Patients are the heart of all clinical trials ranging from recruitment, retention, protocol adherence, assessments, and safety data, making it necessary to ensure that patients are
well-informed on trial protocol, conduct, and patients’ rights. Various measures are in place such as informed consent, institutional review board (IRB) oversight, and Good Clinical Practice (GCP) regulations along with regulatory guidelines to maintain the safety, welfare, and confidentiality of patients. As participating in a clinical trial involves commitment from patients to succeed it is imperative that all aspects of the trial should involve patient protection and welfare. Furthermore, it is important to keep caregivers in the loop regarding patient care as they often form an important aspect of medication and protocol adherence by providing logistical, emotional, and social support.

The following information is often important to give patients and caregivers before and during their participation in clinical trials:

Eligibility and enrolment criteria

Information about the trial and risks and benefits

Patients should be educated on the reason for the trial that can include access to new treatment modalities or better treatments that are available by participating in the trial which is particularly important for diseases that lack current treatment options and for rare diseases. The sponsors/investigators should clearly communicate to patients about the benefits as well as risks (side effects, adverse effects) that they may be exposed to when they are enrolled in the trial. Furthermore, information on the type of trial and trial structure (blinding, randomization, etc) can also be included.

Informed consent

One of the most important aspects for the protection of safety and welfare of patients is informed consent. The informed consent process includes a form that can be paper-based or electronic that provides comprehensive information on the clinical trial including details such as screening and assessment visits, type of tests performed, dosing schedules, risks and benefits associated with the treatment, contact information in case of emergencies, etc. It is important for the patients or their legally authorized representatives (LARs) to understand and be able to ask questions or address any concerns freely before committing to participate in the trial and they should be aware that they cannot be forced or coerced into participation against their will. Therefore, it is critical that patients are informed of their rights and should be allowed to withdraw from the trial in case of any problem.

Eligibility and enrolment criteria and processes

Patients and caregivers must be aware of the eligibility criteria that is necessary for participation in the trial such as age, gender, comorbidities, medical history concomitant medications, and should make sure that these are adhered to prior to applying for participation in the trial. They should be informed of potential screening tests and health assessments that may be necessary prior to their recruitment along with the abovementioned details on informed consent.

Logistical and financial information

In addition to ensuring that a patient is eligible for a trial, it is important that the patients and caregivers are informed about logistical and financial factors that often dictate their ability to participate and remain in the trial. Details on time commitments including screening and follow-up visits, and appointment schedules and length should be explained to patients and caregivers. Location of trial centres and their distance from patients’ homes should be considered as travel to sites is important and can often hinder patients from participating. Compensation for trials and costs of all procedures, medical exams, and travel although usually covered by sponsors also needs to be covered. Insurance, coverage, and reimbursement details should also be confirmed and any financial incentives for participating in the trial should be discussed.

Institutional Review Boards (IRBs) and participant protection

IRBs are independent committees responsible for the protection of the rights, safety, and well-being of participants and have the responsibility of reviewing trial protocols and ensuring that they adhere to ethical standards. They also review the monitor the conduct of trials and have the authority to request changes in trial protocol in case of any potential hazards or risks to the patient. The IRB is responsible for ensuring that patients are completely informed of all trial aspects through the informed consent process. It is important for patients and caregivers to know that they can contact the IRB in cases that they feel that their rights and safety are in jeopardy or if they are uncomfortable with the trial progress or any ethical issues.

Caregiver support

Caregivers are important in terms of providing emotional, logistical, and decision-making support to patients. It is necessary that their rights are also respected during the trial and their questions and concerns are addressed promptly and adequately. In many cases, trial centres offer trial support groups, counselling, transportation services, educational resources,  and resource centres for caregivers as their health and welfare is as important to the trial as the participants. They should be informed of such facilities available to them and must also be actively involved in the informed consent process.

In general, the ultimate success of clinical trials depends upon the safety, well-being, and protection of rights of participants and adherence to ethical considerations and regulatory guidelines throughout the trial. It is of prime importance that patients and their caregivers understand their rights and should be able to make decisions that align with their health and beliefs.

Read More: Food and Dietary Supplements Clinical Trials Regulations in USA

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