For years, data scientists have conducted research using clinical trial data the old-fashioned way by:

• Contacting a wide variety of companies, each with their own data request process—some with a secure access platform and some without
• Conducting parallel research projects using various data sets
• Manually consolidating the results to uncover clinically relevant insights

This time-consuming, complex process creates significant barriers to healthcare advancements. For example, researchers cannot always combine data sets from different providers. Keeping data sets separate is a huge hindrance for those performing large-scale meta-analyses on everything from drug interactions and drug safety to optimal drug dosing.

It was this problem that led to the formation of the Clinical Study Data Request consortium (CSDR), a clinical trial data request and sharing solution that vastly streamlines and accelerates how researchers request, access, and analyze clinical data from multiple organizations. Launched by ideaPoint and DizzyAtom in January 2014, and supported by the first data sponsors, GSK, Roche, Sanofi, ViiV Healthcare, and Boehringer Ingelheim, CSDR quickly became the leader in multi-sponsor clinical trial data sharing. CSDR is a “one-stop shop” for data scientists and researchers seeking to access and analyze third-party clinical patient data from multiple studies to advance human health. Through ClinicalStudyDataRequest.com, CDSR’s publicly available website, at no cost researchers can:

• Request access to global clinical data from 7 sponsors and study funders
• Centrally manage and track proposals, questions, and inquiries
• Combine multi-sponsor data sets in a secure workspace
• Analyze these data sets1 on a single analytics platform with the most complete set of analytics tools available today, including open source, proprietary, and DizzyAtom analytics software
• Access all shared data in the secure workspace for as long as necessary to complete the research

The power of global collaboration

In July 2013, Pharmaceutical Research and Manufacturers of America (PhRMA), along with the European Federation of Pharmaceutical Industries and Associations (EFPIA), called forgreater data transparency and collaboration within the biopharmaceutical industry to help researchers innovate, discover, develop, and deliver new therapies and vaccines. EFPIA and PhRMA also published the Principles for Responsible Clinical Trial Data Sharing as a set of guidelines. The CSDR platform was designed around these principles to ensure clinical study data could be shared with researchers, but with assurances that:

• The data would be secure
• Patient anonymity would be protected
• Any organization conducting and funding clinical trials—from big pharma to university researchers—could share their data with confidence

Today, CSDR is comprised of 13 pharmaceutical companies and four funders—The Wellcome Trust, The Bill & Melinda Gates Foundation, Cancer Research UK, and the Medical Research Council. “We recognized there were major barriers to sharing data and making it accessible and findable by researchers,” explains Georgina Humphreys, clinical data sharing manager at Wellcome Trust. “By signing up, we removed one barrier for researchers we fund to list available data.”

Similarly, one of the main reasons pharma giant Novartis joined CSDR was to tangibly embrace the principles of data sharing defined by EFPIA and PhRMA. Kevin Poirier, data sharing portfolio manager at Novartis, explains that, “We’re happy to make our clinical trial data available to researchers for free, and at the same time, CSDR gives researchers the option to access other member companies’ clinical data. CSDR is a particularly powerful tool because users can pool our data with data from other member organizations—all in one place.”

For Eisai, a Japanese pharmaceutical company headquartered in Tokyo with 10,000 employees—including 1,500 in research—joining CSDR was the obvious choice. “All of the processes were already in place and implemented in a way that was so well thought out and easy to use,” notes Ray Harris, senior director of biostatistics at Eisai. “Researchers benefit from a seamless process, start to finish, and can combine data from many studies and companies while ensuring patient confidentiality.”

Enabling new research that advances human health

CSDR has broken down the barriers to clinical trial data access, aggregation, and analysis, which has significantly improved the end-to-end research experience—especially for individual patient data (IPD) metadata analysis involving the pooling of large volumes of patient data from multiple clinical studies. Long maligned by pharmaceutical researchers generating actual patient data, IPD metadata research is increasingly recognized as playing a valuable, complementary role. Examples of how researchers are using CSDR data include:

• Running novel analyses
• Performing systemic reviews
• Checking for publication and reporting bias

For instance, IPD metadata studies can be used to compare drug efficacy for patients newly diagnosed with a condition so healthcare providers can make more informed drug and dosing recommendations that will achieve better patient outcomes. With IPD metadata analyses, this kind of knowledge can be gained without the time and cost associated with running an actual drug trial, which can take years to complete and cost a great deal of money.

Consider, for example, research shared at the Clinical Trial Data Transparency Forum 2019 in Heidelberg, Germany, where industry leaders, researchers, and peers discussed how the life sciences industry is building on the success of the data sharing movement. Dr. Sarah Nevitt from the University of Liverpool, U.K., explained how meta-analyses of granular patient data, including unstructured text data, can capture real patient experiences such as side effects experienced or reasons for stopping a treatment. Such details can reveal how different drugs affect patient-centered variables like quality of life—not just medical efficacy, which original clinical studies typically focus on. These findings help healthcare providers consider the full burden of treatment for patients when making drug decisions.

At the Forum, Nevitt showcased her own metadata study analyzing patient data from CSDR and other sources. The analysis involved 45 pairwise comparisons of antiepileptic drugs, some of which had never been compared head-to-head in drug trials. The study, titled “Cochrane Individual Participant Data Network Meta-Analysis (IPD-NMA) of Antiepileptic Drugs (AEDs),” is now influencing guidelines on the choice of drugs—guidelines that are used for clinical decision-making and balancing the benefits and harms of commonly-used drugs for patients with different types of epilepsy. This research could not have been done without clinical trial data sharing enabled through CSDR and similar platforms.

Accelerating research through quicker data access

The growing number of research proposals submitted for review by the CSDR team testifies to its perceived value by researchers and statisticians. Since 2014, over 800 researchers from 500 institutions in 42 different countries have submitted proposals, and recently, the number of requests have jumped from 85 in 2017, to 105 in 2019. This is a good indicator that CSDR is making an impact. “The more studies that are listed, the more subtle are the things that people can analyze,” comments EISAI’s Harris.

CSDR’s member companies also measure the impact of CSDR by assessing time to clinical data access, as faster data access accelerates the delivery of published clinical recommendations. “We’ve been able to reduce the average time from submission of the request form to accessing data from 200 days in 2018 to 139 days in 2019, although we accept there are still some that take much longer,” explains The Wellcome Trust’s Humphreys. “Already, there are 70 published studies that used CSDR data, and another 30 that are awaiting publication.”

What’s next?

Six years ago, CSDR was the first organization to offer multi-sponsor clinical study data access. Other sharing platforms have followed, such as Vivli in 2018, which, like CSDR, covers multiple disease areas and multiple sponsors; and Project Data Sphere, which is focused on cancer research. Since CSDR's inception, more than 560 research requests have been received, with nearly 60 studies published using data from the platform, and nearly 30 more anticipated. As CSDR has continued to seek to enhance its data sharing platform, a key success and differentiator has been the streamlining of data requests and access in order to enable researchers to merge data from different pharmaceutical companies, and analyze it directly within a secure platform. In addition, with the availability of DizzyAtom, open source, and commercial capabilities, CSDR is able to provide a complete solution with a truly comprehensive analytical platform.

However, given that multiple clinical data platforms are now available, the long-term industry goal must be platform interoperability; this will unlock all clinical data offered in various platforms and facilitate even richer data sharing, analysis, and insights that will improve patient health. CSDR is actively pursuing platform interoperability as an important next step for advancing human healthcare.

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Nov 2019 – The total number of academic-led trials on CSDR rose to 18 this month as academic researchers show growing interest in making their clinical trial data more easily findable and accessible for re-use by other researchers.

In April 2018, ClinicalStudyDataRequest.com (CSDR), which started as a platform for data-sharing from industry-sponsored trials, partnered with four major academic funders: The Bill & Melinda Gates Foundation, Cancer Research UK, Medical Research Council and Wellcome Trust. This collaboration has meant that any clinical trial supported by one of these funders can be listed as available for data sharing on the CSDR online portal for free. Study data can easily be requested by researchers and shared following a successful data access request to the CSDR Independent Review Panel.

All of the academic funders who joined CSDR are clear about the importance of sharing clinical trial data to create opportunities for research and innovation from re-use of these rich datasets. Funded researchers are now encouraged to make their trials more visible using this platform.

The Southampton Clinical Trials Unit were the first to list an academic-led clinical trial on the platform in July 2018. Staff welcomed being able to hand over responsibility for managing enquiries to access their data, "having CSDR as a common front end to deal with requests for this trial was logical – it makes our lives easier". Since this positive first experience, the unit have gone on to list a further 6 trials.

The academic-led trials investigate a diverse range of treatments. Some of these are trials of potential new medicines, while other trials explore the benefits of a range of non-drug treatments, such as cognitive behavioural therapy in the PACE trial or hyperbaric oxygen therapy in the HOT-II trial. Three trials focus on the treatment of debilitating infectious diseases in lower-and-middle-income countries (South Africa and Ethiopia).

The rate at which academic-led trials are being added to CSDR is now increasing steadily after a slow start. Whereas only 2 trials were added in the first year of the partnership, 16 trials have already been added in the second year. As academic researchers look for ways to share their data without the burden of managing enquiries and access requests, we can expect to see this speed up further in the coming year.

About ClinicalStudyDataRequest.com
ClinicalStudyDataRequest.com is the industry leader in global clinical trial data transparency. Its multi-Sponsor Request System provides a secure process for Researchers to request access to global clinical trial data through a publicly available website. An Independent Review Panel review data requests received from external researchers. Wellcome Trust provides secretariat support to this panel and oversees the review process. Access to clinical trial data provides opportunities to conduct further research that can help advance medical science and improve patient care. This helps ensure the data provided by research participants are used to maximum effect in the creation of knowledge and understanding.

Media Inquiries
Scott Shaunessy
support@clinicalstudydatarequest.com

BOSTON – April 23, 2018 – ClinicalStudyDataRequest.com (CSDR), the first-in-class online resource giving researchers access to patient-level clinical trial data from 14 of the world’s leading pharmaceutical companies across multiple therapeutic areas, today announced new strategic collaborations with four major non-profit partners: The Bill & Melinda Gates Foundation, Cancer Research UK, Medical Research Council and Wellcome Trust. The new consortium partners expand CSDR’s ability to deliver upon its promise to help accelerate life-saving discoveries and efficiently translate big data into smart data that generates valuable research results.

"Making clinical trial data available to biomedical researchers across all geographies will help improve academic and clinical research activities, the drug development process, and ultimately, enhance patients’ health outcomes," said Scott Martin, Chair of the CSDR Steering Committee. "CSDR is pleased to join forces with such outstanding research collaborators who share our vision of safeguarding privacy while enabling transparency around the vast amounts of valuable data borne from clinical trials."

Since its founding in 2013 CSDR has demonstrated steady growth both in the number of pharmaceutical partners making their data available to the research community as well as the number of researcher proposals submitted through the organization’s one-stop shop for accessing de-identified patient data from the more than 3,500 studies worldwide. With 57 researchers who accessed data through CSDR having already published or pending publication of journal articles on their findings, the organization recently launched a redesign of its website to allow for an improved, more efficient user experience. With the addition of non-profit partners, CSDR is uniquely positioned to not only serve the research community through unparalleled access to patient-level clinical data from the pharmaceutical industry, but also as a resource through which academic-led clinical trial data now can be shared..

“Data is one of the biggest outputs of the research that Wellcome Trust supports, and we support CSDR’s goal of ensuring that it is shared in a way that is independent, transparent, and equitable to reduce the barriers of data re-use,” said Jennifer O’Callaghan, Clinical Data Sharing Manager with Wellcome Trust. “CSDR addresses the needs of the academics whom we fund by providing them with a single, innovative solution for accessing and analyzing data from multiple trials as a means of saving time and effort – altogether maximizing the value of the research that we fund and creating an opportunity to make academic clinical trial data more discoverable, accessible and reusable for optimal impact and value. We strongly encourage our researchers to use CSDR for sharing and accessing trial data.”

As clinical trial data sharing continues to expand, both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have put into place basic requirements to support clinical trial transparency and data disclosure, but are still calling for improvements around the scope, clarity, consistency, and usability of disclosed data. Through its innovative and functional approach to data sharing and scientific exchange, CSDR is answering that call with an unprecedented mechanism for ensuring privacy of trial subjects in tandem with expedited advancement of scientific discoveries and innovations.

About ClinicalStudyDataRequest.com
ClinicalStudyDataRequest.com is the industry leader in global clinical trial data transparency. Its multi-Sponsor Request System provides a secure process for Researchers to request access to global clinical trial data through a publicly available website. An Independent Review Panel review data requests received from external researchers. Wellcome Trust provides secretariat support to this panel and oversees the review process. Access to clinical trial data provides opportunities to conduct further research that can help advance medical science and improve patient care. This helps ensure the data provided by research participants are used to maximum effect in the creation of knowledge and understanding.

Media Inquiries
Scott Shaunessy
support@clinicalstudydatarequest.com

BOSTON—December 15, 2016—ClinicalStudyDataRequest.com (CSDR) a cross-industry initiative providing Researchers with access to clinical trial data from 13 major pharmaceutical companies, including trials that involve multiple Sponsors, has significantly increased the number of trials available to more than 3,200.

CSDR offers medical and scientific Researchers an unparalleled array of clinical trial data that can facilitate collaboration, advance scientific knowledge, and potentially improve outcomes for patients. Through this portal, Researchers can request anonymized patient-level data from a list of more than 3,200 clinical trials via an independently reviewed process managed by the Wellcome Trust.

The available trials span all major disease areas. For example, there are more than 300 diabetes trials listed. Since the initiative was launched, there have been more than 250 requests from Researchers for trial data. Study Sponsors interested in listing studies on the site may contact CSDR here.

"ClinicalStudyDataRequest.com and its member companies are proud to have reached these important milestones of more than 3,200 trials listed and 250 requests made. This consortium continues to raise the goal and Sponsors are working together and with others to continually seek new ways to increase the number of trials listed and take steps to facilitate easier request and data-access mechanisms," said Scott Martin, chair of the ClinicalStudyDataRequest.com Steering Committee.

About ClinicalStudyDataRequest.com

ClinicalStudyDataRequest.com is the industry leader in global clinical trial data transparency. Its multi-Sponsor Request System provides a secure process for Researchers to request access to global clinical trial data through a publicly available website. An Independent Review Panel and process overseen by the Wellcome Trust review data requests received from external Researchers. Access to clinical trial data provides opportunities to conduct further research that can help advance medical science and improve patient care. This helps ensure the data provided by research participants are used to maximum effect in the creation of knowledge and understanding.

About ideaPoint

ClinicalStudyDataRequest.com is built on a unique platform called ideaPoint, which is dedicated to providing clients with software solutions that help them repeatedly spot and seize the innovation and partnering opportunities that create growth through new products, new services and new business models. Since its launch in 2008, ideaPoint software has been used to transform and solidify innovation and strategic growth programs across global companies in science-based industries. For additional information, please visit www.idea-point.com

Media Inquiries
Scott Shaunessy
support@clinicalstudydatarequest.com

Initiative designed to facilitate transparent data sharing in support of advancing biomedical research

Quincy, MA - January 2, 2014 - ideaPoint, Inc., a leading provider of partnering and collaboration systems for global enterprises, today announced the availability of a new portal providing a secure request system for research-focused clinical trial data (https://clinicalstudydatarequest.com). Site Sponsors currently include Boehringer Ingelheim, GlaxoSmithKline, Roche, Sanofi and ViiV Healthcare.

With extensive experience providing online collaboration solutions for global pharmaceutical companies, ideaPoint powers the technology behind the new site's secure request and evaluation process.

"The design and development of this user-friendly site is an outgrowth of our collaboration and partnering software. Supporting this global consortium was a natural expansion of our work with pharmaceutical company clients, and we are pleased to work with representatives from the Sponsor organizations to achieve this milestone," said Scott Shaunessy, CEO and Founder of ideaPoint. "Our solution is highly configurable and will allow the functionality to expand as the initiative matures over time".

As Researchers continue to search for treatments and cures to some of society's biggest medical challenges, the need to seek scientific insights that may lead to potential improvements in patient care has become a pressing issue. For the first time, Researchers can select studies of interest from multiple Sponsors across multiple disease areas and submit a single Research Proposal through a user-friendly portal. Research proposals to access data are reviewed by an Independent Review Panel (IRP) to ensure the proposed research makes a useful contribution to science. The site includes easy-to-follow videos and visual instructions on how to submit a proposal - all available at https://www.clinicalstudydatarequest.com/Step-By-Step.aspx.

In addition to Research Proposal requests for data already uploaded to the site, Researchers can also submit inquiries to study Sponsors to ask about the availability of data from studies not yet listed. The site includes a Data Sharing Agreement that requires all Researchers to post a summary of their research within one year of their analyses, and seek publication in a peer-reviewed journal.

The portal currently houses multiple studies available from the Sponsor organizations. It has been designed with a flexible configuration so that other industry, academic, and non-profit Sponsors can join and include their studies. Those interested should contact info@clinicalstudydatarequest.com for more information.

ideaPoint and the founding Sponsors believe this site launch is an important first step towards providing greater access to patient-level data in support of biomedical research, and look forward to continued and expanded collaboration within the research community as this initiative evolves over time.

About ideaPoint

ideaPoint, an Anaqua product, is an enterprise software that helps global Life Science companies accelerate quality decisions on innovation opportunities that have a material impact on their business.

Since its launch in 2008, ideaPoint has delivered software solutions to industry-leading Pharmaceutical, Biotechnology and Medical Device organizations to capture and assess opportunities for collaboration, licensing and acquisition, venture investing, and other partnering models that create growth through new products, new services and new business creation.

Media Inquiries
Scott Shaunessy
support@clinicalstudydatarequest.com