Diversity And Inclusion In Clinical Trials
Any new medicine or therapeutic being developed must go through a series of phases that include tests on humans before doctors can prescribe it for general use. Data from clinical trials on humans is analyzed to determine safety and efficacy of the drug and for seeking approval from regulatory bodies such as the U.S. Food and Drug Administration, Health Canada and European Medicines Agency.
Why is diversity in clinical trials important?
Over the years, there have been growing calls for diversity in clinical trial panels to accurately assess the impact of new drugs on different ethnic and racial groups. This issue is once again under the spotlight now during the COVID-19 pandemic as racial and ethnic minorities have been disproportionately affected across the world, including the United Kingdom and the United States.
Diversity in clinical trials is not all about race, but gender too. There was a time when participants in clinical trials were mostly Caucasian males. For many years, questions related to the safety and efficacy of drugs on women, children and ethnic minorities remained unanswered.
In the absence of diversity in clinical trials, different people may respond differently to the same medication. Age, gender, weight and ethnic origin may play a role in how a treatment may work or how safe it may be. For example, a Hispanic patient may not respond well to a drug that may have worked well for an Asian or Caucasian patient with the same condition, or vice versa. It is therefore critical to ensure diversity in clinical trials.
What steps have been taken?
In 1993, the National Institutes of Health (NIH) released its new policy mandating all federal grants for clinical research to include women and minorities. “Since a primary aim of research is to provide scientific evidence leading to a change in health policy or standard of care, it is imperative to determine whether the intervention or therapy being studied affects women or men or members of minority groups and their subpopulations differently,” the document read.
In the year 2015, the FDA launched an ambitious Drug Trials Snapshots program. The purpose behind this program was to make demographic data more available and transparent, providing the public highlights of where the trials were conducted and whether there were any differences in the benefits and side effects among different demographic groups. The data generated shows that while participation of women has grown rapidly in recent years, and sponsors are including more elderly patients, most studies still enroll relatively low percentages of Black, Asian and Hispanic volunteers.
The FDA, in November 2020, issued a range of suggestions in a document titled ‘Enhancing the Diversity of Clinical Trial Populations’. The document details the different steps sponsors and research sites can take to facilitate participation of ethnic groups in clinical trials.
Challenges to having a diverse study panel
Despite regulatory bodies calling for increased diversity in clinical trials, it’s sometimes difficult to have equal representation in drug development programs. The reasons for this vary from linguistic and cultural barriers to religious and physical barriers. The proximity of study sites to diverse neighbourhoods and lack of awareness sometimes contribute to the challenges as well.
The recruitment process for clinical trials varies from sponsor to sponsor and often leads to lack of diversity in study panels. For example, a sponsor may choose to recruit from a designated medical institute, recruiting one demographic alone, while another sponsor may choose to recruit online, attracting volunteers of different sex, age and race.
What can we do to increase diversity in clinical trials – BioPharma’s response
With thousands of volunteers in our database, BioPharma Services is committed to establish inclusive study panels for its comprehensive drug development programs.
Our team has organized multiple recruitment drives in 2020 to spread awareness among ethnic and racialized communities. We continue to recruit thousands of women for a range of studies via online channels.
At BioPharma, we understand that awareness and personal communication plays a key role in developing trust and educating volunteers of different ethnic groups. Such initiatives, if undertaken by other key organizations will help build more diverse and inclusive clinical trial panels leading to medicines that are safer and more effective for everyone.
To learn more about our award-winning research services, click here
About BioPharma Services Inc.
BioPharma Services Inc. is a full-service Contract Research Organization (CRO) specializing in the conduct of Phase I/IIa and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma has clinical facilities both in the USA and Canada with a total capacity of 300 beds with access to healthy volunteers and special populations. Headquartered in Toronto, Canada, BioPharma’s comprehensive services also include Bioanalysis at our GLP Certified Laboratory, Scientific and Regulatory Affairs, Biostatistics and Safety Data Analysis (CDISC), Data Management and Medical Writing.
What are early phase clinical trials?
Clinical Trials are divided into 4 phases. Phase 1 and 2 trials constitute early phase trials, Phase 3 and 4 research studies are late-phase trials.
The primary objective of Phase 1 studies is to determine the correct drug dosage by evaluating drug safety and determining if there are any side effects. Phase 1 trials are conducted in healthy volunteers.
Phase 2 studies also study the safety of a drug but focus on evaluating its effectiveness. These studies can be conducted in healthy volunteers or in individuals who have a certain disease or condition.
What is a clinical trial?
A Clinical trial is a process which is performed to determine whether an investigational drug, device or therapy is safe and effective. In early phase research (i.e. Phases 1 and 2), the safety and effectiveness of the drug will be evaluated in healthy volunteers.
What is an investigational drug?
An investigational drug can also be called an experimental drug and is being studied to see if your disease or medical condition improves while taking it. Scientists are trying to prove in clinical trials:
- If the drug is safe and effective.
- How the drug might be used in that disease.
- How much of the drug is needed.
- Information about the potential benefits and risks of taking the drug.
Why do you need to take blood draws and how many blood draws will be required?
In order to evaluate the drug profile, we need to understand its pharmacokinetics. This is essentially how the body reacts to a drug after its administration through the mechanisms of absorption, distribution, as well as the metabolic changes. Therefore, blood draws are collected at various time points to better understand this mechanism. Each study requires a specific number of blood draws and total blood volume. These values will be provided to you and clearly stipulated in the informed consent form (ICF). The amount of blood that will be taken is outlined in the ICF.
Should I expect to experience any side-effects while doing studies?
As every study is testing an investigational product, there may be side effects. You will be provided with a list of side effects that have been reported in previous trials (if any), so you can make an informed decision whether or not to participate in the trial. During the trial you will be required to immediately inform clinic study staff of any adverse effects that you are experiencing. These side effects usually resolve upon discontinuation of the study drug.
Will I be compensated for doing a clinical study?
Volunteers are compensated and the amount varies depending on the length of the clinical trial, length of stay and number of follow-up visits. The compensation is not specifically related to the risks or type of drug involved in the trials or studies. Every study is different and therefore, the compensation will vary. Study volunteers may receive between $1000 to $4000 for a trial (based on the factors listed above).
Are food and accommodation provided over the course of the trial?
Food – Clinical trials are conducted in a controlled setting which means that all food is provided and trial volunteers receive standardised meals. Individual meal plans or meal preferences cannot be provided. If you have any food allergies or hypersensitivity to food product(s) that are clinically significant or life-threatening you may not be able to participate in a trial. Please contact us to discuss any food issues.
Accommodation – During your in-clinic stay you will share sleeping areas with other volunteers who are of the same gender. Similar to a hospital setting, supervision will be provided to ensure that your health and safety are being monitored.
What is the length of a study and do I have to complete all the visits?
What is informed consent and how is it carried out?
Before you decide whether or not to take part in a clinical research study, you will be required to read and understand the information provided in an Informed Consent Form (ICF). The ICF describes the clinical research study and the nature of the investigational product to be used, including:
- Your rights and responsibilities as a study participant.
- What you will be asked to do during study participation.
- The potential risks that you should be aware of.
During this process, you will have the opportunity to discuss and ask questions related to the conduct of the clinical research study with the study doctor/ study staff. You are under no obligation to participate and your decision to take part in a clinical trial is voluntary.
Can I bring my own device?
Yes, we encourage you to bring items that will help to pass the time while you are in the clinic. You can use the time to study or work or catch up on the movies you’ve been meaning to watch.
What do I need to pack?
When do I receive compensation for taking part in a study?
You will receive compensation as outlined during the Informed Consent process. Typically, you will receive compensation once all study visits have been completed. If, for any reason, you do not complete all study visits, your compensation will be on a pro-rated basis (i.e. for the time that you have participated in the trial)
Where will I sleep during the clinical study?
What COVID-19 precautions are you taking?
Can I bring my own food?
All aspects of clinical trials are closely monitored including the food and drink consumed by participants. While you are in the clinic, you will be provided with all meals as per the study guidelines. You will need to eat all the food provided to ensure the guidelines are met. Watch video