Ultimately, we need clinical trials to know what drugs and medical devices work. Without them, we will not have the evidence we need for clinical practice guidelines, and clinical care will not evolve. But traditional clinical trial approaches are not sustainable \u2013 too expensive and too inefficient. The new hope for clinical trials is to use clinical registry programs to conduct them more efficiently. And that new hope is now a reality. The Swedish registry proves the concept. And the U.S. registries-\u2013 especially those in the cardiovascular area-\u2013 have also done \u2018proof of concept\u2019. The remaining barrier to this becoming the way clinical trials are conducted is to gain the collaboration-\u2013 and trust-\u2013 of industry to work with the professional society registry programs to conduct the trials. The FDA and NIH and other stakeholders support it, so I believe it will now happen. And the primary beneficiary is patients, because we can spend less to gain critical new knowledge in a shorter time.<\/p>\n
Randomized clinical trials remain the centerpiece for scientific evidence– the evidence for what medical therapies work and should be recommended in clinical practice guidelines.<\/p>\n
Unfortunately, traditional clinical trials are very costly and inefficient. In essence, each new clinical trial starts “from scratch,” including identifying hospitals or practices to participate, developing new case report forms, etc. And each trial includes selected patients from selected centers, who participate in the trial for a specified, usually limited, amount of time.<\/p>\n
The expense and inefficiency of traditional clinical trials is a threat to their existence. Already we see fewer and fewer of these conducted in the U.S.<\/p>\n
But there is a potential new paradigm for conducting clinical trials-\u2013 piggy-backing on existing clinical registries to make the trial more efficient.<\/p>\n
The hope is that large clinical registry programs-\u2013 like those of the American College of Cardiology in the U.S. or the Swedish registry that was used for the TASTE trial published in the NEJM-<\/em>\u2013 may be able to serve as a more efficient infrastructure for clinical trials.<\/p>\n Here is why this hope exists:<\/p>\n 1. Large national clinical registry programs are already a network of hospitals or practices. Participants already have contracts in place to collect and combine data, for quality measurement but also for aggregated research.<\/p>\n 2. The data elements collected in registry programs largely represent the \u2018data standards\u2019 for a given clinical area. At least 80% of the necessary data for a clinical trial is already being collected in the registries.<\/p>\n 3. Thus, it is easy to see how a clinical registry can be used to recruit sites from the existing registry network for a clinical trial, and that only a modest amount of additional data collection may be necessary for the trial. Both of these would greatly contribute to more efficient clinical trials, from both cost and time standpoints.<\/p>\n 4. There are other appealing aspects of this. For example:<\/p>\n a. Existing registry data can be used to plan clinical trials-\u2013 we know what sites provide which types of care, so a given clinical trial can use that data to target specific centers for participation (for example, for doing a certain type of procedure not done at all hospitals).<\/p>\n b. When a clinical trial ends, the clinical registry program will continue to document care and patient outcomes. This suggests that \u2018post-trial\u2019 surveillance can continue-\u2013 which can become \u2018post-market\u2019 surveillance for new drugs and devices. The FDA is working closely with clinical registry programs in the cardiovascular area, supporting the idea of conducting more efficient clinical trials, but then to have the registry data available for post-market safety surveillance.<\/p>\n Traditionally, the two worlds of clinical trials and clinical registry programs have just not overlapped, but that is no longer true. And the hope of using clinical registries to conduct clinical trials is now a reality. The Swedish registry is proof that the two can be combined to run a more efficient clinical trial. In the U.S. the American College of Cardiology\u2019s National Cardiovascular Data Registry (NCDR) has also recently proved the concept, conducting a randomized clinical trial of angioplasty in women (called SAFE-PCI) using the registry infrastructure.<\/p>\n <\/p>\n","protected":false},"excerpt":{"rendered":" Ultimately, we need clinical trials to know what drugs and medical devices work. Without them, we will not have the evidence we need for clinical practice guidelines, and clinical care will not evolve. But traditional clinical trial approaches are not sustainable \u2013 too expensive and too inefficient. The new hope for clinical trials is to […]<\/p>\n","protected":false},"author":811,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[1969,508,638,1420,639,1968],"class_list":["post-38784","post","type-post","status-publish","format-standard","hentry","category-general","tag-clinical-trial","tag-clinical-trials","tag-ncdr","tag-randomized-trials","tag-registries","tag-scaar"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/38784","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/811"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=38784"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/38784\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=38784"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=38784"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=38784"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}