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Sharing Data in Clinical Trials

Learn more about the importance and benefits of sharing clinical trial data at the individual patient level. Discover how data sharing can increase the reliability and clarity of medical trials, provide opportunities for researchers and experts to interpret and evaluate data, and improve medical and regulatory judgments. Explore the methods and platforms for sharing clinical data, as well as the barriers and ethical considerations that need to be addressed to promote data sharing. Understand how data sharing can lead to advancements in scientific drug research and enhance patient care.
Management of Data in Clinical Trials
Published on
July 25, 2023

The building elements of records, known as data, are essential for the development of human study in the current era. 

Rapid technological advancements over the previous ten years have resulted in the daily creation of an unparalleled volume of information and the creation of forums that make storing and sharing that information easier. Data and information sharing are currently essential for the development of any study sector. Each step of the clinical testing procedure generates tremendous data in clinical trial research, which is essential for drug development. Nevertheless, withholding these data could negate several advantages. This article discusses the possible advantages and anticipated difficulties of exchanging clinical data at the individual patient level, solutions to these difficulties, and how the clinical pharmacology society might influence this field’s emerging trends.

When hearing the phrase “real-world data is heard,” you probably picture huge databases stuffed with electronic health information from hospitals and other Healthcare institutions. Information via wearable health monitoring devices and health-related information from ambient sensors fall into this category less frequently. The growing number of data sources poses many key obstacles for medical experts, notwithstanding their growing significance across many domains.

Benefits of Data Sharing

Sharing clinical data can increase the reliability and clarity of medical trials by enabling researchers to confirm one another’s conclusions and reducing the effects of reporting bias. Furthermore, it might provide chances for investigators, experts, and drug regulators to interpret and evaluate data from clinical trials to learn more and improve the data backing medical and regulatory judgments. In addition to producing fresh research questions and hypotheses about the security and effectiveness of medicinal therapies, ethical clinical testing information sharing may also aid in examining new issues and analysis techniques outside the boundaries of the initial study. Furthermore, by doing well-powered meta-analyses, researchers, clinicians, and scientists may be able to construct on each other’s studies and draw quick, conclusive, and relevant findings about the advantages and disadvantages of a treatment intervention. By generating greater information regarding the effectiveness and security of medications, these conclusive findings will enable Healthcare practitioners to make knowledgeable clinical care decisions, enhance public health, and better clinical care.

Sharing of Data During Clinical Testing

Over the past twenty years, significant progress has been made in establishing open methods and guidelines for information sharing in clinical trials. As a result of the US Food and Drug Administration (FDA), Modernization Act (FDAMA) of 1997, a readily accessible web-based library called was released in 2000. The FDA Amendments Act (FDAAA) laws passed the licensing of clinical trial strategy summaries necessary to upload to in 2007. These platforms allow people to access clinical testing results via thorough searches. These successes also involved journal articles. A clinical trial is described as “a research study that retrospectively allocates human patients to involvement or contextual factors to research the cause-and-effect correlation among medical assistance and clinical outcomes” by the International Committee of Medical Journal Editors (ICMJE) in 2005. That year, ICMJE established a regulation allowing researchers to enter their trial design into a public, digitally accessible clinical study database. In articles providing any results from medical studies, the ICMJE, as in 2018, necessitates authors to add a data-sharing declaration. For clinical studies that start recruiting patients in 2019, completing a data-sharing strategy and notifying any modifications after registration also become necessary. The criteria should lessen any risk of bias that may occur.

Clinical trial patients also welcome these inspiring systemic advancements toward end-to-end information exchange in clinical studies. More than 80% of participants in 421 completed questionnaires from various clinical studies were open to sharing their information with researchers from academia and for-profit organizations. Only a small percentage of respondents ( 8%) voiced concern that the advantages of sharing data would surpass the concerns. This study dispelled the skepticism and worries that data exchange would deter participants from partaking in clinical studies.

Methods for Sharing Clinical Data

The methods to support data sharing need to be established if regular medical information sharing is to be mandatory. Individual-level data transfer can primarily be accomplished using a minimum or extended manner. A solitary online exchange of de-identified independent information by a single researcher or tiny group of investigators can be considered a minimum strategy. Despite its benefits, this method makes it difficult for potential consumers to analyze the data, comprehend its layout and requirements, combine it with some other studies, and then use it appropriately.

Platforms that can map various efforts globally are required due to the rapidly expanding number of data-sharing activities. Consortia-Pedia is a centralized repository that offers a qualitative approach of approximately 500 exploratory coalitionsThe Global Alzheimer’s Association Interactive Network is a system that links 51 databases with information on Alzheimer’s disease (AD), which affects over 400,000 people. Researchers can query and visualize data from various sources using the Interrogator tool provided by the Global Alzheimer’s Association Interactive Network. Such instruments would enable the utilization of medical information to improve drug discovery while facilitating interaction and avoiding the duplication of efforts throughout consortia.

Barriers Affecting Clinical Data Sharing

Data sharing for clinical studies needs to be improved by many obstacles. The reasons behind some of these hurdles include the worries of academic researchers who are the data’s owners, organizational policies set in place by research centers that limit data sharing, technical glitches, privacy issues, and ethical implications that prevent the sharing of clinical trial information.

Apprehension of Losing Credit

Peer-reviewed publications are the coinage for academic development for medical researchers, particularly for various pioneers. As a result, many investigators oppose data sharing to maximize the number of papers through further examination of their set of data. To address this obstacle, encourage scholars to disclose relevant medical and scientific data by recognizing their academic achievements and including their data-sharing attempts as a criterion for their career advancement. 42 Research scientists may cooperate to provide clinical information if they receive credit from potential grant assistance and official acknowledgment from research institutes. To give academics who contribute their clinical evidence the proper acknowledgment and credit, further alternatives have also been put forth. As an illustration, investigators whose data were provided may be listed as data contributors on papers that used the shared data. Many data repositories that provide data citations have also been established. To monitor the reusing of this information and acknowledge its inventors, producers, and marketers, appropriate citation of the data and tracking data identifiers disseminated through direct reuse or modeling to other sites can be very helpful. Furthermore, many journals have rules promoting or requiring writers to list data sets utilized and to offer data availability declarations to give academic credit and constitutional acknowledgment to scholars who helped generate and disseminate the data. These initiatives help identify clinical data owners appropriately, promote them to collaborate and disclose their data, increase the reliability and durability of study results, and make data more usable for addressing high unmet medical needs.

Concerns About Privacy and Moral Issues

There are compelling ethical reasons for exchanging data in two distinct but connected ways. First off, there are so many peer-reviewed articles supporting data sharing that it is clear that this is not just a perspective held by a small subset of bioethicists or academics. For instance, a PubMed search for “data sharing” AND “ethics” returns 444 results, the majority of which discuss successful instances of data sharing, make a case for sharing data, or demonstrate the challenges associated with data sharing and the effective ways to solve them. Secondly, and perhaps most crucially from an ethical perspective, people’s justifications for why data sharing is vital are ethically predetermined. As a result, the first element that must be concluded is that sharing data in clinical studies is necessary or required from an ethical perspective.

Most moral considerations still surround the exchange of medical data concerning how to do so without exposing the trial participants’ confidentiality to jeopardy. To address this issue, we require a precise, open-book, and responsive procedure that permits other experts to use information from clinical trials without jeopardizing the confidentiality and safety of research subjects. Significant authentication and authorization architecture must be considered to offer adequate privacy and security for study subjects. To assess and minimize the danger of exchanging medical information over time, it is necessary to analyze the hazards & advantages connected with data exchange over time and investigate recently developing legal and technological instruments. 

To offer improved privacy protection for patient information, we need several factors:

  1. Innovative technology quick fixes 
  2. Appropriate Identity and Access Management solutions 
  3. Integrated security and confidentiality restrictions, such as de-identification, ethical review processes, and secure information vaults.

Technical Difficulties

When constructing the necessary infrastructure to allow appropriate data exchange, it is fair to consider a secure information repository that can retain data and enable data searches. To help implement a digital infrastructure that promotes data sharing, it is essential to discuss these factors and the ongoing expenses related to data curation and large databases, which require a steady funding source. Furthermore, using machine learning algorithms for data analyses necessitates a substantial volume of training data drawn from various potential outcomes. Complete interconnectivity and availability are essential for the transmission of clinical trial data. Furthermore, using non-standardized methods of data collection, crucial details about the design of clinical trials, participant drop-out rates, and other data intricacies may be overlooked throughout the secondary analysis, which could result in incorrect interpretations of the data. Outcomes from this assessment could conflict with the preliminary results of the clinical trial, posing a risk to both the trial’s principal investigators and the participants. Imposing criteria for clinical testing information exchange may be one of the workable solutions. We can take a cue from attempts to standardize data from health records, where methods and standardized principles have indeed been developed and are largely acknowledged. For example, in this case, the Fast Healthcare Interoperability Resource was created by Health Level 7 Worldwide as a methodology for standardized health data to enhance interoperability and computerized data exchange within the care continuum. To allow seamless information reusing, the Fast Healthcare Interoperability Toolkit demands that data be available, compatible, and repeatable. It will be easier to get beyond many data-related barriers and enable even more useful trial data exchange if there is a standard process for exchanging information from clinical trials that mandate thorough and comprehensive data labeling.

For example, the Fast Healthcare Interoperability Resource was created by Health Level 7 International as a methodology for standardized health data to enhance compatibility and digital data transmission within the health sector. To allow seamless data reusing, the Fast Healthcare Interoperability Resource demands that information be approachable, compatible, and reusable. It will be easier to get beyond many data-related barriers and enable more useful study information exchange if there is a standard process for sharing information from clinical trials that mandates thorough and comprehensive data annotations. Given the previously-mentioned challenges, we identify further problems with metadata validation, long-term data maintenance, and organizational policies limiting information sharing. To tackle these issues, it would be necessary for academic, industrial, and legal investigators to team together and establish effective pathways for close cooperation on the part of patients. These partnerships would assist in overcoming those difficulties by developing the necessary regulations that would safeguard research participants’ confidentiality and enable the sharing and repurposing of clinical information to meet the unfulfilled needs of the patient.

What’s next?

Ongoing initiatives have been to promote transparency and lower obstacles to the pharma industry, legal authorities, and research scientists exchanging clinical trial information. Leaders in academic circles, business, and regulatory organizations have realized the importance of information sharing and the need to tear down information silos to unlock the potential of open data for making quick and accurate decisions. As a result, a culture change in the endorsement of sharing data has already started. Additionally, clinical trial volunteers have grown more outspoken in their calls for increased clinical study integrity and sharing data among research organizations to provide previously unimaginable opportunities for medical advances. Given all these developments and the vast volumes of clinical trial information already available, it is anticipated that making this data set public will significantly advance scientific drug research and patient care.

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