Frequently asked questions

Find the answers to some of the most commonly asked questions we get from our patients by clicking on the respective dropdown. Have a question that’s not on this list? Please contact us today to learn more.

Definitions

What is clinical research?

Clinical research involves the examination of a drug or device in human subjects. Each clinical trial is governed by a protocol crafted following government regulations and approved by the sponsoring company. An investigational drug could encompass various scenarios:

A drug not yet authorized for marketing, meaning it has not yet received FDA approval and is unavailable commercially.
A drug currently available on the market but under investigation for a new use or in a novel form, route of administration, strength, or formulation.
A drug currently marketed by one company but under consideration for in-licensing or acquisition by another company, even if it contains established ingredients and has not been marketed by the acquiring company.
A drug presently on the market but under investigation in a population for which it has not yet received approval, such as children or elderly patients.

Before an investigational drug or device undergoes human trials, extensive laboratory studies are conducted to assess its safety and effectiveness. Nevertheless, early-stage research cannot reliably predict the drug's safety and efficacy in humans. Introducing any new treatment carries potential benefits as well as known and unknown risks, and clinical research is essential in developing promising new therapies.

What is a clinical trial?

A clinical trial is a research study designed to enable scientists to discover improved methods of preventing, diagnosing, or treating specific diseases. It is the primary avenue for researchers to determine the safety and effectiveness of new tests or treatments in human subjects. Clinical trials may investigate various aspects, including:

New drugs that have not yet received approval from the U.S. Food and Drug Administration (FDA).
Novel applications of drugs already approved by the FDA.
Fresh diagnostic tests for identifying and monitoring diseases.
Innovative devices and tests that may contribute to improved diagnosis and treatment.
Upon confirmation of safety and efficacy, the tested drug, device, or treatment gains acceptance from medical experts as the new standard of care.

Clinical trials represent one of the final phases in a meticulously designed research process, typically commencing in a laboratory where scientists initially conceive and test new ideas. Before introducing any new treatment in clinical trials involving people, researchers invest several years in comprehending its impact on cells in laboratories and animal studies.

The principal investigator, a physician expert in the subject matter of the clinical trial, assumes the role of overseeing, designing, managing, monitoring, and ensuring the integrity of the research project.

Clinical trials typically progress through four testing phases: identifying appropriate dosages, exploring side effects, assessing therapeutic effectiveness, and post-approval surveillance to guarantee ongoing safety for human use. The FDA approves the drug or treatment once researchers establish its safety and efficacy throughout the Phase I, II, and III trials.

What is a Principal Investigator?

A Principal Investigator (PI) is an individual with the requisite education, training, and experience to oversee the proper conduct of a clinical trial, most often a qualified physician. The PI holds ethical accountability for the study and serves as the leader of the study team. The PI is ultimately responsible for ensuring the quality control of study procedures and upholding the integrity and scientific merit of the study findings. The role of a Principal Investigator is pivotal in ensuring that the clinical trial is conducted ethically, adheres to protocol, and produces reliable and valid results while ensuring subject safety.

What is informed consent?

Informed consent is a voluntary and uncoerced agreement made by a competent individual who possesses complete and relevant information, indicating their willingness to participate as a subject in a clinical research trial. The study subject can only provide this agreement unless the individual is a minor or cannot act on their behalf. In such cases, consent may be granted by the subject's parent or legally acceptable representative. The process of informed consent is formalized through a written, signed, and dated Informed Consent form.

Regulations from the Food and Drug Administration (FDA), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), and Institutional Review Board (IRB) stipulate that informed consent must be obtained before any individual can participate in a clinical trial. This ensures that participants are fully informed about the nature of the study, potential risks and benefits, and their rights as research subjects before voluntarily deciding to participate.

Benefits

How does TVCR benefit me?

Over 90% of the Rio Grande Valley's population identifies as Hispanic, yet less than 1% of individuals of Hispanic origin participate in clinical trials across the United States. It is crucial to undertake a deliberate effort to engage and involve a more representative number of Hispanic individuals in groundbreaking clinical trials. This not only benefits the participants but also aids in developing treatment strategies that are specifically tailored for a predominantly Hispanic population.

Outlined below are condensed advantages that patients can experience by participating in clinical research:

Access advanced and promising treatments at no cost before widespread availability.
Receive treatments potentially more effective than the current standard of care.
Obtain medical care, frequent health check-ups, close monitoring, and additional physician support at no financial cost
Expand the range of treatment options available.
Gain information about support groups and resources.
Play a more active role in personal healthcare.
Contribute to the scientific and medical community's understanding, thereby improving healthcare for oneself, family, friends, and the community.

How does TVCR benefit my community?

Tailored Treatment Options: Our commitment to innovation facilitates the development of cutting-edge treatment options specifically designed to benefit a population predominantly of Hispanic heritage.

Attraction of Experts: By bringing scientists and medical experts to the Valley, we enhance the community's access to top-tier professionals, fostering a culture of knowledge exchange and expertise.

Job Creation: Our initiatives create high-quality jobs, contributing to economic growth within the community and providing valuable employment opportunities.

State-of-the-Art Medical Equipment: Texas Valley Clinical Research brings state-of-the-art medical equipment to the Valley, ensuring residents have access to the latest advancements in healthcare technology.

Infrastructure Improvements: Our commitment contributes to improvements in local infrastructure, promoting overall community development and enhancing the quality of life for residents.

Educational Opportunities: The increased focus on innovation creates opportunities for education, training, and skill development, empowering community members with valuable knowledge and expertise.

Community and Medical Conferences: Regular community and medical conferences foster a collaborative environment, encouraging the exchange of ideas and advancements in healthcare within the community.

Support for Centers of Excellence: Texas Valley Clinical Research supports existing Centers of Excellence and contributes to establishing new ones, further elevating the standard of healthcare services in the community.

Preparing to participate

How do I qualify to participate in a clinical trial?

To qualify for participation in a clinical trial, you need to meet specific criteria outlined in the study's protocol. These criteria, encompassing both inclusion and exclusion factors, are established to ensure that participants at all research sites share similar health conditions. This standardization allows researchers to draw meaningful comparisons among participants and effectively study the overall effects of treatments or procedures.

Is it safe to participate in a clinical trial?

Protecting patients in clinical trials is the paramount responsibility of the institution where the study is conducted. Federal, State, and institutional policies and procedures govern clinical research. All Institutions involved in clinical research are required to assure the federal government that research will be conducted with the following:

The most ethical manner
Safety for the patient
Maintaining the privacy and confidentiality of the patient
Patients willingness (via informed consent process) acquired before their study recruitment
Approval from the Institutional Review Board of all the studies conducted

What should I be aware of before participating in a trial?

Indeed, when considering participation in a clinical trial, it's crucial to gather comprehensive information to make an informed decision. Here are some questions you may find helpful:

Purpose of the Study:

What is the primary objective of this study?
What specific question or problem is the research trying to address?

Duration of the Study:

How long is the anticipated duration of the study?
What is the expected time commitment for participants?

Study Requirements:

What tasks or activities will I be required to perform during the study?
How often will I need to visit the research site?

Treatment Administration:

How will the treatment be administered to me?
Are there any specific protocols or procedures I need to follow?

Placebo Use:

What is a placebo, and will I receive one?
If a placebo is used, how does it compare to the actual treatment?

Treatment Status:

Is the treatment under investigation new to the market?
Has it been approved for use in other medical conditions?

Financial Considerations:

Are there reimbursements for travel or any other out-of-pocket expenses associated with participation?
What financial support is provided to participants?

Withdrawal from the Study:

What happens if I no longer want to participate in the study?
Are there any consequences or steps to follow if I choose to withdraw?

These questions can be a starting point for discussions with the research team and ensure you comprehensively understand the study's details, potential benefits, and any associated risks before participating.

Will I get paid for participating in a research study?

When participating in a clinical study, you will receive compensation for your time after each completed study visit. You may also receive compensation for mileage or have transportation to and from the clinic provided to you. Additionally, certain medical procedures or exams related to the study may be provided at no cost to you. Discussing compensation details and any additional benefits with the research team before deciding to participate in a research study is essential.

During the study

What happens during a study?

During a clinical trial, the procedures and processes can vary depending on the specific type of study in which you are participating. Here's a general overview of what typically happens during a study:

Study Introduction:

Before the study begins, the research team will provide detailed information about the study, including its purpose, procedures, potential risks and benefits, and what is expected of you as a participant.

Informed Consent:

You will be asked to review and sign an informed consent form outlining the study details, your rights as a participant, and the potential risks and benefits of participation.

Health Assessment:

At the start of the trial, your health will be assessed. This may involve a thorough physical examination, medical history review, and baseline tests to establish your health status.

Instructions for Participation:

The research team, including the Study Coordinator and Principal Investigator, will provide specific instructions for your participation in the trial. This may include details on medication administration, lifestyle changes, or other study-specific requirements.

Monitoring and Follow-up:

Throughout the trial, the research team will closely monitor your health. Depending on the study protocol, this may involve regular check-ups, tests, or other assessments.

Communication with Research Staff:

It's crucial to maintain open communication with the research staff. If you have any questions or concerns or experience changes in your health, promptly inform the study team.

Post-Study Follow-up:

After the study concludes, there may be a follow-up period during which the research team monitors your health. This allows for the collection of additional data and ensures your well-being.

It's important to note that some clinical trials may involve more tests and doctor visits than you typically have for your illness or condition. Successful participation relies on carefully following all instructions and staying in contact with the research staff throughout the study.

Can I stop participating in a study once I have started?

You can stop participating in a clinical trial at any time, known as "withdrawing your consent." If you discontinue your involvement in the study, you must communicate your decision to the Study Coordinator or Principal Investigator. Additionally, sharing the reason for your withdrawal is valuable information for the research team. Your decision to withdraw will be respected, and you are under no obligation to continue participating if you choose to stop.

If I have adverse side effects, will I receive medical treatment?

Absolutely! You will receive immediate and comprehensive medical attention if you experience adverse side effects from participating in a clinical trial. Suppose the drug, device, or intervention under investigation directly causes the observed side effect. In that case, the medical care provided will come at no cost to you or your health insurance.

This aspect is one of the advantages of being involved in a clinical trial as a research participant. Not only do you have the opportunity to access innovative treatments without charge, but you also benefit from regular monitoring visits. Importantly, you can have peace of mind knowing that if any complications arise, you will receive prompt and cost-free treatment, ensuring your well-being throughout the trial. An individual does not need health insurance to participate in a clinical trial.

TVCR Locations

How many locations does TVCR have?

We now have two locations! Our original location in Weslaco remains open, and we’ve expanded with a second location in Mission to better serve our community and offer more clinical trial opportunities.

Will both locations offer the same studies?

Not necessarily. Some studies will be available at both locations, while others will be specific to one. If you’re interested in a study, we’ll let you know which location is conducting it.

Can I choose which location to visit?

Your study location will depend on where that specific trial is being conducted. If a study is available at both sites, we can discuss which location works best for you.

How do I know which location I should go to for my appointments?

When you enroll, we’ll confirm your study location. If you’re unsure, just reach out to our team, and we’ll be happy to clarify.

Will the same doctors and staff be at both locations?

Each location has its own dedicated team of doctors, nurses, and research staff. No matter which location you visit, you’ll receive high-quality care from experienced professionals.

How does opening a second location impact your involvement in the community?