Sunday, January 4, 2015
B H
The last 10 years have been witness to an increasing number of clinical trials conducted in India. Indian pharmaceutical companies are investing higher amounts in R & D as they nurture global ambitions. Significantly, many multinational pharmaceutical companies are eyeing the opportunities available in India to augment their R & D productivity. The result has been an exponential growth in the number of clinical trials conducted in India. This growth is mirrored in large measure by the increase in the debate on the ethics of such trials in India. A number of commentators, in India and abroad have alluded to the participation of Indians in clinical trials as the “guinea pig syndrome”. Though the debate has been good to bring clinical trials into limelight, it is also responsible for shaping the attitudes of most Indians towards clinical trials. Any ambiguity about the role of such clinical trials in our society reflects the confidence (or lack thereof) we repose in the process for development of new drugs. Imagine a patient who goes to his doctor looking for a cure. What is he to make of a clinical trial his doctor offers to enroll him in? What is the trial? Is it really needed? Why is my doctor offering this? What’s in it for him? Do I have any options? Will he bear a grudge against me for saying no to participation? Am I really safe if I enroll in this trial? These are some thoughts that are likely to cross the mind of any patient. It is important to examine the reservations that shape these questions and the perception of clinical trials in the country. What is a clinical trial? A clinical trial, simply put is an experiment conducted to study if a new medication is safe and effective in the treatment of a particular medical condition. Because not much is known about the new medication at the time of a clinical trial, doctors are required to follow a rigorous schedule to oversee patient safety. Patients may be required to follow-up with the doctor more often than in routine practice and the doctor’s team is expected to spend much more time with the patient than in routine practice. This usually works to provide much more
stringent oversight for patients in a clinical trial than they might have access to otherwise. Why does a clinical trial need to be conducted? Why can’t we just use the current medicines available? The premise of any clinical trial is the “principle of essentiality” elucidated by the Indian Council of Medical Research. A clinical trial is done, simply because, it needs to be done. If other methods were available to evaluate new medicines, scientists and governments would be more than happy to use those for evaluation of new agents. However, even though a number of initiatives are being explored to reduce the number of patients exposed to new clinical trials, the fact remains that the clinical trial remains the most robust way to evaluate new agents today. It’s also important to appreciate that modern medicine, though highly evolved, is yet an imperfect science. To quote a recent Businessweek story “From heart surgery to prostate care, the health industry knows little about which common treatments really work”. Most medicines used today offer significant alleviation of suffering in relative terms, but in absolution, modern drugs suffer from safety and efficacy issues. Scientists and doctors over the world continue the search to understand which treatments are safer and better for their patients. So when a doctor offers to enroll a patient into a clinical trial, he’s really requesting the patient’s collaboration in an experiment to further the understanding of medicine. The objective is to allow patients access to better medicines in the future to come. Do patients really understand clinical trials? They must! All doctors are obliged by the law and by international guidelines for ethical research to seek informed consent from patients. Informed consent means that doctors must explain the trial to patients, make sure they understand their rights and obligations and have the chance to make a fully informed decision, to participate or not to participate. The exact nature of the discussion is privileged between the doctor and the
patient, but broadly a well taken informed consent requires the patient to understand that he has the option to not participate in the trial, that the trial represents an experiment, that the patient has certain responsibilities should he choose to participate and that there are both potential benefits and risks of participation in the trial. How does the patient know if the doctor can be trusted? Who makes sure the patient is protected? The best person to protect the patient is the patient himself! Patients are becoming more a part of the medical management process today, an effort in which they collaborate with their physicians. An empowered patient should take on the responsibility of understanding all aspects of the trial. It’s also important to note that all trials of experimental drugs (not approved for a particular indication) are required to be approved by the Indian regulators – the Drugs Controller General of India. All trials are also reviewed and approved by an Ethics Committee. The Ethics Committee is composed of individuals that represent a cross section of society, doctors, scientists and non-scientists. The members of the ethics committee approve the conduct of a trial after careful consideration and after establishing that the trial is ethically and scientifically justified. On an ongoing basis, ethics committees are required to monitor the conduct of trials to ensure that they are being conducted in an ethical and law-abiding manner. Patients should know that at any given time, they have the right to approach their doctor and/ or a designated member of the ethics committee with questions about the trial. This provision is to allow free and frank exchange between patients, their doctors and the ethics committees. Needless to say, the better informed a patient is, the better informed he will be to make a decision on participation in a trial. Most doctors on an average take an hour to two of discussions with their patients (usually over 1-2 meetings) and the patient’s family/ spouse before seeking the informed consent. Discussions must be held in the language the patients are most comfortable in. Patients must retain a copy of the signed informed consent form. In many cases, patients refuse to provide consent and choose simply to be placed on one of the other treatment choices. In many other cases, patients choose to participate and may opt out of the trial later for various reasons. Eith
B H
The last 10 years have been witness to an increasing number of clinical trials conducted in India. Indian pharmaceutical companies are investing higher amounts in R & D as they nurture global ambitions. Significantly, many multinational pharmaceutical companies are eyeing the opportunities available in India to augment their R & D productivity. The result has been an exponential growth in the number of clinical trials conducted in India. This growth is mirrored in large measure by the increase in the debate on the ethics of such trials in India. A number of commentators, in India and abroad have alluded to the participation of Indians in clinical trials as the “guinea pig syndrome”. Though the debate has been good to bring clinical trials into limelight, it is also responsible for shaping the attitudes of most Indians towards clinical trials. Any ambiguity about the role of such clinical trials in our society reflects the confidence (or lack thereof) we repose in the process for development of new drugs. Imagine a patient who goes to his doctor looking for a cure. What is he to make of a clinical trial his doctor offers to enroll him in? What is the trial? Is it really needed? Why is my doctor offering this? What’s in it for him? Do I have any options? Will he bear a grudge against me for saying no to participation? Am I really safe if I enroll in this trial? These are some thoughts that are likely to cross the mind of any patient. It is important to examine the reservations that shape these questions and the perception of clinical trials in the country. What is a clinical trial? A clinical trial, simply put is an experiment conducted to study if a new medication is safe and effective in the treatment of a particular medical condition. Because not much is known about the new medication at the time of a clinical trial, doctors are required to follow a rigorous schedule to oversee patient safety. Patients may be required to follow-up with the doctor more often than in routine practice and the doctor’s team is expected to spend much more time with the patient than in routine practice. This usually works to provide much more
stringent oversight for patients in a clinical trial than they might have access to otherwise. Why does a clinical trial need to be conducted? Why can’t we just use the current medicines available? The premise of any clinical trial is the “principle of essentiality” elucidated by the Indian Council of Medical Research. A clinical trial is done, simply because, it needs to be done. If other methods were available to evaluate new medicines, scientists and governments would be more than happy to use those for evaluation of new agents. However, even though a number of initiatives are being explored to reduce the number of patients exposed to new clinical trials, the fact remains that the clinical trial remains the most robust way to evaluate new agents today. It’s also important to appreciate that modern medicine, though highly evolved, is yet an imperfect science. To quote a recent Businessweek story “From heart surgery to prostate care, the health industry knows little about which common treatments really work”. Most medicines used today offer significant alleviation of suffering in relative terms, but in absolution, modern drugs suffer from safety and efficacy issues. Scientists and doctors over the world continue the search to understand which treatments are safer and better for their patients. So when a doctor offers to enroll a patient into a clinical trial, he’s really requesting the patient’s collaboration in an experiment to further the understanding of medicine. The objective is to allow patients access to better medicines in the future to come. Do patients really understand clinical trials? They must! All doctors are obliged by the law and by international guidelines for ethical research to seek informed consent from patients. Informed consent means that doctors must explain the trial to patients, make sure they understand their rights and obligations and have the chance to make a fully informed decision, to participate or not to participate. The exact nature of the discussion is privileged between the doctor and the
patient, but broadly a well taken informed consent requires the patient to understand that he has the option to not participate in the trial, that the trial represents an experiment, that the patient has certain responsibilities should he choose to participate and that there are both potential benefits and risks of participation in the trial. How does the patient know if the doctor can be trusted? Who makes sure the patient is protected? The best person to protect the patient is the patient himself! Patients are becoming more a part of the medical management process today, an effort in which they collaborate with their physicians. An empowered patient should take on the responsibility of understanding all aspects of the trial. It’s also important to note that all trials of experimental drugs (not approved for a particular indication) are required to be approved by the Indian regulators – the Drugs Controller General of India. All trials are also reviewed and approved by an Ethics Committee. The Ethics Committee is composed of individuals that represent a cross section of society, doctors, scientists and non-scientists. The members of the ethics committee approve the conduct of a trial after careful consideration and after establishing that the trial is ethically and scientifically justified. On an ongoing basis, ethics committees are required to monitor the conduct of trials to ensure that they are being conducted in an ethical and law-abiding manner. Patients should know that at any given time, they have the right to approach their doctor and/ or a designated member of the ethics committee with questions about the trial. This provision is to allow free and frank exchange between patients, their doctors and the ethics committees. Needless to say, the better informed a patient is, the better informed he will be to make a decision on participation in a trial. Most doctors on an average take an hour to two of discussions with their patients (usually over 1-2 meetings) and the patient’s family/ spouse before seeking the informed consent. Discussions must be held in the language the patients are most comfortable in. Patients must retain a copy of the signed informed consent form. In many cases, patients refuse to provide consent and choose simply to be placed on one of the other treatment choices. In many other cases, patients choose to participate and may opt out of the trial later for various reasons. Eith
stringent oversight for patients in a clinical trial than they might have access to otherwise. Why does a clinical trial need to be conducted? Why can’t we just use the current medicines available? The premise of any clinical trial is the “principle of essentiality” elucidated by the Indian Council of Medical Research. A clinical trial is done, simply because, it needs to be done. If other methods were available to evaluate new medicines, scientists and governments would be more than happy to use those for evaluation of new agents. However, even though a number of initiatives are being explored to reduce the number of patients exposed to new clinical trials, the fact remains that the clinical trial remains the most robust way to evaluate new agents today. It’s also important to appreciate that modern medicine, though highly evolved, is yet an imperfect science. To quote a recent Businessweek story “From heart surgery to prostate care, the health industry knows little about which common treatments really work”. Most medicines used today offer significant alleviation of suffering in relative terms, but in absolution, modern drugs suffer from safety and efficacy issues. Scientists and doctors over the world continue the search to understand which treatments are safer and better for their patients. So when a doctor offers to enroll a patient into a clinical trial, he’s really requesting the patient’s collaboration in an experiment to further the understanding of medicine. The objective is to allow patients access to better medicines in the future to come. Do patients really understand clinical trials? They must! All doctors are obliged by the law and by international guidelines for ethical research to seek informed consent from patients. Informed consent means that doctors must explain the trial to patients, make sure they understand their rights and obligations and have the chance to make a fully informed decision, to participate or not to participate. The exact nature of the discussion is privileged between the doctor and the
patient, but broadly a well taken informed consent requires the patient to understand that he has the option to not participate in the trial, that the trial represents an experiment, that the patient has certain responsibilities should he choose to participate and that there are both potential benefits and risks of participation in the trial. How does the patient know if the doctor can be trusted? Who makes sure the patient is protected? The best person to protect the patient is the patient himself! Patients are becoming more a part of the medical management process today, an effort in which they collaborate with their physicians. An empowered patient should take on the responsibility of understanding all aspects of the trial. It’s also important to note that all trials of experimental drugs (not approved for a particular indication) are required to be approved by the Indian regulators – the Drugs Controller General of India. All trials are also reviewed and approved by an Ethics Committee. The Ethics Committee is composed of individuals that represent a cross section of society, doctors, scientists and non-scientists. The members of the ethics committee approve the conduct of a trial after careful consideration and after establishing that the trial is ethically and scientifically justified. On an ongoing basis, ethics committees are required to monitor the conduct of trials to ensure that they are being conducted in an ethical and law-abiding manner. Patients should know that at any given time, they have the right to approach their doctor and/ or a designated member of the ethics committee with questions about the trial. This provision is to allow free and frank exchange between patients, their doctors and the ethics committees. Needless to say, the better informed a patient is, the better informed he will be to make a decision on participation in a trial. Most doctors on an average take an hour to two of discussions with their patients (usually over 1-2 meetings) and the patient’s family/ spouse before seeking the informed consent. Discussions must be held in the language the patients are most comfortable in. Patients must retain a copy of the signed informed consent form. In many cases, patients refuse to provide consent and choose simply to be placed on one of the other treatment choices. In many other cases, patients choose to participate and may opt out of the trial later for various reasons. Eith
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