New FDA Guidance. February 2019.

The purpose of this guidance is to assist sponsors of drug and biological products for the treatment or prevention of rare diseases in conducting more efficient and successful drug development programs. Although the statutory requirements for marketing approval for drugs to treat rare and common diseases are the same and issues discussed here are encountered in other drug development programs, these issues are frequently more difficult to address in the context of a rare disease. (fda.gov)

Global contract research organization (CRO) market may reach $55 billion by 2025

According to a new report, the global contract research organization (CRO) market was valued at approximately USD 34.12 billion in 2018, and is expected to generate around USD 55.16 billion by 2025, at a CAGR of around 7.10% between 2019 and 2025. The main factors expected to drive the CRO market in the coming years include an increasing number of clinical trials and growing R&D expenditure. (Zion Market Research)

Real-world survival rates with medical device much worse than in trials

Survival rates in the post-approval study for the Abiomed Impella RP right ventricular assist device were dramatically worse relative to the device’s clinical trial data. While 73% of the device’s users survived at least 30 days in the premarket study, just 17% have met this primary survival endpoint since the device went on the market in 2017. (MEDPAGETODAY)

New research ‘supergroup’ looks to reduce the number of required clinical trials

The MI-based CRO MMS Holdings is among the team at the Health Analytics Collective, a research group hoping to reduce the need for new clinical trials by using readily available data – and an MIT-incubated programming language. (outsourcing-pharma.com)

“Synthethic control” trial design can save time and money

An innovative approach to collecting control group data in clinical trials called “synthetic control arms” means that, instead of collecting data from a newly-recruited control arm, synthetic control arms model those comparators using real-world data that has been previously collected. This approach reduces the number of participants needed for trials and eliminates participants’ fears that they will end up in a placebo group. (STAT)

Guest Blog. “Hey Alexa, find a Clinical Trial for me….”

By Kathy Perez

In this age of smart phones, cloud-based voice helpers and all things “Google” the public and medical profession have many ways to find a clinical trial. The most comprehensive listing of clinical trials in the world can be found at www.clinicaltrials.gov but when you get to that site it’s often difficult to navigate and understand, (Read More Here)

How to increase the number of women in CV device trials

Although the prevalence of cardiovascular disease (CVD) is similar for men and women, men comprise 70% to 80% of enrollees in CV device trials. A new position statement published in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions issued a call to action to multi stakeholders to halt the perpetuating cycle of female underrepresentation in CV studies. (Healio)

TrialAssure discounts trial disclosure software for universities

Only 11% of universities post clinical trial results to the European Clinical Trial Register (EUCTR) within required timeframes. TrialAssure is offering a program called TrialAssure Academic Pricing (TAP) to assist universities globally through managing and disclosing their clinical trial results in a cost-efficient manner, thus avoiding penalties for non-compliance. (CLINICAL RESEARCH NEWS)

An overview of microbiome research

The microbiome is the population of microscopic organisms that live in the digestive tracts of animals, including humans. Recent studies have identified new gut microbiome interventions to promote human health and combat disease. This article gives a brief history of microbiome research and outlines four main areas of ongoing research. (Medical x Press)

CRA burnout in clinical research

Gain insight into the factors of CRA burnout in clinical research from the 2018 PharmaTimes Clinical Researcher of the Year New CRA.
 
It is no secret that CRA turnover is a huge issue in the clinical research industry. It is not uncommon for sponsors or CROs to spend thousands of dollars onboarding a CRA, only to have them leave within one to two years after starting. Recent reports from the ACRP1 show that CRA turnover rates were as high as 25% in 2016, and the trend only continues to move upwards.  (continue reading here)

Last week's chill!

It's 2 degrees and -20 windchill at Carnegie Mellon University in Pittsburgh, PA. Classes are cancelled.  Photo courtesy of D. Kriegman.