All posts by anayansi vanderberg

https://www.linkedin.com/in/anayansivanderberg/

I still Cry – Ilse Delange

I Still Cry
I’m making flowers out of paper
While darkness takes the afternoon
I know that they won’t last forever
But real ones fade away to soon
I still cry sometimes when I remember you
I still cry sometimes when I hear your name
I said goodbye and I know you’re alright now
But when the leaves start falling down I still cry
It’s just that I recall September
It’s just that I still hear your song
It’s just I can’t seem to remember
Forever more those days are gone
I still cry sometimes when I remember you
I still cry sometimes when I hear your name
I said goodbye and I know you’re alright now
But when the leaves start falling down I still cry
I still cry sometimes when I remember you
I still cry sometimes when I hear your name
I said goodbye and I know you’re alright now
But when the leaves start falling down I still cry
But when the leaves start falling down I still cry
Source: LyricFind

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Motto of the Month

Some say ‘seeing is believing’ and sometimes we can’t see with our own eyes what our spiritual mind is seeing.

We don’t need eyes to truly see what matters.

The Eye Sees Only What the Mind Is Prepared To Comprehend

Source:

Henri Bergson? Robertson Davies? Johann Wolfgang von Goethe? Thomas Carlyle? Anais Nin? Anonymous?

Clinical Trials – Computerized Systems

The Food and Drug Administration (FDA) established the Bioresearch Monitoring (BIMO) program of inspections and audits to monitor the conduct and reporting of clinical trials to ensure that data from these clinical trials meet the highest standards of quality and integrity and conform to FDA’s regulations.

Computerized systems used in clinical trials refer to the creation, modification, maintenance, archiving, retrieving or transmitting clinical data intended for submission to the Food and Drug Administration (FDA).

Key Definitions:

Audit Trail: a secure, computer-generated, time-stamped electronic record that allows reconstructions of the data course of events relating to the creation, modification, and deletion of an electronic record.

Certified Copy: it is a copy of the original information that has been verified, as an exact copy having all of the same attributes and information as the original. It must have a dated signature.

Computerized System: it is the computer hardware, software, and associated documents (i.e manuals) that create, modify, maintain, archive, retrieve, or transmit in digital form information related to the conduct of a clinical trial.

Electronic Case Report Form (e-CRF): designed to record information required by the clinical trial protocol to be reported to the sponsor on each trial subject.

Electronic Patient Diary: an electronic record into which a subject participating in a clinical trial directly entrees observations or directly responds to an evaluation checklist or questionnaire

Electronic Record: a combination of text, graphics, data, audio, pictorial, or any other information representation in digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system.

Electronic Signature: a computer data compilation of any symbol or series of symbols, executed, adopted, or authorized by an individual to be legally binding equivalent of the individual’s handwritten signature.

Software Validation: verification and validation is the process of checking that a software system meets specifications and that it fulfills its intended purpose. For these guidelines, the design level validation is that portion of the software validation that takes place in parts of the software life cycle before the software is delivered to the end-user.

Source Documents: original documents and records including, but not limited to, hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments,copies or transcriptions certified after verification as being accurate and complete, microfiches,photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments involved in the clinical trial.

Principles:

Security measures should be in place to prevent unauthorized access to the data and to the computerized system.

1-Identify at which steps a computerized system will be used to create, modify, maintain, archive, retrieve, or transmit data.

2-Documentation should identify what software and, if known, what hardware is to be used in computerized systems that create, modify, maintain, archive, retrieve, or transmit data. This document should be retained as part of the study records.

3-Source documents should be retained to enable reconstruction and evaluation of the trial.

4-When original observations are entered directly into a computerized system, the electronic record is the source document.

5-The design of a computerized system should ensure that all applicable regulatory requirements for recordkeeping and record retention in clinical trials are met with the same degree of confidence as is provided with paper systems.

6-Clinical investigators should retain either the original or a certified copy of all source documents sent to a sponsor or contract research organization, including query resolution correspondence.

7-Any change to a record required to be maintained should not obscure the original information. The record should clearly indicate that a change was made and clearly provide a means to locate and read the prior information.

8-Change to the data are stored on electronic media will always require an audit trail, in accordance with 21 CRF 11,.10(e). It should include who made the changes, when, and why they were made.

9-The FDA may inspect all records that are intended to support submissions to the Agency, regardless of how they were created or maintained.

10-Data should be retrievable in such a fashion that all information regarding each individual subject in a study is attributable to that subject.

11-Computerized systems should be designed so that all requirements assigned to these systems in a study protocol are satisfied and to preclude errors in data creation, modification, maintenance, archiving, retrieval or transmission.

As we read in this blog about guidance for the industry around computerized systems revolts around data quality and data integrity. The users or people using the data from these systems should have confidence that the data are no less reliable than data in paper form.

In the next blog, we will cover audits and inspections, data entry into this computerized system, security and electronic signatures as a way of certifying the data.

Source:

CFR 11 and ICH

FDA.com

 

 

 

X EDC: The Next Generation of EDC?

RaveX is an EDC system that is powerful and easy to learn. Medidata has one of the best eLearning and training courses to get anyone up and running from the first time you use the system.

The study design setup still requires high technical skills including C# sharp for most complex data cleaning and study setup tasks.

Let’s discuss the new study hierarchy:

We already understand the relationship between the studies, sites, and subjects in Rave EDC.

At the navigation bar in RaveX EDC, we choose the study from the list of studies assigned to your role. At the second level, we can see the study dashboard. The dashboard contains information about the sites and subject enrollment.  From the sites, you can drill down to the subject level or subject related eCRFs.

Subject’s landing page:

  • Access eCRFs
  • Perform role-specific functions (e.g. SDV, DM data review, PI signature, enter data)

Understanding Status Icons in EDC:

On a form, when you click on an icon, the action is taken on that data point. Based on your roles and permissions, you could apply this action individually or to “Apply All”.

Common status icons:

When you select a subject, you arrive at the subject landing page. Some old features are the scheduled visit dates (a feel and look of the matrix in Rave Architect), the subject status and the status of their eCRFs and some additional information.

At the scheduled level (for Oracle InForm users, this is the Time and Event Scheduled with the traffic lights), you can open a folder and access a particular form residing on that folder.  You can then proceed with normal data entry.

There are several ways to access the same eCRF for another subject. Navigate to it by selecting a subject from the subject list.

Performing data cleaning and data review:

At the study level, select the RaveX study then select the study name you would like to perform a task.

On the screen, select ‘View Task Management’ link and then select the open queries link. At this level, you can select the particular subject and form a query that is opened on. For example, I noticed an open query on the informed consent form. To view it, select the query link on the screening informed consent row.

What modules are still available in this new design?

  • Rave Architect
  • Rave User Administration
  • Rave Site Administration
  • Rave Reporter
  • Rave Configuration
  • Rave PDF Generator
  • Rave Lab Administration
  • and more…

Overall, the EDC solution has been easy to use for database development, data entry, and data validation. The online, real-time validation feature is a plus as it does no longer requires the form to be saved for the checks to fire.

Have we lost any features to this new fancy design? Find out next.

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O PAPAGAIO – Anne Simoni

I recently found a CD I bought years ago from a Brazilian friend. We used to hang out in the Philly area and finding this CD brought me good memories.

Anne has a lot of talent and a great voice. My favorite songs from the CD are: Longe de Mim, Unidos da Lavra, and Papagaio.

Foi bom lembrar os bons e velhos tempos. ..lembrando de você..

O PAPAGAIO GRITOU
QUANDO LIGUEI O ASPIRADOR
SÓ FALTOU ME PEDIR
DESLIGA ISSO, POR FAVOR

MAS NÃO PODE FALAR
ELE AINDA NÃO APRENDEU
VEIO LÁ DO BRASIL
PRA GAIOLA DO GRINGO ENFEITAR

ENQUANTO ASPIRO A SALA DO SOBRADO
EU FICO PENSANDO NO COITADO
FOI CAÇADO, VENDIDO, EXPORTADO
PRA VIVER ENGAIOLADO
E AINDA POR CIMA, VAI TER QUE APRENDER INGLÊS.

FALA, FALA, FALA PAPAGAIO
VOU TE ENSINAR O PORTUGUÊS
FALA, FALA, FALA PAPAGAIO
VOU TE ENSINAR A CONTAR ATÉ TRÊS

 

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Motto of the Month

‘When the debate is lost, slander becomes the tool of the loser.’ – Unknown.

Even though many websites attribute this quote to Socrates, it is confirmed he never said it. It is still a nice quote and I’m sharing it with you this month.

 

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How the Pharmaceutical Industry became into existence?

The Birth of the Pharmaceutical Industry can be traced back to 1850 – 1875 where the first “authentic” drug was developed by extracting agents from plants.

In those years, there were also developed the microbial theory of disease, medicines and homoeopathy patent and there heavy use of powerful purgatives and cathartics medicines.

By 1875, the Drug Development becomes a science and the first synthetic drug was introduced. By 1900, vaccines and antitoxins form the basis of the new pharmaceutical industry.

From 1900 to 1925, began what is now known as the pharmaceutical century. The U.S. Pure Food and Drugs Act was passed (known today as the FDA) and the development of hormonal and chemotherapy was introduced.

After 1925, it began what is known today as the Antibiotic and Regulatory Era. Vitamins, antimalarials, anticarcinogenic compounds and anti-infectives discoveries were made. The FDA gains independence as a regulatory agency and is given compliance responsibility.

From 1950 thru 1975, a new generation of the drug became apparent. Vaccines for polio became mandatory, oral contraceptives appears on the market and cardiovascular therapies.

Also, an amendment to the Federal Food Drug and Cosmetic Act of 1938 Act was signed by President Kennedy to ensure that consumers will not be the victims of unsafe and ineffective medications. Additional information about this Act can be read here: Kefauver-Harris Amendments

The Globalization of the Pharmaceuticals industry started from 1975 thru 2000. New drugs therapies, new antiviral drugs, and the development of new drugs by biotechnology companies were in global high demand.

By 2000, over 2.8 million people participated in over 50,000 clinical trials and more research and development funding was increased.

R&D Expenditures by Body System

R&D Expenditures

Cost (Billions) Body System
7.0 Central Nervous System
6.0 Cancer, endocrine and metabolic
4.5 Cardiovascular
3.5 Infectious Disease
2.5 Biological and vaccines
5.3 Other

Current Trends in the Industry since the late 2000s

Biotechnology Medicines
Drug Intervention Targets
Vaccines

 

Role of Generic Drugs
Generic drugs account for over 47% of prescription drugs in the market in which 43 major prescription drugs come off patent by 2005.

What does this mean for pharmaceutical drugs?
Between 40% – 60% of sales are lost to the generic brand within the two years of coming off patent.

Factors that will impact the R&D future:

  • There has been over 40 mergers and acquisitions since 1985
    • Sanofi and Synthelabo
    • Zeneca and Astra
    • Monsanto and Pharmacia
    • Roche and Genentech
  • Employment grew at a 3% rate per year

Total Drug Development Time (Years)

Summary:
On average, it takes at least ten years for a new medicine to complete the journey from initial discovery to the marketplace, with clinical trials alone taking six to seven years on average. The average cost to research and develop each successful drug is estimated to be $2.6 billion.

Pharmaceutical Regulation

In 1902, about 10 children die after receiving a vaccine shot. The BIOLOGICS CONTROL ACT was passed to ensure purity and safety of serums, vaccines and similar products used to prevent or treat diseases in humans.

In 1906, “The Great American Fraud” reveals patent medicines laced with addictive drugs, toxic additive and alcohol.

In 1912, Public outcry over the sales of “snake venom” and other wonder cures.  The SHERLEY AMEND was passed to prohibit labelling medicines with false therapeutic claims intended to defraud the purchaser.

In 1927, the government forms a separate law enforcement agency called the Food, Drug and Insecticide Agency.

In 1937, about 107 people, including many children die after drinking a syrup called Elixir of Sulfanilamide. Due to safety concerns, The Federal, Food, Drug and Cosmetic Act (1938) was passed as the first attempt to regulate cosmetics and medical devices.

In 1962, the sleeping pill “Thalidomide“, developed what is known today as Grunenthal Pharmaceutical in Germany, resulted in thousands of birth defects in Western Europe. The KEFAUVER-HARRIS Drug Amend was passed to ensure drug efficacy and greater drug safety.

In 1983, the ORPHAN DRUG Act was passed enabling the FDA to promote research and marketing of drugs needed for treatment of rare diseases. This year there as an outbreak of HIV / AIDS cases.

In 1988, The FOOD and DRUG ADMINISTRATION ACT were established as the FDA under the Department of Health and Human Services.

In 1992, the pharmaceutical industry complained that life-saving drugs were being reviewed too slowly by the FDA. The PRESCRIPTION DRUG USER FEE ACT (PDUFA) is made into law.

Source:

Image: Courtesy of Google image

FDA website

Private information for college researched in the 2000s.