Industry Insights

  1. The Vanguard of Patient Centricity: Patient-Led Clinical Trials

    Amid the AIDS epidemic during the late 80’s, Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, found himself at a crossroads. As a long-time proponent of the traditional “research to approval” drug development model, involving randomized clinical trials and lengthy regulatory reviews, Fauci was faced with the realization that this traditional approach would be of little benefit to AIDS patients without the luxury of time. Something had to be done. But what?

  2. Getting Ready For Phase 1 In Pharmaceutical Development

    At the early stages of product development, pharmaceutical development scientists are under increasing time pressure to select the right molecule form, the right formulation and the right final dose form.

  3. The Pulse On Clinical Study Startup

    Clinical project managers are expected to make smarter decisions on intelligence derived from clinical trial data and sponsors/CROs are looking for ways to incorporate Business Intelligence into the eClinical systems they are using to empower oversight — turning raw trial data into actionable information.

  4. 5 Ways Electronic Data Capture (EDC) Reports Can Protect Clinical Research Timelines

    The adage “time is money” is as pertinent to clinical research as to any other corner of the business world. The longer a study drags on, the bigger its price tag becomes. Study timelines can be a source of much anxiety for researchers, creating the markets for time-saving innovations like EDC, eSource, and  risk-based monitoring.

  5. How eSource Optimizes The Clinical Site Experience

    While one may expect that a new, groundbreaking technology will initially be met with some resistance from the industry it affects, eSource has already proved highly effective in reducing paper usage, monitoring, and many other costly and time consuming aspects of the research process.

  6. Are Clinical Trial Matching Services Truly Patient-Centric?

    If you have ever tried to find the right clinical trial for yourself or a loved one, you know the process can be confusing and challenging. For example, in the age of precision medicine, oncologists often offer multiple treatment options, from FDA approved indications to experimental therapeutics that are not yet on the market. Meanwhile, for sponsors, effective patient recruitment for clinical trials is critical to meeting timelines and budget goals. Recruitment shortfalls for study participants creates a major problem for the pharmaceutical industry by delaying new therapies from reaching the market, estimated to represent a daily loss of $1 – 8 million dollars.i In addition, under enrollment and/or delayed enrollment at investigative sites can compromise a trial's statistical power and scientific validity. And recent research indicates the problem may be getting worse. According to the Tufts Center for the Study of Drug Development (CSDD), clinical trial enrollment rates overall have dropped 20 percent since 2000, with only 2 million volunteers now participating.ii

  7. Modeling And Simulation In Clinical Trials: Real Potential Or Hype?

    Improving experimental drug success rate1 and accelerating clinical developmentare top priorities for pharmaceutical companies. Careful decision making during drug development is essential to minimize development time, manage costs and improve the probability of commercial success. Recently, many of the major pharmaceutical companies have begun to explore computer-based bio-simulation strategies to help generate the information necessary to make better decisions.3,4 These strategies go by many different names – clinical trial simulation (CTS), modeling and simulation (M&S), computer-assisted trial design (CATD), model-based drug development (MBDD), and model-informed drug discovery and development (MID3). The FDA and EMA regulatory agencies have also taken notice of M&S strategies in an effort to support improved drug development efficiencies.

  8. Alternative Fact: Site Identification Is Not Critical To Clinical Trial Efficiency

    On the surface this may seem to have some validity, as sponsors and contract research organizations (CROs) often lack a transparent, evidence-based strategy for this task. Instead, they frequently rely on archaic paper-based or spreadsheet methods to identify sites across the globe with a reasonable chance of enrolling the contracted number of patients on schedule, and the ability to generate quality data. Moreover, the practice of adding more sites per study than necessary and requiring each site to recruit fewer subjects per site is a standard, although questionable, risk mitigation practice. So how important can site identification be to the efficiency of clinical trials?

  9. Using Real World Data To Enhance Clinical Trials

    Randomized clinical trials (RCT) remain the trusted standard for assessing pharmaceutical drug and medical device safety and efficacy. An RCT uses a carefully planned experimental framework to compare an intervention/treatment with a control, investigating the effect of each treatment option on a defined outcome. Patients participating in an RCT are carefully screened based on precise clinical criteria, and usually have very similar characteristics. Unfortunately, life does not always mirror the idealized world of an RCT.

  10. 10 Tips For Selecting High Performing Clinical Sites

    Investigative sites are the heart and soul of clinical trials, essential to ensuring the efficacy and safety of pharmaceutical compounds in humans. Site selection is pivotal to the successful execution of clinical trials, which are not only long and bureaucratic, but are also experiencing diminishing returns1. Studies estimate that it costs upwards of $2B dollars to bring a new drug to market,2 with daily revenue losses in the range of $1M to $8M3 due to delayed market entry.