分散型臨床試験を実施する際の考慮事項

臨床試験における遠隔医療の利用は目新しいものではないが、COVID-19がもたらした社会的距離を縮める取り組みがこの問題に追い打ちをかけるまで、この方法は一般化しなかった。

Companies interested in providing clinical trial services via telehealth have to deal with whether the carrying out the clinical aspects of a clinical trial is part of the practice of medicine. Some argue that clinical aspects of a trial is not the same as the practice of medicine. Others argue that there is clinical care required in case of an adverse event

There exists evidence under state law that performance of clinical research constitutes the practice of medicine. Under Tex. Admin. Code § 177.1(2)(emphasis added), Texas defines actively engaged in the practice of medicine as follows:

“The physician on a full-time basis is engaged in diagnosing, treating or offering to treat any mental or physical disease or disorder or any physical deformity or injury or performing such actions with respect to individual patients for compensation and shall include clinical medical research, the practice of clinical investigative medicine, the supervision and training of medical students or residents in a teaching facility or program approved by the Liaison Committee on Medical Education of the American Medical Association, the American Osteopathic Association or the Accreditation Council for Graduate Medical Education, and professional managerial, administrative, or supervisory activities related to the practice of medicine or the delivery of health care services. The term “full-time basis,” for purposes of this section, shall mean at least 20 hours per week for 40 weeks duration during a given year.”

Texas, therefore, explicitly includes “clinical medical research” in its definition of the practice of medicine, as well as “professional managerial, administrative, or supervisory activities related to the practice of medicine or the delivery of health care services.” Although a number of states are silent on this issue, silence does not necessarily mean that research services are not considered clinical care subject to a state’s practice standards. An argument exists that clinical research is not clinical care per se because the clinicians are typically following an Institutional Review Board (IRB)-approved protocol and any regular care, even when provided in an emergency context, will be provided by a local, licensed clinician. Nonetheless, the fact that there exists states such as Texas that explicitly include clinical medical research in the definition of engaging in the practice of medicine means that entities entering the clinical research support services space must consider this issue when thinking about discerning applicable practice standards.

Where clinical research is considered the practice of licensed profession (such as medicine in Texas), the relevant legal requirements applicable to the practice of medicine will apply. For example, generally, healthcare providers must be licensed in the state in which a study subject is located unless an applicable exception applies. Moreover, applicable telehealth standards of care must be considered and adhered to when interacting with study subjects.

Issues such as compliant creation of the physician-patient relationship, modality requirements when creating and then maintaining the physician-patient relationship, remote prescribing requirements, (if applicable) controlled substance prescribing requirements, (if applicable) medical record requirements for telehealth practice, telehealth identity verification and disclosure requirements, and any emergency or follow-up care plan requirements.

One requirement bears unique consideration in the context of decentralized clinical trials. In addition to the standard IRB-approved informed consent accompanying a clinical trial, a number of states have specific consent requirements when utilizing telehealth that concern the treatment methods, risks, and limitations of using such a platform. Sponsors and sites will want to consider whether a telehealth informed consent must be used in addition to consents required for subjects participating in a clinical trial.

Each practice standard requirement and compliance thereto requires a state-by-state analysis where clinical research is considered the practice of medicine or is arguably considered the practice of medicine. Failure to adhere to such standards could subject study sites, investigators, and staff to unwanted enforcement. Study sponsors will want to think carefully about the representations and warranties in the applicable clinical trial agreement and how use of telehealth may or may not affect protocol development.