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

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

Url: http://ucalgary.ca/utoday/issue/2018-05-16

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 21^st May 2018. Enrol now to avail 10% discount. For more information contact us at 9910068241, 9560665441, 9560102587or email us at info@cliniminds.com

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/ )

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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.

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/ )

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European Medical Agency to increase fees upto 1.7 %

There would be an increase in fees upto 1.7 % from April 1^st 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

http://www.ema.europa.eu/docs/en_GB/document_library/Other/2018/03/WC500246428.pdf

2.       COMMISSION REGULATION (EU) 2018/471 of 21 March 2018

http://www.ema.europa.eu/docs/en_GB/document_library/Other/2018/03/WC500246427.pdf

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

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.

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

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

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

Seminar on Pharma Data / Business Analytics & Career Opportunities

On Sunday, 7^th 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.

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)