Medical and Clinical Research
Creating a treatment plan for an individual varies according to different factors. These factors include a person’s age, gender, height, ethnic background, existing health conditions, risk factors, and more. Human health is complex. It is not just about physical well-being but also the mental and social experiences that humans go through on a daily basis. For example, one’s geographic location or gender identity makes one more prone to certain conditions than others. Therefore, there is a shift in the conduct of clinical research that specifically focuses on diversity in clinical trials.
Health equity is a hot topic and it has been a long-brewing concern for researchers and medical experts involved in a clinical trial. It is important to get volunteers from clinical trials across all aspects of society to ensure that everyone is accounted for in the study of a particular condition, as well as to recommend the best course of treatment for them.
Why Are Diversity & Inclusion Important in Clinical Trials?
The importance of clinical trials diversity has a widespread reach in the healthcare industry as its main goal is to address every representative patient population. In many of the former clinical research studies, minority health needs are often overlooked simply because racial and ethnic minorities are underrepresented during the selection of trial participants.
Addressing the issue of a lack of diversity in clinical trials can offer the following benefits:
Increased Representation for Underserved Populations
Whether we admit it or not, there has been an unconscious bias over the past decades when it comes to participation in clinical trials for various socioeconomic backgrounds. Inclusive participation in clinical trials will provide a more accurate evaluation of the diverse communities and allow the delivery of effective health care. Diversity in the conduct of research studies will acknowledge the healthcare needs of patients belonging to racial and ethnic minorities.
Improved Trust in the Validity of Clinical Research
Clinical research sites are often centrally located. Hence, the issue of the lack of diverse populations among the participants builds mistrust among the general public about the effectiveness and validity of the data generated from the clinical trials.
With the increased globalisation of different national institutes and research professionals conducting clinical trials, there is also an increased need for appropriate representation among trial participants. Improving diversity helps in reducing barriers and offering greater access to the entire population, as far as new treatments are concerned instead of being limited to certain groups.
Improve Treatment Effectiveness for New Drugs or Treatment Methods
As mentioned above, several factors can impact one’s health and well-being. It’s not just physical ones; socioeconomic status, geographic location, gender identity, and other factors that can also result in access to health care services and health disparities. It is important to acknowledge and address the significant differences among each group to ensure treatment effectiveness is continually improved.
Another crucial factor that calls on for increased diversity in clinical trials is that earlier biomedical research studies did not take into account sexual and gender factors. As a result, clinical trial populations do not reflect and address diversity in society. This is about to change as diverse backgrounds are now one of the main interests for setting the eligibility criteria for clinical trial participants.
Types of Barriers to Entry in Clinical Research
There are several known barriers to addressing diversity in clinical trials, which can significantly impact the result of clinical studies. Therefore, it is important to identify these barriers to come up with a decisive plan to bring in more participants, especially those from diverse racial and ethnic backgrounds.
Socioeconomic Status
Socioeconomic status is one of the main barriers to an increased patient population among clinical trial participants. This factor is also one that has the most impact in terms of trial participation diversity.
People who have lost their job or dealing with financial hardship are less likely to become involved in studies. This is true even for patients who could benefit from participation in clinical studies to get new treatments or drugs. Make sure you come up with strategies to get these patients to join, as well as break down the barriers that give them access to clinical trial participation in the first place.
Geography
Geographic limitations are another common barrier to entry to clinical research. According to Science Daily’s study, more than half of the patients don’t have access to clinical trial facilities in their immediate location. Therefore, this can discourage them to volunteer for these studies even if they have an interest or willingness to do so.
Decentralisation of clinical trials is now being looked at as one of the solutions to overcome this challenge. By making clinical trial sites more accessible, you can also expect higher diversity among the patient population for your studies. At the same time, it will allow you to target certain groups based on the specific disease or nature of the study.
Distance is not the only issue that should be addressed here. There is also the problem with time commitment. Virtual trials can resolve this so that patients have more flexibility in participating in these trials.
Limited Technological Access or Literacy
Since the pandemic, there is growing evidence for the need to switch to technological tools or rely on technological advancements to improve the delivery of health services. Unfortunately, it also poses another problem. Those patients who belong to the lower-income brackets don’t have access to technological infrastructure that makes trials accessible to them. Most of the minority groups live in areas wherein there is limited access to or poor internet connection.
For some patients, even if they do have access to technological infrastructure, the lack of literacy in using these tools can also serve as a barrier.
Patient Education
Patient education is an important factor in the success of conducting clinical trials and promoting diversity. The more a patient understands the process and its benefits, the more likely they are to be encouraged to join. Highly engaged patients have higher involvement too.
It is important to focus on patient education first when conducting clinical studies. Make sure you let the patients understand how clinical research works, its benefits, and the role they play in its success. Make sure to take into account the individual level of understanding of each patient, as well as the method of communication used. If you are going to focus on improving diversity, make sure that you adapt your recruitment process to consider factors such as ethnic disparities, language barriers, etc.
Clinical Trial Participation
The best way to understand the level of participation among diverse patient and minority groups is to look at the important statistics of past trials and studies.
Clinical Trials Statistics
The following are the important statistics for clinical trials to understand which areas can be improved. These statistics are derived from the data gathered by the Health Information National Trends Survey and the World Health Organisation.
- 41% of US adults were not aware of what clinical trials are, as of 2020.
- From 2000 to 2020, the number of clinical trials done per year grew from 2,786 to 671,228.
- As of 2020, the highest number of clinical trials activity was conducted in the following regions (from the highest to lowest): Western Pacific, Europe, Americas, Southeast Asia, Eastern Mediterranean, Unknown, and Africa. From 2000 to 2020, the number of clinical trials done in African regions has not had a major increase.
- The majority of clinical trials are done in the USA, followed by China, Japan, Germany, and the UK.
- About 78% of trials included both genders as participants. Meanwhile, 9% of trials consisted of female participants and 4% consisted of male participants.
- Adults make up 73% of clinical trial participants from 2000 to 2020. It is followed by older adults (64%) and adolescents (61%).
Patient Recruitment
The patient recruitment process plays a critical role in the success of conducting clinical trials and addressing diversity. While crucial to the success of the study, it is also the most challenging aspect.
How come patient recruitment is difficult to execute despite being a critical aspect of clinical research?
The main challenge here is to find patients strategically. While there might be available volunteers and participants, ensuring the quality of the demographic data as being relevant to the nature of the study is important. The risk of enrolling participants who are not the best fit for the nature and scope of the study could mean negative consequences to the clinical trial results. It could also lead to a waste of money for sponsors and stakeholders who provide the funding for the study.
Researchers and research organisations need to build patient recruitment strategies that fit the timelines and budget of the study. Make sure there is also a proper alignment with the nature and purpose of the study in the selection process of participants.
Clinical Trial Challenges & Opportunities
Identifying the challenges to effectively conducting clinical trials will help you seize the opportunities to make improvements.
Decentralisation of Clinical Trials
This solution has been tackled a few times in this guide, which explains the urgency surrounding its implementation. Decentralising clinical trials is easier said than done. However, successfully implementing it would mean that you can access patients who are from diverse backgrounds.
Decentralisation will also most likely address any of the barriers to entry to clinical research and give you a more appropriate representation of the patient populations.
Language & Cultural Barriers in Clinical Trials
With more clinical research studies being done outside of the US or other English-speaking nations, language and cultural barriers will arise. However, a reliable language service provider that offers quality medical translation can overcome this issue.
Making International Trials Possible
Conducting studies in more international locations and platforms can give you access to a more diversified study object. The use of virtual tools and technologies can facilitate this to ensure that geographic limitations can be overcome with ease.
At the same time, an understanding of international regulations in performing clinical trials should be at the heart of your clinical trial planning to ensure that you can ethically and safely perform these studies without legal consequences.
Why Clinical Trial Translations Matter
Clinical trials are growing in importance due to the rapid globalisation of the health industry. The only way for a clinical trial to succeed is if the doctors and researchers are able to get a significant representation of the population in the trial to ensure the effectiveness of new treatments and drugs. Hence, it is crucial to conduct clinical tests and trials on a global scale.
This is where clinical trial translations matter. It enables the localisation of clinical research and trials to encourage enough volunteers and reduce the trial costs because the studies are decentralised. For example, clinical researchers in Europe or Asia can conduct their tests and research in their own facilities rather than more centralised locations and facilities in the US.
Translation also matters when conducting clinical trials and promoting diversity among participants because it enhances the understanding of the scope and purpose. If there is a misunderstanding or a lack of knowledge among the participants, they will be hesitant to volunteer. Even if they do participate, the lack of full understanding of the trial’s scope can significantly impact the results. A precise translation of documents related to the trials and studies is important so that the participants can fully consent to the activity. Also, it ensures that they are made aware of the potential risks of participating, especially when it involves new therapies and drugs. Otherwise, the research professionals and biopharmaceutical companies conducting the trials could face legal risks.
With the expansion of clinical studies for new treatments and other drugs, you can expect the geographic location of clinical studies to expand. It will bring greater access to treatments and drugs, which could benefit the healthcare industry in the long run.
Increasing Diversity in Clinical Trials
Understanding the impact of diversity in conducting clinical research studies is only the first step. It is important to devise concrete steps on how to expand access to a more diverse population in finding volunteers for clinical trials. Filling in the diversity gaps can address structural racism in the healthcare industry and ensure more ethnic groups like Asian Americans, African Americans, and American Indian groups can also participate in clinical trials.
The following are the recommendations on how to promote diversity in clinical trials.
Identify the Representative Patient Population for a Particular Disease
Diversity in clinical trials is not just about finding people of diverse racial and ethnic backgrounds. It is also important to identify the best patient population when studying a particular disease. It requires a thorough analysis of your demographic data to match the racial diversity and exclusion criteria for specific health concerns.
Representing minority groups in clinical trials is not enough. You must also address the specific health issues and identify whether racial and ethnic factors play a role.
Shift Focus on Disease Registries
The success of clinical research and trials indeed relies on addressing the unique needs of different populations. But to support the idea above, you can focus on disease registries in the recruitment process of clinical trials. This registry contains crucial information about the personal and demographic data of patients so you can determine if they are the best representative for the research being conducted.
By tapping these registries, the national institute and research organisations can create patient segments and sub-segments. These can be properly matched with the study being conducted, such as for analyzing high blood pressure risks or cancer clinical trials.
Decentralise Clinical Trials
One of the solutions looked at by healthcare organisations and research professionals to improve diversity in clinical trials is to look outside of the traditional academic medical centers when looking for volunteers or trial participants.
This is not a new recommendation and decentralising clinical trials, along with the rise of virtual clinical trials, contributed to this idea. This approach makes sense if you want to target diverse patient populations for your research. Many racial and ethnic communities are located in areas outside where these medical centers are located. Limiting research activities in these traditional clinical research sites and academic medical centers also limits access to underserved populations. In turn, the representative population for the research is inaccurate and is plagued with diversity gaps. The research integrity is compromised as it does not reflect real-world data.
Go Where the Patients Are
Another important step to improving diversity in clinical trials is to reach out to patients. Biopharmaceutical companies will spend more resources and manpower on this but it could be well worth it because it allows them to tap into different communities. Diversity is within reach and it boosts the quality of the research results as you have better representation as far as the community networks and health systems are concerned.
A direct-to-consumer approach is also another creative step to getting more patients involved. You have to think about the right channels to use to reach out to diverse patient populations so that your message can get to them.
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