Road to collaboration 3 – I am a customer

This is the third step along the Road To Collaboration in clinical trials. My second article ended on the realisation that significant remission of symptoms exacts an unexpected toll on a participant.The memory of function temporarily restored is now being aggravated. The Foliglurax Trial is reportedly slipping, so disclosure of drug/placebo remains a distant prospect. To the lack of closure I will add frustration that a personal contribution to progress is being repaid by systemic delay.

I cannot speak for the motivations of other people, but my own altruism is coloured by the notion that if I help prove something works at phase 2, I might have another crack at in phase 3. However, not only must there be a phase 3, but my local clinical trial unit must also have been offered and awarded the trial. This game of chance has become unattractive.

To bring this topic full circle, Foliglurax may be just another example of a trial delayed by recruitment problems. These problems may be attributable to restrictive entry conditions and to fishing in a limited pool of candidates. I suggest they are also attributable to phase 2 being a poor deal for the participant. I have become part of the problem.

My take on this situation is that the currencies used by participant and sponsor of a trial are neither equivalent nor easily exchangeable. Informed consent in reality cements an unbalanced agreement.

The way I measure my contribution to assisting research is more subtle and subjective than simple altruism. It is not convertible to money. Conversely a financial contribution by the sponsor will cover (say) expenses but is not convertible to (say) psychological consequences of a trial. In currency language, the toll has created a debt that may not be recognised. And still less likely to be repaid to me.

What measures could be introduced to create a more balanced agreement between sponsor and participant? I call this a “Trial Compact”? The old Irish joke about getting directions to somewhere ends on “If I were you, Sorr, I wouldn’t start from ’ere”. I start from the proposition that a participant is a Customer, and this trumps the clinical view of him or her as a “Patient”. I am spending my altruism currency in the research participation shop. The shop is owned by the sponsor, managed by the trial organiser and staffed by the clinical trial unit. I demand better service, and ultimately the sponsor is responsible.

I believe these seven proposals are all procedurally and ethically acceptable within the current trials system.

  1. Unblind on completion of trial procedure
    Tell me which compound – drug or placebo – I was supplied with after my participation is complete, not after everybody else has finished.
  2. Disclose personal data
    Provide copies of diagnostic data (e.g. regarding samples) and test results to me and/or a nominated Physician upon completion of my trial.
  3. Report subsequent progress
    Undertake to supply me with unabridged Articles published by the trial sponsor, related to the trial drug through the current and subsequent phase.
  4. Inclusion in subsequent trials
    Enable my participation in subsequent trials of the drug. This to be subject only to a change of inclusion criteria that put me at medical risk or explicit circumstances that imperil the blind.
  5. Opt-out principle
    All the above by default unless I decline at the point of supply.
  6. Evidence of consultation
    Explicit evidence of contribution from PwPs to the trial procedures and sponsor’s arrangements with trial organisers and clinical trial units. For example,
    a) expenses policies allowing accommodation costs for trial unit visits without reference to the sponsor
    b) integration of a Carer where available in qualitative observations.
  7. Obligations survive change
    All the above are carried forward contractually to new Licence holders or new owners of the drug patent(s).

More radical changes to the system are being advocated, notably automatic insurance of the participant against harm. This is a fundamental problem for US residents and Pharma, so I could not include it on a list of gradualist changes. We should get on with changing what should be acceptable now. The big issues are not going to be resolved anytime soon.

This article is Part 3 of 3, and marks a step sideways as I wait for the clinical world to catch up.

© Christopher Maycock 2019

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