Research News

  • FDA Seeks Initiatives for Merging EHR and EDC

    By on August 4, 2015

    The Center for Drug Evaluation and Research (CDER) is seeking proposals for projects to unify electronic data capture from electronic health records (EHR) and electronic data capture (EDC) systems utilized for clinical research for an end-to-end, single-point approach for electronic data capture in clinical research.

    An announcement in the Federal Register states that CDER is interested in supporting demonstration projects to investigate the potential of using an end-to-end Electronic Health Record (EHR)-to-Electronic Data Capture (EDC) single-point data capture approach, under established data and implementation standards and regulations.

    This is an important step towards resolving the disconnect between EHR and EDC systems, that often creates a hassle at the study centre where data is entered into the EHR as part of the patient file and is then transcribed to an electronic Case Report Form (eCRF) to be captured in the EDC system for research purposes. Eliminating the data transcription process would eliminate the potential for transcription errors, would save time, and provide more accurate data.

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  • Patient Diaries Complement Patient Registries

    By on July 22, 2015

    Patient registries are increasingly being utilized for post-marketing surveillance of pharmaceuticals as well as to monitor treatment outcomes and drive future clinical initiatives. Data collection and data management in clinical studies become increasingly more challenging as the complexity of the study and the number of patients increases. For large and long-term studies, utilization of electronic data capture (EDC) systems where most processes and visit scheduling are automated is a must to obtain accurate data in a timely manner.

    With an increased focus on patient-centricity in research and treatment evaluations, electronic patient reported outcomes (ePRO) commonly known as patient diaries or clinical outcome assessments (eCOA) are becoming the standard for capturing data from the patient perspective. The widespread adoption of technology in our daily lives is making it easier than ever to collect real-time data directly from the patient, providing a number of options for the patients to conveniently submit their health and quality of life data.

    Depending on the study design and data collection points, patients can complete diaries electronically either from the comfort of their own homes on their home computers, on their smart phones or tablets, or at the study center during their visits. We are involved in numerous studies currently where these methods are being utilized, providing the study investigators with real-time data from patients so they can stay up to date with their study progress and monitor patient compliance.

    Utilization of Interactive Web Response (IWR) systems that the patients can access either from their own home computers or through Apps from other devices such as smartphones or tablets is a very cost effective solution to collect data from a large number of patients. It is significantly more effective from a convenience and cost perspective as it eliminates the costs associated with transcription from paper diaries, and extra time invested to resolve queries and out-of-range data that can be prevented with the use of an interactive system that automatically flags inappropriate entries.

    A number of studies are benefitting from tablet-based data collection at sites when the study design incorporates patient diary collection as part of the study visit. The patients can complete diaries in the waiting room at the doctor’s office on a study tablet device where the interface is specifically designed for study use. An advantage is that the interface allows both the doctors and the patients secure access to complete study related tasks on the device, providing a reliable and cost-effective tool for data collection where one tablet can serve many patients at the site. We are currently utilizing this method in several ongoing studies, a good example being the COSMiC Study by Janssen Inc. The combination of registries we are involved with are currently investigating diseases in a wide range of patients from their early twenties to their late eighties. The results so far indicate that a properly designed tablet interface that is simple for patients to use can successfully conduct tablet based data collection from patients of all ages.

    Overall, an electronic diary is a significant complementing feature to a patient registry because in the context of large studies, it provides numerous benefits over alternative paper-based data collection including more accurate data, timely results and consequently better decision making by the study team.

     

    HealthDiary provides Electronic Data Capture (EDC), Patient Diaries (ePRO) and Patient Registry services to Biopharma and CRO organizations. To learn more about our services, please contact us today.

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  • Aquinox Pharmaceuticals Completes LEADERSHIP Study

    By on July 15, 2015

    We have recently completed a phase II trial with Aquinox Pharmaceuticals  known as LEADERSHIP Study. The trial investigated the therapeutic potential of AQX-1125 in treating pain in patients with bladder pain syndrome/interstitial cystitis (BPS/IC).

    As a technology partner, we have developed pain diaries and voiding diaries to capture voiding frequency and volume, all delivered on a 7 inch tablet. The patients were able to complete the ePROs as they went about their daily routines. The portability of the device and cellular connectivity allowed the patients to take the device anywhere and submit their daily diaries, even while on vacation. We congratulate Aquinox Pharmaceuticals on completing the study and wish them the best in further development of AQX1125.

    For more on the LEADERSHIP study and results, please click here.

    HealthDiary provides Electronic Data Capture (EDC), Patient Diaries (ePRO) and Patient Registry services to Biopharma and CRO organizations. To learn more about our services, please contact us today.

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  • How Will mHealth Transform Clinical Trials?

    By on July 8, 2015

    Biosensors have the potential to make a tremendous contribution to clinical trials, providing the researchers with data that can be automatically transmitted and instantly analyzed via mobile technologies. Furthermore, patient’s symptoms can be monitored and can trigger a series of notifications, flags and calls to action to resolve any potential issues the patient may be experiencing before they have negative health effects.

    While biosensors are very convenient for obtaining physiological data, the context under which such physiological parameters are recorded is critical to properly understanding the patient’s condition. This is where electronic patient diaries (eDiary) or electronic Patient Reported Outcomes (ePRO) become an integral part of mobile health (mHealth).

    Although the idea of combining the technology of patient diaries (ePRO) and biosensors is extremely attractive for clinical trials, a number of hurdles need to be overcome for widespread usage. This Applied Clinical Trials article discusses the potential of biosensors and mobile technologies in clinical trials, outlining the key advantages as well as the challenges of implementation in an environment with rigorous  laws and regulations.

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  • Google Reveals Health-Tracking Wristband

    By on June 23, 2015

    New health tracking devices are being released at an extremely fast rate and there are countless one’s on the market, but this one claims to be different. The  wristband by Google X won’t be marketed as a consumer product which would suggest additional robustness over commercially available wristbands that can be picked up at any department store. Instead, the device is intended for use in research and disease prevention.

    Clinical trials industry is bound by extensive laws and regulations pertaining to data security and patient privacy. Data collection devices also need to provide accurate results and must be validated sufficiently prior to use in a study to ensure this is the case.  We have tested a health tracking wristband  previously (brand to remain anonymous) where we were not satisfied with the results as it recognized rhythmical typing activity as steps taken during the day. Needless to say, data from such a device would be misleading and inclusion of this device was not further considered for integration with an electronic patient diary (ePRO).

    In any case, data from health trackers is most meaningful when coupled with patient diaries that provide the context for the incoming data. For example, extensive rises in blood pressure or heart beat can be detected and followed up on by asking the patient what they are doing at that moment. There are very different health outcomes if this is the outcome of strenuous exercise versus a stressful event.

    We are looking forward to an opportunity to test this device and see how it measures up against what is already out there. The industry is yearning for a reliable device to continuously track patient health data alongside patient diaries and there is a sizable opportunity if the Google X device satisfies the rigorous requirements of clinical trials.

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