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What Recourse Do I Have if a Clinical Trial Goes Wrong?

Legally Reviewed and Edited by: Terry Cochran

When a new medicine or therapy is being developed for use in the public sector and for the benefit of patient treatment the FDA requires that the procedure or medicine is tested with clinical trials using human beings as the subjects. These clinical trials involve a very complex exploration of a combination of ethical, regulatory, medical, and scientific principles underlying the targeted medicine or device. Because of this large scope of exposure to mistakes and human error, many times a malpractice lawyer at Cochran, Kroll & Associates, P.C. needs to be part of the discussion if something goes wrong and there is an injury to a participant.

In Michigan, as well as in most states, the plaintiff in a lawsuit against a hospital or medical organization conducting a clinical study must establish that the level of care given to the participant was below the expected standard of care in a similar or normal situation. There may also be questions concerning the procedure that those in charge of the testing used to find participants, communicate with them, and evaluate their understanding of the benefits and the risks involved. A lawsuit investigation will deeply examine how each phase of the clinical trial was conducted and the liability associated with any negligence.

How is a Clinical Trial Conducted?

A clinical trial has been proven to be the best way that a product, device, or therapy can be brought onto the market and made available to help people. The first step the researcher takes is to test the item or medicine in the laboratory and with animals if it is appropriate. Once the results indicate that there are promising possibilities for the drug, the next step is to move it into a series of clinical trials using humans. This work is done in phases, and each phase must be completed in its entirety with the results documented. In a lawsuit, the malpractice attorney at our law firm will carefully scrutinize this process to make sure there were no short-cuts taken to speed up the approval of the medicine or apparatus.

Phase I

The first phase of the clinical trial is conducted with a small number of participants, usually 6-10 volunteers who are healthy or a similar number who may be sick and need the treatment to assist them in getting well. Scientists are interested in the effects the compounds have when given to humans. The goal is to study how the patients react and to evaluate the safety and tolerability once the drug is swallowed, infused, or injected.

The people participating in the study are very closely monitored, and very copious notes are taken regarding the severity of any side effects and how often they occur. The participant’s safety should be the critical factor in this first phase. Lawsuits are often based on situations where already sick people have gotten sicker or have even died after only a few ingestions of the medicine.

Phase II

There are larger groups of people involved in the Phase II trials. These groups usually consist of between 20 and 300, and the numbers of participants depend on the type of disease being studied and the scope of the treatment. Once the safety of the drug has been established, the researchers give participants various doses of the medicine and also try to determine how often each dose should be administered.

These results are closely monitored to ensure a clear understanding of how the drug affects humans. There is usually more than one Phase II clinical trial as the scientists and doctors may define different groups depending on whether the participants are healthy or sick and in different stages of a disease or illness. The main focus is to determine the dosing regimen for the medication and how it affects a variety of patient populations.

Phase III

In the Phase III study, like Phase II, larger numbers of participants are used, and in this phase, there could be from 300 to 3,000. Similarly the researchers continue to evaluate the medicine for safety to the participants and also for dosage and efficiency of use. Many times “treatment arms” allow for the drug to be compared to other treatments, and this way doctors can learn how fast the drug may work to attack the disease. The guideline here is finding out how to best prescribe the drug to patients in the future.

Phase IV

Also known as post-marketing surveillance trials, Phase IV takes place only after the medicine has received regulatory approval, also known as market authorization, and in this phase, there is a broader look at the safety and effects the drug may have on patients who may be taking more than one type of treatment at the same time. These are long-term studies, and the researchers look out for uncommon or unexpected effects that need to be communicated to doctors.

Clinical studies are integral to the development of new drugs and treatments. Through this scientific process new medicines have to pass the test of safety to participants, and they are also scrutinized for side-effects and recommended dosages.

Ethical Considerations in Clinical Trials

There are very rigid and clearly defined regulations in place that outline and reinforce the ethical requirements when humans are used to test medicines, compounds, or devices. These ethics guidelines are formulated by the Declaration of Helsinki that was instituted by the World Medical Association (WMA) in June of 1964 and that has been amended several times to reflect the changes in medicine and technology. In addition, most medical research bodies also adhere to the guidelines of the Good Clinical Practices Network (GCP) that closely mirrors the Helsinki agreement and provides a sound ethical base for all research involving humans.

Ethical clinical research is governed by a respect for the individual, nonmaleficence, the duty to do no harm, justice, and beneficence. The concept of respect for participants is underlined when the participant agrees to participate as a volunteer through informed consent and that the information given to the participant is understandable. The person’s participation is held in confidence unless the person gives permission for it to be shared.

Nonmaleficence has a foundation in the Hippocratic Oath and is at the very core of the clinical study. This concept states that the researcher will do no harm to the participants in the study and that the results of the study are reasonably expected to be a positive contribution to society.

For any scientific clinical study to be considered ethical, there has to be a certain degree of medical and scientific evidence that supports exposing the participants to the risks of the study. There must be a clear medical need at the base of the study, and the possible benefits must be compared to the amount of risk inherent to the exposure of the participant to unfamiliar compounds. This is known as the ethical demonstration of beneficence and supports a thorough risk/benefit evaluation within the context of the study.

The principle of justice is very straightforward. No human population can be exploited or taken advantage of in any way, especially if they might be more vulnerable than another group of people. The main ethical guideline here is that the study must benefit the larger community.

In general, the World Medical Association holds the physician and the medical research practitioner accountable to the belief that ‘the health of my patient will be my first consideration.” This binding agreement holds the physician to a high standard of care that is expected by all medical professionals. The recounting of this belief is sometimes the basis of a malpractice claim that might arise if a participant in a clinical study suffers an unnecessary injury due to a doctor taking short-cuts or making other questionable decisions.

World Medical Association

External Controls of Clinical Studies

In any ethically controlled study, there will be independent evaluators and systems in place to protect the participants and control the results to ensure the validity of the trial. Independent Review Boards (IRB), are set up to provide the necessary oversight to studies involving humans. Members of these boards are researchers, ethicists, legal experts, and people from the community. This oversight committee is charged with attesting to the validity of the scientific basis for the study and the protection of the participants. As a result, there is a transparent system in place that protects the safety of individuals through informed consent and justice while at the same time ensuring the validity of the scientific research. In a lawsuit, these independent committees can also be held accountable for negligence. The law firm of Cochran, Kroll & Associates, P.C. looks closely at all aspects of the clinical trial process to make sure that all parties are held accountable if there is injury to a participant in a study.

Recourse When You are Injured in a Clinical Trial

Several parties are involved when there is a clinical trial of a new medicine or a new medical device or therapy. Usually, there is a sponsor of the research which can be a pharmaceutical company or a manufacturer of medical equipment. In addition there are the medical researchers, scientists, and the doctors who oversee the implementation of the compounds or equipment, and lastly the independent oversight committee. All of these factions of the clinical trial process are required to uphold the highest ethical standards of care expected in medical treatment, and they all can be held liable if they are negligent in their particular role in the clinical trial process.

However, even with this high degree of liability, there have not been that many malpractice suits related to clinical trials as compared to other types of malpractice claims within the medical context. Given that, one of the most critical steps in the clinical trial procedure is the presentation and signing of the Informed Consent document. This is the one area that has received the most attention and litigation.

The Importance of Informed Consent

To many, informed consent simply means signing a form giving permission for the doctor to treat you in a clinical study. However, it is really much more than that. Verbal or written consent is only a small part of the process.

Informed consent requires that the participant fully understands the information regarding the clinical study and that they have sufficient time to consider the details before making a final decision. In addition, there has to be ample time to allow the potential participant to ask questions regarding the benefits and risks of the trial. The underlying premise in the informed consent is that the potential participant must have all the information they need, and they have to voluntarily decide to participate without any coercion or pressure from the sponsoring organization or doctor.

Subjects who are involved in a clinical trial may derive benefits for their participation. However, in the informed consent, there is no guarantee that they will benefit from the trial, and they also have to be aware that they might also be exposed to certain unknown risks. Although the study is based on the standard of care held by all medical professionals there may be the possibility of a loss of control due to the effects of the medicine or compounds used.

The potential participants must also be informed as to what will be done to them, any risks or discomforts they may experience, and how the process and procedures work from beginning to end. It must be clearly stated that their participation is voluntary.

The Food and Drug Administration does not specify the language that should be included in the informed consent agreement, but it does regulate these agreements through a review process. Because of the importance of this document and the necessary elements that must be understood by the participant, if there is cause for litigation due to a patient injury or misunderstanding, the malpractice attorney will inspect this document and use it as evidence in a medical malpractice suit.

Final Thoughts

The use of clinical trials in the field of medicine has proven to assist doctors and research scientists in finding medicinal and other cures that help the general public. These medical professionals are bound by high ethical rules when they conduct this research, and their primary goal is to protect the safety of the participants. However, things do go wrong, and there might be a cause for a participant in a trial to claim that the physician was negligent, and the result was injury to the participant.

At Cochran, Kroll & Associates, P.C. understand the complexities involved in the clinical trial process, and we can ensure that your claim will be thoroughly investigated. Contact us at Cochranlaw.com or call us at 866-MICH-LAW for a free consultation. We never charge a fee unless we resolve your case.

Disclaimer : The information provided is general and not for legal advice. The blogs are not intended to provide legal counsel and no attorney-client relationship is created nor intended.

Tristan is a professional writer and had careers as a teacher of English, school administrator, and as a broker in real estate sales. He has gained a great deal of legal experience through his service as the president of a teacher's union, a member of the board for a real estate association, and as the chairman of the Government Affairs Committee for the real estate board of directors. Before beginning a full-time job as a freelance writer, he was the Executive Director of the Global Business Alliance for a local Chamber of Commerce and sat on the Government Affairs Committee for the Chamber.



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