{"id":590,"date":"2018-04-04T11:15:59","date_gmt":"2018-04-04T16:15:59","guid":{"rendered":"http:\/\/waife.com\/home\/?p=590"},"modified":"2018-04-04T11:27:15","modified_gmt":"2018-04-04T16:27:15","slug":"why-do-we-continue-to-struggle-with-clinical-trial-transparency","status":"publish","type":"post","link":"http:\/\/waife.com\/home\/why-do-we-continue-to-struggle-with-clinical-trial-transparency\/","title":{"rendered":"Why do we continue to struggle with Clinical Trial Transparency?"},"content":{"rendered":"

Clinical trial disclosure and data transparency continue to be a challenge to sponsors, regulators and to public advocacy groups. The challenge is across the board \u2013 in methods, requirements and urgency.\u00a0 To the extent they understand the requirement, research sponsors certainly want to comply and publish their trials. But they often fall short in complete achievement of that compliance.\u00a0 Even when they take steps to support and fund the transparency requirements, many organizations do not take the time to address the necessary people and process changes.<\/span><\/p>\n

The typical \u201cknee-jerk\u201d reaction to data transparency is one of annoyance, followed by what is thought to be a quick fix: \u201cimplement a computer system\u201d or \u201coutsource trial disclosure\u201d.\u00a0 Although these are potentially reasonable links in the compliance chain, technology and resources alone are not adequate to address the gap between traditional operations and new requirements.\u00a0 The tried and true maxim of \u201cpeople, process and technology\u201d applies here.\u00a0 The key to clinical trial disclosure and data transparency compliance is: a robust clinical trial disclosure process <\/em><\/strong>which is properly designed and enforced by upper management, which is integrated into all aspects of trial conduct within the organization and supported by adequate resources,<\/em><\/strong>and is supported by a comprehensive technology<\/em><\/strong>solution.<\/span><\/p>\n

Clinical trial sponsors struggle with the trial transparency requirements for a variety of reasons.\u00a0 Perceived as an additional burden and an industry confidentiality risk, trial transparency has often received less than adequate attention and resources from sponsors.\u00a0 This continues today even while it attracts the focus of journal publishers and patient advocacy groups, in addition to increasing government scrutiny on sponsor compliance.<\/span><\/p>\n

In fact, a robust and optimal compliance solution is remarkably complex and resource-intensive: sponsors have to draw people from multiple disciplines (data management, marketing, statistics, regulatory); a process with clear governance has to be designed, understanding and keeping up with changing international requirements is required; compliance assurance has to be monitored and maintained; and the resulting mechanism has be fully funded permanently.<\/span><\/p>\n

The typical reaction to meeting an information requirement is to either implement an information technology solution, or outsource it to someone who has one.\u00a0 Unfortunately, owning a car does not mean you know how to drive. \u00a0<\/span>The slow pace of achieving compliance can be attributed to varying degrees of typical \u201cpeople-focused\u201d reasons:<\/span><\/p>\n