Increasing demands for clinical trial disclosure and transparency are dominating the medical journals and making their way into more general news outlets as well. Recently, Dr Ben Goldacre, Transparency Advocate, said “Clinical trial information is being routinely and legally withheld and this needs to end". While a few may see this as a distraction, many life sciences executives are prioritizing their role in strengthening customer trust by implementing disclosure best practices across their organization.
Global disclosure regulations differ in timing and scope, and a growing expectation of greater transparency is calling on trial sponsors to make more expansive data sharing commitments. Executives are updating their transparency policies and showcasing disclosure commitments made through trade organizations like PhRMA and EFPIA. Before 3rd parties, such as patients, transparency advocates, or the media approach your organization for clinical data, it is your responsibility to establish the policies and processes for responding. Recognizing this, there are two questions you should be asking:
- How strong is your corporate transparency reputation?
- How can we avoid being mentioned in a negative article related to disclosure?
Do You Have Control?
- Does your organization have a simple, clear, and measurable corporate transparency policy that is clear and accepted to all stakeholders?
- Does your disclosure team fully understand the data sharing requirements of the countries where you are running trials?
- Do you have cross-functional teams involved in transparency so that clinical trial disclosure does not unexpectedly impact investor relations, product patents, patient recruitment, publications, or other sensitive areas?
Do You Have Visibility?
- Are you worried that your organization might be highlighted in a negative article about clinical trial transparency?
- How long would it take your team to investigate and respond to a negative article?
- Can you track compliance with disclosure regulations of local affiliates or CROs and confirm that the data made public aligns with what is disclosed in the US or Europe?
At TrialScope, we are the disclosure experts with industry-leading software used to manage over 30,000 trials and advisory services that will help you navigate the complex and evolving expectations to manage your transparency reputation.
Find out why disclosure is so hard on the next TrialScope blog!
For more information on Dr. Ben Goldacre and his transparency initiative please visit: http://fdaaa.trialstracker.net/