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CLINICAL TRIALS: MANEUVERING TO AVOID POTENTIAL PITFALLS

Are you thinking of taking part in a clinical trial, or already involved in one? If done properly, clinical trials can be rewarding, perhaps leading to discovery of crucial, new medical data. However, if done improperly, a clinical trial can not only be unsuccessful, but also pose significant risks, i.e., claims of medical malpractice and legal sanctions. Become aware of

“A clinical trial is typically a scientific research study with human subjects, established for the purpose of studying the effectiveness and/or safety of a new investigational medical treatment, medication, or device.”

precautions you need to take, and appreciate the risks involved. The key steps to ensure a properly conducted trial are: (1) a clear protocol, and (2) the full consent of the participants.

What Is a Clinical Trial? A clinical trial is typically a scientific research study with human subjects, established for the purpose of studying the effectiveness and/or safety of a new investigational medical treatment, medication, or device. Generally, clinical trials must be completed before new research treatments are made available to the public. Such trials enable researchers to develop innovative treatments and new uses for currently available treatment. Of note, CAP-MPT does not “cover” research with non-FDA approved drugs or devices, unless specially authorized.

Pharmaceutical companies, federal health agencies, medical centers, and universities usually sponsor clinical trials, although physicians may also sponsor trials. CAP members Lawrence Sher, M.D., Pediatrics, Allergy/Immunology (Rolling Hills Estates) and Edward Portnoy, M.D., Internal Medicine (Westlake Village) run trials in addition to their daily practices. Both physicians acknowledge that although clinical trials can be challenging, they can also be very rewarding. Dr. Sher notes some of the greatest challenges include finding appropriate patients and appreciating the extent of commitment needed to complete a trial. “All ‘t’s’ must be crossed and all ‘i’s’ must be dotted,” Dr. Sher also cautions. Dr. Portnoy adds, “it’s important to have properly skilled staff to help you run the trial.” Both doctors also point out some rewards, including the quality of the patient-doctor relationship, and the level of care available to participants. “You get to experience cutting-edge medicine before others,” Dr. Portnoy remarks. “Tomorrow’s medicine is today,” Dr. Sher agrees.

Informed Consent and Laws Governing Clinical Trials: Obtaining informed consent is key in clinical trials. Generally, informed consent is the process by which a patient is provided with information about any required or recommended treatment, prior to deciding whether to undergo the treatment. A dialogue between physician and patient should cover all risks and benefits, including the nature of the treatment, and expected recovery duration. Although patient consent must be obtained in a typical treatment scenario, it is even more crucial in clinical trials. Both California and Federal laws require that the physician-researcher obtain the patient’s informed consent.

No clinical trial may involve any human being as a subject in research unless the physicianinvestigator has obtained the legally effective consent of the human subject, or that of a legally authorized representative. For example, information about the trial must be in a language understandable by the patient and consent must be given without undue influence or coercion. Additionally, California law also requires that all subjects be given a copy of the “Experimental Subject’s Bill of Rights” before participation. This Bill of Rights must be in writing (in the patient’s language), and the rights in the Bill include many of the same referenced above. Both California and Federal laws require the consent to remain part of the documented medical record case history of the subject. “You can’t start [a clinical trial] without consent,” observes Dr. Sher. Dr. Portnoy also recommends a complete consent for every patient, making sure each participant understands “all the positives and negatives” of the trial.

The details of the laws on human research can be found in federal regulations (“Protection of Human Subjects” ), the FDA regulations, and the California Protection of Human Subjects in Medical Experimentation Act. The California Experimentation Act governs all human experimentation. California researchers will likely be held to the standard of care that results in the most encompassing protection of participants. In light of the legal complexities, a physician-investigator’s legal counsel should be involved with each study.

Institutional Review Boards, and Potential Penalties: Clinical trials are subject to welldefined legal and ethical standards. A crucial embodiment of these standards is the “Institutional Review Board” (or “IRB”). Federal and State law require the implementation of an IRB for any human research. An IRB is typically a committee of volunteers including medical and scientific experts and also lay people such as community members. However, as Dr. Portnoy points out, the clinical trial process has evolved and “central” IRB’s (those serving clinical trials nationwide) are also currently available. The IRB’s goal is to protect the public and participants and to evaluate and monitor the study benefits, risks and progress. IRB’s must also ensure timely reporting and implement written procedures for the research. The IRB has the authority to suspend or terminate research associated with unexpected serious harm, or not conducted according to its requirements.

There are also penalties for failure to adhere to required research practice. Federal law allows the FDA to withhold approval of new studies or terminate a study. Failure to comply also subjects physician-investigators to the risk of civil liability, including allegations of patient injury and damages. California law also provides for varying criminal penalties, including imprisonment and monetary fines. As noted, physicians should always consider any real or potential “conflicts of interest” when running a trial; examples include financial rewards from pharmaceutical companies sponsoring a trial, and/or the imposition of uncompensated costs on hospitals running trials. Sufficient consent will not necessarily preclude patient claims based on other grounds. For example, the cloning of a human being, or the purchase or sale of an ovum, zygote, embryo, or fetus for the purpose of human cloning is prohibited. However, these are rapidly developing areas of medicine and law and physician-investigators should make all effort to ensure proper compliance.

Conclusion: Clinical trials require serious commitment on the investigator’s part, not only with regard to risk mitigation, but also for the entire process. Although this article mentions a myriad of issues in such trials, some key focus issues include:

• Have detailed and appropriate protocol for patient consenting
• Maintain accurate record keeping for each participant, and the study as a whole
• Use sufficient resources for the trial, whether by supplies or funding
• Retain legal counsel
• Hire sufficiently trained staff
• Clear any conflicts of interest such as advising patients about financial remuneration