FAQ & Glossary

Below you will find an overview of the most frequently asked questions about NSGO-CTU’s clinical cancer research studies.
We hope that you will find the answer to your query below.

A clinical trial is a research project that examines how well a new treatment or medical procedure works in humans. Other studies that are performed only on cells in petri dishes or on animals are referred to as preclinical studies. Clinical studies only begin after preclinical studies have shown that the new treatment or procedure helps people and is also safe for people.

Pre-clinical studies offer researchers a lot of good information. However, studying how a treatment or procedure works in humans is different from studying mice or specific cells in a laboratory. Therefore, clinical studies are required to answer important questions:

  • Does the new treatment or procedure work in humans?
  • Is what is being tested better than what is being used now?
  • Does it cause more or less side effects?
  • Does it work in a group of people who can or cannot use current treatments or procedures?
  • Is the new treatment or procedure safe for people?

All treatments for cancer and some diagnostic procedures have side effects. In clinical trials, researchers are trying to find out whether the benefits of a new treatment or a new procedure outweigh the possible side effects.

 

Researchers carry out clinical studies in different environments. Many clinical trials are carried out in cancer centers at academic hospitals, because the facilities available there are usually the most suitable ones. Nowadays, general hospitals and medical practices can also be part of a clinical trial.

This has broadened the possibility for patients to take part in a trial. Instead of going to a non-familiar hospital and getting treatment from an unknown doctor, patients can participate in clinical trials and still be treated by their own doctor (as long as he or she is involved in the study). The research team that carries out a clinical trial consist mostly of scientists, doctors, nurses, social workers, dietitians, and other health professionals.

 A study can only be carried out if it has been checked and approved by an independent control body. In Denmark, two control bodies are in place, the Ethics Committees and the Health Authorities.

The researchers who plan to start a clinical trial write a plan as to how the trial should be carried out to find the right answers to the questions; is this drug or procedure safe, effective, and/or superior to the current treatment options. This plan is called the protocol. The protocol is a very technical document and contains details of the dosage of each treatment and the frequency and duration of each treatment. It also lists all laboratory work and tests that need to be done to be able to find out how each person in the study responds to treatment.

The protocol is reviewed by both control authorities that either approve or reject the protocol and subsequent study. The control authorities take several questions into account when making their decision:

  • Is it ethical to ask people to volunteer for this experimental treatment?
  • Was the study developed to ensure that the people involved are safe?
  • Will participants receive treatment that is at least as good or better than what they would receive if they did not participate in the study?

This supervisory body is composed of scientists, doctors, nurses, ethics, law and patient representatives who are not involved in the clinical study. If the clinical trial is approved, the review board will monitor the study and formally review it each year.

After the protocol has been approved, the researchers ask participants to participate in the study

The researchers who plan to start a clinical trial write a plan as to how the trial should be carried out to find the right answers to the questions; is this drug or procedure safe, effective, and/or superior to the current treatment options. This plan is called the protocol. The protocol is a very technical document and contains details of the dosage of each treatment and the frequency and duration of each treatment. It also lists all laboratory work and tests that need to be done to be able to find out how each person in the study responds to treatment.

The protocol is reviewed by both control authorities that either approve or reject the protocol and subsequent study. The control authorities take several questions into account when making their decision:

  • Is it ethical to ask people to volunteer for this experimental treatment?
  • Was the study developed to ensure that the people involved are safe?
  • Will participants receive treatment that is at least as good or better than what they would receive if they did not participate in the study?

This supervisory body is composed of scientists, doctors, nurses, ethics, law and patient representatives who are not involved in the clinical study. If the clinical trial is approved, the review board will monitor the study and formally review it each year.

After the protocol has been approved, the researchers ask participants to participate in the study.

If you want to participate in a clinical trial, the first step is to contact your doctor. He or she may know a clinical trial that is open and suits your particular situation best.

If you want to make sure a study is relevant for you, you additionally can call the nearest cancer center and ask for information about this study. You can also search for clinical trials on the ENGOT websites in relation to gynecological cancer.

You can also view clinical trials conducted worldwide from the American National Institute of Health’s international registry https://clinicaltrials.gov or specific for Europe https://www.clinicaltrialsregister.eu

Researchers want to make sure that the results obtained during a clinical trial can be attributed to the new treatment or process and are not caused by coincidence, hence the participants of a clinical trial are being selected on very specific characteristics, the so-called eligibility criteria. For example, a study in which the effectiveness of an hormone inhibitor will be assessed in ovarian cancer will select their participants with the following characteristics:

  • postmenopausal women
  • diagnosed with hormone receptor positive ovarian cancer
  • have had surgery to remove the cancer
  • may or may not have received chemotherapy

One person must meet ALL admission requirements to participate in the study, the so-called inclusion criteria.

Part of the process is to enroll patients who are similar in certain points. For example, a study could serve to answer questions about the treatment of patients who have a certain stage of cancer or who have already received a certain type of chemotherapy. In order for the results to make sense at the end of the study, only those patients who meet these criteria are included.

Another aspect is patient safety. For example, a new drug can only be safe in people with normal kidney or liver function. Therefore, people with poorly functioning kidneys or livers would not be included in the study, they are so-called exclusion criteria.

So patients can only be included when they meet all inclusion criteria and none of the exclusion criteria. This will be assessed by the physician or study nurse prior to enrolment in a clinical trial.

A participant must give a so-called declaration of consent (also known as informed consent) before participating in a clinical trial. Upon consent, researchers must explain the clinical trial protocol to potential participants. Researchers must also inform potential participants about the potential risks and benefits of participating in the study. A person can then decide whether or not to participate in the study. It is also important to know that people can end a clinical trial at any time (long time) before a clinical trial starts.

Each clinical trial has its own benefits and risks depending on the type and aim of the trial. However, some potential benefits and risks are common to almost all clinical trials.

Possible benefits

  • Access to treatment that is not yet available. This treatment can be more effective or have fewer side effects than the treatments currently available.
  • Regular and thorough care from some of the best cancer doctors. The research team that conducts clinical trials typically consists of top physicians and scientists. Due to this close monitoring, possible side effects are noticed early and remedied immediately.
  • Contribution to research that can save lives in the future. The cancer treatments we have today are available because a large number of women have chosen to participate in clinical trials to test them in the past
  • The positive feeling when you play an active role in your own care. The decision to participate in a clinical trial can sometimes make patients feel more in control of their situation, which can lead to an increase in positive outlook and subsequently a better quality of life

Possible risks

  • You cannot decide which treatment to receive. In randomized trials, you are randomly selected to receive a particular treatment. Some studies may give you a placebo (sugar pill). In a randomized, double-blind study, neither you nor your doctor knows if you are selected to receive the treatment or the placebo (but the information can be made available to your doctor if necessary).
  • The new treatment may not work for you, even if it benefits other people in the study. It may also turn out that the new treatment is not as effective as the one currently available.
  • More serious side effects than current treatments. This is more likely in phase I or phase II studies (See section on study phases in FAQ).
  • An increase in testing and doctor visits. Because you are closely monitored, you may need to take more tests or more often than when not participating in the study. This could result in more time and travel to the doctor’s office or hospital.

What  do I definitely need to know before I decide to participate in a clinical trial?

The decision to participate in a clinical trial is very personal. The answers to the following questions by your doctor might help to get a better understanding of the options:

  • Why do you propose this study?
  • Why do you think this new treatment will be effective?
  • Which kind of study phase is it?
  • Has this treatment been tested before?
  • What were the results of previous studies?
  • Can I speak to someone who is already in the study?
  • Who pays the trial costs?
  • What are the possible treatments I can get? How often are they given?
  • What types of tests do I need to have and how often will they be assessed?
  • How will participating in this study affect my daily routine?
  • What are the expected side effects?
  • How long does the screening process take? and what is the total duration of the clinical trial?
  • Is long-term follow-up part of the study? What does it include?
  • If the treatment works for me, can I continue to receive it after completing the study?
  • How do I get access to the results of the study?

After the clinical trial protocol has been approved by the national health care and ethic authorities, the researchers ask participants to participate in the study. Clinical trials typically have between one and four different treatment schemes, the so-called treatment arms. In most cases, people who enroll in a clinical trial are randomly assigned to one of the treatment arms. This is known as a “randomized” study. Many clinical studies are “double blind“. This means that neither the participant nor the researcher know which treatment arm the participant has been assigned to. Double-blinded clinical trials help researchers understand the real benefits and side effects of treatment without distortion of external influences. In this context, external influences mean any preconceived notions about treatment that may affect the way you take the medicine, which in turn may affect the results of the study.

The medication you receive is labeled with a code that is kept confidential by a small group of people who are not involved in your treatment. The code will be released at the end of the study when the results are evaluated. Whenever possible, clinical trials are both randomized and double-blinded as results obtained this way are regarded the most reliable.

Clinical trials are conducted to collect data regarding the safety and efficacy of new medication, health care processes and/or devices. There are several steps and stages of approval in the clinical trial process before a medication, process or device can be implemented in the regular treatment guidelines of a particular disease.

Medication, process or device development usually starts with the search for an improved treatment option with better outcome than the one in place. This development begins with extensive laboratory research, which can take many years of experiments in animal and human cells. If the initial laboratory research is successful, researches send the data to the competent healthcare authorities to obtain approval to continue the research in humans.

After approval, human testing can start and is mostly conducted in four phases (for medication, and at least three for devices and processes). Each phase is considered a separate trial and, after completion of a phase, investigators are required to submit their data again for approval to the competent authorities, before moving to the next phase. In this way, each step or phase builds on the results of the previous phase (see figure for visualization).

Phase I: is it safe?

Phase I trials assess the safety of a drug process or device. It is the first phase that involves humans. (Preclinical studies on petri dishes and animals have already been carried out.) Phase I studies are small and usually involve between 15 and 50 healthy volunteers. In phase I studies, researchers investigate:

  • the best way to give a new treatment (as an injection or as a pill)
  • how the drug is absorbed, metabolized and excreted in humans
  • the highest dose that can be administered safely without serious side effects.

In phase I studies, researchers closely monitor participants and titrate the dose so they can define the amount that works best with the least acceptable side effects. This dose is usually used for all future tests in the subsequent phases.

Phase II: does it work?

Phase II studies test the efficacy of the new intervention. Phase II trials are slightly larger than Phase I trials and typically involve 25 to 200 patients. Most phase II studies are randomized trials where one group of patients receives the experimental drug, while a second “control” group receives a standard treatment or placebo. Researchers start with the dose and method proved best in Phase I. Phase II patients receive the new treatment and researchers observe whether the treatment is beneficial. The benefits that researchers are looking for may vary and depends on the objectives of the research:

  • tumor is getting smaller
  • tumor stops growing
  • an increase in time before the cancer comes back
  • longer survival time
  • better quality of life

If a certain percentage of participants benefit from the treatment and the side effects are still acceptable, the new treatment will likely move to phase III.

Phase III: is it better than the current treatment options?

Phase III studies compare the safety and effectiveness of the new treatment with the current standard of care. Phase III studies are typically large (some include tens of thousands of participants) and are conducted at many locations (multi-centered) and often in different countries around the world (European, International, Global). A phase III trial is the final step before the competent authorities consider approval and grant market access.

Patients are usually randomly selected to receive the current standard treatment or the new treatment. If possible, the study is double-blinded, meaning that neither the researchers nor the participants know who receives which treatment. Double-blinded clinical trials help researchers understand the real benefits and side effects of treatment without distortion by external influences. Results from a randomized, double-blinded study are considered more credible than results from a non-randomized or double-blinded study.

As in Phase I and Phase II studies, participants in a Phase III trial are closely monitored to determine if there are any serious side effects. Treatment is stopped if side effects appear dangerous.

Phase IV: is it still beneficial over a longer period of time?

Phase IV studies, also called Post Marketing Surveillance Trials, typically review whether the treatment offers benefits or long-term side effects that have not been studied or observed during Phase II or Phase III. Phase IV studies are typically conducted after an intervention or treatment has been approved for use by the competent authorities. Phase IV studies are rarer than Phase I, II, or III studies and affect usually hundreds of thousands of patients addressing mainly the following:

  • comparison to drugs already on the market or new treatment options.
  • monitoring long-term effectiveness and impact on a patient’s quality of life
  • determine the cost-effectiveness relative to other traditional and new therapies.

Phase IV studies can result in a drug or device being taken off the market or restrictions of use could be placed on the product depending on the findings in the study.

 

All data collected during the clinical trial is subject to professional confidentiality. Data about you, your state of health and the treatment are recorded and stored so that they are available for evaluation. However, the data will only be passed on for this purpose in encrypted (anonymized) form. As a patient, your personal identity and traceability is protected during as well as after closure of the clinical trial.

Participation in a clinical trial is equivalent to treatment.

The clarification and treatment within a clinical trial does not incur any additional or special costs for you, even if the therapy is more expensive than the standard treatment. However, it might require additional time and travel expenses.

Patients considering participating in a clinical trial should talk with their doctor or medical caregivers. Potential participants should understand the credentials and experience of the staff and the facility involved in conducting the study.

The decision to participate, however, remains very personal, but it can be helpful to ask your doctor these general questions:

  • How long will the trial last?
  • Where is the trial being conducted?
  • What treatments will be used and why do you think this new treatment will be effective?
  • What is the main purpose of the trial?
  • What phase is this study in?
  • How does participating in this study affect my daily routine?
  • How will patient safety be monitored?
  • Are there any risks involved?
  • What are the possible benefits?
  • What are the alternative treatments besides the one being tested in the trial?
  • Who is sponsoring the trial?
  • Do I have to pay for any part of the trial?
  • What happens if I am harmed by the trial?
  • Can I opt to remain on this treatment, even after termination of the trial?

If you are looking for technical terms related to clinical research, you have come to the right place. Here, we provide an alphabetical overview of the most common terms used in clinical research.

To find a specific term, simply click on the letter that corresponds to the first letter of the term you are interested in. This will take you directly to a list of terms that start with that letter.

We have organized the terms to make it easy for you to find the information you need. Whether you are a researcher, clinician, patient, or simply interested in learning more about clinical research, we hope you find this resource helpful.

If you do not find the information you are looking for, we encourage you to contact your general practitioner or visit www.Clinicaltrials.gov.

Clinicaltrials.gov  is a comprehensive database of clinical trials conducted around the world and provides valuable information for patients, researchers, and healthcare providers alike.

We hope this glossary serves as a helpful tool for navigating the complex world of clinical research.

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Privacy Policy for NSGO

NSGO treats personal information and complies with the laws and principles of good data processing practices. Therefore, we have adopted this Privacy Policy, which briefly describes how we treat personal information, so legal and transparent processing is ensured.

We are responsible for processing your personal information:

NSGO is the data controller and you can always contact the organization’s data protection officer:

Mansoor Raza Mirza

Nordic Society of Gynecologic Oncology – Clinical Trial Unit
Copenhagen University Hospital
Department of Oncology, 9431
Blegdamsvej 60
DK-2100 Copenhagen
Office phone: +45 35 45 33 78
fax: +45 3545 2898
Mansoor.Raza.Mirza@regionh.dk.

We treat the following personal information about members:

  • General personal information: For example, contact information such as name, work address, work phone number, private phone number, date of birth, email address, country, work title, date of membership, date of membership termination and cv in relation to membership application. Parts of credit card number via Epay and, if applicable, Bank account number for reimbursement purposes. When applicable, Board Members may be asked to give NSGO copies of other personal documents (for example passport or tax bill) in relation to the Danish Laundering Act.
  • Other information: For example, positions of trust, board membership and other duties in relation to the organization.

We collect personal information from:

Usually we will get the information from you, when you register to become a member of NSGO and when you apply for reimbursements or pay your membership fee

The organization’s legal basis to process personal information:

  • That we as an organization have a (legitimate) interest in processing your information
  • That it is necessary for us to fulfill an agreement with you
  • You have agreed that we can process your information via becoming a member of the

The purpose of processing personal information:

  • That we can run the organization’s activities, including planning, implementing and following up on them
  • To invite to vote for Board and President Elect elections
  • To distribute newsletters
  • To comply with legislation
  • To deliver services, in the form of the possibility to participate in the Annual Meeting, Investigator Meeting and if applicable Strategic Meetings, Board Meetings, Scientific Committee Meetings, Foundation Meetings.
  • To notify members about other Gynecologic Cancer Managing your relationship with the organization
  • To handle your membership rights
  • For you to fulfill your obligations as a member of the organization, including paying the membership fee, etc.
  • Being able to display situation images from a specific event in the organization for instance from NSGO Annual Meetings
  • To maintain historical value data for statistics and the like

Consent:

When you become a member, we have a legal basis to process your personal information for the (legitimate) interest of the organization. However, it may happen that we judge it necessary to obtain your written consent for other purposes. In that case you will have the opportunity to voluntarily agree, and you may withdraw it at any time by notifying us.

Dispatch of your personal information:

We do not disclose information about you to anyone outside the organization without your consent, however, it should be noted, that if you e.g. accept an invitation to a meeting, your personal information might be forwarded to the meeting location or the meeting organizer. Only personal information relevant for the 3rd party will be disclosed in these circumstances.

Storing and deleting your personal information:

For historical reasons and as your details might be saved in old attendance lists, email correspondence and minutes from meetings, we cannot promise that all personal information about you will be deleted, if you terminate your membership.

Your rights:

You have a number of rights via the General Data Protection Regulation (GDPR):

  • The Right to Information (to be informed what information we process about you)
  • The Right to Rectification (to have false information about you corrected)
  • The Right to Restriction of processing (under certain conditions, to have the processing of your data restricted)
  • The Right to Object (to object to your information being used for wrong purposes)

You may make use of your rights by contacting us. If you submit a request to have your personal information corrected or deleted, we will investigate whether the conditions are met and, in that case, make changes or deletions as soon as possible and, if applicable, also notify our data processors to do so.

You can file a complaint with the supervisory authorities – The Danish ‘Datatilsynet’ – About processing your personal information (www.datatilsynet.dk).

Revision of Privacy Policy:

We reserve the right to change the organization’s privacy policy. When we change privacy policy, we also change the date and version number at the bottom of this document. In case of significant changes, you will receive a notification.

The current privacy policy is always available on our website.

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Privacy Policy for NSGO-CTU

NSGO-CTU treats personal information and complies with the laws and principles of good data
processing practices. Therefore, we have adopted this Privacy Policy, which briefly describes how we treat personal information, so legal and transparent processing is ensured.

We are responsible for processing your personal information:

NSGO-CTU is the data controller and you can contact the organization’s data protection officer:

Mansoor Raza Mirza

Nordic Society of Gynecologic Oncology – Clinical Trial Unit
Copenhagen University Hospital
Department of Oncology, 9431
Blegdamsvej 60
DK-2100 Copenhagen
Office phone: +45 35 45 33 78
fax: +45 3545 2898
Mansoor.Raza.Mirza@regionh.dk.

We treat the following personal information about personnel participating in NSGO-CTU trials:
• General personal information: For example; contact information such as name, work
address, work phone number, date of birth, email address, country, work title, date of start
of participation and termination in a trial and, if applicable, CV, GCP certificates, records of
training and other qualification data.
• If applicable, financial disclosure forms and/or Bank account number for reimbursement
purposes.

We collect personal information from:
• We will ask you to provide us the information yourself, when you in decide to take part
in NSGO-CTU trials.
The organization’s legal basis to process personal information:
• That we as an organization have a (legitimate) interest in processing your information, for
example to secure your qualifications in handling the care of the participants in a trial.
• That it is necessary for us to fulfill an agreement with your employer
• You have agreed that we can process your information via signing the delegation log.
The purpose of processing personal information:
• The participation of an investigator or of other individuals in a clinical trial which is being
conducted according to the principals governing clinical research as set out in the
Declaration of Helsinki and with the acceptance of all involved Regulatory Health
Authorities and involved Ethical Committees, requires collection, recording, storage,
transfer and/or other use of personal data (personal data processing).
• Communicate regarding studies.
• To handle payments and reimbursements.
• To comply with legislation.
• To deliver services, in the form of the possibility to participate in the Annual Meeting,
Investigator Meeting.
• To be able to give you access to IT systems, databases, eCRFs etc. related to the functioning
of each individual trial.

Consent:
When you decide to take part in a NSGO-CTU trial NSGO-CTU either makes a contract with you or
your employer where terms and conditions are described, or if you put your name on the
Delegation Log of a trial, you agree to the information described in this Privacy Policy.
However, it may happen that we judge it necessary to obtain your written consent for other
purposes. In that case you will have the opportunity to voluntarily agree, and you may withdraw it
at any time by notifying us.
Be aware that there are legal bases for certain forms of processing of your data for the abovementioned purposes and that your consent is the only legal basis for other forms of processing.

Dispatch of your personal information:
Depending on your role in a trial, your personal information might be shared with personnel at
other sites, monitors, group staff in other countries, NSGO-CTU office staff, members of NSGO,
CRO staff, Ethics Committees and Competent Authorities, both in Europe, but also in countries
outside the European Economic Area (for example the US). If your data (personal information) has
been transferred, they will be subject to the data protection legislation of the respective country,
also if a less severe data protection law should exist.
We do not disclose information about you to anyone outside the organization without the above
consent, however, it should be noted, that if you e.g. accept an invitation to a meeting, your
personal information might be forwarded to the meeting location or the meeting organizer. Only
personal information relevant for the 3rd party will be disclosed in these circumstances.
Furthermore, your data can be transmitted to public databases for registration, as well as
publication of a trial and your data can be stored and published in those databases.
Storing and deleting your personal information:
For historical reasons and as your details might be saved in old attendance lists, email
correspondence and minutes from meetings, we cannot promise that all personal information
about you will be deleted, when you end your participation in a study. In general, all information
about a trial is deleted at least 20 years after end of study.

Your rights:
You have a number of rights via the General Data Protection Regulation (GDPR):
• The Right to Information (to be informed what information we process about you)
• The Right of Access (to get a print of the information we process about you)
• The Right to Rectification (to have false information about you corrected)
• The Right to Erasure (to delete information we process about you, however, information
already received cannot be deleted)
• The Right to Restriction of processing (under certain conditions, to have the processing of
your data restricted)
• The Right to Object (to object to your information being used for wrong purposes)

You may make use of your rights by contacting us, however, the legality of the processing carried out
prior to e.g., a withdrawal will not be affected. If you submit a request to have your personal
information corrected or deleted, we will investigate whether the conditions are met and, in that
case, make changes or deletions as soon as possible and, if applicable, also notify our data
processors to do so.

If you do not believe that NSGO-CTU handles your data correctly, you can file a complaint with the
supervisory authorities – The Danish ‘Datatilsynet’ – About processing your personal information
(www.datatilsynet.dk).

Revision of Privacy Policy:
We reserve the right to change the organization’s privacy policy. When we change privacy policy,
we also change the date and version number at the bottom of this document. In case of significant
changes, you will receive a notification.

The current privacy policy for NSGO-CTU is always available on our website.

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