Clinical Guest Contributors

  1. How Many Team Members Does It Take To Determine The Study Status?

    Sitting on one of those long, painful, study status update calls recently, I was reminded of the famous light bulb joke. You know the one: “How many engineers (lawyers, politicians, etc.) does it take to change a light bulb?”  I was both flabbergasted and frustrated that, after 45 minutes, the project manager was still wading through status updates from a myriad of CRO and vendor partners and CRAs — just to figure out where the study was from a site activation and enrollment standpoint.  

  2. The Evolution Of Medical Imaging In Clinical Research

    Medical imaging plays an instrumental role in the clinical development of new life science products. Although the medical imaging industry is in a constant state of flux — due to increased investment in medical imaging companies, as well as mergers and acquisitions — adoption of novel imaging technologies to support clinical trials for the pharma, biotech, and medical device industries continues to increase. In fact, “centralized” imaging data is now used as a primary endpoint in many clinical research studies. This article will explore the factors driving imaging implementation in clinical trials, the current hurdles to increased adoption, and some of the technologies available to help overcome those challenges.

  3. Will Special Interests Derail The Future Of Personalized Medicine?

    Treatment of cancer using chemotherapy (chemo) drugs began soon after WWII, when a compound called nitrogen mustard was studied and found to work against cancer in the lymph nodes. In the years that followed, many chemo drugs have been developed that work by non-selectively inhibiting rapidly dividing cells. In other words, chemo drugs kill cancer cells, but they also kill healthy cells in patients. The effectiveness of chemo treatments has therefore traditionally been determined by how well the toxicity of chemo drugs can be tolerated and/or managed in a patient.

  4. Improving Patient Retention & Engagement Through Health Programs

    Patient recruitment is often highlighted as the key factor in ensuring clinical study success. Ensuring on-time enrolments of patients, investigators, etc. is a constant concern throughout the clinical trial phases. However, patient retention through engagement is also a key factor — and one that is often overlooked. Patient dropout rates for pharmaceutical clinical trials are estimated to range between 15 to 40 percent of enrolled participants, depending on the trial phase.

  5. Trump And The FDA: What to Expect (And What’s At Stake)

    Donald Trump’s advance team will soon be headed to FDA’s White Oak campus to observe and learn about the agency, to help facilitate the transition from the Obama administration to the Trump administration. In this article, I describe what I expect the nascent 2017 agenda will be as Trump’s team walks in the door, and I offer a few thoughts as to why the Trump team would do well to consider the unique nature of FDA as transition planning takes shape.

  6. A Relationship Driven By Technology: How Sponsors And CROs Can Improve Collaboration

    The typical relationship between clinical trial sponsors and CROs is rarely described as ‘simple.’ And few, if any, are based on the trust and collaboration that would improve efficiencies in clinical research. With over 70% of clinical trials being outsourced to CROs, and less than 10% meeting trial completion dates, the question becomes not when, but how can this critical relationship be improved to make clinical development more efficient?

  7. Three Questions To Ask When Evaluating a Patient Recruitment Plan

    Today is a big day. Today is the day your clinical protocol is finalized. Your inclusion and exclusion criteria are polished to perfection. Your informed consent form has “IRB APPROVED” stamped on it in big, bold letters. Now is the time to deliver it into the eager hands of eligible patients.

  8. The High Price Of Failed Clinical Trials: Time To Rethink The Model

    Back in 2014, a study in Nature Biotech showed that only 32% of drugs have a probability of making it to Phase 3 trials, and only one in 10 drugs overall actually makes it to market. Things haven’t improved since then. BIO recently put out a study reporting that the average overall likelihood of approval (LOA) by FDA from Phase I was 9.6 percent – a 1 in 10 chance. The rate is even lower for major disease areas like oncology.

  9. CROs Can Be Indispensable As Pharma Companies Focus On Value

    The healthcare industry’s transition to value-based care is putting a lot of pressure on pharmaceutical companies in terms of margins and the need to demonstrate improved outcomes at lower costs. In attempting to create breakthrough therapies and “beyond the pill” solutions with fewer resources, companies are demonstrating an increased appetite for outsourcing functions – and Contract Research Organizations (CROs) could be the beneficiaries.

  10. Israel’s Emergence As A Go-To Market For Conducting Clinical Trials

    Driven by the steep costs of hosting clinical trials in the United States and Western Europe, pharmaceutical companies have increasingly turned to global markets to conduct trials over the last decade. During that timeframe, Israel has emerged as an attractive market – bolstered by its high-quality medical infrastructure and well-trained physician workforce, diverse patient population and widespread adherence to Good Clinical Practice (GCP) standards.