Wednesday, 1 July 2020

MEDICAL WRITING – INTRODUCTION

By Dr. Suneet Sood, Monash University & Kamal Shahani, Cliniminds

In the series of short write ups on a medical writing career, we would cover various aspects of medical & scientific writing. This first article covers the introduction and the scope of medical writing.

 Medical writing is, in its broadest sense, writing for the healthcare and life sciences industry. The term “writing” included only the print medium, but now also includes any writing work that is carried out for television (e.g. advertisements), radio (e.g. speeches), and internet. Healthcare related typically refers to medicine, but medical writers also involve themselves in writing for agriculture and veterinary related content.

In this short write up, we would cover the scope and types of medical writing.

 The Scope of Medical Writing

 For persons who wish to become medical writers, the scope is immense. 

Medical writing is today a billion-dollar industry.

The writer can involve themselves in one of two types of writing:

1.      Regulatory Writing        

2.      Publication Writing

Medical writing is conventionally classified into these two types, because the laws governing regulatory writing are considerably more stringent than those governing publication writing. Consequently, someone who is involved in regulatory writing is more likely to require a formal training course than one who will confine themselves to publication writing.

Having said that, everyone needs training!

Regulatory writing is that which is typically carried out by the contract research organizations for the pharmaceutical industry or by the pharmaceutical companies for regulatory compliances. They typically create large texts for firms conducting drug trials. Today the ethical constraints for all trials are so tight that there is a large body of rules that guides this form of writing. The rules ensure that the documents adhere to the International Conference of Harmonization’s Good Clinical Practice guidelines. Medical writers at Pharmaceutical companies write several regulatory documents for submissions to various global regulatory agencies.

Thus, a medical writer involved in regulatory writing will prepare clinical trial reports, write out the investigator brochures, generate new drug applications, compile annual reports, write out clinical study reports, and so on.

In contrast, the medical writer who focuses on publication writing will typically write for magazines, journals, even books. Publication writing includes pharmaceutical marketing and advertising, writing magazine articles, and so on, for the public (see box). Publication writing includes newsletters, speeches, posters, abstracts and other journal content, educational materials, compilation of drug monographs, internet content, and ghostwriting, as well as editing and other activities of publishing houses.

Publication writing

Pharmaceutical marketing and advertising

Magazine articles

Professional Newsletters

Physician speeches Posters

Conference Coverage

Journal abstracts and articles Medical education materials Patient educational materials Internet content

Editing, proofing, publishing Ghostwriting

The debate is not whether there is enough work for medical writers. The debate is, “is there a limit?” Medical writers can get jobs in pharmaceutical companies, contract research organizations, agencies that specialize in communications work, content providers, or institutions that cater for education. Freelance writers have a high demand if they are good. The most skilled writers will create content. Medical writers will also be editors and proofreaders, and may have a role in marketing for medical products. However, all writers should aim to become content creators. Medical writing is a sort of business. Skill, marketing, and durability in the profession make a great difference. Still, the rewards are good overall. In United States of America medical writers earn between US$60,000 and 100,000 or more annually. In India medical writers earn between Rs.400,000 and 20,00,000 or more annually depending upon your level and experience. A lot depends on the market a writer targets. Most of the better earners will have taken a writing course. Very few top earners will be self-taught. As professionals, most should be members of an established medical writing institution/ association.

The scope for publication writing is also immense. One can produce advertising articles, internet content, magazine articles, marketing materials, newsletters, training manuals, and more.

Publication writing itself is directed at two main audiences: the public (popular) and the scientific (professional). Writing for the public includes content for popular newspapers and magazines, educational materials, advertising products such as flyers, and others. Scientific writing includes content for newsletters, reviews for journals that cater to practitioners, and internet content for professionals. Scientific writing may even include writing for specialty medical journals, and medical writers are lobbying hard to make it acceptable for investigators to enlist their services to produce medical papers.

For those who are interested in taking medical writing more seriously, even as a profession, the question we need to address is: are there jobs for medical writers? The answer is, “Of course there are jobs.” Writing for The pharmaceutical and clinical research industry itself is a multibillion dollar business. A simple Google search showed that the industry turnover has multiplied since the nineties. The same holds true for publication writing.

Formal training in medical and scientific writing is important for the professionals who would like to take a plunge in medical writing career or medical doctors who would like to conduct and publish their research. A formal training course would be helpful.


About Cliniminds : Cliniminds offers wide range of health sciences programs since 2004. Cliniminds also offers specialized program in Medical & Scientific WritingNext batch for Live eLearning is commencing from Sunday, 2 August 2020. For more information, please contact info@cliniminds.com or +91 98100 68241.

Monday, 21 May 2018

CLINICAL TRIAL & 13 Principles of ICH GCP


In Clinical Trials to achieve Quality readiness one needs to understand the Principles of Good Clinical Practices. GCP has been well defined in EU Directive 2001/20/EC, under Clause 2 of Article 1, which discusses about scientific quality requirements for designing and conducting clinical trials.


The data obtained from Clinical trials should be credible as well Clinical trials should protect the rights, safety and wellbeing participating subjects as per National Research Act and Belmont Report, to ensure the authenticity of data and protection of human subjects The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) created Good Clinical Practices in the year 1996, which eventually became mandatory to be followed in the year 2004 for conducting trials on all Investigational Medicinal Products (IMP).

Principles of GCP are summarized as follows

1.Clinical Trials should be conducted as per Declaration of Helsinki, which provides ethical guidelines on human experimentation.
2.Before the initiation of clinical trial, the risks for subject and society should be weighed against its anticipated benefits. 
3.The safety and rights of the participating subjects should considered with utmost importance over the benefits of trial. 
4.Clinical information and non-clinical information on the investigational medical product should be adequate to support the trial.
5.Specifics of clinical trials should be well defined and explained in Protocol
6.Protocol should be approved by Institutional review board (IRB)/independent ethics committee (IEC), following which clinical trial should be conducted in compliance with Protocol. 
7.During the trial, qualified physician would be responsible for the well the being of the subject 
8.The staff conducting the trail should be qualified in education, training and experience to perform task allocated to them.
9.Prior to the clinical trial signed informed consent should be obtained from the subject
10.To allow accurate reporting, interpretation and verification of clinical trial data, measures to and record and maintain the data should be sought out.
11.The records identifying the confidentiality of subject should be protected in respect to privacy and confidentiality regulations.
12.The Investigational medicinal product in Clinical Trials should be manufactured as per Good manufacturing practices (GMP) and should be used in accordance to the protocol. 
13.Quality systems should be maintained to ensure quality in Clinical Trials.

Reference: GCP 13 Principles
(Url:  https://www.abdn.ac.uk/hsru/documents/GCP%2013%20Principles.pdf )
Cliniminds (www.clinimids.com ) welcomes all the students and professional who are seeking a bright career in Clinical Research and Pharmacovigilance. We have 14 + years of lineage and our faculties are seasoned experts with vast experience from the Industry. We provide 100% assured placement support, for more information contact us @ 9560102587 or email us at pharmacovigilance@cliniminds.com

Wednesday, 16 May 2018

Clinical Research- opening new doors to Duchenne muscular dystrophy




Duchenne muscular dystrophy (DMD) is a muscular dystrophy characterized by severe muscle weakness due breaking of skeletal muscles. DMD mostly occurs in boys at around age of 4. The aetiology of DMD is said to be attributed to the mutation of a gene called dystrophin located at locus Xp21 or on Chromosome X. Dystrophin is responsible for connecting the cytoskeleton of each muscle, without dystrophin, excess calcium would enter into the cell and cause the cell to burst.
It was not too long before Erin realized that her two year old son Oliver Lambright was diagnosed with Duchenne muscular dystrophy, a generic disorder which occurs in one in 3000 boys. She looked at every possible treatment on the internet, only to realize that there was no cure, till she found Dr. Jean Mah, who was an Associate Professor at Cumming school of Medicine in the Department of Paediatrics, she told her family that there is ongoing clinical trial on DMD at the University of Calgary in Alberta, Canada in which around 100 patients with DMD from all over the world participated in the trial.

Clinical trials are essentials as it paves way for new line of treatment drugs. Before a drug is dispensed in a clinic,It has to undergo clinical trial. At the University of Calgary there are around 563 active trials.

Reference: UToday, University of Calgary
Cliniminds www.cliniminds.com has been on the forefront in delivering quality education in Clinical Trial Monitoring accredited from the Accreditation Council of Clinical Research Education- United States. Our course on Clinical Trial Monitoringcovers module on Clinical Research, Pharmacovigilance and Clinical Data Management. Our program comes with assured placement support.

Our Classroom sessions for new batch commences from 21st May 2018. Enrol now to avail 10% discount. For more information contact us at 9910068241, 9560665441, 9560102587or email us at info@cliniminds.com


Wednesday, 25 April 2018

Social media analytics ‘The WEB RADR trials’



Web RADR (Recognising Adverse Drug Reactions) is platform which provides technological solutions for robust pharmacovigilance. Web RADR has its key contributions in Governance and policy, Social media and Analytics.

Web RADR is led by the European Medical Agency to provide its recommendation on developing mobile based application and use of social media for monitoring adverse drug reactions. Web- RADR goes in consultation with bodies like Eudravigilance- Expert Working Group (EV- EWG), Patient’s and Consumer Working Party (PCWP).

Key stakeholders in this project include Novartis Pharma, Janssen Pharmaceutica, Sanofi-Aventis, UCB and Amgen
Web RADR along with Epidemico (An organization with the capability to analyse and visualize data, comprising of public health leaders, software experts and data scientist) is now working its way to provide access to social media content by visualization using technology by Epidemico in detecting signals. Analysis of social media content through Big Data Analytics would be applied in forecasting problems with marketed medicinal products, it would enable the regulators to understand nature of safety signals and all of the content screening would be done on data which would be publically available, without violating data protection act adding further to this where social networking users would also have the provision to opt out of data collection.

Through a recent it was determined that in 2016, Facebook has highest number of threads with 2.2 Billion post, Twitter following with around 318 millions tweets and You tube with 1.5 billion videos.
Alongside with screening digital content from social media, Web RADR in collaboration with World Health Organization’s, Uppsala Monitoring Centre would be developing analytical tool, which would help in extraction of relevant and quality data from social media for  screening and would also focus on case triaging and linkage of duplicate reports.
Another initiative led by Web-RADR is designing android/ IOS based apps with key functions to report ADR and provide alerts. The apps would be linked with various regulatory agencies and would provide tailored alerts to the users about safety issues and warnings. The app would also facilitate anonymous ADR submissions using customized reporting forms. Web-RADR would be making the app soon available in different languages and additional products would be added in the product list for easy recognition of suspect.

In UK almost 4000+ users have used Yellow Card app with 400+ safety reports being sent to MHRA


Web- RADR , together with University Medical Centre Groningen and University College London would analysing barriers for patient and healthcare professionals to use mobile application for reporting ADR, studies through conjoint analysis where different versions of app are tested on different levels of health, literacy and usability on focussed population groups of patients adolescents, orphan disease populations and elderly patients have been undertaken by the University.
Web-RADR would also be conducting Scientific Impact Evaluation, together with University of Liverpool to determine whether mobile based application and social media content screening would be a value addition to Pharmacovigilance as output of these activities would impact policy recommendations.

Reference:
·         WEB-RADR, Work Packages (url: https://web-radr.eu/work-packages/wp5/ )
·         EPIDEMICO (url: https://www.epidemico.com/ )

Brought to you by:
Cliniminds (www.cliniminds.com ) imparting quality education in Clinical research and Pharmacovigilance since last 14+ years with 100 % placement record.
Cliniminds offers training in aggregate reporting, our students are trained on PSUR, PBRER, Addendum, Summary Bridging, DSUR, ASR, EOS Reports with Hands On’ experience on ORACLE Argus Safety and other safety databases for line listing, summary tabulation extraction.

Monday, 2 April 2018

MHRA’s Black Triangle Report




In United Kingdom, there are certain drugs in which although they were granted marketing approval by the Medicines and healthcare product regulatory agency (MHRA), they need to be closely monitored, since limited information were available about these drugs.

One of the key reasons attributed to this may be, less subjects being enrolled in the clinical trials, short therapy duration etc.…thus, in order to identify rare adverse reactions, effect of the drug in different populations or effect of the drug under different co-morbidities, such drugs are tagged with an inverted black triangle () on their package insert, to ensure that these drugs are intensively monitored.

The Commission on Human Medicines (CHM) and MHRA encourages expedited reporting within 15 calendar days of all such drugs with an inverted black triangle symbol if, found to have caused serious or non-serious adverse drug reaction.

You may find the black triangle drugs at the Electronic Medicines Compendium, British National Formulary, Nurse Prescribers’ Formulary etc.… A black triangle symbol may be assigned to any new active drug / vaccine or even a Biosimilar (Biosimilar are similar biological therapeutic products). Black triangle is not restricted to only drugs, it may also include new route of administration, new drug delivery systems or even new patient population.

Black triangle drugs are reviewed every 2 years by the MHRA and monitoring black triangles reports helps in identifying benefit risk profile of drug and unrecognized adverse effects.

Reference:

·         List of medicines under additional monitoring, European Medical Agency (url: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000366.jsp&mid=WC0b01ac058067c852 )
·         EMC (https://www.medicines.org.uk/emc/ )

Brought to you by:
Cliniminds- Leaders in Pharmacovigilance and Clinical research training. Our training include hands on experience on pharmacovigilance software (Argus safety). To catch with recent updates on pharmacovigilance, check out our newsletter at Cliniminds Pharmacovigilance page (www.cliniminds.com)



Thursday, 29 March 2018

European Medical Agency to increase fees upto 1.7 %



There would be an increase in fees upto 1.7 % from April 1st 2018 as mentioned in the notification of Commission Regulation (EU) No 2018/471 (amending Council Regulation (EC) No 297/95), the fees however would be implemented for all activities carried out by the agency except pharmacovigilance. Apart from Pharmacovigilance the agency has also exempted fees ofMicro Small or Medium Sized Enterprise, Orphan Medicinal Products, Medicinal Products for Paediatric Use, Advanced Therapy Medicinal Productsetc… Detailed information on has been provided on an explanatory note.

The agency every year revises its fees as per the statistical data from EUROSTAT (European Union’s statistical office), the current revision is made in accordance with the inflation rate for 2017.
Reference:

1.       Explanatory note on general fees payable to the European Medicines Agency
2.       COMMISSION REGULATION (EU) 2018/471 of 21 March 2018
Brought to you by:

Cliniminds (www.cliniminds.com),leader in Pharmacovigilance & Clinical research training and consulting 

Clinimindsoffers ‘Hands On training case processing on ORACLE Argus Safety and other safety databases. Our students are entitled for free DIA membership.


Friday, 9 March 2018

Artificial Intelligence Seeing through the lens of Pharmacovigilance

Pharmacovigilance as we know is a science with a set of pre defined functions to collect, analyse, monitor adverse event reports in understanding the safety profile of drug.
The set pre defined functions would include case processing through data entry of adverse event forms into safety database, medical review, aggregate reporting, signal detection, risk evaluation and mitigation strategies.


With patients awareness and regulatory compliance we may have seen a surge of adverse event data over last few years , resulting in the urgent need for the application of automation. Pharmacovigilance is the only discipline where in which timelines and quality data are evaluated on a benchmark of 100 % and a compromise in these two parameters are considered to be a zero tolerance.
Automation of above pre defined function is possible through machine learning, which is an integral components of Artificial Intelligence.

What is Artificial Intelligence ?       
Artificial intelligence may be called as an ability of a computer system to perform task that require human intelligence such as cognition through visual acuity, voice recognition, language translation leading to decision execution of a certain function.
Machine learning is based on reinforced data, where in which when an algorithm is executed to accomplish a specific task.

If it accomplishes the algorithm ends and the entire procedure in auto stored in the program, which means next time one does not need to manually execute the program, it would be auto executed in order to accomplish the task, if presented with the exact same variables as that of the earlier scenario.
In the second case if the task is not accomplished then too the procedure would be stored in the program and next time when the program is auto executed it would not take the same path thus minimizing error.

This process self-learning through experience is called machine learning For example imagine a scenario where in which you have you have received an email from a patient who has experienced nausea, followed by headache and bleeding from nose on Lisinopril, the patient also mentions that he has a history renal impairment and also that he was a chain smoker for which he took Varenicline to quit smoking.

An algorithm created on the principle of machine learning would have the capability to auto recognises and identify the suspect drug from concomitant therapy, adverse event from medical history and not only this through robotic process automation it may integrate the email with safety database, which means not only it identifies the suspect drug and the adverse event, it now also does the auto data entry, prepares auto case narrative and auto sends letters to the patient or physician for further follow up  from the safety database.

This is ‘Artificial Intelligence’, a capability attained through self-learning to process thousands of data within seconds.With automation employees engaged in manual data entry would be upskilled in the execution of AI process.

Cliniminds (www.cliniminds.com ) offers training in aggregate reporting, our students are trained on PSUR, PBRER, Addendum, Summary Bridging, DSUR, ASR, EOS Reports with Hands On’ experience on ORACLE Argus Safety and other safety databases for line listing, summary tabulation extraction.


Thursday, 8 March 2018

PvPI to include vector borne disease as part Pharmacovigilance for Public health


Pharmacovigilance programme of India (PvPI), soon to include diseases caused in tropical climate, vector borne diseases like malaria and dengue, tuberculosis and HIV- AIDS as part the Pharmacovigilance for public health. The programme would be soon incorporated by all South East Asian Regulatory Network (SEARN) member countries.


When carrying out pharmacovigilance activities for the above targeted diseases, a common questionnaire has been developed by the  WHO for SEARN countries.

The PvPI would now have an added responsibility of updating adverse drug reaction database on Vigiflow based on the reports received from other SEARN centres.
This indeed shows a remarkable progress of our country- INDIA in translating pharmacovigilance for better patient safety.

Cliniminds offers corporate training programs exclusively designed for working professionals who want to get upskilled in pharmacovigilance, upon the completion of which each participant would awarded with Advanced Post Graduate Diploma in Pharmacovigilance accredited from ACCRE, USA

For more information visit: www.cliniminds.com or email us at info@cliniminds.com

Tuesday, 20 February 2018

Increasing Role of Business Analytics in the Pharmaceutical Companies

A pharmaceutical company wanted to in-license a phase I molecule and wanted to estimate its future value and take decision, whether to in-license the molecule at current offered price or not.                                                                   Approach: A detail study of molecule and its therapy area of development was undertaken to understand disease landscape and current market players. In-order to identify futuristic events an in-depth research related to upcoming molecules, epidemiological changes, pricing and treatment patterns was conducted. These inputs were further validated through primary research with KOLs, physicians and regulatory bodies, primarily to understand expected quantitative impact of future events. Once all required information was available, a robust macro enabled excel based forecast model was developed, with future trends in epidemiology, pricing, patient numbers and upcoming molecules as inputs. These quantitative inputs were derived using benchmarking studies and analogue analysis and were applied at appropriate step within the forecast model. Based on trial and clinical data analysis of the molecule of interest, primary research and analogue analysis studies, potential market share was estimated in next 10 years. These all when entered into the forecast provided potential revenue of the molecule that was being evaluated for in-licensing.
Outcome:The results of the model showed that asking price for the molecule was too high as compared to its expected revenue in next 10 year, thus pharmaceutical company did not pursue buying that molecule. When finally the molecule got launched, its revenues were quite in line as predicted by our model, thus saving the pharmaceutical company from a loss making deal.                                                                                                                                                                  About Cliniminds: Cliniminds offers professional job linked programs in pharma business analytics, clinical trials, pharmacovigilance and other health science domains. Programs are designed in line with industry requirements. For more information, visit our website – www.cliniminds.com or call at +91 9810068241

Monday, 15 January 2018

How pharma data / business analytics are helping pharmaceutical companies?

Case Study:
A top pharmaceutical company was interested to develop a medicine for diabetes, and for which it wanted to asses and identify attractive patient segments.


Approach
Secondary research was undertaken to understand current diabetes treatment guidelines and therapy landscape, to identify patient segments. Following this trial analysis was undertaken to identify upcoming trends and molecules in different patient segments of diabetes. The molecules and trends were further analyzed to ascertain their expected relevance on the diabetes landscape through clinical data and benchmark analysis. Key trends analyzed during the study were related to epidemiology, pricing, regulatory activities, and market access regulations across geographies. These findings were further validated through an intense primary research involving key opinion leaders, payers, physicians and regulatory bodies. The all inputs from primary and secondary research with collated together and analytical tools, such as PESTLE, SWOT, ANSOFF and 5 WHY’s were used to generate insights out of the information. Final report clearly laid out “WHERE TO PLAY” and “HOW TO PLAY” strategic options within diabetes.

Outcome
Project helped client to clearly understand the development opportunities within diabetes and design development plan for molecule as per plan.

About Cliniminds

Cliniminds is India’s leading Health Sciences Education, Training & Consulting organization offering specialised program in pharmaceutical data / business analytics, and other health sciences programs. All Cliniminds programs are linked with job placements. Cliniminds has trained and placed over 6,500 professionals in the health sciences domain.


For more information, please call 9810068241 or mail at info@cliniminds.com; www.cliniminds.com

Monday, 8 January 2018

Seminar on Pharma Data / Business Analytics & Career Opportunities

On Sunday, 7th January 2018 Cliniminds organized Seminar on Pharmaceutical Data / Business Analytics with focus on career opportunities for the graduates and post graduates in pharmacy, medicine, dental, IT/Computer Science, life sciences and biotechnology. Demo class on the topic of Analogue Analysis was conducted for the benefit of the participants. Experts from leading pharma business analytics firms conducted interactive session with the participants.



Pharma data / business analytics is one of the fast growing sectors in the life sciences domain with annual growth of 27%, and by 2021, industry size would be over US$21 billion.

The sector offers attractive career opportunities with excellent long term career opportunities for pharmacy, medical, IT/computer science, life sciences, and biotechnology graduates and post graduates.


Cliniminds offers first time in India, Specialized program in Pharma data / business analytics. For more information and assistance, please contact +91 9810068241 or info@cliniminds.com.

Thursday, 4 January 2018

Pharma Data Analytics - Opening Doors to a New Vertical In Healthcare

The pharmaceutical industry is currently ranked as 2nd on the global scale with a market of estimated US $874 billion which would exponentially soar to US $ 1.22 trillion by 2022, the key drivers for this high stake is mainly due to poly-therapy used in the treatment of multiple chronic conditions like hypertension, diabetes, COPD, hyperlipedmia.

The healthcare system of India is growing at an incredible pace with a current compounded annual growth rate of (CAGR) of 22.9 % which is expected to reach a net worth of USD 150 Billion by 2020.

With easy accessibility of medicines, better nutritional supplements, better formulations and the switch from supervised to self-therapies using engineered technologies like controlled delivery systems, has impacted the pharmaceutical market to a great extent globally.

This impact has also led to many changes in the regulatory framework for instance, with respect to compliance, the marketing authorization holders (MAH) have been asked to focus more on the outcome, rather than the input Irrespective of whether MAH has a robust pharmacovigilance system in place, if the risk of a drug causing a Serious Adverse Reaction which may also be life threatening is not controlled through implementation of risk mitigation strategies, it may lead to reactive measures which may include complete withdrawal of drug from the pharmaceutical market.

Through the use of Digital/social media platforms like facebook, twitter, blog spot has led people to take health related decisions. Data from such websites when mined and analysed using predictive analytical solutions would help in understanding the patient needs and accordingly this data may be applied in understanding the current market share of the product.

Pharma analytics is a science which provides data insights through reporting, descriptive, predictive and prescriptive analytical solutions. Pharma analytics helps companies to understand current trends in pharmaceutical space.

Its core components comprises of Drug discovery analytics, Supply disruption predictiveanalytics, Product failure analytics which uses predictive analysis to understand product failures, Risk analytics used in understanding the benefit vs risk how the well risk be tolerated in a study population, Social analytics to understand the actual need of the drug in the population. Pharma analytics also enhances reporting systems to ensure effective communication and adherence to regulatory compliance. The use of Business intelligence Visualization software enables better analysis of the business data.


Direct to customer selling, aggressive marketing strategies and launch of a molecules in many countries at the same time has led the MAH to highly depend on analytics for e.g. Pharma analytics is now been profusely used in the reduction of cycle time for clinical trials.

Analytical systems are designed in such a way that they are self-learning, evolving as per feedback received from end users. Lifesciences organisations are now relying on decision made using analytical tools, Pharma analytics thus promises a huge scope in the coming years.

For more information on the career in pharma data analytics, please contact info@cliniminds.com or call +91 98100 68241.

References:

Analytics

1. Analytics in Pharma and Life Sciences; Abhishek Menon, Anupam Jain; Everest group research; page 3,6,7,9

Weblink:http://www.genpact.com/docs/default-source/resource-/analytics-in-pharma-and-life-sciences

(Last accessed on 29 Dec 2017; 16:00)

2. Life Sciences

Weblink: https://www.infosys.com/data-analytics/verticals/Pages/life-sciences.aspx

(Last accessed on 29 Dec 2017; 16:15)

3. Pharmaceutical Commerce; “Global pharma market will reach $1.12 trillion in 2022”; September 26, 2016

Weblink: http://pharmaceuticalcommerce.com/business-and-finance/global-pharma-market-will-reach-1-12-trillion-2022/

(Last accessed on 29 Dec 2017; 16:15)





Tuesday, 7 November 2017

Proactive pharmacovigilance through Social media data


Adverse drug events (ADEs) are a significant cause of morbidity and mortality worldwide. Clinical drug trials have limited ability to detect all ADRs due to various reasons: small sample sizes, relatively short durations, lack of diversity among participants usually excludes specific conditions: kids, elderly, pregnant women, patients with co-morbidities. Pharmacovigilance practice has evolved and grown more complex over the past 5 to 10 years due to higher data volumes, evolving regulations, increased influence of emerging markets and the emergence of social media and innovative technological advances. Social media is a promising source for new safety data and potential emergent safety signals.

Social media may be a method by which pharmacovigilance could be strengthened given that approximately 72% of internet users search for health information online. Social media have significantly expanded recently with Twitter and Facebook now registering over 300 million and1.4 billion active users, respectively. Social media have already been utilized in different domains illustrating their potential application to pharmacovigilance. A relatively new resource that can tackle the current surveillance systems is the user posts in:

Social health networks
Microblogs (e.g. Twitter)
Disease specific communities, and etc.
Millions of health-related messages can reveal important public health issues.

There may be several example user posts in social media:
Schizophrenia (indication) Risperdal did not suit me, had tremendous weight gain and my breasts were enlarged.

 Levaquin fetched me with Achilles tendon rupture. 

Reporting may have irregularities, spelling errors, misinterpretations and grammatical errors. Extraction of information could be done by various methods including medical records, user posts, blogs and health social networking sites: DailyStrength, PatientsLikeMe, MedHelp etc. Although this kind of post on social media does not resemble a traditional adverse drug reaction (ADR) report, pharmacovigilance experts are investigating whether this type of public information on Twitter, Facebook and on patient forums or blogs, might help regulators and pharmaceutical companies monitor the safety profile of medicines. It could be utilised in potential signal detection in post marketing surveillance if handled appropriately. 

Challenges:

1) Drugs may be described by their brand names, active ingredients, colloquialisms or generic drug terms (e.g. ‘antibiotic’).

2) May be referred to using creative idiomatic expressions or terms not found within existing medical lexicons. Consumers does not always use medical terms, instead they are using phrases, their own verbatim, descriptive symptom explanations and idiomatic expressions.

3) The existence of a side effect may be clear while the specific side effect experienced remains unclear.

4) Discussion of a drug could involve indications, beneficial effects or concerns of an adverse event. For example, there may be information with respect to benefits of drug or concerns associated with adverse events that might influence selection or rejection of drugs.

5) A minority of companies also utilize social media in patient engagement for marketing purposes or for recruitment and retention within clinical trials. The latter may cause significant difficulty if the subjects enrolled use social media for communication, as it may lead to the unblinding of investigational medicinal products including the product of interest, active comparators and/or placebo. 

6) Underreporting is common but there may be pattern of reporting bias observed such as patient suffering from impotence may be less likely to post this on a social media site. Rivalry among different Marketing authorization holders (MAHs) could result into notoriety bias as a result of publicity or because the drug has recently been introduced onto the market.

7) In a social media setting, patients are likely to be reporters themselves, without any confirmation of data from HCPs. Credibility and origin of these self-generated reports are key issues. These reports are reluctantly acceptable and need confirmation. Due diligence should be conducted for patients and reporters.   

8) The large amount and variety of information obtained via social media as well as its rapidly changing nature, makes it a typical big data problem.

Technical Challenges:

1. Identification of duplicate safety information with respect to data originating from digital media.
2. Multiple languages
3. Data privacy and personal data protection issues

Advantages: 

1) Mining data from social media gives us a greater chance of capturing ADRs that a patient wouldn’t necessarily complain about to their doctor or nurse. Physician could better diagnose problems and illness but patients can better relate to adverse events and reactions. For example, a psychiatrist can’t see suicidal ideation as an ADR while a patient can describe it perfectly.” 

2) Importance sampling: Patient groups such as pregnant women and children are often excluded from clinical trials due to concerns of teratogenicity and ethical issues yet they represent active social media users. So trend of events can easily be identified by using this medium. 

3) Sponsors within the industry are utilizing social media for commercial purposes to distribute information about diseases and their treatment, medicines and company like: 

The industry — e.g., costs of medicine
Their therapy — e.g., tolerance, adverse events, side effects
Their disease or condition — which is an opportunity for R&D to identify unmet needs
A particular company — e.g., its service and reputation
Competitors — so this can be a form of competitive intelligence

4) Social media sites are increasingly being adopted by healthcare professionals and patients for the discussion of adverse experiences with licenced medicinal product.

5) Social media presents new channels and methods that can enable companies to move away from traditional PV systems and safety reporting methods towards more patient-centric models for reporting, analysing and monitoring of safety data. These channels have the capability to allow swift and open communication between companies and the consumers/patients and healthcare providers using the medicinal products, thereby helping foster transparency and build public trust.

Conclusion:

To realize fully the benefit social media have to offer, requires careful combination of each of data sources or information to generate significant signals. Appropriate use of the internet and social media can prove to be a significant catalyst in the transformation of the PV practice in the not so distant future. Traditional PV methods will certainly prevail, yet social media has the potential to become an added new-age tool to monitor data in real-time, making it an early indicator of potential safety issues for further investigation. Further, this would enable companies to generate more robust product safety profiles by leveraging the additional social media information.

References: 

1. Utilizing social media data for pharmacovigilance: A review Accessed from http://www.sciencedirect.com/science/article/pii/S1532046415000362on 28-DEC-2015.

2. Searching social networks to detect adverse reactions Accessed from http://www.pharmaceutical-journal.com/news-and-analysis/features/searching-social-networks-to-detect-adverse-reactions/20067624.article on 29-DEC-2015.

3. Social media and pharmacovigilance: A review of the opportunities and challenges Accessed from 
http://www.researchgate.net/publication/279807301_Social_media_and_pharmacovigilance_A_review_of_the_opportunities_and_challenges on 01-DEC-2015.