Study merges clinical research investigators data from three government databases

Complete Picture

The three primary U.S. government sources of data about clinical research investigators -- National Library of Medicine: ClinicalTrials.gov, FDA: Bioresearch Monitoring Information System (BMIS)and CMS: Open Payments (Sunshine Act) -- provide incomplete and inconsistent data not linked to data in the other databases. While the FDA is aware of the problems, researchers have used the databases to understand investigator demographics and activities.

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FDA steps up in regulating safety concerns

Data-Driven Progress

The U.S. Food and Drug Administration (FDA) has established a new objective for itself: “to become the international leader in medical device safety through better use of big data,” according to an article by Conor Hale in FiercePharma. The agency has made a commitment to quick device safety responses “using real-world data and active surveillance,” Hale explained.

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Analyst says blockchain technology could help clinical trials

Blockchain Bonanza

Caron Dhillon, a health care analyst at Results Healthcare, believes that the use of blockchain technology could solve many of the challenges of the clinical trials process, according to an article in Outsourcing Pharma by Melissa Fassbender.

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New cloud-based Parexel technology provides better patient interactions

Meaningful Data

Leveraging its relationship with Microsoft to assist with drug development, Parexel has introduced the world to several new patient-centric solutions that utilize its Perceptive Cloud platform. The patient-centric solutions for drug development feature mobile and wearable tech to make access to data for better patient interactions during clinical research faster and better, the company explained.

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Veeva announces single app to manage clinical trial data

Cloud Tool

Veeva Systems Inc. -- a leader in cloud-based software for the global life sciences industry -- is offering a new cloud-based application that combines several of its tools. It includes coding, EDC, data cleaning and reporting. Enabling companies to manage clinical trials from build through execution, the new app is designed to achieve a complete and concurrent view of all clinical data within a trial, according to the company.

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FDA suggests heavy fines for not posting clinical trial results online

Transparency 101

The U.S. Food & Drug Administration (FDA) has issued a draft guidance statement proposing heavy fines for pharmaceutical companies and clinical research organizations (CROs) that neglect to post clinical trial results online. According to the statement, the FDA wants to fine organizations that fail to register clinical trials or to report results on to the government database ClinicalTrials.gov as much as $10,000 per day.

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Forbes contributing writer takes aim at Harvard professor who pans pharma

Disclosure Dilemma

Leading cancer researcher Dr. Jose Baselga, the former chief medical officer of Memorial Sloan Kettering Cancer Center, did not disclose income he received from biopharmaceutical companies in articles that he published in major medical journals and, as a result, resigned from his position. This prompted a scathing response from Dr. Marcia Angell, a senior lecturer at Harvard Medical School and the first woman to serve as editor-in-chief of The New England Journal of Medicine.

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Uninsured People and Clinical Trials

Both ethical and practical issues raise concerns

 How does an uninsured person’s participation in a clinical trial affect the outcome? Does the lack of affordability of healthcare give rise to untenable situations in choosing participants for clinical trials?

 These were some of the issues addressed by George Marzouka, MD, who wrote an article called “Ethical Concerns Arise in Clinical Trial Enrollment as Number of Uninsured and Underinsured Americans Skyrockets” in Medical Bag recently.

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Can virtual clinical trials be as good as the real thing?

New Reality

 While the drug testing is real, the recruitment, the screening and the venue are changing the way clinical trials are conducted, reported an article by Barbara Mandark in Undark and reprinted by Fast Company.

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Market research study focuses on clinical trials

Global Growth

Clinical trials, research studies performed on humans, are designed to gain specific information about biomedical interventions such as vaccines, treatments and drugs in order to prove the safety and efficacy of the products.


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Tufts report cites complexities of clinical trials as source of delays and costs

Complex Clinical Trials

A recently completed analysis by the Tufts Center for the Study of Drug Development cites rising protocol complexity as a key factors that negatively impacts clinical trial performance and efficiency, while driving up the cost of developing new pharmaceuticals, reported Melissa Fassbender in Outsourcing Pharma. The situation could get even worse.

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Gottlieb proposes plan to simplify FDA structure

Reorganizing FDA

Dr. Scott Gottlieb, who became the 23rd Commissioner of the Food and Drug Agency (FDA) on May 11, 2017, is proposing “to flatten out FDA’s structure by having the Center directors report directly to him, instead of through a level of “directorates” between the commissioner and Center staff,” as reported by Jill Wechsle of Pharmaceutical Executive. The objective is “to give more authority to the agency’s six product regulatory Centers and to the Office of Regulatory Affairs (ORA) and will ensure that the commissioner remains in close contact with the Center leadership,” according to Gottlieb in an email to FDA staff this week.


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Market surge creates opportunities and challenges

Biopharma in China

The sophistication of drug production in China has come a long way in a short time, offering both opportunities and challenges for Chinese and Western pharma and biotech companies, according to an article by Peter Young in Pharmaceutical Executive. In recent memory, China was “principally a low cost, low quality producer of pharmaceutical intermediates and fine chemicals,” according to Young, but the country cleaned up its manufacturing practices, developed more sophisticated medicines, conducted clinical trials, improved its regulatory system and developed “a more diversified, modern system of providing patient care.”

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Study shows that female scientists’ career length compares favorably with that of men – once they get their first grant

Gender Issues

An analysis published this week by L. A. Hechtman et al. in Proceedings of the National Academy of Sciences shows that the career trajectory of women scientists is nearly as long as that of their male counterparts, once they attain a US National Institutes of Health (NIH) grant. The story, reported in Nature News by Holly Else, indicates that women are nearly as successful as men at garnering additional awards from the agency.

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Artificial intelligence system projects future symptoms

Predicting Progression of Alzheimer’s

Alzheimer’s disease, the sixth leading cause of death in the US, kills more senior citizens than breast cancer and prostate cancer combined. The disease affects millions of people annually, says the Alzheimer’s Association. If diagnosed early, as much as $7.9 trillion in medical and care costs could be saved, according to an article by Kyle Wiggers in Venture Beat.

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Sen. Patty Murray reprimands BIO and PhRMA about gender diversity

Silent on Sexism?

Sen. Patty Murray, D-Wash., the top Democrat on the Senate Health, Education, Labor and Pensions Committee, is furious. After an industry party that objectified women, Murray sent letters to the Biotechnology Innovation Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA) about their efforts to combat workplace harassment at their member companies, according to an article by Amirah Al Idrus in Fierce Biotech.

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Google, Amazon, Facebook, and Apple Spur Life Science Growth

Leading the Way with Strategic Partnerships

Frost & Sullivan, which analyzes markets to help investors, corporate leaders and governments navigate economic changes and identify disruptive technologies and companies, as well as Mega Trends and new business models, predicts that data monetization, direct-to-consumer and eCommerce business models will create growth opportunities in life sciences.

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FDA approves first medicine made from marijuana in US

Help without High

On Monday the US Food and Drug Administration (FDA) approved the country’s first medication derived from marijuana. GW Pharmaceuticals’ Epidiolex, is a drug administered as an oil to treat two kinds of epilepsy, Dravet or Lennox-Gastaut syndromes.

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President signs act to help terminally ill patients seek drugs

Right to Try

Giving a measure of hope to people with serious illnesses, President Donald Trump signed the "Right to Try Act" at the end of May. The measure would enable terminally ill patients to gain access to drug treatments that are not yet completely approved by the Food and Drug Administration.

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FDA Publicly Shames IQVIA

Gottlieb takes IQVIA to task on Twitter for inaccurate opioid sales data

FDA Commissioner Scott Gottlieb, M.D., has publicly reprimanded IQVIA, a global provider of advanced analytics, technology solutions, and contract research services to the life sciences industry, for providing inaccurate sales data on opioids, including fentanyl.

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