Clinical Trials Awareness – Spread the word in India

Clinical Trials Awareness – Spread the word in India,

International Clinical Trials Day, 20 May 2015

You feel lucky when you take medicines when you are suffering from any medical illness. Or even you feel better when you take biological products like vaccine to prevent major illness diseases. But wait a moment when was your last thought that how medicines are made and available in markets? What did you think how much efforts and care are being taking for any drug development process. Before any drug approvals, it has to pass several phases of clinical trials which are part of drug development and in these phases volunteers are required to participate in clinical trials. So in that case “without volunteers there are no cures

I ask everyone to take moment to thank thousands of volunteer participants that have contributed to the advancement of medical science. These heroes are the reason for life saving or life enhancing medicines which are available in market. It calls to mind that we all owe an enormous debt of gratitude to participating patients and their families. We all are beneficiaries to drug development process. There is so much that goes into R &D well before you even get to clinical trials.

From the 7000 to 10,000 molecules looked at as being potentially useful as a new medicine, only one ever makes it all the way for patient use. Clinical trials are carefully designed to test the benefits and risks of specific medical treatment or intervention, such as new drug or any behavior change like in your diet or thinking process.

On this day (international clinical trials day), I feel it is an ideal time to raise awareness about the importance of clinical trial participation and recognize the individuals who have made new, innovative treatments a reality for patients worldwide. There are lots of misperceptions about clinical trials in India, and I hope that on this day it will provide an opportunity to learn more facts about clinical trials. India was the hub of clinical trials it also means that Indian population are the ones who receives the latest medical treatment and advance medical technologies among the world. India is still hub of clinical trials if we asked to forget some unethical issues over the last 3 years. Beyond that regulatory and laws are strengthen to conduct clinical trials and prevent unethical moves.  However another consideration when thinking about the drug testing and approval process is that clinical trials have become more complex. During the last 10 years clinical trials design and procedures have become increasingly complicated, demanding more attention and effort with the unintended effect of discouraging patient enrollment and retention.

There are many common myths were created for clinical trials but facts should be know eventually. I am directing several myths over clinical trials in India.

·         Clinical trials volunteers are merely human guinea pigs

 

Strict guidelines are in place to ensure that you and all other clinical trial volunteers are treated fairly and ethically.  Before an investigational drug can be given to people who volunteer to participate in clinical trials, scientists must complete a rigorous screening and preclinical testing process, which can take up to six years to complete. Additionally, every clinical trial also has a thorough informed consent process to help you understand your rights as a participant, including the right to leave the trial at any time if you change your mind about wanting to participate.
·         Clinical trials are dangerous because they use new medicines and practices.

 

Clinical trials are designed for research purposes, and as a result, some level of risk is involved. However, investigational drugs are given to clinical trial participants only after the drugs have gone through a rigorous testing process and scientific evidence indicates that the drug is likely to be effective and safe for use in humans. In addition, keeping you safe when you volunteer to participate in a clinical trial is a top priority for everyone involved in the trial. For example, all clinical trials are reviewed before they start by an institutional ethics committee (IEC), a committee made up of doctors, scientists and community members who have the responsibility to protect clinical trial participants.  The purpose of IEC review is to ensure both before and during the trial that appropriate steps are taken to protect your rights and safety. During the clinical trial, researchers frequently and rigorously assess and monitor participants’ safety. These are just some of the ways in which your safety and well-being are prioritized before a clinical trial begins and throughout the trial process.
·         Informed consent is just reading and signing a piece of paper

 

Informed consent for a clinical trial involves much more than just reading and signing a piece of paper. Rather, it involves two essential parts: a document and a process. The informed consent document includes all the information you will need to help make a decision about taking part in the clinical trial, including all the known information about the safety and potential efficacy of the investigational drug being studied in the trial.  The informed consent document also describes the purpose of the clinical trial, explains the visits and procedures to be done, and includes the possible risks and benefits of participating in a way that is easy to understand.  The informed consent process provides you with ongoing explanations that will help you make educated decisions about whether to begin or continue participating in a trial. Researchers and health professionals know that a written document alone may not ensure that you fully understand what participation means. Thus, informed consent is an ongoing, interactive discussion, rather than a one-time informational session. 
·         If I join clinical trial, I might get a sugar pill or placebo instead of real drug.

 

A placebo is a product that looks exactly like the investigational drug but does not cause harm or good. The decision about whether to use a placebo in a clinical trial is based on how serious the illness is, whether an existing treatment is available and other considerations that ensure a high standard of ethics. If you have a serious or life-threatening disease, the best available treatment (called “standard of care”) will be used instead of a placebo.
·         Clinical trials may include painful or unpleasant parts

 

Like all medical interventions, clinical trials have potential benefits and risks, such as side effects or pain. Processes and procedures can be different for each clinical trial.  Some, like in general medical care, may be unpleasant or carry risks. However, the doctor will talk to you about what to expect, and the procedures and risks will be listed in the informed consent document for you to consider while you are deciding whether to participate.  The IEC will also ensure that the benefits and risks are carefully weighed and that the trial is reviewed for unnecessary harm or discomfort before it starts.
·         Being in a clinical trial is expensive and isn’t covered by medical insurance.

 

Volunteers for clinical trials rarely have to pay any costs related to participating in the trial.  There are two types of costs associated with a clinical trial: research costs and patient care costs. Research costs are those associated with conducting the trial, such as data collection and management, research physician and nurse time, analysis of results, and tests performed purely for research purposes. These costs are usually covered by the sponsoring organization, such as the biopharmaceutical company, and are not the patient’s responsibility. Patient care costs are costs that are not covered by the research sponsors doing the clinical trial, such as the costs for routine care including doctor visits, hospital stays, clinical laboratory tests, x-rays and other clinical trial-related activities that would be done even if you were not in the trial.  Many health insurance carriers will cover patient care costs, but you should ask the clinical trial research team which costs will be your responsibility and also check with your health insurance carrier about the coverage they provide for clinical trial participants before making the decision about participating in a clinical trial.
·         Being in a clinical trial won’t help me.

 

Before you decide to participate in a clinical trial, you should speak with your doctor or the research team about the trial design and the possible risks and benefits of participating. If you choose to participate, you may have the opportunity to receive an investigational drug that is not available to people outside the trial.  The clinical trial research team will watch you closely, perhaps even more closely, than your own doctor or nurse during your regular office visits.  And, because trials have detailed treatment plans (called protocols), you may get additional tests and lab work that might not be part of your usual care.  Some trial volunteers also report great personal satisfaction in the fact that they have played a key role in advancing medical science and helping scientists find new treatments that will help more people live longer, better lives
·         I have heard that some people who try to volunteer for a clinical trial are told by the research team that they are not eligible to be in the trial. The process seems unfair. Every clinical trial has a protocol, which is a plan that describes what will be done during the trial, how the trial will be conducted and why each part of the trial is necessary.  The protocol for the clinical trial also includes eligibility criteria which includes guidelines for who can and cannot take part in the trial.  Common eligibility criteria include age group, gender, having a certain type or stage of cancer, having received (or not received) certain medicines in the past, medical history and current health status. It is important to note that eligibility criteria are not used to reject you personally. These guidelines are used to identify the people most likely to benefit from the clinical trial.  The criteria are also necessary to help ensure that researchers will be able to answer the research questions about the investigational drug that they plan to study.

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