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    Something Celeste said on another thread got me to thinking about clinical trial patient rights and what can be done to advance the rights of the patient. One thing that has bothered me for some time now is the fact that I know BMS has tested my melanoma every which way possible yet I cannot seem to get any of that information. I can’t even find out if my melanoma expresses PDL-1. I can kind of see reasons why they may not want to release some of the information while you are in the trial (i.e. maybe patients would leave a PD-1 trial for another trial if they found out their melanoma did not express PDL-1) but I think you should be entitled to every bit of information they have on you when you leave the trial or the trial is ended. Does anyone agree with me on this? Catherine, what are your thoughts and what would need to be done to start a movement to get this changed.



    I totally agree. I had to leave a blind study nivolumab/dacarbazine. After 9 weeks my melanoma had grown and I had to quit. I so much want to know if I got nivo and failed that. It’s importent for my coming treatments. I can’t understand why they can’t inform me about that.

    Catherine Poole

    Brian and Ninni,

    I agree totally and just attended an international meeting where we discussed this in length. The NCI just sent something out about how clinical trials haven’t changed their set up in 55 years! So I’m reaching out to those in power with these questions and looking for answers. In the meantime, I would appeal to your doc in charge of your trial and ask why you can’t have access to this information.


    When leaving the trial, this should have automatically led to unblinding- please contact your doctor about that and should they not tell you, get back to Catherine or me.

    It cannot be that patients’ future treatments are endangered like this.

    In my opinion, this Nivo/ DTIC blinding was NEVER done for scientific reasons anway- blinding is intended to control for the psychological effect of the belief of the doctor or the patient that a treatment is effective. Considering the previously existing data on both Nivo and DTIC, how great do you think is the psychological contribution to DTIC not working and PD1 working?

    This type of blinding is purely done to prevent patients to make use of their RIGHTS- namely to leave the trial at any time point. This is also called ‘voting with your feet’….

    I fully agree that patients should be made aware of trial results that become available- after all, they present interim results at public meetings! I also think that it is entirely legitimate to leave a trial if the interim results shows that one arm is not working- in theory, this should lead to amendment of the trial but that does not always happen. Leaving such a trial is the patients’ way of amending the trial.

    We need ETHICAL and MEANINGFUL clinical research respecting PATIENTS RIGHTS and I actually feel that we as citizen need to ensure that we get those as anything else induces suffering in people and hampers true progress.

    In case you wonder whether your demands are unreasonable, you should be reading the World Medical Association Declaration of Helsinki in its latest update from 2013:


    Article 8 states:

    ‘While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.’

    Article 26:

    ….’The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal.’…

    Our interests are a chance to survive- and as stated above, this takes precedence over ALL our interests in medical research. And otherwise we need to make use of our right to withdraw consent.



    And now the link to the original source-


    Catherine Poole

    Just wanted to add that using drugs proven to be ineffective for melanoma such as dacarbazine as a comparator is so inhumane. Yes, we need to get those in power to realize that patients are the center of trials and they should treat them with respect as they would a close relative who is undergoing therapy for this serious disease.


    I am going to see my onkolog (melanomaspecialist) next week, we shall discuss ipi. I will ask again if I can get to know what I got. Perhaps I have got nivo, not all responde to that even if in this forum it seems that almost all responde. I did hesitate to participate in the study cause I have no confidence in chemo. I have got that before and it didn’t help at all. But my onc said it could help me. Now after three months I am worse than before the study and so tired. I am so greatful for your support here at the forum.



    You should be entitled to medical information that impacts your diagnosis, disease status, and future cancer care. You said that BMS tested your tumor for many things, but that you have no information on the results. What did your informed consent document state? Were you to be tested for PD1 or PDL status prior to treatment or some time during the course of the trial? What other tumor testing were they going to perform on your tumor tissue or blood samples? That should be stated in the consent form. If specific testing was not described, but rather a statement that your samples may be used at a future date for tests that have yet to be determined, then your consent form should have stated that, and should have asked whether or not you consent to these future not yet specified tests (you should have a right to consent or not consent to such testing, without impact on your care). If your PD1 or PDL stautus was required to be known at enrollment in order to be treated, then that information should be available to you. However, if such correlative studies are to be collected and analyzed sometime during the course of the study, it is quite possible that the results are not yet available. Very frequently, especially in large trials, blood or tissue samples are collected at the study specified timepoints, frozen, and archived. They are then later run during the course of the trial in huge batches containing samples from many patients (they are not usually run in “real time” like ordinary lab tests for your health and safety eg, hematology or clinical chemistry). And if some of the tumor testing that may be performed (or yet to be performed) is truly investigational or exploratory, the results may not at the present time be used as part of patient care. Exploratory laboratory testing (i.e., tumor markers, etc) must also undergo an FDA review, validation, and approval process (like for the investigational drugs), before they can be approved for commercialization for patient care.

    Brian, are you still on the trial? If not, when did you complete the trial? When is the trial planned to finish? At the very least you are entitled to your results at the end of the trial. You should document in writing that you are requesting your results at the end of the trial.

    A clinical trial patient has the right to withdraw from a study at any time, for any reason. And no patient should be kept on-study when there is confirmation that the cancer has progressed, in spite of study treatment.

    Catherine Poole

    Philly Red,

    What about Ninni, should she not be told what drug she had in the trial so she knows how to move forward? If dacarbazine, she will get a chance at PD1 perhaps.


    Leaving the trial should automatically lead to unblinding. If this is not done, this is something to address urgently.

    Can’t remember whether there was cross-over in that trial *it messes up the nice statistics you see*, I am so tired of seeing comments amounting to that in trial evaluations. Major cross-over happens if one of the arms is greatly inferior to the other one, now whose fault is that, duuh??

    There are extremely smart statisticians out there and surely they can device a way to account for patient-friendly trial designs. Statistics are surely there to serve people not vice versa!

    We need to start with trial designs that full fill patients’ needs and then develop the tools required for that- and not bamboozle patients into signing up for trials with ‘if you want new drugs, you have to put up with this’- which is somewhere between a lie and blackmail.

    We as patients need to stop blindly supporting research. We need to start supporting GOOD research only. There is a recent publication in the Lancet- which is one of the most coveted medical journals- citing a study that staggering 85% of clinical research are waste: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)62329-6/fulltext

    So let’s support the remaining 15% and hope that we’ll soon be able to say ‘in the old times, Melanoma was a terribly disease….today, patients nearly have a normal life expectancy’. This has happened for HIV and now CML!

    And- none of my friends who is a football (which tells you I am European, so: soccer) fan just supports ‘FOOTBALL’- they all have their favourite team and give you ENDLESS eulogies why is THAT specific one (which tells you that football is not the thing closest to my heart ;-))…we should spend the same energy on our trials!



    Generally, blinded trials are unblinded at the end of the study when the database is locked, or during the course of the study when a serious safety issue becomes apparent and the investigators need to know which patients are at risk, so they can be treated appropriately. However, the extent of blinding, and provisions for unblinding can vary with the trial. It is likely that Ninni’s study doctor does not know what treatment she received. My suggestion to Ninni would be to inquire from the sponsor of the trial if there is a mechanism whereby the patients who received dacarbazine can be notified of their treatment, so that they can receive a PD1 drug in a future trial.

    I previously replied to this thread, but my response didn’t show up.

    Celeste Morris

    As many of you know, I have been a rattie in a clinical trial since Dec 2010. I started caring for patients when I was 19 years old. I have seen this world from all sides. It is complicated, often painful and un-pretty. Despite all I have seen and learned….I am thankful. Thankful to have had the honor to serve my patients all these years and lucky to have gained participation in my trial. Ipi wasn’t even on the market when I started. I had no other options.

    Which brings me to perhaps the most important point of this whole discussion. No one participates in a clinical trial for fun. Ratties are only there because they are running off a sinking ship. And the researchers? Many are wonderful, compassionate people who want to use their lives and careers to do good things for others. But, think about it. Where is their allegiance? It is to the drug company and their institution first. That is who is funding at least some of the research. The institution provides their paycheck. The drug company wants to do great wonders with the drug (read: make big bucks!$!$). And, if the researcher/institution wants to do more fab research…they’ve got to make the trial work so that they can get additional opportunities to participate in the next break-through trial. Next, they must have an allegiance to science. There is greater commitment to the results of the experiment, than to you, the individual. It is not really the patient’s well being calling the shots. The participation forms are very clear on all of this. They say: You may do great. You may acquire any of PAGES of side effects. We (the doc, the institution, and the drug company) CANNOT be held accountable if you grow three heads, turn purple, or croak. Additionally, we will not be held financially responsible for any costs related to care for any side effects or extra head amputation that you may later need. And….if your scans or labs or wayward body doesn’t play right, you will be dropped from the trial. Oh, yes…you can quit when you want, but…then you’re done.

    So, all this brings reams of papers and confusing medical terminology to patients in desperate circumstances. Signing up for a clinical trial is not for the faint of heart. Nor is the information presented in terms that most folks understand…especially when feeling sick, worn, and worried. Rather, patients feel they are completely at the mercy of the doc, the drug company, and the trial. They are afraid they are going to die. They are not going to quibble. In Chapter 3, from Cancer Clinical Trials…by Robert Finn…he writes: “Cancer patients are in a one-down psychological position. They have to trust their doctor. They want a cure. They need a cure. They dare not risk any…alienation from the physician-researcher. So, they’re very much inclined to do what the researcher wants and accede to the requests of the researchers.”

    Bettin you are absolutely right. We need to make things consistent and better. There is no need for clinical trials to be so “random!” Yet, we ratties hope for good results for ourselves…and that even if we are not so lucky…then at least others will benefit from what is learned. WRONG again!!! In July of 2013, The Journal of Clinical Oncology published a review done of Phase II, III and IV cancer drug trials done between December 2007 and May 2010 and found that 50% of those results WERE NEVER PUBLISHED!!!!

    Brian, my tumors were tested, because of the express desire from BMS, for PDL1 as well. The wording of the additional consent form was purposefully vague. Explanations from the researcher, clinical trial coordinator, and everyone else involved, ranged from…”oh my hands are tied to give you more intel”….to….”I don’t know nuthin bout birthin’ babies!”…to…”Hmmmm.” And trust me, honey. I’m a patient who asks! Most do not. I’ve made rounds with untold numbers of doctors. Some are very happy to escape the room as quickly as possible. But, others are perfectly willing to sit and really try to answer any question. Yet….more often than not…patients just nod and smile. But, when I return to the room after the doctor is gone, the questions flow. Sorry…just an aside. But, my expectations for getting the results of my testing??? Pretty much…NONE!

    When I see trials that are still comparing new meds to ineffective ones like interferon and dacarbazine, I feel physically ill. It is wrong. It is abusive. In a conversation reported from the European Cancer Congress in 2013, Ribas said, “taking all the studies…comparing ipi and dacarbazine vs dacarbazine, …vemurafenib vs dacarbazine, dabrafenib vs dacarbazine, and trametinib vs dacarbazine – all of these studies have shown that another treatment was better than our old standard.”

    So what does all this mean and what can we do about it? It means that we still have a long way to go in attaining equal rights between drug companies, researchers, institutions and patients. I have no easy answers. All I can do is try to pay my fortunate circumstance forward, to make the path a little better, a little more comprehensible, for others. Some ratties squeak!!!

    My best to you all. Celeste



    I cannot possibly add anything to Celeste’s post… except this should be required reading! I have posted in the recent past my struggles with switching from one cancer facility to another because I was randomized to chemo on one anti pd1 trial and disqualified from another because I had already been treated with two out of four chemos I may have been randomized to…nonetheless…the point is I went from a facility that included me every step of the way to another facility where I absolutely began to understand the term “feel like a number”. When I go in for treatment now..I already have an attitude and I am geared to “teach” these researchers how to treat “receivers of care”. I am not a patient. This past Monday, I was all ready to speak with a “fellow” who was working in my case and he was absent…boy was that anti climatic!!! When I did have the opportunity to speak to one of the researchers who specializes in melanoma (usually I am seen by a lung cancer specialist who is part of the immunotherapy team) …and made the point that no one was even examining my area of disease…he suggested I have regular follow ups with my previous mel oncologist as they (the institution I am currently being treated at) are only interested in my immune response. I was glad to finally hear it from the horse’s mouth. Now that I know how they play the game, I can move forward and get what I need from my “home” team at NYU. They may not be as big and mighty (and believe me, I am glad to be on the trial I am on at MSK) but when it comes to “customer service” NYU wins hands down. (disclaimer: I am only speaking for myself)

    Now, I also agree about the emotional “step down” psychological element…that’s why..no matter where you are being treated..or what treatment is offered to you…it is ESSENTIAL to either have an advocate or be capable to advocate for yourself. No matter where a person is in the process…nothing has to be decided today. I have not been afraid to say to my oncologist…I need to be convinced that this or that treatment is really in my best interest…or how will this effect future treatments? will it defer me from participating in other trials etc? I have had a conversation with Catherine about this being one of the most critical points of treatment and that a really evolved cancer center would provide patient advocates at this juncture just so everyone could be on the same page. When you think about it..here we are…stage IV persons…having to deal with a certain amount of apathy…insurance companies and the hoops of drug companies. Rising to the occasion can be overwhelming for some. I always say I am not a warrior, hero or fighter…but I really rebel when I am treated like I am less than. All of us are still extremely viable human beings as are the docs and researchers. I have always considered myself an equal partner in this equation. They can’t do what they do without us, I humbly lean into that approach.

    Ok..thanks again Celeste for the wonderful insight…I’m fired up now and need to get back to my spring cleaning…nothing like hosting Easter to motivate me to clean the house.

    Wishing everyone an easy day,



    I am happy to see this discussion. It is for me some kind of confirmation. Sometimes I was thinking must be a mistake, they dont want to be insensitive or disrespectful, it is only what we feel and ok, this might be subjective…You may remember that my sis is in the trial with nivolumab. Well, for us the doctors from my sister trial did not feel at all compassionate or at least respectful. In fact to use the word ”doctors”is too much. They put only one investigator in front and the rest are very well hidden in the back. When you ask too much or the questions become uncomfortable they are not responding to you anymore to the emails. An example: in the consent form is written that trips of patient to the trial site will be reimbursed. Even clear enough, they said’ we must ask the company’. After three months of ‘hard’ asking they came back with the idea of giving to my sis the sum of 77,50 euros (?) for all her trips from our country to germany. Why this ridiculous sum we dont know. We sent an email with an extras from the consent form to the person charged with financials of trial (as told). That person never replied to our email, just transmitted (verbally) that what is written in the consent form (in English actually) is only for national germans,which obviously we are not, so…end of a glorious article of the consent form. Better to take it out , if is not applicable and not to play like patients are idiots. Then ok, you feel like you are doing something wrong, you are not german, but they accepted you in the trial, be grateful and do not demand too much. But this is not working inverse. In the same time my sis is imperiously asked to report every paracetamol is putting in the mouth or to schedule her next infusion without knowing the results of her staging. Even ‘nicer’ recently she was informed they cannot change anymore the bandages around her arm tumors, because of the costs involved. My sis felt quite bad about this.. so they are going to take pictures of the arm tumors whenever they want, but she has to bandage afterwards alone or to pay for it. How compassionate or human is this?..Like is not enough to have melanoma.


    Dear all, I am happy that this melanoma support community exists. Like everybody said before, we need clinical trials and clinical trials needs us. And like many others here, I wrote my experience not only to get rid of frustration, but also with the hope that we can do something to change these things. I am happy my sis had access to the new treatments. She gained more time due this treatment. For her, for our family the biggest psychological support is to NOT be left without treatment options. Research is for us the hope. Until a cure will be discovered, to gain time for her, this is our fight in melanoma. This is the fight I will never give up. And within this big fight we have to find an way to balance the relationship between patient and clinical research. With all the best for all of you, Violeta

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