Clinical Data Management Interview Questions

Clinical Data Management Interview Questions

I’m posting to let you know what kinds of questions you might expect to be asked during a CRA interview. Practice these in the shower, in front of the mirror, or with a friend so you are prepared!

Typical Questions
Here are general questions that you will likely be asked with tips for answering shown in italics:

  • Tell me about yourself? Keep it short and hand them a copy of your resume to look at while you give the penny-tour of your background and experience. Showcase yourself, “I live in San Francisco and I have 5+ years experience in this industry. I have been working as a CRA for over 18 months. I have had the opportunity to work in Phase I, II, and III trials for the following indications… I attended courses for CRA training through a local university and I am an active ACRP member.” Be prepared to explain why you are currently job seeking and any gaps in your employment history or a trail of many past job over a short period of time.
  • What are your salary requirements? I’ve had success with this script, “I will consider the entire package including employer flexibility, 401K, a competitive benefit package, etc. However, my minimum salary requirement is $$$$. I would be pleased by a compensation package that includes benefits and incentive compensation to increase the value. From my research, it appears that similar positions in this industry are paying between $$$$ to $$$$.” Then be quiet!!!
  • What percentage/amount of time are you willing to travel? Be honest. Travel is difficult and it is not in yours or the employer’s best interest for you to misrepresent yourself when this question is asked.

So here are the more role-specific questions:

  • Have you had GCP training or formal CRA training through an employer or accredited course?
  • Do you have experience with the following?
    o Regulatory document review
    o Selecting and recruiting qualified and interested investigators
    o Performing source document verification
    o Utilizing EDC, electronic diaries, or IVRS systems
    o Database close
    o Development of protocols or ICF?
  • Do you have experience with the following therapeutic areas: Cardiovascular, CNS, Oncology, Diabetes, HIV, etc.? If you are interviewing with a CRO this is especially important because they will need to market you internally and to clients. There is no sense in lying here because there is no substitute for experience. Try to highlight experiences you have from other jobs that better prepare you for a monitoring role. For example: “Although my oncology experience at this point has been limited to clinical database and CRF design, that experience has afforded me the opportunity to read through no fewer than 10 to 15 different oncology protocols from a variety of sponsors and assist (at least on the data end) in these sorts of trials. I have had the opportunity to develop some very fundamental and transferable skills in XYZ indication this past year related to study start-up, maintenance, building/maintaining relationships with study sites, trial fiscal management, and facilitating cross-functional trial specific working teams to track and deliver important study milestones on time/budget.”
  • What is the greatest number of [protocols, sites, patients] that you have been responsible for at any one time?
  • Which phases have you worked in?
  • How many [pre-study qualification visits, site initiation visits, site monitoring visits, site close-out visits] have you conducted in your career?

Undoubtedly, the last question you will be asked is, “Do you have any questions for me or about our company?” And the answer is, Yes, you do! I know you will be nervous, but ask good questions and listen to the answers to the questions and try to get feedback during the interview so you know how you are doing.  You may have been misunderstood during the interview or missed an opportunity to really sell yourself.  Asking great questions will give you one last chance to show your best or address any concerns the interviewer has before you part or even in a follow-up letter or email.  Here are some generic ones, but you have to ask something:

  • Describe the three top challenges that I’ll face in this job?
  • What are the key metrics for measuring success in this position?
  • If I were offered the opportunity to work with your organization, what would you like me to accomplish in my first 90 days?
  • How would you describe the qualities of the most successful people at your company?
  • How closely do my qualifications match the requirements for the open position?

Interview Styles
At this point, I want to mention that there are various interview styles. Being familiar with how (and why) questions might be asked will only help make you more prepared when it is time to come up with the answers. I am going to discuss a few interview styles below. The person conducting the interview may stick to just one style or have a mix of several – this is especially true when you are in a panel interview. Then it feels like you are in a firing range but just stay calm and try to engage the panel so you aren’t doing all the talking. After all, this is your opportunity to interview them, too, right? Anyway, here are a few interview styles you might encounter:

Behavioral – Everyone knows that past behavior is a very good indicator of future performance. This interview style will require you to answer in a manner that shows you are creative and quick on your feet. Sometimes the right answer is not as important as the delivery. Before you answer think hard about why they are asking this particular question and try to cite examples of past behaviors that are relevant to the job you are applying for and explain at the end how the skills and experience you are describing would be transferable in your new role. If they ask you about a past mistake or you describe something you did but would now do differently, say so and explain why. Nobody is perfect so showing that you learn from past experiences can only help you in the interview.

  • Tell me about a time when you showed your ability to [adapt to a new situation, solve a problem, etc.].
  • Tell me about a time when you demonstrated [initiative, integrity, excellent communication, etc.].

Situational/Scenario – If you have no idea what the right answer is, you can try stalling, asking the interviewer for help, or just qualifying your response. For example, “Honestly, I am thinking of a few possible answers for the question. On the one hand, I feel like this might be the right response, but on the other hand, I can see a scenario where this might be the right approach. Which are you looking for?” or “Well, I must admit that I haven’t ever been faced with this particular situation, but I imagine I would handle it as follows….” Here are some examples of situational questions:

  • You’re at a site and discover an unreported SAE, what would you do?
  • You are performing a routine monitoring visit and discover that the site has enrolled a subject but forgot or improperly consented them, how would you handle this situation?

Assertive – I personally find this style offensive. Any employer that utilizes these tactics is likely not one that I am very interested in working for. After all, if they are a jerk in the interview, what is it going to be like on a daily basis or when it is time to sign your expense reports, or partner to work on your performance goals, etc. In any case, an assertive interviewer will treat you really nastily or act very cold/aloof to see if you will get nervous or flustered. I find brevity is key in these types of interviews and if there are long periods of silence, just sit calmly and pretend like you are unaffected. Be careful not to be too defensive – it is usually a trap to see if you can keep your cool under pressure. They might say something catty like:

  • It sounds like you don’t have a lot of experience with [insert something rude here], what makes you think you can do this job?
  • I have a lot of other more qualified candidates, why should I hire you?

Structured – This interview is basically just like a test and you need to pass to make it to the next round. It is a typical style for CROs (where many different people perform new candidate interviews but then need to assess all applicants against the same standards) or for first-round interviewers. Essentially, the interviewer is looking for a specific answer, and once you say the magic word or list the 3 bullets they are looking for, they will move on to the next question. It is fine to ask how you are doing if you are feeling nervous along the way – they will probably find it endearing rather than count that against you (they probably suffered through the same type of interview when they were hired).

  • What are the critical components of an ICF document? Know your regulations and GCP guidelines – All of them – this one is CFR 21 Part 50.
  • What are the activities that take place during an [initiation visit, close out visit, etc.]?

Clinical Data Management Interview Questions

What is a clinical trial?

Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. ClinicalTrials.gov includes both interventional and observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.

What is informed consent?

Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant’s native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

What are side effects and adverse reactions?

Side effects are any undesired actions or effects of the experimental drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.

How is the safety of the participant protected?

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants’ names will remain secret and will not be mentioned in these reports (See Confidentiality Regarding Trial Participants).

What should people consider before participating in a trial?

People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.

Does a participant continue to work with a primary health care provider while in a trial?

Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.

Can a participant leave a clinical trial after it has begun?

Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.

Where do the ideas for trials come from?

Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the experimental treatments with the most promising laboratory results are moved into clinical trials. During a trial, more and more information is gained about an experimental treatment, its risks and how well it may or may not work.

Who sponsors clinical trials?

Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran’s Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors’ offices, or community clinics.

What is a protocol?

A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.

What is a placebo?

A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the experimental treatment’s effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or experimental treatment.

What is a control or control group?

A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.

What are the different types of clinical trials?

  • Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
  • Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.
  • Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
  • Screening trials test the best way to detect certain diseases or health conditions.
  • Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.

What are the phases of clinical trials?

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

  • In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
  • In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
  • In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
  • In Phase IV trials, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.

What is “expanded access”?

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Most human use of investigational new drugs takes place in controlled clinical trials conducted to assess the safety and efficacy of new drugs. Data from these trials are used to determine whether a drug is safe and effective, and serve as the basis for the drug marketing application. Sometimes, patients do not qualify for these controlled trials because of other health problems, age, or other factors, or are otherwise unable to enroll in such trials (e.g., a patient may not live sufficiently close to a clinical trial site).

For patients who cannot participate in a clinical trial of an investigational drug, but have a serious disease or condition that may benefit from treatment with the drug,FDA regulations enable manufacturers of such drugs to provide those patients access to the drug under certain situations, known as “expanded access.” For example, the drug cannot expose patients to unreasonable risks given the severity of the disease to be treated and the patient does not have any other satisfactory therapeutic options (e.g., an approved drug that could be used to treat the patient’s disease or condition). The manufacturer must be willing to make the drug available for expanded access use. The primary intent of expanded access is to provide treatment for a patient’s disease or condition, rather than to collect data about the study drug.

Some investigational drugs are available for treatment use from pharmaceutical manufacturers through expanded access programs listed in ClinicalTrials.gov. If you or a loved one is interested in treatment with an investigational drug under an expanded access protocol listed in ClinicalTrials.gov, review the protocol eligibility criteria and inquire at the Contact Information number. If there is not an expanded access protocol listed in ClinicalTrials.gov, you or your health care provider may contact a manufacturer of an investigational drug directly to ask about expanded access programs.

1. Describe the phases of clinical trials?

Ans: These are the following four phases of the clinical trials:

Phase 1: Test a new drug or treatment to a small group of people (20-80) to evaluate its safety.

Phase 2: The experimental drug or treatment is given to a large group of people (100-300) to see that the drug is effective or not for that treatment.

Phase 3: The experimental drug or treatment is given to a large group of people (1000-3000) to see its effectiveness, monitor side effects and compare it to commonly used treatments.

Phase 4: The 4 phase study includes the post marketing studies including the drug’s risk, benefits etc.

2. Describe the validation procedure? How would you perform the validation for TLG as well as analysis data set?

Ans: Validation procedure is used to check the output of the SAS program generated by the source programmer. In this process validator write the program and generate the output. If this output is same as the output generated by the SAS programmer’s output then the program is considered to be valid. We can perform this validation for TLG by checking the output manually and for analysis data set it can be done using PROC COMPARE.

3. How would you perform the validation for the listing, which has 400 pages?

Ans: It is not possible to perform the validation for the listing having 400 pages manually. To do this, we convert the listing in data sets by using PROC RTF and then after that we can compare it by using PROC COMPARE.

4. Can you use PROC COMPARE to validate listings? Why?

Ans: Yes, we can use PROC COMPARE to validate the listing because if there are many entries (pages) in the listings then it is not possible to check them manually. So in this condition we use PROC COMPARE to validate the listings.

5. How would you generate tables, listings and graphs?

Ans: We can generate the listings by using the PROC REPORT. Similarly we can create the tables by using PROC FREQ, PROC MEANS, and PROC TRANSPOSE and PROC REPORT. We would generate graph, using proc Gplot etc.

6. How many tables can you create in a day?

Ans: Actually it depends on the complexity of the tables if there are same type of tables then, we can create 1-2-3 tables in a day.

7. What are all the PROCS have you used in your experience?

Ans: I have used many procedures like proc report, proc sort, proc format etc. I have used proc report to generate the list report, in this procedure I have used subjid as order variable and trt_grp, sbd, dbd as display variables.

8. Describe the data sets you have come across in your life?

Ans: I have worked with demographic, adverse event, laboratory, analysis and other data sets.

9. How would you submit the docs to FDA? Who will submit the docs?

Ans: We can submit the docs to FDA by e-submission. Docs can be submitted to FDA using define.pdf or define.Xml formats. In this doc we have the documentation about macros and program and E-records also. Statistician or project manager will submit this doc to FDA.

10. What are the docs do you submit to FDA?

Ans: We submit ISS and ISE documents to FDA.

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  1. Explain Clinical Research?

Clinical research refers to any kind of investigation in human subjects which aims to discover or check the clinical, pharmacological, and other pharmacodynamic effects of an investigational product.

  1. Explain Various Types Of Clinical Trials?

Clinical trials can be of several types. These are as follows:

New approaches of prevention trials test like medications, vitamins, or other supplements which according to doctors may can lower the risk of development of a certain type of cancer. Generally the prevention trials are conducted with healthy people with no cancer history. Certain trials are also conducted with people who have cancer and want to reduce the chance of developing a new type of cancer or returning of cancer.

Diagnostic trials are conducted usually on people who shows signs or symptoms of cancer whereas treatment trials are conducted with the people who actually have cancer. They answer certain questions and effectiveness of new treatment or a new way of using a standard treatment is judged. These trials test treatments such as new drugs, new approaches to surgery or radiation therapy, vaccines, or new combinations of treatments supportive care (also called Quality-of-life) trials explore ways to improve the comfort and quality of life of cancer patients and its survivors. These trials will be helpful in the study of treatment of patients experiencing nausea, vomiting, depression, sleep disorders, or other effects from cancer or its treatment. To detect cancer earlier screening trials are done and are often conducted to determine whether finding cancer at early stage of symptoms decreases the chance of dying. These trials include people who do not have any signs of cancer. Diagnostic trials study could be used to identify cancer more accurately. They are sometimes part of another cancer clinical trial. The genetics component of the trial also focus on how genetic makeup can affect diagnosis, detection, or response to cancer treatment.

  1. Explain Clinical Trials ?

There are Five phases of clinical Trials:

Pre-clinical: animal tests and In vitro (test tube), to determine dosing and any other potential risks to administration in the human beings.

Phase One:The determination of safe doses of a new drug by trials on healthy human volunteers and the drug’s effect on the body (pharmacodynamics) and the body’s effect on the drug (pharmokinetics). Often performed by CROs (Contract Research Organisations) or in large teaching hospitals.

Phase Two: Treatment or the experimental drug is given to a large group of people (100-300) to see that the drug is effective or not for that treatment.

Phase Three: Studies with large numbers of patients undertaken by GPs or in hospital. Comparing of the efficiency and side effects of the drug with existing placebos and treatments.

Phase Four: Is performed after the product licence has been granted by the regulatory authorities. Industry conducts large, long term epidemiological studies to assess optimal use and for the marketing strategy of the drug these are essential. Safety (pharmacovigilance) is monitored by post marketing surveillance studies.

 

  1. Why Sap Is Important?

SAP is the document that contains detailed information regarding the statistical methods and study objectives to help in the production of the Clinical Study Report (CSR) including figures, summary tables, and subject data listings for Protocol. Documentation of the program variables and algorithms that will be used to generate summary statistics and statistical analysis are also contained in this.

 

What Do You Understand By Crt?

CRT means Case Report Tabulation. CRT’s are sent to the FDA whenever a pharmaceutical company is submitting an NDA.

 

  1. What Are All The Procs You Know?

I know about many procedures like proc sort, proc report, proc format etc. I have generated the list report using the proc report; in this procedure I used subjid as order variable and sbd, trt_grp, dbd as display variables.

 

  1. Explain Verification?

Verification ensures the accuracy of the final tables and the quality of SAS programs which  generates the final tables. I selected the subset of the final summary tables for verification according to the instructions SOP and SAP.

 

  1. Tell About Domains/datasets You Have Used In Your Studies?

Medical History, ECG, Labs ,  Demography, Physical Exam, Adverse Events ,Vitals etc

Give Examples Of Edit Checks  In Your Programs?

Demography: Body mass index is below expected and Weight is outside expected range ( check weight and height).

DOB is greater than the Visit date or not.the Gender value is a valid one or invalid. Age is not within expected range.

Adverse Event

Visit Start is before birthdate or Stop is before the start. Study medicine discontinued due to the adverse event but completed

Labs

Result is within the normal range and also abnormal is not blank or the case can be ‘N’Result is outside the normal range and also abnormal is blank.

Vitals

Diastolic Blood pressure more than Systolic Blood Pressure

Medical History

Visit date prior to Screen date Physical Physical exam is normal and also comment included.

Biomedical Engineering Interview Questions

 

  1. Tell About Locf?

Pharmaceutical companies spend several months to conduct longitudinal studies on human subject. It is unrealistic to expect patients to keep timely visit over such a long period of time. Despite all the efforts, patient data are not collected for some and these become missing values in a SAS data set later. For reporting, the most recent previously available value is substituted for each of the missing visits. This is known as Last Observation Carried Forward (LOCF).LOCF doesn’t mean the last SAS dataset observation which gets carried forward rather it means last non-missing value carried forward. It is the values of individual measures which are actually “observations” in this case. Also if there are multiple variables containing these values then they will be carried forward independently.

 

  1. Explain Crm?

CRM means Clinical Research Managers. They supervise informed consent forms for clinical trials, case report forms and design and writing of protocols. CRM ensures that Case Report Forms are reviewed timely and submitted to the data management group.

Operating Room Nurse Interview Questions

 

  1. What Is A Clinical Trial?

Clinical trials, also known as clinical studies, test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. A treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy.

Potential treatments, however, must first be studied in laboratory animals to determine its safety before they can be tried in people. Treatments having acceptable safety profiles and showing the most promise in the animal model are then moved into clinical trials.

Clinical trials are an integral part of new product discovery and development, and are required by all regulatory agencies (e.g. the Food and Drug Administration (FDA) in the United States), before a new product can be brought to the market.

 

  1. Why Participate In A Clinical Trial?

The decision to participate in a clinical trial is one that should be made by the patient and his/her loved ones working in close communication with the physician. Participants in clinical trials play a key role in drug development and discovery;

clinical trials contribute to knowledge and progress in treating and preventing diseases. First and foremost participants can help others by contributing to medical knowledge and improving public health. Further, a participant does not need to be a patient diagnosed with a specific disease or health problem as some clinical trials, focusing on safety, will include healthy volunteers.

Patients who take part in clinical trials may benefit from the treatments they receive. As part of a clinical trial, a patient will receive either the experimental treatment being tested, an accepted standard treatment for the condition, or a placebo. It is important to understand that there is no guarantee that any treatment received in a clinical trial will produce the desired results.

 

  1. What Should One Expect During A Clinical Trial?

For all types of trials, participants work with a research or clinical trial team, including doctors, nurses, social workers, and other health care professionals. Prior to the trial, the research team will check the health of the participant and review any special instructions for trial participation. As the trial begins and throughout its duration, the research team will administer treatment, (whether that be the experimental treatment, a standard treatment or a placebo depending on the requirements of the study) and monitor the participant on a regular basis to determine effectiveness and side-effects of the treatment.

Ongoing communication is an important part of any clinical trial and after the trial has been completed the research team will stay in touch with the participant for a specified period of time to assess any effects of the treatment after treatment has stopped. The data collected before, during and after the trial is a crucial component to the drug’s approval submission to drug regulatory agencies.

 

  1. What Is Informed Consent?

Informed consent is the verification of a person’s willingness to participate in a research project. Prior to enrollment in a clinical trial, researchers inform participants about all relevant study details and known risks.

Participants are then provided an informed consent document that details all the important study information including its purpose, duration, risks, potential benefits, required procedures, and key contacts. Once participants have had a chance to read this form and ask questions, if they agree to participate in the trial, they will be asked to sign an informed consent document. The informed consent document is not a contract. Participation in the clinical trial is voluntary and the participant may withdraw from the trial at any time without penalty or loss of benefits to which he/she is otherwise entitled. The research team actively maintains informed consent throughout the entire trial by providing the participant with any new or developing information, as needed.

 

  1. Who Can Participate In A Clinical Trial?

Before joining a clinical trial, a participant must meet certain criteria. This is an important aspect of any clinical trial to ensure that the treatment is being investigated accurately and safely. Factors that allow someone to participate in a clinical trial are called “inclusion criteria,” and those that disallow someone from participating are called “exclusion criteria.”

These criteria are used to identify appropriate participants. Acceptance of a participant into a clinical trial is based on such factors as age, gender, the type and stage of disease, previous treatment history, and other medical conditions.

For example, some research studies seek participants with specific illnesses or conditions, while others need healthy participants. Some studies may include only men, some studies may include men and women but not women of child-bearing potential, and some studies may include men and women within a specific age range (ie, 18-65 years of age). These criteria are defined by the amount of scientific and safety information that is known about a treatment being tested at the time the trial is planned to start.

 

  1. What Are The Benefits And Risks Of Participating In A Clinical Trial?

Benefits include: Playing an active role in one’s health care, gaining access to medications that may not be available for a significant amount of time, and helping others by participating in the trial so the treatment can potentially be approved and made available to the public.

Risks include: Participation in a clinical trial may involve some risks that your doctor will explain in more detail. These risks include:

  • side-effects that are known and those that have not yet been identified;
  • risks associated with study procedures;
  • the experimental treatment may be ineffective or less effective than the current standard;
  • the experimental treatment may not work for every patient.

Additionally, in some clinical trials the patient may not receive the experimental treatment,but the current standard or a placebo.

In addition to the risks listed above, the trial might require the participant’s time and attention—including trips to the study site, more treatments, hospital stays or complex dosage requirements.

  1. Will I Be Paid To Participate In The Clinical Trial Or Is There A Cost To Participate?

Compensation for participants is unique with each clinical trial and each sponsoring partner. This is a question that should be discussed with the researcher when considering participating in a clinical trial.

The experimental compound as well as tests and procedures associated with the trial are usually provided at no cost to the participant. In most cases, the cost of routine tests and procedures—not associated with the trial—are the responsibility of the participant, or the participant’s insurance carrier.

 

  1. What Is A Protocol?

A protocol is the study plan on which the clinical trial is based. Each trial is carefully designed to safeguard the health of participants as well as answer specific research questions. The protocol describes in detail what types of people may participate in the trial, the schedule of tests, procedures, medications, dosages, and length of the study.

 

  1. What Is A Placebo?

A placebo is an inactive pill, liquid or powder that has no treatment value. In a placebo controlled trial, some portion of the participants will receive placebo instead of an active drug or experimental treatment to assess the experimental treatment’s effectiveness and safety relative to no treatment at all.

 

  1. What Is A Control Or Control Group?

A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.

 

  1. What Are The Phases Of Clinical Trials?

Clinical trials are conducted in a series of stages, called phases, each having specific goals. This process provides information about the treatment in a controlled process intended to also protect the participants. The number of participants in each phase of the trial may be based on the overall incidence of the condition being studied.

Clinical trials are usually classified into one of four phases:

Phase 1: Sometimes called dosing, pharmacokinetic, or clinical pharmacology studies, these trials test methods of administering the treatment (e.g. by mouth, injection, etc.) and how often, as well as the safety of the treatment. These trials usually involve a small number of healthy participants (20-80 healthy volunteers).

Phase 2: These trials continue to test the safety of the treatment and evaluate how well the treatment is tolerated and how well it works. Phase II studies usually evaluate the treatment in a specific condition. These trials usually involve 100-300 patients.

Phase 3: These trials compare the experimental treatment to the current standard of treatment for a specific condition, establishing both efficacy and adverse events. Participants are usually assigned to either receive the experimental treatment or the current standard. Phase III trials typically enroll large numbers of patients (1,000-3,000) and may be carried out at hospitals and doctors’ offices nationwide.

Phase 4: Post-marketing studies to gain a greater understanding of the treatment, including its risks, benefits, and optimal use. Depending on the purpose of these studies they may be small studies like the Phase I type OR may be even larger than a Phase III study.

 

  1. What Is A Prospective, Randomized, Double-blind, Controlled Clinical Trial?

A prospective, randomized, double-blind, controlled clinical trial is the most rigorous clinical trial design, and the one that regulatory agencies mandate must be conducted to demonstrate a medication’s effectiveness and safety. In a new drug application, these studies represent the highest quality data regarding the drug and its actions, and form the basis for approval. In this study design, patients are carefully selected for participation and are randomly assigned to receive the experimental drug or a matching active drug or placebo. Neither the patient nor the treating physician knows which treatment was provided, thereby eliminating possible bias.

Individual definitions of the study descriptions are:

Prospective: Forward looking, beginning before the patient has started treatment.

Randomized: Patients are randomly assigned to receive the experimental treatment or alternative (e.g. standard of care or placebo)

Double-blind: Neither patients nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo or standard treatment.

Controlled: One group of patients will be given an experimental drug or treatment, while a second group is given either a standard treatment for the illness or a placebo.

 

  1. What Are Side Effects And Adverse Reactions?

Side effects include any undesired actions or effects of a drug or treatment.

Experimental drugs must be evaluated for both immediate and long-term side effects.

 

  1. Can A Participant Leave A Clinical Trial At Any Point?

Yes. A participant can leave a clinical trial at any time. The participant should let the research team know when withdrawing from the trial and the reasons for leaving the study.

 

  1. Who Sponsors A Clinical Trial?

Clinical trials can be sponsored or funded by a variety of organizations or individuals including physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to government agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), Human Health and Services (HHS), and the Department of Veteran’s Affairs (VA).

 

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