From The Editor | March 22, 2017

AstraZeneca Strives For Greater Trial Transparency

Source: Clinical Leader
Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

AstraZeneca Strives For Greater Trial Transparency

In February 2017, trial transparency provider TrialScope announced the launch of its Trial Results Summaries Portal that was developed in partnership with AstraZeneca. The Portal is a publicly accessible website where clinical trial sponsors can inform and educate trial participants and the general public about trial results in a non-promotional and non-biased venue.

Until now, there has not been a place for clinical trial participants to obtain information about their trials. The Trial Results Summaries Portal represents a new way to communicate trial results that leverages technology to connect patients to their critical health information, closing the communication loop between sponsors and patients.  It also replaces outdated, paper-based processes that are rarely tracked and often fail. There is currently no legislation in place requiring this type of communication, but in the near future Lay Language Summaries will become mandatory.

In this Q&A, Julie Holtzople, clinical trial transparency operations director for AstraZeneca, offers insights on the portal, why AstraZeneca made the decision to participate in it, and the benefits patients and sponsors can expect to see from it.

Ed Miseta: What specific challenges were AstraZeneca up against regarding transparency, and how did the Portal help to solve them?  

Julie Holtzople: The Portal provides a place where sponsors of clinical studies can easily return Trial Result Summaries to study participants. It also allows sponsors to share study results with the public. It provides a unique tool and another communication channel for sponsors. At AstraZeneca, this is in line with our commitment to transparency. By providing this summary information in an easily accessible location via the Web, we can reduce distribution challenges and avoid privacy risks of direct mailing such summaries to patients.

Miseta: There are reasons sponsors might want to avoid transparency in clinical trials. What made AstraZeneca want to do this now?

Holtzople: AstraZeneca has a longstanding commitment to making information about our clinical research publicly available, while at the same time safeguarding patient privacy. We believe that transparency enhances the scientific understanding of how our medicines work and is also in the medical interest of our patients. As a result of the EFPIA/PhRMA Responsible Data Sharing Principles as well as emerging EMA Policy and the new EU Clinical Trial Regulation, AstraZeneca continues to evolve and streamline its policies, processes and systems for trial transparency. In 2015, we took the step to provide Trial Results Summaries, also known in the EU as Lay Language Summaries, to all patients that participate in an AstraZeneca sponsored clinical trial. We provided this in the same language as their signed informed consent form. This new portal provides an improved way to deliver on this commitment in a way that study participants find useful.

Miseta: Is AstraZeneca seeing any benefits to patients or to the company as a result of this effort?  

Holtzople: Through the development cycle and the engagement of study participants and patient advocates who reviewed the website and provided comments, we learned patients would find this site very valuable. We have heard requests from patients who hope this portal does become an industry tool. We have talked to patients who say they are speaking with other sponsors whose trials they are involved in and hoping they will commit to using this tool to return Trial Result Summaries as well.

Miseta: Does AstraZeneca have any practical tips for how smaller sponsors, who might not have the budget of a large pharma company, can still be more transparent? 

Holtzople: Although Trial Result Summaries, also known as Plain Language Summaries and Lay Language Summaries, are a newer transparency tool for patients, there are many new tools available to support smaller sponsors who wish to begin providing these valuable tools to patients. For example, TransCelerate has published an implementation recommendation guide that can be a great reference. There are other tools and examples available to help sponsors get started with this process.

Making these summaries available to participants and the public through this new Trial Results Summary Portal is an efficient, cost-effective process, and we would recommend sponsors talk with TrialScope to better understand options that will work for their situation.

Miseta: Were there any internal hurdles you faced in getting this project approved?

Holtzople: As part of AstraZeneca’s commitment to put patients first, this initiative was viewed very positively as an opportunity to help us meet our objectives around transparency of study results to patients supporting clinical research.

 Miseta: Will you be publishing trial results from all trials on the portal?

Holtzople: Yes. AstraZeneca plans to publish Trial Result Summaries for all completed Phase 1 to 4 interventional studies that started after April 2015 on the portal, regardless of the outcome of the study.