Saturday, 9 August 2014

Influencing recruitment for clinical trials

What motivates MSers to participate in trials? #MSBlog #MSResearch

"The participation in clinical trials is essential if we want to move the field forward and bring new and better MS therapies into clinical practice. Therefore it is essential for MSers to be an integral part of the research process and for them to be actively engaged with the clinical trial process. Part of the function of this blog is to inform you about new and upcoming trials and the results of MS trials when they become available."
"At present several ethical issues regarding trial design are being discussed; for example: (1) is it ethical to still run placebo-controlled trials; (2) is it ethical to use an injectable 1st-line therapy as an active comparator; (3) should we always off subjects a greater chance being on an active therapy compared to placebo. The ethics of placebo have been discussed on this site many times and will become topical again should one of the current progressive trials be positive. I think most MSers want to help with research and in my experience the main reason for not participating in trials is the time commitment required to participate. One of the reasons highlighted below for trial participating is the expectation 'of a greater chance of a cure'. The latter is unrealistic and expectations need to be appropriately managed. Investigator's should be honest about what the trial can deliver; little will be gained by offering false hope. I would be interested in your perspective on this important topic."



Epub: Maida et al. Overcoming recruitment challenges in patients with multiple sclerosis: Results from an Italian survey. Clin Trials. 2014.

BACKGROUND: Recruiting MSers for randomized clinical trials is still extremely difficult. While there has been much research in oncology patients, no previous studies have consistently addressed specific factors affecting the willingness to enroll in multiple sclerosis trials from the MSer's perspective. To this end, we conducted an exploratory study to assess the related factors and to find ways to improve recruitment.

METHODS: This is a single-center, observational study involving 352 consecutive outpatients followed at one site in Italy. MSers completed the Enrollment Problems Questionnaire and Beck Depression Inventory.

RESULTS: Over 50% of the MSers would consider participating in a randomized trial. Willing patients are frequently older, with no children, have a diagnosis of secondary progressive multiple sclerosis, and have already participated in clinical trials. MSers' choices were positively influenced by expectations of having (a) a greater chance of cure, (b) an unavailable drug, (c) a specialist's care, and (d) the chance to contribute to medical research. Willingness was significantly increased by the use of optimistic language and practical/psychological assistance during the decision-making process.

CONCLUSION: MSers' willingness to participate in a randomized trial is mainly related to both altruistic and individual considerations, as well as to a greater chance of specialist/improved care. More effective information flow and an effective, long-standing patient-physician relationship may improve recruitment overall.

8 comments:

  1. Rentention (and compliance) is just as important as recruitment. Here the quality of the trial nurses is essential. People are giving a huge amount of time and if appointments are poorly managed (not enough notice given etc) this can be frustrating. Likewise if you turn up for an EDSS assessment and the neuro isn't there, and you have to sit around waiting.

    In my experience of your own trial centre this can vary hugely, and is normally linked to staff changes.

    Well worth considering evaluating satisfaction regularly so that issues can be identified and resolved, before they result in people dropping out.

    Even more important during long term follow up when you want people to stay in the trial and contribute to science, but they could easily choose to leave and get the drug on the NHS.

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  2. I participated in the INSPIRE trial because I can't expect a cure / improved DMDs unless I help the researchers.

    For me, of course I want the trial to result in the discovery of the Holy Grail of a cure, but I managed my own expectations by telling myself that to move forward, it is as important for researchers to disprove hypotheses as it is to prove them. Every trial that yields unfavourable results also provides important information, which, I hope, informs and influences future research.

    I sought to be on the trial, after I heard about it at the 2013 research day, rather than being approached to take part.

    Things that influenced me to take part:
    - the hypothesis made sense to me: it was based on fact and the logic appeared to be sound, as to how raltegravir might work
    - a powerful urge to help to destroy the disease that is trying to destroy me
    - the fact that I was newly diagnosed and had not commenced treatment

    Things that might deter me from volunteering for future trials:
    - a "pie in the sky" hypothesis that doesn't convince me with logic
    - the idea of stopping an effective DMD (Tysabri) and taking a placebo

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    Replies
    1. How did it worked for you?

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    2. whether the outcomes are good or bad .....We need to wait until the study is complete and the results are analysed and announced

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  3. My neuro gave it the thumbs down when I asked if I could go on a trial. He said he couldn't risk me coming off Copaxone.

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  4. But from what I read here, there is a chance certain aggressive drugs can stop the disease in some of us, i.e., the monoclonal antibodies, especially if we get them early in RRMS. Not true?

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  5. "One of the reasons highlighted below for trial participating is the expectation 'of a greater chance of a cure'. The latter is unrealistic and expectations need to be appropriately managed."
    "Over 50% of the MSers would consider participating in a randomized trial. Willing patients are frequently older, with no children, have a diagnosis of secondary progressive multiple sclerosis, and have already participated in clinical trials."
    Regarding the two statements above; MSers with low EDSS are fairly content with the existing therapies, why would they choose or need to participate in clinical trials? The clinical need is not in developing more immune modulating therapies that are cash cows for pharma but offer limited increase in efficacy (i.e. beta interferon/pegylated beta interferon). Why is recruitment of MSers difficult for clinical trials? Because the need is not in the realm of RRMS that was the hotbed of research 20 years ago. Pharma has to realize where the demand is in MS research and evolve.

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  6. Is there a reason that my post mentioning the INSPIRE trial didn't get published?

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