Biostatistics Featured Articles

1. Biopharma Trends That Will Impact The Industry In 2016 2/9/2016

   The beginning of the year is always a good time to take a look ahead at the trends most likely to impact the industry in the coming months. One area that is changing quickly, and which promises to impact clinical trials in the coming years, is biopharma. I recently spoke with Jim Esinhart, CEO of Chiltern, about some of these trends, including study protocols, big data, mergers, and new technologies.

2. What You Need To Know About FDA's Clinical Outcome Assessment Compendium 2/8/2016

   One of the goals of CDER (The FDA’s Center for Drug Evaluation and Research) is to foster patient-focused drug development. As part of that effort, the agency has published a compendium of clinical outcome assessments (COAs) to promote the use of patient-focused outcome measurement in the drug development process.

3. Home Clinical Trial Visits – A Patient Centric Solution 1/20/2016

   The continuing rise of patient-centricity within the drug development industry is a crucial consideration for sponsors when designing their clinical development plans. With initiatives such as the FDAs Patient-Focused Drug Development Program, patient experience and voice within a clinical trial is becoming increasingly important.

4. MDR-TB Study Requires A New Approach To Trials 1/19/2016

   Otsuka Pharmaceutical has been an industry leader in TB drug development for over 30 years. The company is currently focused on MDR (multidrug-resistant)-TB, which refers to a form of the disease that is resistant to at least the two main first-line drugs available on the market.

   In a recent clinical trial, many of the sites lacked proper personnel, training, and equipment. Learn how the company overcame these challenges to make the trial a success.  

5. Do Your Clinical Trial Participants Feel Like Valued Customers? 1/13/2016

   According to Roslyn F. Schneider MD, MSc, Global Patient Affairs Lead at Pfizer, patients can often have a feeling of being powerless, and be left with the impression they are there to serve the drug development process, and not the other way around. “There are times when it seems we are asking patients for their opinions simply so we can paste them in a pre-defined place in an existing system,” she says. “That is not how a company should be treating one of its most critical stakeholders. As an industry we need to continue to find new ways to incorporate participant feedback in a way that is good for patients, their families, and caregivers. This will be beneficial for our companies and societies as a whole since all of these stakeholders are very closely aligned.”

6. Can You Guess What This Trial Is Using To Fight Obesity? 1/12/2016

   A promising new diet may work wonders for helping individuals lose weight and fight obesity. The trial will involve taking fecal matter from the digestive tracts of healthy and thin humans, which would then be freeze-dried and put in a pill. Individuals in the study would then ingest the pills. The research does have some validity. Researchers at the Massachusetts General Hospital in Boston have discovered the microbes in digestive tracts of healthy individuals are different from those in obese individuals.

7. Speed, Savings And Security: Leveraging The Power Of E-Signatures In Clinical Trials 1/12/2016

   The devil is in the documentation. At least, so it seems with clinical trials. Every step, decision and result of each trial phase must be inked, approved, filed and submitted to appropriate parties. Because trials are part of drug and therapy development, keeping detailed records is a must. But the sheer amount of paper-pushing can dramatically slow the pace of a clinical trial.

8. Quantitative Systems Pharmacology Brings Value To Drug Development 1/12/2016

   Quantitative systems pharmacology (QSP) sits at the interface between pharmacometric modeling and simulation, and systems biology. It uses mathematics to describe biological processes. While pharmacokinetics describes what the body does to the drug, pharmacodynamics quantifies what the drug does to the body; the pharmacological response. QSP is a mechanistic modeling approach and an emerging technology, which mathematically integrates pharmacokinetics, pharmacological response and disease progress/modulation.

9. Mobile Devices In Clinical Trials: Tested, Effective, Proven! 1/11/2016

   Patient recruitment and retention remains a challenge for most pharma companies. New mobile tools bring the promise of a better patient experience, which would serve to alleviate both problems. And yet the conservative nature of pharma, coupled with regulatory concerns, seem to be keeping these solutions from gaining adoption. It’s no surprise that some technology companies are attempting to prove the effectiveness of these mobile tools themselves.

10. Can Your Clinical Patients Benefit From Good Human Practices? 1/7/2016

    Nektar Therapeutics is attempting to create a new experience for sites and patients taking part in clinical trials. With over 25 years of experience in clinical trials, Eileen Daniel, Nektar’s Executive Director of Clinical Operations has been instrumental in bringing together leaders within the company to make the vision a reality. Just a few years ago, her frustration over how some companies handled communications with sites and patients almost caused her to leave the industry. Now, she is excited about efforts being made to better engage both groups, and feels the future looks bright.