not exist.

Clinical trials are already performed at multiple sites, with PIs being allowed some degree of discretion. Why not perform trials more sites? There could be a few geographic central hubs, with PIs who oversee the data and the medical records of patient’s taking part. Meanwhile, the screening period could occur at a patients’ home institutions: none of the tests that Jake traveled to UCSD for couldn’t have been done at Mayo. Maybe one day the study drug could just be sent to the infusion clinic at Mayo and he could receive the infusions twenty minutes from home. If in-person visits are required, they could occur at less-frequent intervals, for testing or evaluations that can’t be done remotely.

As clinical trials include more real-time data on biometrics using wearables, the amount of safety and efficacy data that can be collected even remotely vastly increases, and the limitations—for patients, researchers, and pharma companies—vastly decreases.

There’s a future that can support the interests of patients who are willing to take part in trials, the patients who will benefit from the results, the doctors who are trying to do what’s right for their patients, as well as the interests of the pharmaceutical companies supporting the trials.

There’s a better path. We’re just not on it. Yet.

If you’ve gotten this far, consider the Go Fund Me that’s funding Jake’s ongoing care.

Part 1 is here: A clinical trial story. This is Part 3.

Part 2 is here: The patient’s perspective.

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If you’ve joined me on this odyssey, you’re probably either:

1.     Going through the clinical trial process yourself, or on behalf of a sick family member, in which case godspeed.

OR

2.      You’re interested in reforming the trial process and by extension the FDA, in which case godspeed as well, because we can and should be doing better. I don’t personally have control over drug companies, the FDA, or clinicaltrials.gov, but, if you do, please think of the patients who are dying while the process shambles slowly along. And if you think Jake or I can help you to improve this process in any way, we want to. Please reach out.

If you’re looking for help navigating the clinical trial process, or just want Jake and I to rewrite government policy, you can find me at DrBStillman@gmail.com