Some local newspapers and newsletters now publish dedicated weekly sections listing clinical trials. Some trials are advertised through telephone hold messages, bill boards, or social media sites.
All solicitations for participation in a clinical trial must be approved in advance by an Institutional Review Board Ethics and Safeguards in Clinical Trials Patients have different reasons for wanting to participate in clinical trials. Some want access to the newest treatments, which they hope will be more effective than the current standard of Many communities have one or more research centers that consumers can call directly to get information or to get on a mailing list.
Almost all clinical trials are listed at ClinicalTrials. National Library of Medicine database of privately and publicly funded clinical studies conducted around the world. Some websites help match people to specific trials. For example, the National Institutes of Health NIH has an internet-based registry called Research Match that people can use to connect with researchers seeking participants for their trials.
CenterWatch is another service that contains thousands of trials that are currently enrolling people. Clinical trials are complex, and few patients begin the process with adequate understanding of what is involved. Physicians running the trial can provide some guidance throughout the process.
A good place to start is to provide patients with a list of questions they should ask to better understand the specific clinical trial they are considering. The study investigator and often a trial coordinator should be actively engaged with the patients, providing information and answering any questions. Following is a list of key questions participants should ask before participating in a clinical trial 1 Reference Patients have different reasons for wanting to participate in clinical trials.
What has already been learned about the trial treatment and have any trial results been published? Deciding whether to participate in a clinical trial is an important and complicated decision. Physicians can help the patient consider both the risks and benefits. Patients should be aware that in a randomized trial they are not guaranteed to receive the new treatment and may instead receive a placebo or other active treatment.
A trial drug may have adverse effects and cause serious reactions, including, on very rare occasions, death. Not all possible adverse effects of the study drug are fully known at the time a patient enters a clinical trial. In fact, a purpose of the trial is to learn what the adverse effects are. Although the researchers try to warn participants of all adverse effects that are known at the time they enroll, unanticipated problems may develop.
A similar risk exists for interventions that are procedures, except that the risks for procedures are complications of the procedure, some of which are known but some of which may not yet be known. The experimental treatment might not work as well as intended, possibly not even as well as standard treatment. There are also some very real potential benefits to clinical trial participation.
If a treatment works as expected, participants could have a better outcome than with other treatments normally available to them. During a clinical trial, participants typically receive excellent care that might otherwise be costly. Because participants are so well monitored, they tend to learn a great deal about their overall health and any underlying medical conditions.
Occasionally, the regular monitoring, especially laboratory tests, may detect a separate disease before it becomes clinically evident, allowing for early intervention. Sometimes there is an opportunity to build camaraderie with other participants, which may be particularly welcome by people who have rare or uncommon diseases.
At a minimum, clinical trial participants can be sure that they are helping to advance medical science and public health. However, the study team must not guarantee any trial-related benefits. Consent forms for participation should state explicitly that there is no guarantee of benefit. In a very small fraction of situations, investigators in charge of clinical trials have acted unethically.
One particularly shameful example is known as the Tuskegee experiments. Conducted around Tuskegee, Alabama, from to , this study enrolled about poor, mostly illiterate, Black sharecroppers who had syphilis. These participants were not told that they had syphilis, and despite the eventual availability of the effective treatment penicillin, the Tuskegee investigators withheld penicillin and information about penicillin purely to continue to study how the disease progressed.
Participants were also prevented from accessing syphilis treatment programs that were available to other people in the area. As a result of this serious breach of ethics and trust, several safeguards were put in place.
Included in these safeguards are the establishment of Institutional Review Boards and the concept of informed consent. Institutional Review Boards IRBs are specific committees in each medical institution that participate in clinical trials. The purpose of these committees is to ensure that the trial consent form appropriately describes the trial, including its design. IRBs must include at least one non-scientific member and at least one member must not be affiliated with that institution.
IRBs review all proposed clinical trials involving humans. The purpose of these committees is to ensure that trials are conducted in an ethical manner and to avoid any unreasonable risks associated with the trial design. Only trials that have been approved by the IRB of an institution or a central IRB are allowed to proceed in that institution.
When many different institutions participate in a trial, the U. Using a central IRB can eliminate a lot of duplicated effort by separate committees and also ensure a consistent set of protections and requirements at all the study centers.
Central IRBs must still follow all local requirements at each participating site. When trial requirements are governed by law, both independent and central IRBs must ensure that those requirements are included in the trial protocol and the corresponding consent form. Many interventional studies have an independent data safety monitoring board DSMB. The DSMB is a committee of experts not affiliated with the trial and who get unblinded data during the trial.
The DSMB reviews the data to determine if there is a safety signal evidence suggesting the possibility of more harm with the intervention than with the control group of sufficient magnitude to stop the trial eg, if evidence of efficacy is sufficient or to determine if the trial may never meet its efficacy goal called futility and should be stopped.
Evidence of efficacy helps determine whether continuing the trial is worth continued potential safety risks. DSMBs do not make the final decision about a trial but make their recommendations to the sponsor. Sponsors usually accept the recommendation s of the DSMB. Informed consent means that a person is given all the information needed to make an educated and informed decision as to whether to participate in a clinical trial. Information should describe all aspects of the trial, from its purpose to a statement about who pays for medical care to treat any research-related injuries.
Informed consent documents tend to be lengthy in some cases, dozens of pages long , technical, and sometimes use language that may require explanation for the potential trial participant. However, it is essential that participants read the documents carefully. Following are the major elements of informed consent documents 1 References Patients have different reasons for wanting to participate in clinical trials. A disclosure of any alternative treatments or procedures that might be advantageous to participants.
An explanation of any compensation and whether medical treatments are available if injury occurs. A statement that participation is voluntary and that there is no penalty and no loss of benefits for refusing to participate or discontinuing participation at any time during the trial. Other elements of informed consent documents that may be included when appropriate include the following:.
A statement that there may be unforeseeable risks to the participant, embryo, or fetus—if the participant is or may become pregnant. A statement that participants will be informed of significant new findings that might affect their willingness to participate.
If practical, participants should take the informed consent documents home, read them over several times, and discuss them with their personal physician and family members. The physician may be able to help clarify some of the participation risks.
Family members and friends particularly need to be involved if they will be providing assistance to the person such as transportation to the research center. After reviewing the informed consent documents carefully, participants should return them to the investigator and trial coordinator and ask any further questions.
That distinction, at least in terminology, is no longer firmly recognized Impaired consent capacity may be due to a wide range of disorders and conditions, such as dementia, stroke, traumatic brain injury, developmental disorders, serious mental illness, intoxication, and delirium.
Enrolling participants with impaired consent capacity raises many considerations and requires additional safeguards, one of which is involvement of a legally authorized representative. Some trial participant candidates called vulnerable populations require greater protection of their rights to ensure that their consent is as truly informed as possible.
Vulnerable populations include the following:. With vulnerable patients and with potential candidates with whom investigators have a relationship that could cause pressure to participate eg, an investigator's own patients, medical trainees, caregivers in the same office or institution , investigators must be careful to ensure the truest possible informed consent.
Medical advances can only happen through the efforts of many people, especially the patients who volunteer for clinical trials. They are our partners in research. Advanced Search Search All Studies. Merck cares deeply about helping the world be well. We strive to improve health for others in the future by developing new drugs and vaccines that treat and prevent disease.
Clinical trials are an essential part of this process. We are thankful for the thousands of volunteers — patients and healthy persons — who participate in clinical trials. Corporate Site.
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