Pharmapedia

Data Integrity in Clinical Research

Importance of Data Integrity
The scientific community has been a witness to some of the worst tragedies in the history of clinical trials data integrity. From the year 2015 till date, The Journal of the American Medical Association (JAMA) and the JAMA network journals have published at least 18 notices citing concern over data error and/or falsification of data.(Bauchner H et ael., 2018) For instance, the trials conducted by a Japanese anesthesiologist and researcher, to treat post-operative nausea and vomiting, were reviewed by the Japanese Society of Anesthesiologists (JSA) in the year 2012 to find startling revelations. The data obtained from the trials were either totally fabricated or fraudulent and approximately 210 papers published by the anesthesiologist had falsified data.(George SL et al., 2015) Lapses in data integrity causes significant loss of revenue with the direct costs estimated to be close to 525,000 US dollars while indirect costs amounting to approximately 1.3 million US dollars.(Michalek AM et al., 2018)

Such scientific misconducts served as a wake-up call to tighten regulations and laws to monitor drug development and drug use. Scientists acknowledged the need for data integrity at every stage to safeguard human subjects, starting from pre-clinical development to pharmacovigilance.

New health era will begin in India with National Digital Health Blueprint

  • Posted on: 16 July 2019
  • By: PharmaTutor News

The National Health Policy 2017 had defined the vision of ‘health and wellbeing for all at all ages’. Continuum of Care is a concept strongly advocated by the Policy. These lofty ideals are sought to be achieved by refactoring the existing schemes and introducing several new schemes including some digital initiatives.

E-MAIL ETIQUETTE

“There are four ways, and only four ways, in which we have contact with the world. We are evaluated and classified by these four contacts: what we do, how we look, what we say and how we say it”
-    Dale Carnegie (1888-1955), An Educator

Time to change our perception towards affordable generic medicines

India is growing as one of the biggest economy of the world. The Pharmaceutical Industry in India is one of the largest in the world and it ranks 4th in the world, pertaining to the volume of sales. As per report of India Brand Equity foundation, India's domestic pharmaceutical market turnover reached Rs 129,015 crore (US$ 18.12 billion) in 2018, growing 9.4 percent since 2017. In the world, India is the largest provider of generic medicines.

INFERTILITY TREATMENT : HOPE NEVER DIES

Planning a family is one of the most important aspects of life. But, in this modern age, planning for a baby comes with lot of challenges for many. Couples these days prefer good planning before they conceive. They wish to be financially sound, have essential assets in place and always have a backup in case things don’t go as planned. Baby planning starts with fertility evaluation which involves history and physical examination, lab testings, transvaginal ultrasound, semen analysis and hysterosalpingogram. Fertility evaluation should be an essential step to determine a woman’s or a man’s fertility status. In 2017, U.S recorded its lowest birth rate in last 30 years. Millennials, people born from 1981 to 1996 are being blamed for the same and the most talked about reasons are waiting too long for marriage, financial concerns and career plans. This has driven an added fear among people for infertility. But, as much as this concept is talked about, the treatment for the same is talked about more. With the advancements in medical science, couples that face fertility issues can receive the best of treatments which fetch results. Speaking about millennials and the things they have to listen to, here are some of the most common causes of infertility.

ALLERGIC RHINITIS : SYMPTOMS, CAUSES, DIAGNOSIS, TREATMENT AND MANAGEMENT

Allergic rhinitis is a group of symptoms which affects the nose. It is commonly known as hay fever.

Allergic rhinitis develops when the immune system of the body becomes sensitized and overreacts to something in the environment that normally causes no problems in most people. Allergic rhinitis is caused by an allergen, such as dust, pollen, mould, or flakes of skin from certain animals.

WAYS TO STANDUP AGAINST ‘SERVICES SEEKING DOCTORS’

First of all,  Medical Representatives must understand that their services are far more  important to the Pharma Companies in the promotion of their products as per strategy, than the kind of services or supports that some Companies may offer to some Doctors.  If Companies can win over the Doctors with supports or services, then the Medical Representatives will have too little to contribute and the job may cease to exist soon.  Companies may send the services, supports, samples and other promotional inputs by Courier to the Doctors directly in such a scenario.  A few small Pharma startups who tried this route couldn’t sustain such services for long and hence had to close down operations, because ‘greed has no limit’, and the demand keeps on increasing month after month.  Besides,  it is difficult to quantify the exact returns in terms of prescription support from such serviced Doctors, though some Companies try to see the details of supplies made to nearby Retailers from the Stockist/Distributor concerned every month, i.e. secondary sales. Once a Company falls into this trap, it may be very difficult to revert back to ‘purely ethical promotion’ again, because if we stop such ‘services’ one day,  drastic sales loss may last for many months and rebuilding a healthy sales base again may take a few years, which may be difficult to deal with from business perspective.  The working habits of frontline salesmen of such ‘service’ based Companies may come down drastically as their focus gets shifted to delivering the agreed upon services to the Doctors on time and then ensuring agreed upon returns from each Doctor serviced month after month, than sincere implementation of marketing strategies in the field.  In addition, the sales base created through sincere implementation of marketing strategies may last long when compared through the sales base created through offering of other services, because if we stop the ‘other services’, the sales base may crumble quickly like a pack of cards.

RESULT IS THE CULMINATION OF ACTIVITIES

We all know result is the culmination of many identified activities.  A student scores good marks and comes out with flying  colours, only after years of hard work and preparation in studies.  Likewise,  in ethical Pharma selling/marketing, achievement of objectives – targets – is the result of implementation of identified activities, i.e. strategies,  consistently.

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