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Ingeborg Beunders
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MS 27 - Engaging Patients in Research: Best Practices (ID 549)
- Event: WCLC 2017
- Type: Mini Symposium
- Track: Patient Advocacy
- Presentations: 1
- Moderators:S. Shilo, J. Kerr
- Coordinates: 10/18/2017, 14:30 - 16:15, Room 311 + 312
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MS 27.04 - Approaches to Patient-Centric Clinical Trials: Sharing Challenges and Lessons Learned (ID 7772)
15:30 - 15:50 | Presenting Author(s): Ingeborg Beunders
- Abstract
- Presentation
Abstract:
INTRODUCTION: Patient-centricity means much more than episodic patient involvement in health care. A Patient-centric culture requires that patients play an active role in all health care subareas from identifying unmet needs, pre-clinical research, clinical research, drug authorization, drug reimbursement to drug prescription. This study focus on patient-centricity in clinical trials. While in former days a patient participating in a clinical trial very often felt like a “laboratory mouse” only being instructed what to do and often without any understandable information nowadays those responsible for research and drug development discover the advantages of patient involvement such as better recruitment, patient friendly protocols, a better retention rate etc. Till now the main focus was effectiveness and safety of drugs to be shown by cost-intensive clinical trials. Nowadays value of treatments and relevance of outcomes to patients are of special interest. Patient Advocacy organizations help with recruitment by informing their members about new clinical trials. Crowdsourcing techniques addressing different communities like medical experts, patients and researchers are used to provide responses to survey questions. Apart from the arising enthusiasm about the doubtlessly potential opportunities the necessary requirements and their costs such as patient education costs, efforts to establish long-term partnership with patient advocacy groups, implementing patient advisory boards, legal framework conditions which protect patients but do not hinder their active participation as stakeholders etc. should not be underestimated. Additionally, pharmaceutical companies need to implement patient-centricity as a strategy across their functional departments. Successful patient-centric clinical trials require the willingness of patients especially of those who experienced clinical trials to provide their input in order to support improvement. METHOD: An anonymous survey has been designed and submitted to patients who already participated in a clinical trial. As patient-centricity in clinical trials is not just a lung cancer but a general issue Patient Advocacy Groups for different diseases such as lung cancer, breast cancer, cancer in general, lung fibrosis, arthritis, HIV etc. have been involved in US and Europe and further countries aiming to learn more about patient experience in clinical trials. As there is an increasing number of industry-funded clinical trials[1] another online survey was submitted to pharmaceutical companies in order to to find out more about the daily practice. RESULTS: 40 of 61 participants who already have been on a clinical trial completed the survey. Almost 50% recently (2016 or 2017) participated in a clinical trial. 16 patients live in US, followed by 8 patients from Austria and single patients from different European countries, one from Australia and one from Israel. Almost 40% of the surveyed have not been asked for feedback concerning the procedure during or after participation in the trial. 87% of patients would take part again in a clinical trial due to reasons like getting effective treatment, new treatment, helping others etc. Previous studies have found that trial participants do not receive the trial results.[2 ]This study replicated this finding. Almost 50% have not been informed about the final trial results although the WMA Declaration of Helsinki 2013 requested that all medical research subjects should be given the option of being informed about the general outcome and results of the study.[3] There is a high rate of willingness (82%) to provide input from patient perspective to improve the design of clinical trials. The analysis of the survey did not show any relevant differences concerning geographic area. 7 research-based pharmaceutical companies completed the second survey. Asking in which parts of the trial process (clinical question, clinical trial design, patient recruitment, trial management) patients are actively involved two companies indicated that patients are not involved in any of the mentioned parts. About 70% of the surveyed request feedback from patients about the procedure of clinical trials (30% do not). 3 of 7 companies do not see any hurdles for driving forward patient-centricity, 3 companies mentioned hurdles like e.g. substantial differences in the patients´ attitudes / concerns / current management across different countries/regions, added complexity, clarity on compliance rules, contractual framework and often patient report disease impact is difficult to quantify (e.g. I´m feeling tired). The most important measures in the pharmaceutical companies are understanding of patient needs, inclusion of patient reported outcomes, patient satisfaction, safety of IMP (investigational medical product) and patient selection biomarkers. The 2 companies who do not actively involve patients in the different parts of the trial process mentioned patient selection biomarkers, safety of IMP, safeguarding of patient’s rights, data quality and integrity as important measures. Both did not see any hurdles to drive forward patient-centricity in clinical trials. CONCLUSION: Although the number of participants in both surveys is quite low, the informational results gained by the patient survey can shed some light to the patient experience concerning clinical trials, the willingness as well as the reasons to participate more than once in a clinical trial. “Effective treatment” as most frequently mentioned reason to participate in a trial indicates a lack of information about clinical trials. There is a vast majority of patients with clinical trial experience being willed to provide their input in order to improve the design of new clinical trials. On the other hand there are researching companies who do not involve patients/patient advocates in the clinical trial process at all and the results of the survey provides an indication of the inconsistent proceedings within the pharmaceutical industry. In order to increase patient-centricity in clinical trials it is necessary that all relevant stakeholders (patients, patient advocates, regulators, medical experts, pharmaceutical companies etc.) compile consensual guidelines that ensure inclusion of relevant and adequately validated PRO, accurate patient information about clinical trials (in different languages), the option to be informed about the trial results for trial participants, information and education about clinical trials and collection and usage of patient feedback. [1]Ehrhardt S, Lawrence J. Trends in National Institutes of Health Funding for Clinical Trials Registered in ClinicalTrials.gov. JAMA. 2015;314(23):2566-2567 [2 ]Partridge AH, Winer EP. Informing clinical trial participants about study results. JAMA. 2002;288(3):363-365 [3]https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ (August 2[nd], 2017)
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