Data Standards Featured Articles

41. Increased Access And Use Will Maximize The Value Of Data 8/20/2015

    The collection and use of data in clinical trials has changed dramatically over the years. Just 15 or 20 years ago, researchers were generating volumes of valuable data in both the lab and the clinic. Yet somehow the isolation that existed between those two worlds prevented optimal value creation (getting therapies to patients faster). The result was frustration amongst researchers and a feeling of missed opportunities.

42. Clinical Insights: Market Growth Projected In China and South Africa 8/10/2015

    Zaher El-Assi is always looking for new opportunities. The president of Merge Healthcare’s eClinical division believes China and South Africa are two interesting locations for the conduct of global trials. In this Q&A article he shares his insights on both markets, why pharma companies need to be there, and the challenges companies can expect to face.

43. Source Data Verification: A Quality Control Measure in Clinical Trials 8/3/2015

    In an industry that seems to be focused on cutting the cost of clinical trials, it’s no surprise that reducing the amount of source data verification (SDV) performed in studies—the process of cross-referencing data recorded in a case-report form to the original source information—is an integral part of risk-based monitoring (RBM) strategies. Eliminating source data checks that do not add value to the study is certainly a breakthrough for trials where we have historically performed 100 percent data verification. After all, why verify data that we already know to be correct, and is a low risk to the study as well?

44. How One Bio Company Tackled Its Data Visualization Challenge 7/16/2015

    Data visualization is a problem for many life science companies. Being able to visualize reliable data in real-time, and make smarter decisions faster, is vital to delivering speed and quality across clinical trials.

    While many companies struggle with quality uncertainty and surfacing relevant data trends, those that specialize in rare diseases have a more unique challenge. With rare diseases, trials are open label (patients and researchers both know which drug is being administered) and non-comparative. By design, personnel have access to data in an unblended way. That provides the opportunity to see actual data as it emerges, enabling personnel to understand the data in a way that would not be possible in a blended trial.

45. Why Rater Training Matters in Clinical Trials: A Science Overview 3/16/2015

    Rater training has been proven to reduce rater errors and standardize scale administration. Training on each instrument and its administration is recommended for clinicians, observers and patients by global regulators, and endorsed by ISPOR. 

46. Challenges In The Reanalysis of Randomized Clinical Trial Data 1/13/2015

    In September, the Journal of the American Medical Association (JAMA) published a study on the reanalysis of randomized clinical trial (RCT) data. The main objective of the study was to identify published reanalysis of RCT data to characterize methodological and other differences between the original trial and the reanalysis, and to assess whether the reanalysis changed interpretations from the original article.

    The study notes that, after careful re-examination, secondary researchers did not always come to the same conclusion as the original researchers. A surprising total of thirteen studies (35 percent of the 37 eligible studies discovered) led to interpretations that were different from that of the original article regarding the types and number of patients who should be treated.

    The central issue appears to revolve around the data. In many instances, researchers are not sharing their raw data and are therefore missing important opportunities for additional analysis. But more importantly, the study questions whether researchers always have the right tools to properly analyze the data. These two factors together could create critical holes in clinical trial findings.

47. Technology Trends Will Impact Clinical Trials In 2015 11/21/2014

    I have written several articles recently about companies in the pharma industry that continue to use paper for clinical trials when technology now exists to make all of it obsolete. Folks involved in the process have also given me opinions on why there is a reluctance to part with it. Theories range from the conservative, risk-averse nature of pharma companies, concerns over cost, and even older employees in regulatory oversight positions that did not grow up in the electronic age in which we currently live. But as a new guard comes along and people become more confident with electronic solutions, the trend may finally be shifting.

    “When you look at what the cost is of continuing to handle large quantities of paper, not just the monetary cost but also the cost to the environment, it is just enormous,” says Sandra Freeman, Senior Director of Customer Success for goBalto. “As we come up with new systems that not only drive but better document the business, and provide better audit trails to what is going on, I believe we will begin to see much less reliance on paper.”

48. Screening Prospective CROs: What Are Their Data Capabilities? 9/25/2014

    Clinical development is the most costly aspect of getting a drug, medical device or diagnostic to market.  Previously priced at $1.3 billion, getting a product approved is now estimated to cost as much as $5 billion. If you entrust management of your clinical trial to a CRO, what criteria should you look for in a partner to ensure the most reliable results with the greatest efficiencies at the most affordable price?

    One major issue for sponsors partnering with CROs for analytic services is the ability to directly access and retrieve their raw data, which may only be accessible from the CRO's data warehouse, source systems, or down-stream analysis platforms.  Requesting and receiving both ad-hoc/custom and periodic standard reports from their CRO can potentially result in critical time lags and inefficiency for program, country, study and data managers, as well as for clinical research associates, investigators, clinicians and safety officers. 

49. How To Prepare Clinical Data For Greater Transparency 4/23/2014

    With the rationale of making Europe a better environment for clinical research, the European Union is taking steps towards greater transparency of clinical trial data. In this article, CROS NT highlights the connection between traceability and transparency, and makes recommendations on how to satisfy the regulatory authorities and be prepared for future clinical data transparency obligations.

    Background

    A recent initiative (April 2014) by the European Medicine Agency (EMA) on data transparency was finally passed into draft law by the European Union, requiring that detailed summaries of clinical trials are published in a publicly accessible database once marketing authorization is granted. Sponsors could face strict fines for not complying. Also, in March 2014, the EMA published the first summary of a risk management plan (RMP) for a newly authorized medicine, stating “the Agency will pilot the publishing of RMP summaries for all newly centrally authorized medicines during 2014 and at a later stage will start producing RMP summaries for previously authorized medicines”. The RMP will be a publicly available document that describes all that is known and unknown about a drug’s safety and what actions will be taken to monitor the drug on the market and mitigate any risks.

50. Do The Right Thing: GSK's Case For Data Transparency 10/2/2013

    GlaxoSmithKline’s head of science and innovation argues that the future progress of R&D industrywide depends on open but qualified sharing of all clinical-trials data.