Understanding Clinical Trials: Frequently Asked Questions
Are you new to the healthcare industry and want to learn more about clinical trials? Or are you curious about the specifics of patient care during clinical trials?
Clinical trials are often complex studies that span multiple years, with a wide variety of professionals taking an active role. This blog breaks down the critical stages of clinical research and how patient support services can benefit trial stakeholders and improve performance.
Why are clinical trials important?
Clinical trials are essential because they test the efficacy of a new drug, medication, or procedure before it is available to the public. These health-related studies test new drugs or procedures on humans to prevent, diagnose, and treat diseases. Clinical trials are the safest and most streamlined way to find treatments for conditions like diabetes, genetic disorders, or rare cancers. The goal of clinical trials is to save lives.
Who conducts clinical research?
A clinical research team includes a wide range of professions and roles, comprised of doctors, nurses, social workers, research assistants, and other healthcare specialists. Clinical researchers play a crucial role in conducting clinical trials under the guidance of the Principal Investigator. Their duties include screening patients, maintaining patient care, and submitting clinical trial findings.
Pharmaceutical sponsors, contract research organizations, and clinical sites often work together to support clinical research studies. Their roles are unique, but they all work together to reach specific clinical trial endpoints.
- Often provide financial support and oversight
- Staff collect and analyze trial data
Contract Research Organization (CRO):
- Supplies clinical trial management services for the pharmaceutical, biotechnology, and medical device industries
Clinical Trial Sites:
- Support both the patient and pharmaceutical sponsor
- New therapies and medical devices are tested on humans at clinical trial sites. The data collected at clinical sites is then provided to the United States Food and Drug Administration (FDA) for approval.
- The sites must follow strict regulations and standards to ensure patient safety
- Sites also implement technology focused on streamlining the operational processes at the site to increase performance efficiencies.
How do clinical trials operate?
There are four phases of a clinical trial. Each phase investigates the new treatment to find the proper dosage and understand the medication’s effects on humans.
Phase I: Safety
- Involves 20-80 participants
- Tests experimental treatment on a small group of healthy participants to determine the safety and side effects
Phase II: Effectiveness
- Goal is to understand the effectiveness of the medication
- Research finds preliminary data on whether the drug/procedure works for people with a particular condition
- Investigates short term side effects and the safety of the study
- Often lasts several years
Phase III: Effectiveness – Part 2
- Number of patients is larger, ranging between several hundred to 3,000
- Focuses on various populations and investigates different drug dosages and interactions with other drugs
- Phase III determines if the drug is FDA approved
Phase IV: Post-Approval
- Takes place after the FDA approves the new treatment
- The approved drug/device is monitored in diverse populations, measuring effectiveness and safety.
Who can participate in clinical trials?
Clinical trials would not be possible without participants. Patients often participate in trials because most standard treatment has failed or want to contribute to medical advancements. Participant diversity is essential in clinical trial research. It is crucial to have diversity in age, gender, race, and ethnicity to determine how the drug will affect differing patient populations. Clinical trials including diverse participants will yield results benefitting a broader patient population.
What are orphan drugs and rare disease clinical trials?
Rare disease trials are one of the many areas of focus in the medical community. The main challenge for rare disease trials is a lack of awareness and in-depth knowledge in the medical community because the disease is so rare. This education gap can affect the frequency of trials and funding. These challenges impact sponsors by making it difficult to identify principal researchers.
Other challenges include:
- Expensive travel costs for patients, as most must travel over 60 miles to be a part of the trial
- According to NORD, 76% of people experience financial hardship due to their rare disease
The key to a successful rare disease clinical trial is focusing on the perspective of the patient. Patient support services are vital for trials focused on rare diseases, as they help eliminate many of the barriers to trial participation.
Orphan drugs are treatments specifically intended to treat rare diseases. While the pharmaceutical industry does not develop them for economic reasons, they respond to public health needs.
What are clinical trial reimbursements?
Patients receive reimbursements for expenses throughout the clinical trial process. Finding what payment is suitable for your trial is a key step in providing the best care for patients.
Choosing the correct payment method for your trial depends on many factors:
- Type of clinical trial
- Patient population
- Disease type (common vs. rare)
- Number of patients
- Trial site locations
- Regulatory hurdles
Clincierge reviews the study-specific requirements of each clinical trial and consults with the study team to determine their patients’ best payment options.
What are Institutional Review Boards (IRB) and Independent Ethics Committees (IEC)?
Independent Ethics Committees (IEC) are comprised of various pharmaceutical stakeholders who discuss the clinical trial’s scientific, ethical, and legal ramifications and evaluate the benefit/risk factors involved. They ensure all research and medical experiments operate according to national and international laws.
Institutional Review Boards (IRB) are a formally designated group assigned to monitor and review any medical research involving human subjects. This team has the authority to approve or disapprove research and ask for research modifications to lead to FDA approval. Their responsibilities include protecting and assuring that patients’ rights and welfare are honored before they begin their participation (with appropriate protocols in place) and throughout the clinical trial process (through periodic study reviews).
How do patient support services impact clinical trials?
Patient retention is vital to the success of a clinical trial. However, many patients find it hard to continue through the trial due to a plethora of emotional, financial, and logistical burdens. The main mission of a patient support company is to support patients and their caregivers throughout the trial. By focusing on patient-centricity, retention rates increase, and study outcomes improve.
How does Clincierge support clinical trials?
Clincierge is a market leader in the patient support service industry. We have multiple white glove services, including patient logistics management and clinical trial site support. These services include patient travel, accommodation, and global translation. With many years of expertise in the field, over 300 trials supported, and the highest industry retention rate, Clincierge provides well-rounded patient support services. Clincierge additionally supports patients with our Pay Portal, providing faster reimbursement payments, less paperwork, and vetted payments to ensure accuracy and ease the burden on trial teams and patients.
Clincierge provides unique and tailored support for trial sponsors and patients through our one-on-one coordinator model. Building trust with patients and caregivers is a top priority for our patient support services coordinators. Each coordinator is assigned to a patient to provide continuous support and works with them for the length of the clinical trial. Our services help clinical trials follow set timelines, enable better outcomes, and increase patient retention.
The ultimate value of partnering with Clincierge is ensuring the clinical trial patient has a voice and support during their trial. Our services and vision are to humanize the patient’s experience while providing a reasonable return on investment.