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Is Collaboration in Research a Pipe Dream?

Researchers have traditionally been rewarded for innovation and being the first to publish unique results.  Unfortunately, in a new era promoting collaboration, such a culture presents barriers to sharing information in a timely and useful manner and, in turn, to bringing therapies to patients sooner. Certain organizations such as One Mind are trying to change this culture.   

The theme of the 2015 One Mind Summit was “Open Science and Collaboration in Action.” Examples of One Mind collaborations were presented by key opinion leaders, while barriers to further collaboration were identified in a fluid exchange of great ideas mixed with cautious optimism about what changes can actually be achieved.

Impediments to successful collaboration in Traumatic Brain Injury (TBI) discovery in the U.S. were shown on a slide by one of the world’s leading experts in this field during the panel discussion “TBI: A Field Moving from Competition to Collaboration.” These impediments, which are not limited to TBI, include:

  •         A societal culture that values individual discovery;
  •         An NIH funding culture that favors individual research and discovery;
  •         An NIH funding culture that emphasizes innovation and impact, which are not necessarily major components of collaborative research.

Collaboration provides an opportunity to streamline the research process and produce more meaningful results that can be used to improve patient care. In addition to the cultural barriers created by NIH incentives and funding mechanisms, the following barriers were discussed at the One Mind Summit and recent Data Sharing meetings such as those sponsored by the Harvard MRCT and the Institute of Medicine:

  •         Study results are often not shared until the time of publication, which may take years
  •         Funding does not necessarily link to requirements for formatting (standardizing) data such that it can be aggregated or even accurately compared (and researchers see this as an added cost at the end when standardizing the data collected can yield significant savings in time and resource);
  •         Clinical researchers are not always trained in appropriate study design or statistical analysis methods nor in data management techniques that can ensure quality and usefulness of the data collected;
  •         Federal agencies and federally funded initiatives within the U.S. are creating their own data formats anew, using inappropriate models for the purpose of normalizing data, and/or not using globally accepted data standards or common formats (even across the 27 different centers within the NIH).

Fundamentally, studies must be designed such that the results are meaningful; a poorly designed study without an appropriate analysis plan for the data is a waste of time for researcher and patient. Such studies were referred to as ‘small, crappy trials (SCTs)’ at a Harvard MRCT meeting, and the NIH representative took responsibility for funding such studies when grants issued are under $500,000. NIH researchers are asking for additional funding to put the data into a common format. (Again, why is this being done after the fact vs. planning the study appropriately and integrating this quality step into the beginning?)  One comment at the One Mind summit was that we should certainly provide more funding to NIH, but this funding should be tied to requirements for the use of international clinical research data standards from the start (e.g. CDISC CDASH).

With the generation of more and more data comes the need to aggregate data from various disparate sources to increase the meaning and statistical power and/or to be able to accurately compare these data across studies.  Powerful statistical analyses rely on having sufficient data in a common format to ensure trustworthiness of the conclusions made from that research. ‘Big data’ does not necessarily imply that it is meaningful data. In fact, there are numerous examples in which big data cannot be analyzed in a manner that produces any useful results.

Those who are making global research possible, such as One Mind, WHO, the Worldwide Anti-malarial Resistance Network, the leaders of nutrition companies (such as Danone, Nestle and Abbott), the Critical Path Institute, the MS Society, the PKD Foundation, in addition to the Innovative Medicines Initiative in Europe, the Translational Research Informatics Center and Academic Research Organization Council in Japan and regulators in the U.S. and Japan are realizing the value of global standards for clinical research. They are all endorsing CDISC global standards for research data such as demographics and adverse event reporting while collaborating to augment these standards in the therapeutic areas of interest.

CDISC Standards have been shown to reduce the overall cost and resources for conducting a research study significantly (~ 60%) while decreasing the time and resources to start a research study by 70-90%. And, there is encouragement by FDA to use electronic data from the beginning (eSource), such as from mobile devices or electronic health records. CDISC, a charitable non-profit standards development organization (SDO) acknowledged by ISO, has been developing consensus-based global clinical research standards for 18 years for regulated and non-regulated clinical research. These standards (historically on paper like other global standards) are now being loaded into the Shared Health and Research Electronic Library (SHARE) such that they can be electronically accessible and machine-readable, which will make additional research efficiencies possible.

The phrase ‘pipe dream’ comes to mind. Is it just a dream of the impossible to think that the world of clinical research could have shared, collaborative global standards for all to use? According to the Urban Dictionary, pipe dreams are a vision or dream that will never happen, given the harsh reality of life. The example provided is world peace and human equality. These represent pipe dreams because “humans are more naturally inclined to kill off their competition than to cooperate.” CDISC was told by one NIH representative that creating a global standard for data collection would be impossible; however, through the productive collaboration of thousands of volunteers around the world, CDISC’s CDASH is now a recognized global standard for data collection that is used around the world and is being required by regulators who review new drug applications.  It is a minimum essential core set of data collection elements that are required for all research studies.

Why should we not collect data in a standard format at the beginning to avoid the additional expense and loss of data integrity when mapping into the standard after the study is over? When will we stop building silos? General Chiarelli asks when we will ‘draw the chalk line’ and use standards from the start? He and his colleagues at One Mind are doing everything in their power to encourage collaboration, data sharing and better treatments for those with brain injury and related mental health disorders.  

The One Mind conference identified barriers to scientific progress; this is a step forward in turning what is considered a pipe dream into a realizable benefit.  The next step is to break down the silos and create advocates who will ultimately enable more trustworthy data, better science and a more rapid path to treatments. Dr. Andrew von Eschenbach encouraged the attendees at the end of the One Mind Summit, stating that brain research is now where cancer research was when he took the lead position at the National Cancer Institute in the early 1970s. There is a tremendous opportunity with the new technology and data we can generate. However, he cautioned everyone to change the way they are working. We must go from a game of golf to a game of basketball. We must move from incentivizing the lone investigator to teamwork and collaboration.


CDISC is a 501(c)(3) global non-profit charitable organization that streamlines research and enables connections to healthcare through the development of clinical research data standards. CDISC has developed a suite of standards to support clinical research from protocol through analysis and reporting. CDISC standards make it possible for data to speak the same language, empowering simple data collection and private sharing that makes the most of the valuable information offered by patients participating in research studies around the globe. Using CDISC standards from the start of studies enables Smarter Research to Unlock Cures, saving ~60% overall in terms of time and resources to conduct research. CDISC is the patient’s advocate, creating therapeutic area data standards for over 25 different disease areas that advance medical product development and various types of clinical research.


By Rebecca Kush, PhD, CDISC President