MedCity Influencers, Devices & Diagnostics

Five benefits to developing a global transparency policy

As clinical trial compliance and disclosure remain in the spotlight and more and more countries continue to establish regulations, it is more important now than ever for sponsors to adopt a Global Transparency Policy.

There are over 90 countries that require some form of public disclosure of clinical trial data with new requirements and regulations coming into effect every year. As public expectations on disclosure, in addition to these regulations evolve, many organizations are developing holistic clinical trial transparency policies to keep up. These policies include positions on study registration and results disclosure, data sharing, publications, lay-summaries, and sharing of individual patient data.

Current global requirements on clinical trial disclosure weave a complicated web that includes a different scope of studies that require disclosure, different timelines, various types of data, and a myriad of standards for submitting the data. Evaluating each of these requirements in isolation results in complexity and confusion. A better solution is a comprehensive Global Transparency Policy, which can produce three significant benefits to an organization.

Simplification

A good Global Transparency Policy considers the global scope of disclosure and results in simplified positions that meet the most stringent global criteria. It does not require disclosure and transparency teams to follow a complicated decision tree to determine if an individual study is applicable. Simple statements such as “All interventional studies that started on or after January 1, 2000 will be registered on ClinicalTrials.gov and any locally required registry before the study starts recruiting participants, regardless of study location,” is an example of a straightforward and clear policy position on study registration that eliminates ambiguity for anyone who is responsible for clinical trial registration. In addition, this position meets current global registration requirements, including EU and US regulations, the ethical requirements of the Declaration of Helsinki, guidelines of the International Committee of Medical Journal Editors (ICMJE), as well as the expectations of most transparency advocates, looking to make sure that clinical trial data is publicly available.

Consistency

Organizations approach global disclosure in a multitude of ways. Some establish dedicated teams, others assign disclosure to individuals as part of their other job responsibilities, and still others outsource to CROs, local affiliates, or dedicated disclosure vendors. In addition to the various approaches to disclosure, the individuals responsible for disclosure may be in different functional areas and have different levels of knowledge of global requirements. A Global Transparency Policy will help guide disclosure decisions, resulting in greater consistency in public disclosures, regardless of the approach used to disclose.

Efficiency

Lack of a clear global policy on clinical trial transparency often leads to study teams questioning the necessity of disclosing study data. Without a central policy, the disclosure team spends significant time explaining and re-explaining the requirements that impact individual studies to progress the review and approval of disclosure data. A Global Transparency Policy eliminates the need for these time-consuming one-off discussions and brings disclosure into the realm of “Business as Usual.”

Measurement

“If you can’t measure it, you can’t improve it,” is a common mantra when organizations are looking to improve operations. Improving disclosure compliance is becoming a priority for many organizations, especially in light of the many articles criticizing the levels of clinical trial disclosure. Measuring performance across global requirements can be a challenge, but establishing a common Global Transparency Policy allows an organization to consolidate these requirements into a single metric.

Reputation

Clinical trial disclosure is becoming a more prominent part of a company’s global reputation.  Companies wishing to control their reputation are turning to the development of a strong Global Transparency Policy. These policies help improve public perception because they drive behavior in the various functional areas of a company that disclose and result in a more robust and harmonized view of the clinical trial data that is made public.

As clinical trial compliance and disclosure remain in the spotlight and more and more countries continue to establish regulations, it is more important now than ever for sponsors to adopt a Global Transparency Policy. By establishing this, sponsors will not only benefit, but they will also ensure they are providing the best and most accurate information to their patients.

Photo: Stethoscope and glass globe from BigStock Photo

This post appears through the MedCity Influencers program. Anyone can publish their perspective on business and innovation in healthcare on MedCity News through MedCity Influencers. Click here to find out how.