A Roadmap to Clinical Trial Efficiency

This article will discuss the process and roadmap needed for optimizing clinical study and trial and review why and how are the Trials being performed.

Clinical study is a research which involves human volunteers, also called as participants, with an intention to add to the medical knowledge.

Mainly there are two types of clinical studies, namely: Clinical Trial (aka Interventional Study) and Observational Study.

Clinical studies are the experimental studies to determine a better treatment of a particular disease. They are designed to answer specific scientific questions like:

• What side effects do the drug have?
• Does it reverses or stops the disease for which it is designed to heal?
• Are the outcomes effective than existing treatments?
• Can it be given along with the drug which is already being given for the same disease?

The answer to every question above must come in the form of scientific data and not in the form of opinions or the impressions of the scientists, doctors or patients involved with the studies.

The results can be enclosed by many factors and can be affected by bias. It is to be made sure this does not happen.

What is a Clinical Trial?

Clinical Trials are clinical studies for exploring a medical strategy, devices or a treatment, which is safe as well as effective for humans.

Also called as interventional study, clinical trial is a clinical study where participants are assigned to receive one or more inventions or  sometimes no inventions at all, for the researchers to evaluate intervention's effect on health related outcomes. For certain illness in humans or a particular group of people, these studies help to find out which medical approach will work better to their cure.

What is a Clinical Trial Intended for?

The main purpose of performing a clinical trial is nothing but a research and so strict scientific standards are followed . These standards are required to be maintained for the protection of patients and generate study results which are reliable.

How are the Clinical Trial Approved?

Before starting a Clinical Trial, the protocol or the plant of the trial is approved by an independent and unbiased group of researchers who are not going to e involved in the trials, which is called an independent scientific review.

The trial protocol is reviewed by National Research Ethics Service, which is a Research Ethics Committee. The aim is to be concerned with the rights, safety, dignity and well-being of the patients taking part in trials. This committee is made up of 7 and 18 volunteers.

The researchers are bound with the protocol they proposed at the beginning of the trial. they cannot change the protocol without approval from ethics committee. They have to report to the ethics committee in case of any happening of serious side effects in-between trial. The committee receive reports at the end of clinical trial.

How is the Clinical Trial Performed?

The process of a clinical trial begins in the laboratory. The scientists develop and test the ideas regarding the tests. Clinical trials are performed as a part of one of the final stages of a lengthy and carefully performed research procedure.

If the basic idea of clinical research is worth promising, animal testing is performed as the next step.

• Why are animals used for clinical testing?

           Using animals for clinical tests is because there is a need to find out what happens to a living              body. Replacing animals with any other alternative method of testing samples is not yet                        discovered. As the basic cell formations of animals are similar and human's body performs                  same tasks of movement, breathing, hearing, digestion, sight and reproduction, it is likely to                perform tests on them rather experimenting them on humans first. Before testing ideas on                    humans, animals such as rats are used for sampling.

• What does the animal testing indicate?

          It shows that how the biomedical approach will affect a living body and whether it is harmful               or not.

However, it may be possible that the approaches working well in labs or on animals are not necessary to show exact results in case of humans. Hence, it  is required to perform tests on humans.

As a safety measure, clinical trials are performed on a small group of people on initial stage and it is found out whether it affects or harms humans or not. The later phases of clinical trials involve larger amount of humans on which the study is focused.

      Clinical Research Coordinator : Educational Requirements and Career Options Transcript

Are you a whiz when it comes to organization and planning? Consider a career as a clinical research coordinator. These professionals manage medical and scientific research projects that investigate new medicines, therapies and treatments. A bachelor's degree in a scientific field and professional certification are required for most positions. Armed with these credentials you can also pursue positions as a clinical data management professional or a clinical research assistant.

Introduction

Clinical research studies have been responsible for groundbreaking advances like cancer-fighting chemotherapy drugs and the polio vaccine. Organizing a clinical research study requires meticulous planning and attention to detail. Duties include recruiting test subjects, scheduling appointments, collecting data and more. A bachelor's degree in Chemistry, Biology or a related field is needed along with a professional certification.

Job Duties and Skills

Testing a new medical treatment or prescription drug requires the combined efforts of many health care professionals. Clinical research coordinators are the professionals who oversee this daunting task.

Clinical research coordinators begin by finding test subjects and securing a test site, usually in a hospital, clinic or lab. During testing, the coordinator must assist with the testing process, provide medications, and answer questions from testers and subjects. After completion of the study, the coordinator is responsible for working with data management professionals to organize the data for analysis and report.

Clinical research coordinators must be organized and able to focus on many small tasks without losing sight of the big picture. Attention to detail is essential, as even the slightest error can contaminate test results. Excellent communication skills are also needed to work with doctors, nurses, research scientists, and the other professionals involved with a clinical research study.

Training Required

Employers look for candidates who have completed at least a bachelor's degree in a scientific field, such as biology, chemistry or biomedical engineering. These programs include coursework in mathematics and the sciences, as well as analytical research and laboratory skills. However, due to the administrative demands of the profession, employers also look for research and teaching experience. Many students gain these experiences in a master's degree program.

Professional certification is required for many positions. The Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SoCRA) both offer clinical research coordinator certifications. These certifications require periodic renewal through continuing education courses. Associate's and professional certificate programs exist to help scientific professionals prepare for the licensing examination. Such programs normally take six months to a year to complete and include coursework focusing on health care legislation, research guidelines and methodologies and medical terminology.

Career Options

Clinical research coordinators are typically employed by research hospitals, universities, pharmaceutical manufacturers and other health care organizations. Many employers look to promote clinical research coordinators to management positions because of the unique blend of scientific, technical and administrative skills that they possess. However, most opportunities for advancement will require a master's degree and some employers may require a doctoral degree.

Clinical research coordinators do not necessarily need to work in medical research. Other opportunities exist in industrial, chemical and technological research companies as well. Depending on their scientific and technical backgrounds, clinical research coordinators may find positions managing research laboratories or coordinating the efforts of teams of research scientists in a variety of industries with far reaching applications.

With their strong scientific background, research coordinators may work as research assistants or research technicians. Due to growing interests in medical research and increased need for new medicines, positions in government regulatory agencies like the Food and Drug Administration (FDA) will also be available.

Adverse Event Reporting

The activity that is most commonly associated with Pharmacovigilance (PV), and which consumes a significant amount of resources for drug regulatory authorities (or similar government agencies) and drug safety departments in pharmaceutical companies, is that of adverse event reporting. Adverse event (AE) reporting involves the receipt, triage, data entering, assessment, distribution, reporting (if appropriate), and archiving of AE data and documentation. The source of AE reports may include: spontaneous reports from healthcare professionals or patients (or other intermediaries); solicited reports from patient support programs; reports from clinical or post-marketing studies; reports from literature sources; reports from the media (including social media and websites); and reports reported to drug regulatory authorities themselves. For pharmaceutical companies, AE reporting is a regulatory requirement in most countries. AE reporting also provides data to these companies and drug regulatory authorities that play a key role in assessing the risk-benefit profile of a given drug. The following are several facets of AE reporting:

Origin of pharmacovigilance

A new breakthrough in this field only happened after an episode occurring in 1937. In that year, Sulfanilamide (Prontosil), used since 1932 for treatment of streptococcal infections, was launched as a syrup, containing diethyleneglycol as solvent. Although tested regarding aspect, taste and odor, its safety was not evaluated before launching. It was responsible for the death of 105 individuals (34 children and 71 adults) and diethyleneglycol was incriminated. This tragedy caused the American Congress to approve in 1938 the Food Drug and Cosmetic Act, under which pharmaceutical product manufacturers would have to show scientific evidences of the safety of the drugs before releasing themfor sale.

The thalidomide tragedy is a milestone in the origin and development of pharmacovigilance. Thalidomide was introduced in 1957 and widely prescribed as an allegedly harmless treatment for morning sickness and nausea. It was tested in approximately 300 patients without toxicity. It was soon linked to a congenital abnormality phocomelia, which caused severe birth defects in children of women who had been prescribed this medicine during pregnancy. In 1962, after reports of numerous cases of phocomelia, it was discontinued. In the same year, the Kefauver-Harris amendment was approved, requiring scientific evidences of efficacy and safety before drug tests in humans. ^[2] 

As a means of pooling existing data on ADRs, WHO's Programme for International Drug Monitoring was started in 1968. Initially a pilot project in 10 countries with established national reporting systems for ADRs, the network has since expanded significantly as more countries worldwide developed national pharmacovigilance centers for the recording of ADRs. Currently, 86 countries participate in the programme, which is coordinated by WHO together with its collaborating centre in Uppsala, Sweden. The collaborating center is responsible for maintaining the global ADR database, Vigibase. At present the database contains more than four million ADR reports

History of pharmacovigilance in India

The origin of pharmacovigilance in India goes back to 1986, when a formal adverse drug reaction (ADR) monitoring system consisting of 12 regional centers, each covering a population of 50 million, was proposed for India. However, nothing much happened until a decade later when in 1997, India joined the WHO Adverse Drug Reaction Monitoring Program me based in Uppsala, Sweden. This attempt was unsuccessful and hence, from 1January 2005, the WHO-sponsored and World Bank-funded National Pharmacovigilance Program for India was made operational. 
The National Pharmacovigilance Program established in January 2005, was to be overseen by the National Pharmacovigilance Advisory Committee based in the Central Drugs Standard Control Organization (CDSCO), New Delhi. Two zonal centers-the South-West zonal center (located in the Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai) and the North-East zonal center (located in the Department of Pharmacology, AIIMS, New Delhi), were to collate information from all over the country and send it to the Committee as well as to the Uppsala monitoring center in Sweden. Three regional centers would report to the Mumbai center and two to the New Delhi one. Each regional center in turn would have several peripheral centers reporting to it. Presently there are 26 peripheral centers. The program has three broad objectives: the short-term objective is to foster a reporting culture, the intermediate objective is to involve a large number of healthcare professionals in the system in information dissemination and the long-term objective is for the program to be a benchmark for global drug monitoring.

Given this background on pharmacovigilance in India to date, things have definitely changed for the better but at a very slow pace. The Regulatory Authority for India should be commended for introducing and implementing the Schedule Y and for reporting of all serious adverse events (SAEs) including suspected unexpected serious adverse reactions (SUSARS) from clinical trials. However, there is a need of spontaneous adverse event reporting from post-marketed medicines to the zonal centers and in turn to the National Pharmacovigilance Centers to the WHO Uppsala Monitoring Center, which at the moment is woefully lacking. Therefore, in these circumstances, the questions that arise are whether the strategy should be changed and if so, how?

Ethical issue in Clinical Research

History of Clinical Research