ICMR Makes Ethical Guidelines for Biomedical Research Mandatory - ACRI India

The Indian Council of Medical Research (ICMR) has issued certain National Ethical Guidelines for Biomedical Research, which has now become mandatory. Every biomedical research in the country needs to adhere to these guidelines, as per the New Drugs and Clinical Trials Rules 2019. These new rules had been recently released by the Ministry of Health and Family Welfare, Government of India.

Clinical Trial Monitoring – What Is It?

Clinical trial monitoring checks on the safety, rights, and well-being of clinical trial subjects to ensure that they are protected. It also checks for the data coming out of a clinical trial to be accurate and credible. This kind of monitoring is carried out by a sponsor representatve, like the Clinical Research Associate (CRA) by visiting a clinical trial site in person at regular intervals, where the sponsors study is being conducted. Along with other duties andresponsibilities of a CRA , there is a lot that the CRA has to do to conduct a clinical trial monitoring.

Clinical Trials – Compensation Rule To Be Modified - ACRI India

Stringent rules are followed in every country for conducting clinical trials, with every country forming their own individual rules. While strictness is good and important, it could prove disadvantageous if extended above a certain level. This is what happened in the case of the clinical trials rules drafted by the Government of India.

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?

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.

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.

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.