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I'm Alfonso Aguarón and I welcome you to my blog. Inspired by my own diagnosis of a Hodgkin's Lymphoma in 2008 I decided to get involved in patient advocacy.
A few years later, I keep commited to my desire of help and support patients. There's still a lot to do so, do we look for change in healthcare together? Let's go!

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Monday, August 4, 2014

I'm not a rat lab

I’ve met many patients who have been proposed to enroll in a clinical trial and some of them first reaction was: “I’m not a rat lab!”. While it is true this fact might be influenced by the fact that clinical trials are usually referred in Spain as “experimental treatments” and that most of the patients agree to be part of a clinical trial (mainly because in some cases the doctor told them to do it), what is true is that there’s still a information gap that should be filled.

At this point I’d like to make the difference when talking about patient involvement in clinical trials:

  • The patient as a “passive” subject, that is, the patient is going to participate in the trial after receiving certain type of information in order to receive a treatment which is intended to be potentially beneficial for treating his or her disease.
  • The patient as an active agent in the clinical trial development, who’s able to provide its own value to the whole process, not only by being the subject of investigation.

When talking about the patient as a “passive” subject, we have to refer to the informed consent. Let’s have a look at informed consent definition: "In a clinical trial, an ongoing (in contrast to the “one-off” informed consents of non-trial-related clinical practice) interactive process that provides a trial participant (subject) with explanations to help him or her make educated decisions about whether to begin or continue participating in a trial." (Segen's Medical Dictionary. 2012 Farlex, Inc.). Many pilot studies have been conducted to know about the patients’ perception of the adequacy of the informed consent (if you’re interested in accessing them just type “perception of informed consent” in Google and you’ll get hundreds of abstracts). Although results might vary, a representative percentage of patients still considers the informed consent more like a disclaimer than a patient's right itself. Also the recruitment process may drive doctors to try to find patients meeting the criteria that might benefit from the trial while they forget about the patient’s needs, concerns and other emotional and social issues. Informed consent has to represent a process in which all actors involved have to establish an honest, deep, committed and clear dialogue about the clinical trial and its implications so the patient can really have a clear overview of the whole process in order to make a well considered decision. An, at this point, I think including in the process an independent expert patient, previously trained, with proper skill and who has already participated in a trial could really help a lot and act as a link between the healthcare team and the patient and relatives.

But, how could patients could participate in a more active way into the clinical trial development? Here comes where I think patient advocates should work hard in the upcoming years. First of all, let’s talk about real facts:

  1. Most clinical trials are developed and funded by the pharmaceutical industry.
  2. Patients are not included in the development process.
  3. Patient-reported outcomes have had so far a low specific weight in research.

I’ve to say that most of my activity in advocacy has been developed in oncology so this perception might differ from other disease (for example, I know in some rare diseases patients become more involved into the whole process when orphan drugs are being studied). Anyway,my opinion is that involving patients in the trial development process through powerful and well-trained patient organisations is the key. I don’t like repeating myself, but as I said in my previous post about HTA, I have the feeling that sometimes patients are not yet considered an actual stakeholder.

Getting patients involved in the development process is a real challenge that requires the effort of all agents:

  • First of all, the pharmaceutical industry. One of the reasons I’ve heard from industry representatives about the difficulties of getting patients involved into a clinical trial development process is related to trade secret. Well, there should be a way to get rid of this problem, and above all, it has to be a real commitment to find it. I can understand most trials are promoted and funded by private companies that compete with each other, but health is much more than just a business. And above all, getting patients involved in the development process is more and an advantage than a pain in the ass. After all, if you’re thinking just about business, which company is not interested in what their customers demand? (Author’s Note: I don’t like talking about customers when referring to patients, but here it’s a perfect interplay).
  • Decision-making bodies. Both national and international regulations should be focused in providing patients a greater presence in R&D. Also promoting rules and laws to grant more transparency and quality of the ongoing studies is a must. If patients are going to be involved they should be able to access information about research so they can provide their unique view. A good example could be the European Medicines Agency decision to oblige the sponsors to publish summary results in the European Clinical Trials Database.
  • Finally, patients’ representatives. So if us, patients, want to be involved in all this whole process we need to show from the outset that we are prepared to face the challenge. And it’s a big one. Understanding research phases and scientific methods might be a overwhelming task, so a proper training is required to introduce the demands of the patients in good time and in an appropriate manner. Traditionally, clinical endpoints like PFS (Progression Free Survival), RD (Response Duration) OS (Overall Survival) have served to produce new drugs and treatments that have mainly improved the survival of patients: we live longer . Now patients have to introduce topics such as quality of life and patient reported outcomes to improve our lives: we live better.

I know I say this many times but it’s the time for patients. And it is our responsibility to become part of the speech. So let’s go for it.


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