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Survey examines issues related to clinical trials quality and participation from the patients' view.
The Avoca Quality Consortium (AQC) commissioned a patient survey as part of its ongoing commitment to transform clinical trials. The overarching objective of the survey was to identify actions that pharmaceutical companies, CROs, and study teams might take to positively influence clinical trial participation and impressions of the clinical trial experience, and to increase the relevance of clinical trial results to patients.
This was a standalone survey, but incorporated parallels with questions that had been asked in other AQC and Avoca surveys of sponsors and clinical survey providers, to allow for comparisons where applicable. After the research plan and survey were reviewed and granted exemption status by Western IRB, potential participants were contacted by email using email addresses from the PMG Research, PLM (PatientsLikeMe), CISCRP (Center for Information and Study on Clinical Research Participation), and Avoca Quality Consortium databases, all of which are “opt in” databases comprised of individuals who have elected to receive email contacts from the relevant organizations.
Understanding by providers
On average, survey participants did not feel that their healthcare providers had a very good understanding of what it was like to be a patient with their condition. Mean “perceived understanding” ratings ranged from only 2.9 to 3.4 on a scale of 1 (no perceived understanding at all) to 5 (perceived to understand “very well”), and for each question, between 26% and 39% of patients gave a rating of 1 or 2.
There was pronounced heterogeneity across patients in the extent to which they felt understood. Multivariate analyses that accounted for multiple disease and demographic characteristics at once were performed to better understand this heterogeneity. In these models, the strongest drivers of differences across patients were age group (patients aged 76+ generally felt the most understood by their providers, and those aged 31-45 the least), marital status (single and married patients generally felt the most understood, and divorced and widowed patients the least), and role (or not) in providing financial support or care for family members (providers generally felt less understood than non-providers). Disease characteristics and history of clinical trial participation had relatively little impact on these results.
Confidence in the trial process
With respect to confidence in the information provided to prospective clinical trial participants, most of those surveyed had at least a fair level of confidence that trial participants are fully and honestly informed. Participants were most likely to be confident in information provided about the right to withdraw, procedures, and possible benefits, and were most skeptical about information relating to treatment alternatives, risks and side effects, and doctors’ motivations.
With respect to confidence in the quality of the clinical trial process overall, most participants again had at least a fair level of confidence in the compliance, caring, and ethics of the site study teams and patients involved in clinical trials; however, many were skeptical about the honesty of pharmaceutical companies and about the extent to which they cared about study patients.
In both cases, the distributions reflected considerable response heterogeneity, particularly for areas that were rated, on average, most poorly. Interestingly, in multivariate models, the most frequent drivers of differences across patients with respect to confidence in the information provided appeared to be a history of clinical trial participation (positive impact on confidence), disease impact (highest confidence in those with mild disease), and marital status (divorced people demonstrate less confidence); all other disease and demographic characteristics had relatively little impact on the results once the effects of these three were accounted for.
The strongest drivers of differences across patients with respect to confidence in clinical trial compliance and ethics appeared to be a history of clinical trial participation (positive impact on confidence), educational level (highest confidence in those with least education), and marital status (divorce associated with less confidence); all other disease and demographic characteristics were again of relatively low impact.
Common themes in patient comments to this section included: the positive impacts of including patients in the design of both protocols and operational approaches to study execution; demonstrating respect and caring of patients in all aspects of execution, including compensation; and exercising transparency at every level. Business concerns both positively and negatively impacted confidence levels: some patients were skeptical of the ethics of pharmaceutical companies, given the large amounts of money involved in researching and selling therapeutics, while others saw the high stakes as providing assurance that maximum rigor would be applied. Regulatory requirements and a belief in human nature and professionalism further bolstered confidence, while media stories regarding litigation and drug recalls eroded it.
Overall, the results from this study lead to the clear conclusion that as an industry, we can do more, today, to impact both patients’ perceptions of clinical trial participation, and the relevance of our trial designs to patients’ personal experiences of their diseases. From basic training in mindsets for key stakeholders to incorporating the patient voice in the protocol design process, there is work to be done to move the needle on patient engagement.
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- Denise Calaprice, PhD, is Senior Consultant, The Avoca Group; Jennifer Byrne is Chief Executive Officer, PMG Research; and Jeremy Gilbert, is Vice President, Product and Strategy, PatientsLikeMe