Clinical Research Coordinator Handbook, 5th edition

 

“This extremely useful title is written for anyone planning to implement clinical trials at an institution. … the author has carefully detailed the types of forms, study records, and case report forms. … A powerful appendix and glossary of relevant terms help make this a needed book for any clinical trials office.”
— Journal of Hospital Librarianship

In this fully revised and expanded fifth edition of the essential reference for clinical research coordinators, Deborrah Norris provides expanded coverage of CRC duties and regulatory requirements, including new sections on investigator responsibilities, data clarification, and adverse event reporting. The book's five appendices include a directory of CRC resources, updated forms and checklists, state regulatory requirements and contact information, conversion charts and tables, and a glossary.

This book covers these topics and more:

Federal Regulations/GCP and ICH Guidelines
Clinical Research Coordinator Responsibilities
Investigator Responsibilities
Obtaining Informed Consent/Assent
Creating and Examples of Source Documents
Electronic Data Capture (EDC)
Preparing for Regulatory Inspections
Reporting Study Results

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Single-Case Research Designs: Methods for Clinical and Applied Settings

 

Kazdin's text is a notable contrast to the quantitative methodology approach that pervades the biological and social sciences. The methodology in Single-Case Reasearch Designs focuses on a widely applicable methodology for evaluating interventions, such as treatment, or psychotherapy, using applied behavior anlaysis. However, this revision aims to encompass a broader range of research areas that utilize single-case designs. The text will convey the pertinence of this research methodology to disciplines ranging from psychology and medicine to business and industry. The first edition of this book, which was published in 1982, still sells a steady amount of copies today. The fact that professors continue to use the first edition of this book more than twenty years after it was published is a testament to the quality of information, organization, and narrative throughout the text. The possibility of a revision has professors excited that they can expose their students to a well-written, clear, and updated text that will reflect the current status of single-case research.

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The Clinical Research Associate (CRA) Career & Beyond

 

The Bio Pharmaceutical industry and the drug development sector in particular is a VERY CLOSED industry and difficult to penetrate. For most graduates, the role of a Clinical Research Associate is the first step into the lucrative drug development sector of the Bio Pharmaceutical industry. For readers new to the clinical research industry and the bio pharmaceutical drug development in general, this book gives you a detailed picture of the role of the CRA and may serve as your career guide into this lucrative industry. For the experienced CRAs this book shows you the way forward beyond a CRA career within the clinical research industry. Reading this book you will understand why demand and hiring of Clinical Research Associates has continued to grow year after years despite an economic crisis in all other areas of the world economy. What awaits your career beyond a CRA within the drug development industry years ahead. This book shows readers the future of the clinical research industry. it shows projected clinical research market growth and trends in the foreseeable future. The Clinical Research Associate (CRA) career and Beyond. INSIDE THE LUCRATIVE BIO PHARMACEUTICAL INDUSTRY will help readers answer the following 7 KEY QUESTIONS about the CRA career. 1. What is a Clinical Research Associate (CRA)? 2. Why Do We Perform Clinical Research? 3. What Is The Value And Importance Of A CRA? 4. Who Can be a CRA? Pre-Requirements and Qualifications. 5. How to become A CRA? Ways on how to get into the CR industry 6. Where Is Best To Be A CRA? Contract Research Organization (CRO) or Bio-Pharmaceutical Industry (Sponsors). 7. What Are The Open Career Options Beyond A CRA? For those CRAs with the ambition to grow and develop within the bio-pharmaceutical industry and clinical research in particular, what are the future opportunities and options. Possible career growth options are detailed in the book. In addition the book gives readers an insight about CRA salaries with year 2015 CRA salary benchmark.

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Novartis $2 million gene therapy for rare disorder is world's most expensive drug

Swiss drugmaker Novartis on Friday won U.S. approval for its gene therapy Zolgensma for spinal muscular atrophy (SMA), the leading genetic cause of death in infants, and priced the one-time treatment at a record $2.125 million.The Food and Drug Administration approved Zolgensma for children under the age of two with SMA, including those not yet showing symptoms. The approval covers babies with the deadliest form of the inherited disease as well as those with types where debilitating symptoms may set in later.“This is potentially a new standard of care for babies with the most serious form of SMA,” said Dr. Emmanuelle Tiongson, a pediatric neurologist at Children’s Hospital Los Angeles who has provided Zolgensma to patients under an expanded access program. “The job now is trying to negotiate with insurers that this would be a long-term savings.”Novartis executives defended the price, saying that a one-time treatment is more valuable than expensive long-term treatments that cost several hundred thousand dollars a year.

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Gut enzymes convert donor blood to much-needed universal type O

TORONTO — Canadian researchers believe they have found the means to convert any type of blood into universally usable group O with enzymes found in the human gut — a finding that could expand the pool of potential blood donors and make blood-matching easier and safer.

For transfusions to be safe, blood from a donor — for instance, A, B or AB types — must match that of a patient. O-type blood can be transfused into anyone and is always in high demand.

"Blood type is determined by the presence of antigens on the surface of red blood cells; type-A blood has the A antigen, B has the B antigen, AB blood has both antigens and O blood has none," said lead researcher Stephen Withers, a professor of chemistry and biochemistry at the University of British Columbia.

"Antigens can trigger an immune response if they are foreign to the body, so transfusion patients should receive either their own blood type, or type O to avoid a reaction," he said. "That's why O blood is so important."

Withers said the UBC team sampled DNA from millions of microorganisms found in various environmental samples to find one in which the desired enzymes might be found.

The researchers then turned their attention to the mucosal lining of the human gut — which contains sugars similar in structure to blood antigens — by extracting bacterial DNA from fecal samples.

"By homing in on the bacteria feeding on those sugars, we isolated the enzymes the bacteria use to pluck off the sugar molecules," said Withers, adding that researchers then used E. coli bacteria as "little factories" to produce quantities of the enzymes "and found that they were capable of performing a similar action on blood antigens.

"So we just simply add them to the red blood cells, they attach themselves to the surface of the red blood cell and then they cut the sugar off," he said Wednesday in an interview from Boston, where the research was presented at this week's American Chemical Society annual meeting.

Scientists have been studying the use of enzymes to modify blood since 1982, said Withers. "However, these new enzymes can do the job 30 times better."

The UBC team focused on transforming A-type blood into O-type. Enzymes to snip sugars off the surface of B-type blood cells had already been identified, so using both groups of enzymes together could convert AB blood to O, he noted.

Withers and his colleagues plan to apply for a patent on the newly identified enzymes and are set to work with Canadian Blood Services and the Centre for Blood Research to test them on different types of blood from a variety of donors.                 

"The next step is very much all about safety," he said. "There are further tests we need to do to make sure that in the process we've not inadvertently changed anything else on the red blood cell surface which could be deleterious to its function."

One advantage of these enzymes is that they work in whole blood, not just components of blood, meaning that donations could be quickly converted to universal type O, he suggested.

"So I could imagine that what could happen is it could be added to blood when it's donated and just left sitting there to do its conversion while this stuff is being stored."

Canadian Blood Services said 46 per cent of Canada's population has group-O blood, while 42 per cent is group A, nine per cent group B, and three per cent group AB.

"One of the main challenges with maintaining an adequate blood supply in developed countries is that the use of group O is not in proportion to the incidence of that blood group in the population," said CBS chief scientist Dr. Dana Devine, who called the blood-converting enzymes a potential "game-changer."

"This imbalance arises because group O blood can be transfused to any recipient and is used to treat patients in emergency settings when there is no time to determine the patient's actual blood type," she said in a statement. While it would be unnecessary to modify all non-O blood units, Devine said the technology will be important in settings where there are anticipated shortages of group O, including Canadian summers marked by increased motor vehicle accidents, as well as hurricane season in the Caribbean and troop deployments to combat zones.

Expanding global blood supply is critical in light of growing populations and the frequency of natural disasters, Withers agreed.

Sheryl Ubelacker, The Canadian Press

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Dutch medical trial using Viagra stopped after 11 babies die

A Dutch trial with the drug best known under the brand name Viagra, has been immediately halted after 11 babies of mothers using the medication died, one of the participating hospitals said on Tuesday.

When the trial was stopped on Monday, roughly half of 183 pregnant women participating were taking sildenafil, the Amsterdam University's Academic Medical Centre (AMC) said.

A similar Canadian study has been halted because of the Dutch findings, although the researchers say there have been no negative side effects reported in that study. 

A professor at the University of British Columbia confirmed 21 Canadians have been taking part in the trial. They were recruited in 2017 under Health Canada approval, with funding from the Canadian Institutes of Health Research.

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The Canadian trial's principal investigator, Dr. Ken Lim, said all three recruiting sites in Canada have been suspended.

"We are not aware of an increase in adverse outcomes," among the Canadian participants," Lim said in a statement.

"We contacted the one Canadian woman who was currently in the trial, directing her to stop taking the drug or placebo."

The Dutch study started in 2015 and involved 11 hospitals. It was designed to look at possible beneficial effects of increased blood flow to the placenta in mothers whose unborn babies were severely underdeveloped.

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Around 15 women who took the medication have not yet given birth.

"Previous studies have shown that sildenafil would have a positive effect on the growth of babies. The first results of the current study showed that there may be adverse effects for the baby after birth," the AMC said.

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Yet the results showed that 17 babies were born with lung conditions and 11 died. Among the roughly equal control group, just three babies had lung problems and none died.

Among the women taking sildenafil, 11 of the babies died due to "a possibly related lung condition" that caused high blood pressure in the lungs and may have resulted from reduced oxygen levels.

'We cannot take chances'

An interim analysis found that the chance of blood vessel disease in the lungs "appears to be greater and the chance of death after birth seems to have increased. The researchers found no positive effect for the children on other outcomes," the AMC said.

Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said the small number of trials with pregnant women has limited our knowledge of medicines in pregnant women.

"There have been other studies in this area, both involving preliminary work using animals and using pregnant women, and there was no indication that the treatment was dangerous based on previous research," he said.

UBC's Lim said although there were no known negative reactions in Canada, "we cannot take any chances with the health of mothers and their infants," and researchers will look into previous studies on sildenafil.

"We are working co-operatively with our international research partners in the Netherlands, the United Kingdom, Australia and New Zealand to better understand the cause of the results in the Netherlands, and how they relate to results being reported by U.K. and other researchers, which did not indicate any evidence of harm," Lim stated.

Sildenafil was originally developed by Pfizer but is now off patent and available as a generic. Pfizer had no immediate comment.

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Boys should be given HPV jab, says vaccine committee. Here’s what happens next.

It’s nearly a decade since the human papillomavirus (HPV) vaccine was first introduced in the UK to help protect against the virus that causes most cases of cervical cancer. But until now, it has only been routinely offered to girls.Today, the Joint Committee for Vaccination and Immunisation (JCVI) recommended that adolescent boys should now also receive the vaccine.When and how this will happen is now down to the Government. But the recommendation comes from years of mounting evidence around likely health benefits and overall cost effectiveness.

HPV and cancer

HPV is a big family of viruses. There are more than 100 different types and some are more dangerous than others. While some low-risk types cause growths like warts or verrucas, there are thirteen high-risk types that are linked to cancer.HPV is very common, with 8 in 10 people infected at some point in their life. Usually our bodies clear the infection without it causing any problems. But in some cases a lasting infection can lead to cancer.This is because the virus damages the infected cells’ DNA and causes them to start dividing out of control, setting them on the road to cancer.Thanks to the vaccination programme, many people know that HPV causes cervical cancer – in fact it’s linked to all cases of the disease in the UK. But HPV is linked to other cancers too – including anal, penis and some types of mouth and throat cancer.

Why wasn’t the HPV vaccine always available for boys?

The HPV vaccine protects against 4 types of HPV. Two are linked to cancer: HPV 16 and 18, which together cause around 7 in 10 cervical cancer cases in the UK. The vaccine also protects against HPV 6 and 11, which cause most genital warts.The vaccine has been available to girls in the UK since 2008. It was initially only recommended for girls as the strongest evidence of health benefits and cost effectiveness was for cervical cancer and genital warts.Since the vaccine was introduced, we’re starting to see HPV infections in people who have been vaccinated falling. This suggests the vaccine is preventing HPV infection and, in the future, this should prevent cervical cancers.But HPV is linked to cancers in men as well as women.Men who have sex with women will get some protection from the current vaccination programme if their partner is vaccinated. The same can’t be said for adult men who have sex with men .In 2015, the JCVI, which advises UK health departments on vaccines, recommended extending vaccination to adult men who have sex with men. This group of men are at a higher risk of anal cancer. Up to the age of 45, these men can request HPV vaccination at sexual health clinics.But up until today, the programme hadn’t been recommended for boys, as the JCVI weren’t convinced it would be cost-effective.Today’s decision brings the UK in line with other countries including the US and Australia, which already offer the vaccination to boys.

Who will be offered the vaccine?

The JCVI has recommended the vaccine for boys aged 11-13, similar to the vaccination programme for girls. HPV vaccination is most effective in people who haven’t ever had an HPV infection. And as HPV is mostly transmitted through close sexual contact, vaccination is offered at a young age when people are unlikely to have had any sexual experiences.Men above the vaccination age who don’t have sex with men won’t be offered the vaccine. But it’s important to remember that most people clear HPV infections without them causing any symptoms or problems. And for most cancers linked to HPV there are also other ways to reduce your risk through things like not smoking or drinking less alcohol.

What happens now?

The recommendation for a gender neutral vaccination programme for adolescents has been years in the making. The next step is for the Government to formally accept the recommendation and extend the programme to boys.Until it does, we won’t know the details of when and how the programme will be rolled out. Once they have accepted the recommendation, the Government must publish a plan and timetable for the roll-out.This will need to be accompanied by more details on the programme itself. When the vaccine was first offered to girls in the UK, a ‘catch-up’ programme was introduced for girls up to the age of 18, and we want the Government to do the same for boys.Finally, the programme will do nothing if people aren’t aware it’s happening. We want to see a national awareness campaign to clearly communicate about the vaccine and its potential benefits, as well as new information for parents and boys.By offering the vaccine to everyone aged 11-13, the number of cases of HPV, along with the cancers they cause, could be dramatically reduced in the future.

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