By Rebecca Li, Vivli Executive Director

I started my career at a small biotech company and understand the intensity of the start-up experience as well as the experience of the more mature mid-size biotech and pharma company. Data sharing can be an after-thought to the challenges of bringing treatments to the clinic. We at Vivli often receive inquiries along the lines of: “When should we start implementing a ‘real’ data sharing program?”  The inquiries run the gamut from companies just beginning their data sharing journey to those that have done this proficiently.  We know many who have started to outgrow homegrown sharing systems and processes that functioned well initially, and now the rate of incoming enquiries may be more than those systems can handle. Companies beginning the data sharing journey may be clinically early stage or have a marketed drug.

What’s it take to get serious about data sharing?  Some questions and answers may help.

Why should we share?

There are numerous ethical reasons to share clinical trial data responsibly.  Various industry organizations have set public commitments for their members as principles. For example, BIO a trade association that represents thousands of small and mid-size biotechnology members, committed in 2014 to make transparent and facilitate the process for qualified data requests of individual participant level data for approved medicines [1]. Likewise PhRMA/EFPIA[2] and IFPMA[3], influential trade organizations in the US and internationally for the industry, have committed to data sharing for the pharmaceutical industry

When should we begin the program?

If a company has one or more programs in late-stage clinical development, then 18 months prior to either marketing authorization or regulatory decision is a realistic timeframe to seriously considering putting a data sharing program in place. Like most things in life, starting the planning earlier allows for a high-quality program to be implemented with greater degrees of freedom. Therefore, if you anticipate that there will be trial data to share within the next 18 months or less it is important to start the planning process for a data sharing program now.

How do we start to build a data sharing program?

A data sharing program consists of three primary components – a Policy, a Mechanism and the Resources to manage and oversee the program – we describe these components in brief below. A Policy for data sharing typically includes a written public statement for governance (covering areas such as which trials are available for sharing, when those data are available, who is qualified to make a request and how, and whether there are exceptions to these policies). Additionally, a Data Use Agreement – the legally binding agreement which governs data access to outside researchers – should be developed to protect all parties involved including the research participants. A Mechanism for data sharing should be described – this is the IT infrastructure, portal or platform management system that has been developed to manage the data sharing program. Lastly, sufficient Resources (human and capital) should be tapped to oversee and implement the program and scalable to meet demand once Policy and Mechanism are set in place.

If you are interested in learning more you can watch the webinar.

How can we manage a data sharing program?

On your own internally or through a trusted external partner. Similar to other partnering decisions such as the tactical use of a CRO, externally managed mechanisms for data sharing exist.  If there are available resources internally that are capable of initiating this effort – they should also be available to oversee and sustain this effort over time. Internal efforts, may be typically comprised of a multi-functional team drawn from biostatistics, clinical data disclosure, biometrics and at times members from other functions such as medical writing, program management, legal, IT, and clinical operations are called upon for their expertise.

What can partners like Vivli do for us?

VIVLI was established several years ago and offers our members a comprehensive data sharing program including Policies, a Mechanism for data sharing and Resources. This includes assistance with setting up policies and access to harmonized legal agreements that are already vetted with a broad range of stakeholders. Additionally, the Vivli team can advise your leadership if necessary on public-facing data sharing policies for public or private organizations and will discuss a solution tailored to your current situation. The Vivli platform is user-friendly and flexible, and provides a team – an extension of yours – to ensure seamless data sharing.

If you are interested in learning more you can watch the webinar.

[1] https://www.bio.org/articles/bio-principles-clinical-trial-data-sharing

[2] https://www.phrma.org/press-release/joint-efpia-phrma-principles-for-responsible-clinical-trial-data-sharing-become-effective-today

[3] https://www.ifpma.org/wp-content/uploads/2010/11/IFPMA-Principles_Data-Sharing-FINAL-w-QA-vF.pdf

 In June of 2017, the International Committee of Medical Journal Editors, or ICMJE, released new requirements for data sharing statements, for submissions to their publications. The ICMJE represents the most well-respected and influential publications in the biosciences, including the New England Journal of Medicine; the Lancet; Annals of Internal Medicine; the BMJ; and PLOS Medicine: These publications, and the many others which follow their lead, now require the inclusion of a data sharing statement in all submissions for publication. ICMJE publication editors may take these statements into consideration, when making editorial decisions. Researchers should also know that as of 1 January 2019, ICMJE requires inclusion of your data sharing statement at the time of trial registration.  

In their guidance to researchers, the ICMJE notes that when it comes to data sharing, “undecided is not an acceptable answer.”   When pre-registering interventional trials on clinicaltrials.gov, if “Undecided” is selected for the “Plan to Share IPD” data element, a note now appears indicating that the ICMJE data sharing policy requires a “Yes” or “No” answer to this question. The “Plan to Share IPD” data element is optional on CT.gov, but is required by the ICMJE as part of registration information for interventional studies  Rather than remaining “undecided,” see the chart below to learn how to use Vivli in completing your ICMJE data sharing statement: 

ICMJE Question	How to respond, if using Vivli to share your data:
Will IPD (and data dictionaries) be made available?	Yes
What data in particular will be shared?	Final cleaned individual participant-level data, de-identified*
What other documents will be made available?	Final protocol, statistical analysis plan, and the data dictionary. (Note: additional documents such as CRFs and analytic code may also be included.)
When will data be made available?	X months /years after study completion
With whom?	Anyone with the relevant skillsets to conduct the analysis,  who submitted an approved proposal on Vivli. Proposals are submitted on Vivli.
For what types of analysis?	To achieve the aims and objectives in the scientific proposal as approved via Vivli.
By what mechanism will data be made available?	Following an approved request, a data use agreement must be signed.   Data are made available via a secure research environment or download.

 

For more information or assistance in using Vivli to meet data sharing requirements, email suppport@vivli.org.  

* Vivli partners with Privacy Analytics, to provide de-identification of data sets at a discounted rate for researchers who store and share their data on Vivli.