Recruitment we need more than a Trial Linked-In.

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I was recently chastised for not working on the “real MS” what ever that is. But if I do come up with something for the “real MS” then it will need a trial, otherwise people are unlikely to accept the evidence. However, as I have said before “trials kill MS treatments” because sometime the people entering a trial is not optimised…So studies fail because they can’t recruit and this paper by Tom looks are their experience in recruiting to large studies to provide tips on how to recruit to studies. So according to this:

ProfK needs to get himself on tele and the radio to talk about ChariotMS and AttackMS, any ideas of how to get media interest.

Get a website for registering interest and provide online tools to work out if you are eligible helps save time and resource, it may also help you to go back to the drawing board to change criteria for inclusion. I have had personal experience of this where too strict an inclusion criteria lead to years delay in recruitment.

These websites allow the team to contact you, but you still may be ineligible

it is nice to see a Blog reader get a mention in this paper, it shows that you input to trials and MS research is vital. Being chastised is perhaps part of it, as long as there is something constructive to take from it.

Williams T, Alexander S, Blackstone J, De Angelis F, John N, Doshi A, Beveridge J, Braisher M, Gray E, Chataway J; MS-SMART and MS-STAT2 Investigators. Optimising recruitment in clinical trials for progressive multiple sclerosis: observational analysis from the MS-SMART and MS-STAT2 randomised controlled trials. Trials. 2022 Aug 9;23(1):644.

Background: Slower than planned recruitment is a major factor contributing to the delay or failure of randomised controlled trials to report on time. There is a limited evidence base regarding the optimisation of recruitment strategies. Here we performed an observational review of our experience in recruitment for two large randomised controlled trials for people with secondary progressive multiple sclerosis. We aimed to explicitly determine those factors which can facilitate trial recruitment in progressive neurodegenerative disease.

Methods: Recruitment data from the sequential MS-SMART [NCT01910259] and MS-STAT2 [NCT03387670] UK randomised controlled trials was reviewed from the largest recruiting site, University College London (UCL). The trial population was similar which allowed comparison over the two recruitment periods of 2015-2016 and 2018-2021. This included sources of referral, progress through stages of recruitment, reasons for participant ineligibility and the impact of publicity events upon recruitment.

Results: In MS-SMART, 18% of patients contacted were enrolled, compared to 27% for MS-STAT2. Online registration of interest portals provided the greatest number of referrals (76% in MS-SMART, and 51% in MS-STAT2), with publicity in national media outlets producing a demonstrable increase in the number of potential participants. The introduction of an online self-screening questionnaire for MS-STAT2 resulted in 67% of potential participants (3080 of 4605) automatically determining their own ineligibility. In both studies, however, around 60% of those directly telephoned to discuss the study were not eligible, with difficulties related to travel to trial visits, or excluded medication, being the most common issues. Eighty-four percent of those deemed potentially eligible following telephone calls were enrolled in the MS-STAT2 study, compared to only 55% for MS-SMART.

Conclusions: Through a detailed review of recruiting participants at the largest centre into two large randomised controlled trials with similar entry criteria, we have identified a number of approaches that may improve recruitment efficiency. We highlight here the importance of mandatory online self-screening questionnaires, a coordinated publicity campaign, and simple interventions such as eligibility checklists and appointment reminders. Recruitment approaches should be further assessed through a studies within a trial design.

Trial registration: MS-SMART: NCT01910259 ; registered July 2013 and MS-STAT2: NCT03387670 ; registered Jan 2018.

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MouseDoctor

8 comments

  • Sounds really great. Info via Prof G s selfie has been invaluable, this blog too. We have MS Champions at the Norfolk and Norwich University Hospital Trust , they too may be a good way of spreading the word. The MS society is probably involved too. If I think of any more I will drop you a line.

  • This site tells me I have already made a comment obout this issue, on this site. I have not. Just to let you know it’s being discrimatry.

  • May I add that control arm needs to be best available treatment (as opposed to interferon or teriflunomide)? Otherwise, nobody in their sane mind will participate.

  • This is where I feel neurologist/doctors have to play their part. I have been involved in three clinical trials and each time I found out the details of these trials.. Not one neurologist or doctor has ever suggested to me anything about entering a trial or given me details of any trials taking part. So, unless you have a switched on and well-informed neurologist, it is highly likely that you will never be involved in a trial. So, I think they should take part of the blame for the slow recruitment onto these trials

  • Maybe people with SPMS are taking medication that excludes them from the trials. And yes, people with secondary MS do get relapses.

  • Patients are rarely asked what the barriers they face in participating are too. Being part of a clinical trial is not easy as a patient. We often need to make significant personal sacrifice to be part of one. Trial designers should talk to patients about ways to make it easier.

    As someone else pointed out, this assumes we actually know about them too. My experience is that we need to search them out . I have a wonderful neurologist but here in canada there are strict rules about investigators asking their patients to participate (perhaps too strict but I see both sides of this). I ended up participating only because I asked if there were any trials I could be part of.

    I also agree with the comparison drug. If your choice is a drug like Ocrevus, Mavenclad or a clinical trial where the control arm drug is a low efficacy one why would you take the risk. I was in mine before Ocrevus was available to me as an option.

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