{"id":712,"date":"2015-04-14T23:29:40","date_gmt":"2015-04-14T21:29:40","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=712"},"modified":"2025-05-26T16:53:23","modified_gmt":"2025-05-26T14:53:23","slug":"patients-committee-clinical-researc","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/patients-committee-clinical-researc\/","title":{"rendered":"The patients committee in clinical research, a definite advantage for promoters"},"content":{"rendered":"<p><strong>The patients committee in clinical research, a definite advantage for promoters<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p>On 26 January under\u00a0Elodie B\u00e9gu\u00e9 and Mary Lanta&rsquo;s invitation, I went to a plenary meeting for the\u00a0League against Cancer <strong>Patients Committee in clinical research<\/strong>. I wanted to understand the functioning of this committee and the importance of their work for laboratories or CROs.<\/p>\n<p><!--more--><\/p>\n<p>The Patients Committee in Clinical Research (PCCR) aims to review the information notes and informed consent forms for patients to enhance their quality and accessibility, by:<\/p>\n<ul>\n<li>Checking that the trial objectives, means, constraints and benefits are clear enough to facilitate an informed decision.<\/li>\n<li>Suggesting, if necessary, measures and practice changes to improve the quality of patients life during the trial.<\/li>\n<\/ul>\n<p>The aim is to offer to all academic or industrial clinical trials promoters in oncology, proofreading of all their information notes and consent by the PCCR.<\/p>\n<p><img data-recalc-dims=\"1\" decoding=\"async\" class=\"size-full wp-image-14010 aligncenter lazyload\" data-src=\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/comite-patient.png?resize=1080%2C713&#038;ssl=1\" alt=\"CPRC\" width=\"1080\" height=\"713\" data-srcset=\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/comite-patient.png?w=1298&amp;ssl=1 1298w, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/comite-patient.png?resize=300%2C198&amp;ssl=1 300w, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/comite-patient.png?resize=1024%2C676&amp;ssl=1 1024w, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/comite-patient.png?resize=768%2C507&amp;ssl=1 768w, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/comite-patient.png?resize=600%2C396&amp;ssl=1 600w\" data-sizes=\"(max-width: 1080px) 100vw, 1080px\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" style=\"--smush-placeholder-width: 1080px; --smush-placeholder-aspect-ratio: 1080\/713;\" \/><\/p>\n<h2>1. Cancer plan 3 and the Patients Committee in Clinical Research<\/h2>\n<p>We are currently developing the\u00a0cancer plan 3 (2014-2019). The <a href=\"https:\/\/blogdelarechercheclinique.com\/en\/\"><strong>PCCR<\/strong><\/a> was recognized during the second cancer plan and responds to 5.4 and 7.16 measures of the current cancer plan 3.<\/p>\n<p>Action 5.4: \u00ab\u00a0Involving patients and their representatives in clinical trials and in the course allowing access to these researches.\u00a0\u00bb<\/p>\n<ul>\n<li>\u00ab\u00a0Well informing patients and patient organizations of current and future research, get them more involved in their development and help them participate.<\/li>\n<li>Systematically Share the results of clinical research with different audiences, including people who participated in the tests. \u00ab\u00a0<\/li>\n<\/ul>\n<p>Action 7.16: \u00ab\u00a0Improve information on oncology clinical trials.\u00a0\u00bb<\/p>\n<ul>\n<li>\u00ab\u00a0Make trial results in the registry of clinical trials in oncology of INCa accessible to patients \u00ab\u00a0<\/li>\n<li>\u00ab\u00a0Make trial information sheets, proofread by patients committees, available to them. \u00ab\u00a0<\/li>\n<\/ul>\n<p>The Inca <a href=\"http:\/\/www.e-cancer.fr\/\" target=\"_blank\" rel=\"noopener noreferrer\">http:\/\/www.e-cancer.fr\/<\/a> entrusted the steering of the measure 5.4 and the co-piloting of the measure 7.16 to\u00a0the League against cancer <a href=\"http:\/\/www.ligue-cancer.net\/\" target=\"_blank\" rel=\"noopener noreferrer\">http:\/\/www.ligue-cancer.net\/<\/a>.<\/p>\n<h2>2. The PCCR League in figures<\/h2>\n<ul>\n<li>Date of PCCR creation by the League and UNICANCER: 1998<\/li>\n<li>Number of consents and revised synopsis: 26 in 2009, 62 in 2013, 104 in 2014<\/li>\n<li>85 reviewers throughout France<\/li>\n<li>22 promoters are already engaged in the PCCR collaboration<\/li>\n<\/ul>\n<h2>3. Who are the reviewers?<\/h2>\n<p>They are patients or old patients and some relatives. Spread throughout France, including the French overseas departments, they represent different pathologies in the field of <strong>cancer<\/strong> and often come from patient associations.<\/p>\n<p>Reviewers are volunteers. They have an interest in clinical research, are comfortable with text, have a critical thinking and master computers. They are trained in clinical research subject twice a year in plenary session by the League against cancer. In addition, workshops are planned to train the beginners, and a guide has been created specifically for reviewers by the policy officers.<\/p>\n<h2>4. Proofreading organization with promoters<\/h2>\n<p>Nothing is left to chance. Reviewers sign confidentiality agreements with the League but the promoter may also put his own model in disposal. In addition, a framework model agreement between the promoter and the League is suggested.<\/p>\n<p>The deadlines are imposed by the promoter. Generally, the <strong>PCCR<\/strong> has one to three weeks to proofread the submitted documents but they may\u00a0give, if needed<strong>,<\/strong> a faster feedback after agreement with the League depending on the reviewers availability (48h for example).<\/p>\n<p>The promoter informs the Ethics Committee\u00a0during the submission that the informed consent and the information note has been reviewed by the PCCR of the League against cancer.<\/p>\n<p>In this case the documents reviewed by the Committee of patients will mention the following sentence:<\/p>\n<p>\u00ab\u00a0Following the recommendations of the Cancer Plan (Measure 5.4.), this document was submitted for review, advice and guidance to Patients Committee for National League Against Cancer Clinical Research in Oncology\u00a0\u00bb<\/p>\n<p>To date, there have been many positive feedbacks from Ethics Committee. A large number of promoters are now seeking protocols blanks (\u00ab\u00a0drafts\u00a0\u00bb) or intent letters proofreading in the PHRC framework. This allows to know\u00a0whether the study is acceptable to patients in terms of quality of life and to check\u00a0the potential inclusion of their study or identify some potential inclusion barriers.<\/p>\n<p>UNICANCER, INSERM, APHP and many cooperative groups also work with the PCCR: <a href=\"http:\/\/www.unicancer.fr\/patients\/la-recherche-clinique\" target=\"_blank\" rel=\"noopener noreferrer\">http:\/\/www.unicancer.fr\/patients\/la-recherche-clinique<\/a><\/p>\n<h2>5. What are the benefits of proofreading for promoters?<\/h2>\n<p>The promoter will probably save time by avoiding a second submission to the Ethics Committee\u00a0because consent was not satisfactory. In case of participation with PCCR further upstream (\u00ab\u00a0drafts\u00a0\u00bb letters of intent), he can easily identify barriers to inclusion and enhance the patients quality of life during\u00a0the trial.<\/p>\n<p>Finally, future patients will thus have more accessible information to enable them to participate in the proposed therapeutic choice. This can help prevent drop outs because, well\u00a0informed, patients are more committed in their care.<\/p>\n<h2>6. Future projects?<\/h2>\n<p><u>The overall studies results<\/u><\/p>\n<p>At the end of a clinical trial, the patient must be informed of the overall results of the research if he desired (see Act No. 2002-303 of 4 March 2002 on patients&rsquo; rights and quality of the health system). According to the article R.1123-60 of Public Health Code, one year after the end of the participation of the last person who consents to the research or, at most, the end defined in the protocol, a final report\u00a0is expected to be established under the responsibility of the investigator and promoter . It is to be noticed that\u00a0many patients never receive this kind of information. It would be absurd to provide the study complete final report to the patient; however\u00a0the promoter could create an information note exposing the overall results of the study to the patients. The PCCR of the League against Cancer are currently working on this with some promoters.<\/p>\n<p>The PCCR wishes\u00a0that information on the overall results were\u00a0given in the right way\u00a0to the patients knowing that clinical trials results are generally small advances in science.<\/p>\n<p><u>Simplification of informed consents<\/u><\/p>\n<p>The PCCR would work closely with the Ethics Committee\u00a0and the different actors of clinical research in order to encourage simplification of informed consents which can be difficult to understand for patients sometimes.<\/p>\n<p><u>Contact with the CROs<\/u><\/p>\n<p>In cases where the studies are outsourced, the PCCR wishes to get in touch with the authorized CROs by their client, to sensitize them on\u00a0the proofreading option.<\/p>\n<p><strong>Who to contact at the cancer League?<\/strong><\/p>\n<p>The entire mechanism is framed by Elodie B\u00e9gu\u00e9 and Marie Lanta. They are policy officers for information on clinical trials for the benefit of the patients, Actions For Patients service of National League against Cancer.<\/p>\n<p>Elodie B\u00e9gu\u00e9 has a biology doctorate in cancer, a DU of project manager in clinical research (Paris V) and had clinical research technician experience at the Saint Louis Hospital before joining the League against Cancer.<\/p>\n<p>Marie Lanta, literary training, participated in the PCCR\u00a0creation. She is also Meeting and Information Areas (ERI) Coordinator\u00a0and drafting coordinator, updating and publishing pamphlets service \u00ab\u00a0Action for Patients\u00a0\u00bb.<\/p>\n<p>Elodie and Marie have a proactive attitude and directly contact promoters and CROs to offer their proofreading consents. They participate in various conferences and clinical research training to raise awareness and develop this innovative mechanism.<\/p>\n<p>If you&rsquo;re CRA or SSC, talk about it in your workplace. If you are clinical project manager, clinical operations manager, you can directly contact Elodie and Marie by email if necessary:<\/p>\n<p><a href=\"http:\/\/Marie.lanta@ligue-cancer.net\" target=\"_blank\" rel=\"noopener noreferrer\">Marie.lanta@ligue-cancer.net<\/a><\/p>\n<p><a href=\"mailto:Elodie.begue@ligue-cancer.net\">Elodie.begue@ligue-cancer.net<\/a><\/p>\n<p>&nbsp;<\/p>\n<p>If you liked this article, I invite you to click on \u00ab\u00a0I like\u00a0\u00bb or share with your CRA colleagues and friends and project Manager<\/p>\n<p>Also, visit Pharmaspecific website : \u00a0<a href=\"http:\/\/www.pharmaspecific.fr\/\" target=\"_blank\" rel=\"noopener noreferrer\">http:\/\/www.pharmaspecific.fr<\/a>\u00a0and discover our activities.<\/p>\n<p>You can visit the Facebook page of \u00ab\u00a0blog de la recherche clinique\u00a0\u00bb\u00a0and the\u00a0\u00ab\u00a0Pharmaspecific\u00a0\u00bb\u00a0and click on \u00ab\u00a0I like\u00a0\u00bb to support us.<\/p>\n<p>See\u00a0\u00ab\u00a0<a href=\"https:\/\/www.linkedin.com\/company\/pharmaspecific\/\" target=\"_blank\" rel=\"noopener noreferrer\">Pharmaspecific Linkedin\u00a0<\/a>\u00bb\u00a0and\u00a0\u00ab\u00a0<a href=\"https:\/\/www.linkedin.com\/in\/vanessamontanari\/\" target=\"_blank\" rel=\"noopener noreferrer\">Vanessa Montanari Linkedin<\/a>\u00a0\u00bb\u00a0for more relevant news on clinical researches.<\/p>\n<p>See us as well\u00a0<a href=\"http:\/\/fr.viadeo.com\/fr\/company\/pharmaspecific\" target=\"_blank\" rel=\"noopener noreferrer\">Pharmaspecific Viadeo<\/a>\u00a0and\u00a0<a href=\"https:\/\/viadeo.journaldunet.com\/p\/vanessa-montanari-820852\" target=\"_blank\" rel=\"noopener noreferrer\">Vanessa Viadeo<\/a><\/p>\n<p>You can also subscribe to the blog&rsquo;s newsletter and we will keep you posted once a new article is published.{:}<\/p>","protected":false},"excerpt":{"rendered":"<p>On 26 January under\u00a0Elodie B\u00e9gu\u00e9 and Mary Lanta&rsquo;s invitation, I went to a plenary meeting for the\u00a0League against Cancer Patients Committee in clinical research.<\/p>","protected":false},"author":4,"featured_media":14010,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":{"facebook_122143508198123560_331463380343150":""},"rop_publish_now_history":[],"rop_publish_now_status":"pending","_sitemap_exclude":false,"_sitemap_priority":"","_sitemap_frequency":"","_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[882],"tags":[159,137,160,161,162,163,164],"class_list":{"0":"post-712","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-practice-the-profession-cra","8":"tag-comite-de-patients-en-recherche-clinique","9":"tag-consentement-eclaire","10":"tag-inca","11":"tag-ligue-du-cancer","12":"tag-plan-cancer-3","13":"tag-roche","14":"tag-unicancer"},"translation":{"provider":"WPGlobus","version":"3.0.2","language":"en","enabled_languages":["fr","en"],"languages":{"fr":{"title":true,"content":true,"excerpt":true},"en":{"title":false,"content":false,"excerpt":false}}},"yoast_head":"<!-- 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