The basis of clinical research lies in the fact that it is not possible to conduct a clinical trial of new drug/device/diagnostic kit/treatment methodology on all the applicable patients across the globe. One shall select the group of patients who remarkably resemble total populations. Once the clinical trial is conducted in most representative patients and found safe and effective, the underlying test product is approved for the use in larger patient population and gain access to the market.

As the research is conducted in representative patients determines approval (based on the safety and efficacy), it’s imperative that clinical research shall be conducted in accordance with national and international guidelines. These guidelines demand basic commitment to safeguard the rights and safety of research participants which is ultimately related to ethical conduct of clinical trials.

Current approaches and execution

The eligibility criteria are varied across a broad clinical trial criterion thereby raising chances for patients for more than a single trial. A clinical trial needs strategic assessment of the availability of trial with stakeholders, including treating physicians, research investigators, institutions involved, funding agencies, ethics committees, regulatory agencies and, most importantly, should also include patients and caregivers.

From the time at which the clinical trial option is decided to be considered the approach towards complete disclosure and the procedure of the trial is presented to the patients based on individual risk factors, potential therapeutic benefit, and study requirements. Under some rare circumstances where clinical trials are considered the most encouraging option available, it often results in a demand for participation that exceeds the availability of the spots with a shift in the immediate aim to protect patients and ensure equal access to therapies.

In such circumstances, the ethical weightage plays a vital role in determining the entitlement, fair access such as enrolling the most needed patient first.

Ecosystem of ethics

The system around the decision making of a patient’s enrolment and the evolving environment of clinical trials is charged with multiple challenges. At times, some research may be exposed to minor pain, uneasiness, discomfort, or also injuries from medical procedures as well as side effects of drugs. All of these should be considered as ethical risks for review. Participation in a trial could also affect an individual emotionally and mentally resulting in stress, guilt, depression which could be transitory, concurrent, or permanent in nature.

There is a need to address any conflicts of interest to guide the investigators for ethical ramifications and change in approaches. This also includes medical management of adverse events during the study, compensation for serious adverse events related to the drug/treatment under investigation and considerations to avoid risks associated with biases.

The new drugs and clinical trials rules 2019 has helped the clinical trial industry in alleviating few ambiguities related to medical management of adverse events and compensation related queries.

Steps to deal with challenges

Permitting clinical trials post risk benefit analysis favouring participating patients

Creating an article of faith who volunteer for trial with respect and justice. This includes allowing the patients to have the autonomy to choose, right to discontinue or withdraw without loss of any benefits that could occur potentially in the future.

Ensuring informed consent being obtained without coercing and post providing necessary information to participating patients

Making new information on drug/treatment under investigation available to participating patients in real-time basis

Mitigating the conflicts of interest through full disclosures without which the risks will definitely be amplified. The clear definition of privacy and confidentiality.

Ethical committees should work with investigators for potential harms and how it can be monitored as per the research proposals with minimum risk.

Identifying pertinent issues through patient advocacy groups and addressing them with ethical research mandates.

Working towards globally accepted and guidelines and adoption of fair practices to adhere by ethical means to tackle issues that resonate with the values of ethical trial in a seamless manner

Improving the quality of data so that it can be reproduced, compared, and validated with utmost transparency of conduct of the trial

In case of study on vulnerable subjects, there shall be direct benefit to them from the results of the research

Making the trial information available to public through registration of clinical trial on www.ctri.in (Clinical trial registry, India)

Ensuring post trial access to participating patients if the drug is showing benefit to the participating patient

Providing medical management for adverse events assessed related to study drug and compensation in case of study drug related injury

Ethical aspects in clinical research identify and check risks for individuals participating in clinical trial for the benefit of society at large. When a treatment option is being considered as a part of a clinical trial all the potential parameters and basic framework outlining the ethical challenges should be given due consideration.

Any kind of practical, political, and economy-related factors that inadvertently or deliberately play into a decision-making to not disclose investigational options to a patient should be strictly mandated. Patients should be acquainted with all the options in a balanced and unbiased accession.

The ethical wins should be successfully cast forward in a virtuous manner ensuring access to information and research. Post-research issues must be addressed with considerable understanding by stakeholders meanwhile protecting every right of the participants. A well-structured regulatory principle and capacity building at various levels can ensure the ethical well-being of clinical trials.

At times there may not be a single solution for all types of research, however, ethical committees can continue having dialogues with the relevant stakeholders to get the maximum possible benefit for the participants.

The writer is Vice President Clinical Operations and Biometrics, SIRO Clinpharm

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