Clinical Trial Protocols and their relevance to trials

Advancements in medical and new research are crucial to the well-being of the human population today. Those who suffer from health problems can expect to benefit from new advancements in science in the long run. To ensure an orderly process of research which facilitates new discoveries, we take the help of clinical trial protocols.

It is always a highly desired situation in which the clinical managers have access to the clinical trial protocol. This is a highly important piece of paper that has the entire game plan of the clinical trial research. Each and every trial is based on the protocols and the prescriptions therein.

Protocol takes up the task of outlining what are the goals and objectives of the clinical trial. The whole endeavour and what its underlying principles are reiterated in the protocol. The data generated during the clinical trial is also managed as per the stipulations of this protocol. Lots of information will be generated during the course of the trial and the retention of the same shall be done under the guidance of a protocol document. The use of the data generated is done under a basic formula provided by the protocol.

There are several other points that are not included in the protocol document. These can be available in another document which can be a brochure or a record that maintains all the details of the clinical trial.

The whole reason for having a protocol in clinical trials is to safeguard the well-being of the participants. The venture is to find permanent stable solutions to the health problems of individuals rather than jeopardizing their lives. Also, it must be taken care of that the participants are not forced into circumstances that will give them a low self-esteem.

The protocols can also lay down guideposts that will help the managers of the trial in executing the design. The protocol can be the decisive factor in choosing the qualifications of the participants in the trial.

  Conducting clinical trials involves certain tasks and responsibilities. There is little room for error as much is at stake. The protocol initiates the project and sustains the long-term effectiveness of the trial. Clinical trials plays an important role in Indian CRO as a part of Clinical Research. 

CROs and what it’s like working for them

In a simple frame of mind, lab based careers can be split up into options like academic research or work in industrial sector. Either of the two options, particularly the second one can encompasses a broad spectrum of roles and goals. Working in the industry does not mean you have to be employees of Glaxo or Pfizer. You can alternately work for Contract Research organizations that take part in a host of phase-1 clinical trials according to Elisabeth Allen.

Allen designs phase-1 clinical research for a living. The contract research organization she works for, Quintiles, partners with big pharma companies to hasten up the drug development process. In her estimate, a typical drug costs about nine hundred pounds to go through the developmental phases which can take up to 10-12 years. With sky rocketing costs and more stringent regulations, chunks of developmental work is increasingly being outsourced to contractors. This is where the role of CROs comes into play.

A CRO is an independent research organization that steps into the developmental process after a pharma company makes the discovery of a new molecule that holds promise. Some CROs are Quintiles, Covance, Icon, and HMR. Typically, it’s a CRO that organizes research into the effect of the new molecule on humans. In most cases, a CRO will organize and conduct clinical trials to test the effects of the new molecule on humans. 

As independent entities they facilitate an objective assessment of the new drug in clinical setting and because they have liaison with pharma companies, they offer a much broader scope of study of the effects of the drug on human subjects. If the pharma companies had themselves conducted these trials, it would have been very limited in scope because the limitations imposed by limited functionality of these companies. Elisabeth Allen describes her role as highly rewarding and playing a key part in improving the lives of many people for whom the new drug is researched into existence. Working for an Indian CRO is a job of high responsibility as it involves the lives of thousands of people.  

Bioequivalence

A similarity between two drugs that implies that they both will have the same effect on a patient is called bioequivalence. Bioequivalence implies that two drugs release their active component in the bloodstream in the same quantities in the same rate. When evaluating how good a generic drug works it bioequivalence is compared to the name-brand version.

For a generic drug to obtain the U.S. food and drug administration’s stamp of approval, the manufacturer of the new drug must prove that it is bioequivalent to the branded version. FDA approval before marketing or selling a different version of a branded drug is necessary too. For example it must be proved that a once-a –week tablet is bioequivalent to a daily tablet. Apart from this, depending upon how the drug is taken, i.e. as a pill, injection, patch, inhaler or through another method, the regulatory authority has its own standards in bioequivalence. If a generic drug is not bioequivalent to a name-brand drug then it cannot be used as a substitute for it but rather approved for a different use.

The generic drugs need not undergo the various clinical trials the established brand drug has to. This is because the generic drug has to be only bioequivalent. The company seeking approval to market the generic drug has only to test it against the name-brand drug on two small groups of test subjects, extract timed blood samples from each patient and show through statistical study that any difference in the drug’s bioavailability in participants taking the brand name version versus participants taking the generic version is not clinically substantial.

It is simpler to make a bioequivalent variant of a traditional pill or injectable drug than to make a bioequivalent form of a biologic drug. As a result the generic version of the biologic drugs called “Biosimilars” will have to undergo clinical trials to obtain approval. These bioequivalence services are offered by all the leading CRO company in India.         

History of Antibiotics

The history of antibiotics is classifiable in two segments: Early history and modern history. A landmark in the history of antibiotics is the discovery of penicillin by Alexander Fleming.

Antibiotics

 An introduction

Infections are very common to human life and cause significant number of diseases that have an adverse effect on human health. Most of the diseases caused by bacterial can be prevented, managed and treated with the help of a group of compounds with the collective name: Antibiotics. 

Definition

Antibiotics can be roughly defined as the variety of substances derived from bacterial sources (microorganisms) that have the ability to control the growth of or kill other bacteria. However, synthetic chemicals that are related to the natural antibiotics also have a similar effect on microbial growth making antibiotics an industry in it.

There are many types of antibiotics namely, antibacterials, anti-virals, antifungals, anti-parasitics. Some of the antibiotics have an effect on a wide range of microorganisms and are thus called broad-spectrum antibiotics while there are some that are effective against a very few microorganisms, which are called narrow spectrum antibiotics. The most frequently used antibiotic is anti-bacterial.

This is sort of familiar as kids receive ampicillin for an ear infection or penicillin for strep throat. Antibiotics have saved many human lives over the last few decades. Major illnesses that once killed thousands of people especially youngsters, have now been eradicated in many parts of the world by the use of vaccinations. The discovery of anti-microbial drugs was one of the main medical discoveries of 20^th century. With the discovery of the effect of these drugs on harmful bacteria, it became possible to combat infections of a wide variety.

With the discovery of Penicillin dawned the era of anti-biotics, which provided a powerfully ally to the body’s inbuilt defences.  In 1920s British scientist Alexander Fleming discovered Penicilin by accident when working in his lab of St Mary’s hospital in London,  he observed that colonies of the commonly occurring Staphylococcus aureus bacteria had been killed by mold growing on the same petri-dish. Fleming named this mould Penicillin. The substance released by this mould could dissolve bacteria effectively and so Fleming and other conducted a wide range of tests that showed the ability of penicillin to kill infectious bacteria. Over some time, researchers in Europe and United states began to conduct various tests of their own and developed and perfected many antibiotics that were successfully tested on animals and then humans.

Around 1941, it was widely realized that even miniscule quantities of antibiotics were able to cure serious infections. Fleming was awarded the Nobel Prize for his contribution to Physiology and Medicine.

Indian CRO & CRO in India deals in the clinical research of all the components related to pharmaceutical company and help us to acquire a better product.