What are the Safety Measures of Clinical Trials?

Are Clinical Trials safe? What are the Safety Measures of Clinical Trials?

Introduction

In a clinical trial, the safety and well-being of the volunteer participants is paramount. All researchers, investigators and healthcare workers involved in the clinical study must ensure that the risks of a trial do not outweigh its benefits. Participant inclusion and exclusion criteria are designed accordingly. This is done by sharing complete information of the clinical trial with the participants and their acknowledgement that they understand the risks involved. The participants are made aware of all the procedures, benefits and risks associated with the study. There are also many stakeholders who monitor trials to protect the participants of a clinical study. A regulatory firm like CliniExperts can aid sponsors and stakeholders in conducting clinical trials safely and successfully.

Clinical research offers a lot of hope to patients, researchers, sponsors and all the stakeholders. With the help of clinical trials, patients gain active treatment while scientists and researchers gain insights into the treatment of the particular condition.

Clinical trials also help clinical research stakeholders in successfully translating years of drug research, into finally launching an effective and safe drug into the market and helping patients to get the outcomes they deserve.

Are Clinical Trials Safe?

Participants of a clinical trial can first ensure their own safety by collecting thorough knowledge and information about the clinical trial. This is done with the help of an informed consent form (ICF) provided to them by the investigator and HCPs of the trial.

The informed consent form is a regulatory document which includes:

Details, purpose, duration, procedures of a clinical study.
Risks and benefits associated with the study.
Contact details of the clinical trial personnel.
Participants are free to clear all their doubts and seek additional information related to the study before signing the form and enrolling in the study. They are also free to withdraw from the study at any point of time during the trial.

The following table describes the safety parameters along with its duration in each phase of a clinical trial.

Safety Parameters in a Clinical Trial
Pre-clinical	Lab studies	Several years
Phase I	Human safety	Days or weeks
Phase I/II	Expanded safety	Weeks or months
Phase III	Efficacy & Safety	Several years

Table 1: Safety parameters in a clinical trial

Benefits of Participating in a Clinical Trial

There are a multitude of benefits for patients participating in a clinical trial. Some of these are:

They help patients suffering from a particular disease (E.g.: cancer) to obtain active treatment and careful medical attention from physicians and HCPs.
Patients also receive access and benefits to the new drug/treatment before it launches into the market. They are given additional information, resources, participation in support groups etc.
They are given careful attention from physicians and their health is regularly monitored.

Risks of Participating in Clinical Trial

Along with its benefits, one cannot ignore the possible risks occurring in a clinical trial. A few of them are:

Trials do involve tests/ procedures which may cause side effects, mild complications, and even serious complications such as AEs and serious adverse events (SAEs) to the patients.
The new drug/treatment may not be as effective or may not work as compared to the standard, conventional treatment.
The new drug/treatment involved in a clinical trial may cost the patients more time as compared to them receiving the standard treatment such as additional hospital visits, blood tests, complex schedules, and procedures etc.

Risks involved in clinical trials

Fig. 1: Risks involved in clinical trials

How is the Safety of Participants Protected?

In order to keep the trial participants as safe as possible, there are stringent rules and regulations set in a carefully designed and executed research protocol which must be followed by all the investigators, HCPs, trial patients etc.

Safety measures implemented in clinical trials

Fig. 2: Safety measures implemented in clinical trials

There are 3 main safeguard groups which protect participants namely:

Institutional Review Boards (IRBs): IRBs consist of a committee of experts such as physicians, scientists, authoritarians etc. who ensure that the clinical trial is designed with the highest ethics, and accuracy. They also help ensure that the rights, safety, and well-being of participants are protected at all times. IRBs review and approve clinical trial before commencement.
Regulatory authorities: Authorities like the Food and Drug Administration (FDA), European Medicines Agency (EMA), Central Drugs Standard Control Organization (CDSCO) in India, etc. are responsible for approving clinical trials, providing guidance on trials’ processes, ethical requirements etc. All these are performed to safeguard the trial participants.
Data Safety and Monitoring Boards (DSMBs): DSMBs are made up of experts who closely monitor and inspect a clinical trial as it progresses through the various phases. They are responsible for reviewing trial data, offering insights to the investigators, watching over the safety of the patients, and have the power to stop the trial early, if needed.

How CliniExperts can help?

CliniExperts is a well-established, 360-degree, regulatory consultants’ agency who have many years of industry expertise for clinical trials in India.

They provide faster and better solutions related to clinical trial safety management needs of global local sponsors.
They help in launching the sponsors’ drugs to the market by supporting the products’ life cycle via pharmacovigilance and regulatory activities.

Summary

The safety of participants in a clinical trial is of prime importance. This is why every clinical study goes through stringent review and quality control processes in order to get approved by the regulatory authorities. The healthcare professionals (HCPs) involved in a clinical trial are also trained to always protect the rights, safety, and well-being of participants.
For participants to take part in a clinical trial, they must be given complete and accurate information about its processes. An informed consent form helps achieve this and confirms the participation of the volunteer. It ensures that they are completely aware of the benefits and risks associated with the study.
There are many benefits for patients participating in clinical trials such as better medical knowledge, free treatments, free tests, etc.
Along with their benefits, clinical trials also possess many potential risks such as ineffectiveness, adverse events (AEs) etc.
The Drugs and Cosmetics Act 1940 & Rules 1945 and 21 C.F.R sets out strict rules and for every clinical trial to ensure the safety of participants. The safeguards of a clinical trial are the Institutional Review Boards (IRB), regulatory authorities and Data Safety and Monitoring Boards (DSMB).
CliniExperts’ regulatory services can provide an all-in-one solution to all the safety needs of a clinical trial conducted by sponsors across India.

Conclusion

In conclusion, the safety of participants in a clinical trial takes precedence over all other aspects of the trial as it is one of the main principles of Good Clinical Practice (GCP). Hence, CliniExperts can provide seamless guidance and support to the participants and sponsors associated with a clinical study.

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Are Clinical Trials safe? What are the Safety Measures of Clinical Trials?

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