Why Is Pediatric Clinical Research So Challenging?

Paediatric clinical research is a research done for finding effective treatments for ailments in children. Children are very different from adults, and they need different kinds of treatments and medications. However, while on one hand, there is clinical research done for every medication produced for adults before it comes into the market, almost 50-90% of medicines for children haven’t been tested for safety and efficacy! Isn't that very shocking and unbelievable?

Smart Clinical Trials Designed With Cutting Edge Technology - ACRI India

Technology has made its mark everywhere. All across the globe, newer innovations are coming up every day to make life easy, fast, and comfortable for today’s people. And, in the process, the field of clinical research is not left anywhere behind. Technological innovations in the clinical research space have given rise to amazing developments in the drug development arena. Four “smart” clinical trial programs have been developed that have brought about significant results for the medical field, involving both medical practitioners and patients.

Enhance Your Competencies With Courses Offered In Clinical Research

The clinical research industry is expanding at a rapid pace, making it an industry worth billions of dollars. With such expansion, there are amazing opportunities for professionals in this field to explore their career options and move ahead. However, simply to enter into this field, it takes a lot! You need apt certification from a reputed institution along with professionalism and complete knowledge about the industry. To help students gain all of this, many top clinicalresearch institutes in Bangalore are offering various courses to render suitable competencies for effective handling of clinical research.

The Importance Of Clinical Trials - ACRI

“Clinical research is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.” This is the definition of clinical research by the World Health Organization. In simpler words, clinical research is the study wherein individuals, maybe patients or healthy volunteers, participate to have a new medication or treatment experimented on them to determine whether it works, and to what extent.

How Can Artificial Intelligence Transform The Clinical Trial Arena? - ACRI

The clinical trial field is already very challenging with researches being made over new ailments and improvements on old medications. So, anything done to overcome these challenges could be of great help. And, artificial intelligence (AI) is one such element, which when combined with Big Data, holds the potential to resolve many such challenges.

The combination can increase trial efficiency through better protocol design, patient enrolment, patient retention, etc. Anyways, sponsors are looking for ways to accelerate timeliness and reduce costs because clinical trials account for 40% of the entire research budget; and AI can help with such cost-effectiveness and efficiency. This is possible with data-driven protocols and strategies that are powered by advanced AI algorithms processing the data collected from mobile apps, electronic records, mobile sensors, and other such sources. Data quality is improved, while increasing patient retention and compliance; thus allowing effective and reliable treatment more than ever before. Obviously, newer challenges are presented with these new elements, but on the whole, the entire process becomes cost-effective, hassle-free, and reliable.

Even so, AI has the capability to transform clinical trials by uncovering new therapeutic options in masses of data that can't be found by humans. This transformation begins with protocol development, reducing or replacing outcome assessments, and utilizing remote connected technologies that reduce the need for patients to travel long distances for site visits. Furthermore, masses of real world data can be included into protocol designs, unlike in the case with traditional processes. Objective data from sensors and mobile devices captured in real time data from individuals carrying out their normal activities can capture more meaningful clinically relevant insights. Such real-time real-world data with wearable devices can produce consistent and objective evidence of actual disease states and can impact drug efficacy on disease symptoms, unlike in the case of verbal or written evidence from patients at clinical visits and clinic observations. With wearable devices, a wide range of signals can be captured like heart rate, blood pressure, activity/inactivity throughout the day, which isn't possible through human assessment. Thus, with AI, much richer and more detailed amounts of data can be collected!

With all of this happening remotely, patients can comfortably be at home without having to travel long distances to the clinic frequently. This ultimately reduces the burden on patients, lowers site costs, and improves the quality of patient retention. In fact, patients can also send feedback on treatment symptoms and manage medication intake, and share information with researchers easily right from home. All of this thus affects patient retention.

All-in-all, Artificial Intelligence when incorporated into clinical trials can generate new insights into disease processes that can open up new treatment opportunities. It also brings potential of personalized medication by identifying patient responses to treatments; thus reducing the risk of drug development by creating predictive models that are much more powerful.

Just like Artificial Intelligence has made its mark in the clinical research industry to help patients test and report from home, AvignaClinical Research Institute has also innovatively developed its educational system to help students learn and attain professional education from the comfort of their home! With its self-designed online courses that are led by professional teachers, students can learn from anywhere and at anytime without disturbing their current jobs and responsibilities, and attain a valid and legitimate post graduate diploma inclinical research Bangalore.

Suggested Topics: Clinical Research Trends Of 2018, Clinical Trials Are Important To Improve Medical Care, Why Participating In A Clinical Trial Is A Good Thing, Different Types Of Clinical Research

Clinical Research Trends Of 2018 - Avigna Clinical Research Institute (ACRI)

Clinical research has found its way in the medical profession since decades, and is only increasing with leaps and bounds. But, with the advancement in technologies, the costs associated with such trials are also increasing. Thus, it is important that steps are taken to lower these costs so that the prices are affordable for healthcare providers. Companies are therefore needed to optimize value and curb expenditure by streamlining research and development. To control these costs, there have come up some latest trends in the clinical research field this year. So, let us take a look.

Recent Updates That Will Attract New Trials In India

The DCGI (Drug Controller General of India), who is responsible for the approval of licenses of specified categories of drugs, and lays down the standard and quality of manufacturing, selling, import, and distribution of drugs, has brought forward a few changes in the clinical trials rules and regulations, which are sure to attract more and more new trials in India. The alterations and updates made are stated below.

• The turnaround time for approvals of all global clinical trials has been given a deadline of 180 days.
• Instead of just one New Drug Advisory Committee, the approval of new drug clinical trials will be decided upon by the Subject Expert Committee, after which the recommendations will be reviewed by the Technical Review Committee. Finally, it is the Central Drugs Standard Control Organization that will grant approval. This entire procedure will thus decrease the turnaround time of clinical trial approval.
• The Investigator will undertake a maximum of three trials to ensure more accountability and the least possible chances of negligence in clinical trials.
• All individuals subject to trials will be provided with primary care for any kind of illness they experience during their trial participation.
• The last update has been revised over the compensation for trial related injuries, and an order has been released confirming the compensation for trial related injuries or death to be paid to the trial subject or nominee.
• The Phase-I clinical trial is exempted for medical devices, but the procedure for clinical trial approval, accreditations of investigators, ethics committee, sites, and other conditions will remain the same.
• Academic studies will be conducted after approval by the Institutional Ethics Committee, but any new drug or the new usage of an existing drug will require approval of the Drug Controller General of India.
• Any generics of biosimilars that have been marketed in the USA for more than 4 years and have a satisfactory report would be approved for marketing in India after short trials.
• Clinical trial for new drugs that are already approved in other countries can be waived in India if it is for extreme urgency, extreme diseases, or national emergency.
• It two or more countries have removed a drug from the market on the grounds of safety and efficacy, then the continued marketing of the drug in India will be subject to examination and action.
• The SEC will review all the factors that are responsible for deciding if they are ethnically sensitive or insensitive, before giving any clinical trials approval.
• The Central Drugs Standard Control Organization considered that there should be an existing therapy to compare the test drug related to placebo control, to ensure that it is appropriate, efficient, and ethical.
• If the Indian population is participating in global clinical trials, for an indication that is prevalent in India, the sponsor or innovator should market the NCE in an expedited way by manufacturing. This should be confirmed in the form of an application submission.
• The Central Drugs Standard Control Organization requires post-marketing surveillance of drugs, rational use of drugs, adverse drug reactions monitoring, and drug utilization studies, for which is will work with the Indian Council of Medical Research to sponsor the related studies.

With all of these alterations made in the rules and regulations of Indian clinical trial procedures, the country will definitely see a rise in the number of clinical trials being performed here. And with this rise, there will also be a rise in the career opportunities for clinical trial professionals. Join the league and get yourself enrolled with Avigna Clinical Research Institute, one of the top clinical research institutes in Bangalore, which will provide you with the best quality training, along with 100% placement guarantee in the best CROs, pharmaceuticals, and Biotech companies.

Suggested Tags: Why Do People Join Clinical Trails, Why and How Should You Learn Clinical Research, The Past and Present of Clinical Research, What Are The Career Prospects Of Clinical Research In India

What Is Medical Excellence?

The practice of medicine has changed in a huge manner since the past few years. Some of these practices have resulted in great results, while others haven’t matched up to the patients’ expectations. Thus, we need to understand why some practices succeed, while the others fail. There is a divide between reasonable intentions and the reality.

The medical industry has its own set of rules and regulations; and it is important for us all to abide by all these rules and laws. This is a very well-known fact. It is believed that when rules and regulations are followed, it leads to excellence. But, this is not always the case! Now, this statement may have got you into confusion. How can following rules not lead to excellence? When rules are followed, everything is standardized, thus in turn, leading to brilliance, isn't it so? On a general note, yes. But, always, no! Let us explain.

Which Soft Skills Do You Need In A Clinical Research Career?

Clinical research professionals definitely need a legitimate certificate of diploma in clinicalresearch Bangalore from a reputed institution like Avigna Clinical Research Institute. But, along with this, there are certain soft skills that are important in the industry too. And, when you get to learn the course along with getting training for soft skills in the same institute, there can be nothing better! In this blog, we state the most important soft skills that are needed to not only get a job, but sustain it.

Genuineness and consistency

Not only in clinical research, but in every industry, genuineness and consistency is important. If you want all your teammates – juniors, colleagues, and seniors – to greet you with a genuine smile, you need to have these qualities. And, only when you have these qualities within you, can you inspire others to be genuine to you too.

Learning and teaching

Any organization works only because of a team. And, when you work in a team, there are many things that you have to teach those who don’t know how to execute something. Similarly, there may be some things that you may not know. So, while you teach others how to do something, don’t hesitate to learn from others too. Learning and teaching are not only parts of professional life, but personal life too.

Adaptability

Just like everything else, the clinical research industry is also constantly changing, and to sustain oneself in this changing environment, it is important that one can adapt to these changes. And, these changes include changes in the government regulations, changes within the department you work in, changes within your project, or change of your roles and responsibilities. Change is hard, but crucial too.

Collaboration

You must be willing to collaborate with all those who work within the organization, or at least on the project you are working on. The more cooperative you are, the more respect you will earn. The more cooperation within the organization, the more successful it will be.

Consciousness

Consciousness about what you say or do is very important. Clinical research is a very demanding, difficult, and delicate industry. You need to be in complete control and think about what you are saying or doing at every point of time.

Attentiveness

Clinical research is a very intricate industry, where attention to every detail is very crucial. Every detail is very important. Every word said in a meeting, every word written in a report, every detail mentioned by a patient – everything is important.

Listening skills

Listening is absolutely important. Try to give your feedback only after listening to all that the others have to say. This will help you understand what people are saying, and will also give you enough space and respect to speak when it is your turn.

Motivation

Clinical research is a very challenging field. When you face really difficult challenges, don’t get afraid or uncomfortable. Keep your motivation alive, as it is only your passion and motivation that will take you through it.

Planning

Meticulous planning at every stage is important. Put in your efforts to plan your tasks and try to put up convincing and acceptable tasks for others too. As a team, everything needs to be planned as per the time to achieve successful outcomes.

Management

Managing everything that is under your responsibility is important. One mistake in clinical research, and everything can be a mess! So, be very careful with how everything is managed and kept on schedule.

Technology savvy

The clinical research industry is becoming more and more advanced, and is adapting to latest technologies. Thus, you must also be capable of adapting to all the technologies as and when required. Without this, you won't be able to achieve anything in this tech-savvy world.

These are just some of the most important soft skills you need to possess. For understanding and being able to acquire all the required soft skills, you must get enrolled with an institution that can help you with the required training, along with courses for diploma inclinical research Bangalore.

Clinical Trials Are Important To Improve Medical Care

Clinical trials help to explore new medicines and medical equipment to treat various kinds of old and new ailments. They test the safety and efficacy of the drugs and equipment, and prove the best treatment for certain diseases, disorders, and illnesses. Following strict scientific standards to protect patients and help produce dependable study results, they produce the most reliable data available for health care decision makings.

The procedure involved in a clinical trial is long, and a very cautious one. It begins with a laboratory procedure where scientists and technologists first develop and test new ideas. If the development seems appropriate and hopeful, it goes on to the next step of animal testing. The drugs are tested upon animals to check for how the approach affects a living body, and to determine if the approach is safe, or involves any risks. However, this does not prove that the approach is safe and effective for human beings too. Yes, it definitely eliminates the usage of the medication and procedures for humans, if the animal testing proves unsuccessful or risky. But, if the animal testing goes well, the next step involves testing the same approach on humans.

The Role Of A Clinical Data Manager

Every clinical trial generates abundant amounts of data like patient reports, medical history, age, gender, consent forms, laboratory notes, trial design, dose regimen, transcriptions copies, and much more. With such immense of data, and each piece being so important, it is highly crucial for all this data to be completely organized. Databases that are specially designed for the particular set of trials are used to achieve this.

The data is entered into the database and stored in a rows and columns format, after which it is checked for any discrepancies, which are then corrected. This data is then analyzed using statistical analysis methods before being presented to the concerned authorities. This entire process of data collection, integration, and validation is collectively known as clinical data management; and the person responsible to execute this role is known as clinical data manager.

Is Clinical Research A Curse Or Blessing?

Clinical research involves experiments conducted on human beings to evaluate the efficacy and safety of new drugs, new drug delivery systems, and medical devices. Because of the vast geographical and biological diversity, lower trial costs, faster recruitment rate, and a large number of patient population, India has become a hub for conducting clinical trials. Every year large pharmaceutical companies are coming up with newer elements that help to develop better, safer, and more effective drugs in the market. And, to make sure that these drugs are not only useful, but also safe, it is vital to test the same on a group of humans first, before putting out the drug into the market. The human body is unique, and no computer generated model or animal can accurately determine the effect of drugs on humans. This is why it is imperative to check the effect of drugs on humans. But, there are many who consider such experimenting and research as a wrong doing.

What Has Helped Attract New Clinical Trials In India?

The Drug Controller General of India (DCGI), along with the Central Drugs Standard Control Organization (CDSCO), is responsible for the approval of licenses of specialized categories of drugs in India, which include blood products, vaccines, IV fluids, and sera. It is the DCGI who lays down the standards and quality of manufacturing, selling, importing, and distributing drugs in India.

For a long time, India has been out of the list for sponsors to invest in conducting clinical trials in India because of lots of uncertainties and losses. But, the changes brought to the guidelines and standards of drug manufacturing, importing, and selling in India by the DCGI recently has helped India again gain momentum for clinical trials. Here are the recent updates by DCGI that have helped attract new clinical trials in the country.