Medicare's Stance on Clinical Trials

This post on Health PROSe discusses how Medicare is not only important to health care delivery but it is also key to all clinical research taking place across the country. Cures and treatments for diseases all require that Medicare beneficiaries participate in clinical trials, and that was exactly what President Clinton ordered back in 2000.

This memorandum though was not followed through by the Bush administration, and it was actually dismantled. Obama's administration must recognize the important of the Medicare clinical trial policy to ensure that Medicare beneficiaries are covered. It will be interesting to see if the new administration will soon address this policy and take action.

Repros Therapeutics Inc. halts clinical trial

Repros Therapeutics Inc. may face bankruptcy after suspending their clinical trials fro Proellex. The studies were postponed due to concerns for trial participants safety. The drug being tested treated chronic symptomatic uterine fibroids, anemia associated with this condition and endometriosis. Read the full article here.

New clinical trial for congestive heart failure

According to the South Florida Business Journal, a Phase I clinical trial will begin for a treatment to congestive heart failure. If this trial is successful, it would be one of the first to combine gene and stem cell therapy for cardiovascular disease. Read more about this trial that will begin taking place next year.

Education on clinical trials to begin in Qatar

According to the Gulf Times, Sidra Medical and Research Center of Qutar will start to educate the public on the importance of clinical trials. It will educate the public on the importance of volunteering for these trials both in terms of the purpose of the clinical research and the effects it will have on both future patients and generations.

Professor David Kerr, who has an international reputation for the treatment of and research into colorectal cancer, stated, “As we are building a research institute into a hospital, we are also building research partnerships with some of the leading institutions around the world, so that we can initiate research that can start even before the building is ready, so that we can begin to start benefiting our citizens in advance medicine.”

Swine Flu vaccines approaching time for clinical trials

According to the Guardian, many labs have progressed with the Swine Flu vaccine to the stage of clinical trials. The WHO did point out that this doesn't necessarily mean that the final flu vaccine is ready for use by the general public.

GlaxoSmithKline recently stated:
"We have started production. We are talking to the different health authorities and the governments around the world to find out what level of clinical trials will be required, for instance, how long, [and] how many people would be involved."

Read the full article here.

PRA International opens office in Korea

PRA International has opened up a new office in South Korea to manage clinical trials. It has been conducting trials in the area since 2005, but mostly through local partners.

Edward Ian, who is director of PRA’s Asia-Pacific efforts stated:
"Increasing customer expectations and project needs have prompted us to establish a legal entity and a local team of clinical professionals. We anticipate significant growth of our operations in South Korea in the next few years to conduct clinical studies across a wide array of therapeutic indications, including oncology, neurology, respiratory disorders, infectious diseases and cardiovascular, endocrinology and metabolic disorders.”

Source

Innovation needed for biotechs

An article in the San Francisco Chronicle believes that Biotech is in need of innovation, and points to diagnostics testing and biofuel production as the next possible chance, as it takes many many years to develop blockbuster drugs. Innovation was possible before because of the fact that investors were willing to risk time and money to come up with the next blockbuster drug. Innovation is critical in these few fields. What do you think? Where will innovation and production in teh biotech industry go next?

Clinical trial shows hope for no more insulin injections

According to The Medical News, an Australian clinical trial will commence for the treatment of type I diabetes that will not require daily insulin injections. The trial will now move on to Auckland, New Zealand in Middlemore Hospital.

Prof. Bob Elliott, Founder of LCT and diabetes specialist, said: "We have great hopes for these trials. We already have two patients in the Russian trials that are now off insulin and we are planning to use much higher doses of our product Diabecell in these trials."

Find out more here.

New software for clinical trials

TranSenda has a new software that will help the efficiency of all clinical trails. It'll improve the ability to manage the clinical study.

Cortex will enable organizations to leverage the power of access to centralized operational data from all applications used across all clinical studies.

Read more about the software here.

How do you pay the participants in your clinical trials?

In an article at ClinPage recently, they look at how Greenphire is speeding up the process of paying those involved in the clinical trial process. They believe that by making payments available through prepaid cards which are also electronic payments, a lot of confusion can be saved as well as those trial participants involved who are underbanked have a way to receive payments. Read the full article here.

Phase III Clinical Trials

Psych Central recently wrote a post about why Phase III trials may often be misleading. At this stage, the clinical trial has to prove that the drug is both safe and effective. However, the article points out that oftentimes, Phase III trials are conducted on patients that may not be the consumers of the product in normal circumstances. Read the full article here. What do you think? If clinical trials are conducted on those who are not the preferred profile for the drug, will the results still be completely reliable?

Speaker Profile: Harris Koffer, Pharm.D

Dr. Harris Koffer is President and Chief Operating Officer for Research Pharmaceutical Services (RPS), a clinical research organization providing services to the Pharmaceutical and biotechnology industries in support of clinical drug development.

Prior to joining RPS, Dr. Koffer served as Vice President, Clinical Trials and Pharmaceutical Business Development, for Quest Diagnostics; Vice President and General Manager of Covance Clinical Services and President of Covance Periapproval Services. In these roles, he was responsible for global central laboratory services as well as full service clinical research and development capabilities for Phases 1 through 4 of drug development.

In addition to over 28 years of experience in clinical drug development, he has served as Adjunct Assistant Professor of Pharmacy in Medicine at the University of Pennsylvania School of Medicine and Clinical Associate Professor of Pharmacy at the Philadelphia College of Pharmacy and Science.

Dr. Koffer has published and presented numerous papers in the fields of cardiovascular clinical pharmacology and pharmacoeconomics.

He earned both a BS in Pharmacy and a Doctor of Pharmacy degree from the Philadelphia College of Pharmacy and Science and completed a Fellowship in Clinical Pharmacology at Thomas Jefferson University Hospital in Philadelphia.

Harris Koffer will be presenting MMAX: Development, Evolution, Growth and Maturation of a Large, Integrated Drug Development Solution along with Jim Dannemiller, M.S., Wednesday, April 29 at 9:15.

Speaker Profile: Christopher C. Gallen, MD, PhD

After receiving his M.D. and Ph.D. (Biochemistry) degrees and completing a medical internship at the Emory University School of Medicine, Dr. Gallen went on to complete Psychiatry residency training at Stanford and Neurology residency training at the University of California, San Diego. He then joined the Neuropharmacology Department of The Scripps Research where he developed an international reputation in brain functional imaging, published the first definitive demonstration of human cerebral plasticity, and was as a scientific support to the successful IPO and secondary offerings of Biomagnetic Technology Inc (BTi). Dr. Gallen next took on responsibilities rising to Senior Director of Medical and Scientific at Quintiles directing several successful registration programs. Dr. Gallen then started the Premier Research Worldwide CRO, led its IPO, grew it into a successful trans-Atlantic CRO and conducted trials in a wide variety of therapeutic areas and approaches. Dr. Gallen subsequently moved to work in big pharma with responsibilities as Vice President of Medical Development at Pharmacia including three major roles, Head of Global CNS Medical Development, Head of Clinical Operations managing the “internal CRO” for conduct of all clinical trials in all Therapeutic Areas in the Western Hemisphere and eventually, after helping lead a successful re-engineering, as Kalamazoo R&D Site Head CNS and ID, Dr. Gallen subsequently became Vice President and Chief of Operations for Clinical Research and Development at Wyeth in charge of a range of global clinical development functions. In this role Dr. Gallen partnered with Accenture to help create the Alliance for Clinical Data Excellence (ACE) outsourcing of Wyeth Clinical Data Management to Accenture and to drove the successful re-engineering of Wyeth to the top quintile of clinical research performance. Dr. Gallen subsequently became President and CEO of Neuromed, a Philadelphia and Vancouver-based biopharma company developing products to manage and treat complications of pain, epilepsy and hypertension.



Christopher Gallen will be hosting the panel discussion "Leading Through Change: Innovation and Future of the BioPharmaceutical Industry," Wednesday, April 29, 2009 at 8:30 AM.

The Use of Bid Grids for Selecting a CRO as a Partner

This article in Applied Clinical Trials details how most companies use bid grids in order to establish both an overall outsourcing budget and the expected budget for individual major outsourced studies. So who's using bid grids?

According to the article 90% of the American participants of a suvey conducted by the University of Health Sciences and TTC reported using a common bid grid, in contrast to just over half, 52% percent of locations worldwide. 81% of larger pharma companies reported using a common bid grid as opposed 49% of participants from smaller companies that use a common bid grid.

Do you think bid grids are useful?

Patient recruitment costs continue to increase in clinical trials

According to Earth Times, the patient recruitment step in clinical trials accounts for 23% of the clinical trial time line. They also contribute to the increasing costs of performing clinical trials.

Emerging means for screening potential patients, such as genetic tests, mean that companies must plan for higher lab-testing costs and a lower rate of prospective patient enrollment. And the Canadian Medical Association Journal (CMAJ) in February published an article claiming that drug development costs had increased at a rate 7.4% higher than inflation.

Read the full story here.

The Political Economy of Pharmaceutical Clinical Trials

Metapsychology has a review on a new book following 20 clinical trials from around the US analyzing for profit clinical trials.

Medical research for hire combines indeed ethnography and ethics. The former prevails: the book is rich in quotations from the many interviews conducted by the author and we get to know how the participants in the private clinical trials studied perceive themselves. However, the author only visited a minor fraction of the many organizations conducting trials in the USA and had unequal access to the different types of participants.

Read the full review of the book here.
Buy the book here.

ICON teaming up with MedAvante

To improve clinical trials dealing with central nervous systems, ICON has teamed up with MedAvante. This alliance will allow a better look into the trials, as they are often difficult to monitor. It will also allow for the two groups to offer new services to drug companies developing drugs to treat central nervous system disorders. For the full story, read here.

Partnerships with CROs now has a Twitter! Follow us here.

More suicidal monitoring needed in clinical trials?

In a recent post by Dr. Michael McKelvey, he addresses the issue of suicide monitoring in clinical trials. He states that the number seeking regulatory approval is increasing. And the FDA has recently issued guidelines for the topic. However, there needs to be a fully structured, procedurally reliable and replicated process for monitoring suicidality. What do you think? Is this an issue for your clinical trials?

Contract work for clinical trials on the upswing

The Pharma Times reported yesterday that 84% of respondents claimed that they'd be interested in contract work when it comes to clinical trials.

While the perceived benefits of contracting – better remuneration, independence and flexible working – were offset in the survey by inhibitions about job security and loss of company benefits, 55% of the respondents recognised there was an increasing shift towards contract-based employment in the sector, with more than 20% seeing it as the prevailing dynamic.

For the complete article, read here.

Unethical Clinical Trial Outsourcing

This article on Outsource Portfolio details that the growing numbers of companies outsourcing to India is a good thing, so as long as it does not cut the need to protect patients’ rights.

To ensure that patients’ rights are protected overseas India has created an online registry for all trials being conducted in India. This registry allows data to be integrated with data from the World Health Organization further ensuring that all global standards are met. Will this truly help ensure the ethical conduct of clinical trials in India?