Conflicts of interest may affect MSer participation in clinical trials. #MSBlog #MSResearch
“Not surprising conflicts of interests are an important issue and may affect MSers decisions to participate in clinical trials. In many centres there are financial rewards for doing clinical trials; i.e. the income from clinical trials supports the centres and staff who work in them. The latter is particularly prominent in countries without socialist healthcare systems. In the NHS as we are salaried there are no personal rewards for doing clinical trials or recruiting study subjects; however, our hospitals receive the money from doing them. In the past we used to received a small proportion of the so called overheads associated with clinical trials to be used to support research projects of our choosing. Recently, this has changed; all trial overheads are now being taken towards our CIP (cost improvement programme) to help with our large and ever increasing budget deficit. Therefore, there is no direct incentive for doing trials or if there is it is now far removed from the investigators.”
“I sit, or have sat, on commercial trial Steering and DSM (data and safety monitoring) committees; this is done in a personal capacity for which I get paid consultancy fees for my time. My commitment to these committees is not linked to subject recruitment, but obviously my membership in these committees is a conflict of interest. The following is a list of my prior and current commitments to commercially sponsored trials:
- Steering Committee Member for the “Oral Cladribine in Early Multiple Sclerosis (MS)” and “CLARITY Extension Study” trial (Merck-Serono) – NOT ACTIVE
- Steering Committee Member for the “Safety and Efficacy Study of Daclizumab High Yield Process to Treat Relapsing-Remitting Multiple Sclerosis (SELECT)” and “Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) in Subjects With Multiple Sclerosis Who Have Completed Study 205MS201 (NCT00390221) to Treat Relapsing-Remitting Multiple Sclerosis. (SELECTION)” trials (Biogen-Idec & Abbvie) – NOT ACTIVE
- Data and Safety Monitoring Committee Member for the “Efficacy and Safety of GTR in Comparison to Copaxone” trial (Synthon) – NOT ACTIVE
- Steering Committee Member for the “Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)” trial (Novartis) – ACTIVE
- Steering Committee Member for the “A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis” trial (Roche) – ACTIVE
- Steering Committee Member for the “Laquinimod in PPMS (Arpeggio) Study” (TEVA)- ACTIVE
- Clinical Advisor for the VSN16 clinical development programme (Canbex Therapeutics), phase 1 and 2a trials – ACTIVE
“What do steering committees do? We help the sponsor design and manage the trial and when the trial is completed we help analyse and interpret the results, present the results at meetings and then write-up the results for publication. Some steering committees have adjudication subcommittees to assess whether study subjects are eligible for inclusion in the trial and to assess whether or not they have had protocol-defined relapses or not. Steering committee members often help with training of investigators and often lead on add-on studies in clinical trials, for example I am the lead of the CSF neurofilament level substudy of the EXPAND and ARPEGGIO trials.”
“To address the findings of the study below we will need to start including in the patient information sheet a paragraph about conflicts of interest. I suspect the ethics committees will need to lead on this to make sure it happens. What do you think?”
“My approach to conflicts of interest is transparency and to try and remember to declare them. One of the tabs on this blog lists our current conflicts. Please remember, if you want to be involved in MS drug development it is almost impossible to avoid conflicts of interest, which is one of the reasons the EMA and FDA have such problems finding non-conflicted expert members for their SAGs (scientific advisory groups).”
Epub: Solomon et al. Patient perspectives on physician conflict of interest in industry-sponsored clinical trials for multiple sclerosis therapeutics. Mult Scler. 2015 Feb. pii: 1352458515569101.
BACKGROUND: Pharmaceutical industry financial support of physicians, physician practices, and academic departments involved in multicenter industry-sponsored clinical trials of novel therapeutic agents is a relatively new and infrequently acknowledged source of potential physician conflict of interest. Detailed disclosure of these relationships to study participants is not uniformly a part of informed consent and documentation practices.
OBJECTIVE: To understand attitudes of MSers concerning disclosure of potential physician-industry conflicts of interest created by clinical trials and how such disclosures may influence study participation.
METHODS: An anonymous online instrument was developed.
RESULTS: 597 MSers participated in the study. The study found that detailed disclosure of conflicts of interest is important to potential participants in industry-sponsored clinical trials for multiple sclerosis therapies and that the presence of these conflicts of interest may influence MSers decisions to participate in these studies.
CONCLUSIONS: Findings from this study support a call for uniform guidelines regarding disclosure of physician-industry relationships to prospective research participants for industry-sponsored clinical trials.