Safety/Efficacy Featured Articles

  1. Mersana's Goal: Make ADCs Deadlier For Cancer, Safer For Patients 2/6/2017

    One of the tag lines you will see on the Mersana Therapeutics website states the company is advancing a pipeline of precisely targeted, tailored therapies to radically improve patients’ lives. It is doing so by rewriting the rules for immunoconjugate therapies.

  2. Patient Survey: Technology Use Up, Pharma Disconnect Remains 1/25/2017

    The patient advocacy firm Inspire has released the results of its second annual Insights From Engaged Patients survey. Over the last two years, Inspire has captured insights from nearly 24,000 patients and caregivers who face multiple health conditions. The survey looked into several areas related to patient interactions with social media, physicians, and most importantly, pharma companies.

  3. Clinical News Roundup: Should Patient Advocacy/Private Funds Connection Raise Concerns? 1/20/2017

    Clinical news roundup for the week of January 15, 2017 with information on the financial relationship between pharma and patient advocacy groups, the FDA take on diversity in trials, HHS rules on patient safety, venture funding of mobile apps, and more.

  4. Are You Correctly Conducting Your CRO Qualification, Oversight, And Audits? 1/19/2017

    David Kim has spent most of his career working on clinical trials. His areas of expertise include implementing strategic alliances, leading and directing sourcing and vendor management teams, and partner negotiations. In this interview with Clinical Leader, Kim discusses the challenges of CRO qualification, oversight, and audits, and how to make sure you are not being overcharged for the work you outsource.

  5. Clinical News Roundup: Is Duke Underreporting Clinical Trial Results? 1/12/2017

    Clinical News Roundup for the week of January 8, 2017 with information on Duke clinical trials, the new NCI drug formulary, how poor physician and nurse engagement by pharma leads to low patient recruitment, and ways to become more patient centric.

  6. Key Considerations For ICH-GCP Guidance On Quality Risk Management 1/10/2017

    By now, many of you are probably wondering about the recent adoption of the Good Clinical Practices (ICH E6 Guideline, R2). More specifically, you are likely wondering how it will apply to your own organization. In this Q&A, Elizabeth Bodi, senior consultant at Halloran Consulting Group, answers some of your questions and sheds some light on the guidance and how it may impact research, resources, and patients.

  7. Lexicon Uses Patient Input To Support Primary Endpoint 1/4/2017

    When Lexicon Pharmaceuticals began planning for a clinical trial on neuroendocrine tumors, there were two things it hoped to accomplish. First, it wanted to incorporate patient voice into the trial design. Second, the company wanted to incorporate some type of mobile technology into the trial to help track feedback from patients.

  8. Is CRA Shortage To Blame For CRO Turnover? 12/20/2016

    The results of a study on compensation released by HR+Survey Solutions (HR+SS) show that turnover in the U.S. for clinical monitoring jobs at CROs remained high in 2015. Clinical monitoring jobs, such as clinical research assistants (CRAs), involve individuals whose job function is monitoring the health of study participants in clinical trials.

  9. Innovative Patient Study Examines Effect Of Drug Use In Pregnant Women 12/19/2016

    In 2009 the European Medicines Agency (EMA) launched PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium), a new research program designed to strengthen the monitoring of the benefit risk of medicines in Europe. Stella Blackburn, vice president and global head of risk management for QuintilesIMS, was heavily involved with this groundbreaking study and discusses key findings of it with Clinical Leader.

  10. How Pfizer Uses Patient Video To Improve Sickle Cell Trials 12/16/2016

    Sickle cell disease is a red blood cell disorder where patients have abnormal hemoglobin in those cells. In this interview Brenda Cooperstone, VP and chief development officer for the specialty care business unit at Pfizer, discusses the efforts made to understand sickle cell patients, their condition, and how the company should interact with them during visits to the emergency room.