Phase III trial to Standard of Care

[Brysonal]

I am wondering if anyone is advocating for the regulating bodies to be involved in final period of a stage III clinical trial so when the results are released it becomes standard of care immediately. It seems that red tape is costing lives as I watch trial results released at big conferences ( is waiting for the next conference necessary or ethical) and then the eureka of success leading to no immediate impact on treatment protocols as only then do the regulators start discussions about approval it appears. Surely we can do better!

[LearnAll]

When a drug is released..in first 2 to 3 years ..there is massive marketing campaign . It seems like this new drug costing thousands of dollars a month is the best thing ever happened to mankind. The marketing propaganda is very powerful. Once this new drug goes generic and prices fall...suddenly research articles start coming out about what a harmful drug it is...and new expensive drug is promoted as Gold ...and the cycle repeats. If you want to confirm what I am saying.. go to research articles from 1980s, 1990s when Casodex (bicalutamide ) was promoted as Golden drug. But now the propaganda is that it can make PSA go up. This scares people from older, time tested drugs. And I always say "fear is the key to selling new drugs which are not necessarily better" Choosing the best drug from all available drugs Old and New.. for each person on individualized manner should be the standard.

[Hidden in reply to LearnAll]

You do realize this is how advanced countries operate...otherwise people would still be driving model Ts, using the scrub board for laundry and boy if you have a beef with drug companies, you must really hate the electronic industry.

Any MO with a brain would not be doing what you advocate because they wouldn't be able to get liability insurance and therefore they could not practice medicine. For some reason you fail to include the role of the legal system in the realm of SOC. It's not this big conspiracy that you make it out to be.

[LearnAll in reply to Hidden]

Dude..You already verified my point by saying "MOs will not be able to get liability insurance..and will not be able to practice" if they go out of SOC box ...So you already know well how the hands of Doctors are tied and make them unable to choose what is best treatment for a given patient. As for your "advanced country" logic.. you just need to go and see Covid19 death rates on Worldometer website.

[MateoBeach in reply to LearnAll]

Hi LearnAll. Lively discussion here, appreciate your views.I know you are an advocate of bicalutamide. I benefited from nearly 5 years on bicalutamide 50 mg plus dutasteride 1mg as my sole (and quite effective) therapy until it started promoting PC growth as reflected in rising PSA. So I had to stop it. Conventional thinking is that I can never go back on it. However I question if that is true. I have been off it for 8+ years now. Currently on modified BAT for a year. Wondering if when the time comes and need to go back on full time ADT plus an Advanced AR Drug if I might use bicalutamide again along with ADT? Any research reports on re-introducing bicalutamide? Thanks.

[LearnAll]

All I am saying is that our SOC is greatest in the World because we only had about ONE MILLION people die due to Covid19. ( I just found out this is highest number of deaths for a nation in entire World)

But, Still I love my SOC.. Long Live SOC !!

[Hidden in reply to LearnAll]

Q....the near 1 million deaths wasn't a result of SOC. You tout conspiracy theories about SOC with nothing more than your self studied opinion. How many of those pebmed articles you read have been tossed aside? How many of the pubmed research papers have actually been duplicated?

You tout your treatment protocol as if it's some stellar work of research. Many with similar cancer characteristics as you have had much better success than you...following SOC. If you want to use the remaining time you have left on this earth reading pubmed research papers, have at but stop the nonsense you know better than the medical community...that's a hufdle you'll never clear.

[CAMPSOUPS in reply to LearnAll]

If you think our SOC is why we have a million covid deaths you have been living with your head in the sand. Period!

[tango65]

What are your ideas to de better? The presentation of data from a RCT in a meeting, usually as a summary report is not peer reviewed, These data can not be used as SOC after the presentation.

[Brysonal in reply to tango65]

My blue sky thinking would be to move forwards towards International harmonisation with an International Standards Board (divorced from funding decisions) . I would expect a full International consultative model around Standard of Care with discussion documents, leading to exposure drafts with all stakeholders contributing to the discussion leading to final regulatory approval documents with 'International Standard of Care 1: XXX .

You'd need an Urgent Issues Taskforce type body in addition.

It all feels fragmented and inefficient at the moment.

Obviously completely bluesky and I'm sure full of flaws !

[NickJoy in reply to Brysonal]

One thing I do know is that the NHS itself is completely disjointed - goodness knows how they could link up internationally - if you live in Wales you can't get into the trials in England unless there is a prior agreement by Welsh NHS to pay the fees - but most of the best trials are in London so how is that OK? Also, conspiracy theories about drug companies aside, I do think that once a drug has been proved to be effective and safe, the drug companies should make them available ASAP on compassionate grounds and before formal FDA approval but subject to some restrictions - after all they have been tested on people putting their lives at risk with the hope of some benefit other than to companies choosing the optimum time to release the drug in order to maximise share price etc. And aside from all of that, the seemingly constant research papers and trials reinventing the wheel instead of actioning ides and building on work undertaken elsewhere sometimes feels like a complete lack of international cooperation etc etc etc Please bring on the blue skies...

[Brysonal in reply to NickJoy]

I agree 100%. Olaparib is approved in Scotland but not in England or Wales. At least agree is it International Standard of Care or not for relevant patients.? . Let it be transparent that the govt/ insurance companies in some parts of the world are saying they can’t afford it, but at least be upfront with reasons!

And yes to so much ‘working in silos’ even between institutions in the same country let alone across borders. Cancer is cancer surely international harmonisation should at least be on a wish list.

I am not suggesting cutting corners on regulation just if consideration is being given to rethinking the approach to the timeline and organisation.

[Tall_Allen]

In the US, the FDA looks over the results of each submitted Phase III trial on a record-by-record basis. That is their job. They are the watchdog. What if some unscrupulous drug company faked the results to get their stock price up? I know it is frustrating to have to wait, but it protects us.

From the time of FDA approval, it becomes SOC immediately. There are supply chain issues in getting the new drugs manufactured and distributed, and, unfortunately, it all takes time.

In the UK the situation is a little different. NHS approves the drug (like the FDA - often, they accept the FDA ruling). But NICE determines whether the drug will be paid for. Sometimes, they rule that since a cheaper alternative is available, they will not pay for the more expensive drug. My understanding is that one can still get the drug if one is willing to pay for it out of pocket.

[Proflac in reply to Tall_Allen]

Yes you are right. NICE considers not just clinical effectiveness but also cost effectiveness in deciding what treatments they mandate. In many cases it depends on deals they are able to do with pharma for NHS use. It's a bit smoke and mirrors how it all works but sometimes seems harsh to patients e.g. those in England who cannot get Zytiga on the NHS. But in a world of ever increasing costs and finite resources I guess there needs to be some rationing mechanism. Private (out of pocket) prescriptions are available but for the costly drugs this is beyond the reach of most people. I guess it seems strange to those in the US but only a minority of people have private health insurance in the UK. Its not a perfect system but it also has great merits IMHO, one being fewer unnecessary or questionable interventions.

[Tall_Allen in reply to Proflac]

I think some countries have a hybrid system where there is cheaper private insurance that many people pay for in addition to the free public insurance. In the (backward) US, only for those over 65, there is almost free (about $200/mo - deducted directly from Social Security checks) Medicare that covers 80%, but many purchase a private supplemental plan (also costs $200/mo) that covers the remaining 20% of doctor/hospital costs. Then there is a drug plan on top of that- and cancer drugs cost a lot. I hope that Medicare will be able to negotiate drug prices some day (sigh). There are also HMO plans that include everything but require you only see certain doctors.

I hope all is forgiven for that spot of bother in 1776, and you are willing to take us back

[dhccpa in reply to Tall_Allen]

You raise an interesting point. I had a discussion last week on this group with a citizen of a very small (population) European country, and later I wondered: how many European countries simply (substantially) accept the FDA approvals, thus saving on much of the very expensive drug (and device) testing costs?

[j-o-h-n]

They'll take us back as soon us we drop Rapp..........

Good Luck, Good Health and Good Humor.

j-o-h-n Sunday 02/20/2022 8:16 PM EST

[Proflac in reply to j-o-h-n]

Not to be too political John but I think there is a better chance without Tr... 😃

[JRPnSD]

I am presently serving as a Patient Advocate for SWOG's Patient Advocate Committee and on their GU committee. My focus is presently the need for representation of under-served communities in the NCI based oncology clinical studies (racial, rural, LGBTQ+, etc.). I am finding the biggest barriers to be the outreach challenges, but mostly financial hurdles. Often people that are not insured with coverage for the hosting institution (e.g. UCSD, etc.) or covered by original Medicare, are told they must pay out-of-pocket to participate. Many times even the entry interview will come with a hefty physician appointment fee ($500+). We will never approach truly representative clinical studies (SUPPORTED BY ALL OUR TAX DOLLARS) until these barriers are addressed. A presentation I attended at ASCO's GU 22 Symposium in SF last week, by Kosj Yamoah, MD, PhD from Moffitt Cancer Center on DEI perspective of delivering Novel Therapies was an excellent summary of this challenge.

[Proflac in reply to JRPnSD]

Wow. That is truly shocking. In the UK anyone who meets the eligibility criteria can access trials free of any charge. If one's treatment centre is not included in a trial they can refer you to one that is. (No money invovled). We have our issues here for sure but even the poorest have decent access to standard cancer care. Everyone is guaranteed a referral from their GP to a specialist within 2 weeks if cancer is suspected, though this target is slipping with the pressures of government underfunding. For less urgent cases eg hip replacement though there are often now long waiting times on the NHS while paying patients can get quicker treatment. The situation you describe does leave a question mark over trial validity. Same here in that many have under representation of minority groups - though its primarily an issue of failure to effectively communicate with and recruit from , underserved communities than an issue of charging.

[JRPnSD in reply to Proflac]

Without the financial means for access....outreach can just be a futile exercise for many when it comes to enrollment.

[Proflac in reply to JRPnSD]

Absolutely so. Outreach needs to include facilitating access by financial and other help e.g. reimbursing loss of income, resources for translation so all communities understand the relevance of trials, investing in staff training in inclusive recruitment etc and of course no actual charge for enrollment!

[Brysonal in reply to JRPnSD]

That really is shocking as Proflac says in the UK there are no costs for clinical trials and I thought it was the pharma companies heavily subsidising the trials all over the world as UK participants often report much better care when they are in a clinical trial than in standard of care NHS clinics. Paying out of pocket for a clinical trial is unheard of here, but yes out of pocket to jump a queue for a cataract op or hip replacement is quite common though.