Biostatistics Featured Articles

31. Do You Know If Concomitant Medications Are Impacting Your Trial? 10/20/2015

    There are a lot of things that can sink your clinical trial. Low patient recruitment, poor data, or issues with safety or efficacy, for instance. But what shouldn’t be a problem are issues arising with concomitant medications (two or more drugs used or given at or almost at the same time.) Unfortunately, many sponsor companies currently do not see concomitant medication tracking as a topic that is particularly important.

32. BMS Employees Embrace Working Together For Patients 10/13/2015

    When you step off the elevator on any floor of the Bristol-Myers Squibb R&D facility in Wallingford, CT, the first thing you will see is a mosaic of a patient, made up of hundreds or thousands of photos of BMS employees. The message the mosaics are trying to convey could not be clearer: We are the patients, and the patients are us. BMS believes every task performed by every employee has to have those patients in mind, and with its new Working Together For Patients program, the company is proud to be sharing that vision for the world to see.

33. Building A Culture Of Patient Centricity At Sanofi 10/9/2015

    Dr. Anne Beal has been involved in the medical community her entire career. After earning a BA in biology, an MD in medicine, and a masters degree in public health, she began her medical career as an attending physician. After spending time working for Harvard Medical School, The Commonwealth Fund, and The Aetna Foundation, she was tapped to be the Deputy Executive Director and COO and Chief Officer for Engagement at the Patient Centered Outcomes Research Institute (PCORI). In April 2014, she was asked to join Sanofi as its Chief Patient Officer. The past year-and-a-half has been a whirlwind of activity for her, defining the meaning of patient centricity and how it applies to pharma, while developing a culture of patient engagement within Sanofi. In this Q&A article, Beal discusses Sanofi’s vision for patient centricity, and getting individuals more engaged with the trial planning process.  

34. Is Preventing Dual Enrollment Essential To The Integrity of Clinical Trials? 10/7/2015

    Patient recruitment is an issue in most clinical trials, and continues to get more difficult as protocols become more complicated than ever. While many patients have never heard of a clinical trial or would never consider taking part in one, there is a growing group of individuals out there who rely on them to pay the bills and put food on the table. Unfortunately, these human lab rats have the potential to corrupt your data or possibly even torpedo your entire study.

35. Transparency In Clinical Trials: Will It Ever Be Achieved? 10/1/2015

    A lot has been made recently about transparency in clinical trials. In the EU a new regulation is about to address the issue, and CISCRP recently sent a petition letter to the FDA asking it to pass a similar regulation in this country. The petition, signed by hundreds of patients, hopes to make trials results more accessible to patients. It’s also not hard to understand why a patient participating in a trial would want to know the results of the study, and whether or not they received the active drug or a placebo. But while changes might help companies with patient recruitment and retention issues, will true trial transparency ever be possible?

36. IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For September 2015 9/29/2015

    September was another very active month on Clinical Leader. In case you missed them, the top three articles for the month featured coverage of the ethical dilemma that can result from patient-funded trials, industry insights from Mike McKay, Associate Director of Operational Excellence for Shire Pharmaceuticals, and a look at research that seems to show the Sunshine Act might be having an unintended effect of reducing clinical research.  

37. What Does Success Look Like In Patient Centricity? 9/25/2015

    Dr. Anne Beal spent almost three years working for PCORI (Patient-Centered Outcomes Research Institute) before joining Sanofi about a year-and-a-half ago. As the Chief Patient Officer for Sanofi, she has the opportunity to take what she learned at PCORI and apply it within a pharma company, finding ways to make the entire drug discovery process more patient centric. While pharma has been placing more emphasis on getting patients involved, patients have generally become less engaged. “We need to engage patients, know patients, and know their needs, and we still have a long way to go,” notes Beal. “Any company that does not start to actively engage patients will be quickly left behind.”

38. Should A Clinical Mastermind Run The FDA? 9/23/2015

    We all know that a primary driver of the high cost of drug development is clinical trials. The process is not only costly, but lengthy and difficult. And even once you complete the four phases and submit your data to the FDA, there is no guarantee the drug will be approved. All this might make you wonder: Could the drug development process be made easier if we had a clinical researcher at the helm of the FDA? You may not need to wonder much longer.

39. WIB Profile: Embrace Change Management Or Expect To Fail 9/22/2015

    Risk management is a concern for all pharma companies, and the increasing rate of adoption of new approaches, such as risk-based monitoring, will keep it a concern for years to come. Of course with any new approach comes the resistance to change from employees and managers who don’t trust the new approach, feel it will make their jobs more difficult, or even worse, eliminate their jobs altogether.

    Change management can be one of the most difficult tasks for pharma executives to oversee. Consultant Angie Maurer’s job is to help them manage it more effectively. “It seems to take executives and personnel in the pharma industry a long time to accept, adapt, and deal with change within their organizations,” she says. “Everyone knows the pharma industry tends to be rather conservative, and that is as true today as it has always been.”   

40. Five P's For A Productive CRO Relationship 9/18/2015

    You have done the research and selected a CRO that looks like it can meet all your research needs. Now you are about to entrust your precious samples to a team of people you may barely know. How do you safeguard your research, meet your timelines, and develop a productive working relationship with your CRO? Few things are less stressful than managing these relationships. A good CRO can bring your project in on time, meet all regulatory requirements, and do so with the level of quality you expect. Unfortunately, choosing the wrong CRO can result in delays, poor quality, and the feeling that you have a CRO that will require constant monitoring and hand-holding.