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Outside a major city? Had Xgeva (Denosumab) to protect bones during prostate cancer treatment? Read on:


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This notice if only for men outside a major city who are receiving, or who have received Xgeva (Denosumab) to help preserve their bones in the past two years during treatment for metastatic prostate cancer.

 

This is not the standard research study we sometimes present you with.

It is actually marketing research for a pharmaceutical company.

But the reason I am putting it before you is that there seems a genuine desire to identify the problems men outside major cities have in getting and being treated with an important prostate cancer treatment.

 

If you think you can help, please phone Liz Knox on 0419 416 737.  Other details are in the letter Liz sent me (below).

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Dear Jim,

 

Thanks for taking the time to talk to me today.  As promised here is a little more about the study – 

 

Firstly we are looking to speak to prostate cancer patients with bone metastases who are or have been receiving Xgeva  during the past two years.  It is a telephone interview of 60 minutes with myself plus a short piece of “homework”  (this should take around 15 minutes) and for this we would pay an honorarium of $175 either by a direct bank transfer or if they prefer and e-gift card (from giftpay.com.au can be redeemed and used in multiple outlets including Coles, Woolworths, Myer, for fuel etc).

 

The Xgeva team want to understand patient needs from their perspective (plus we are interviewing physicians, nurses and caregivers) and the research results will be used to identify and create solutions to address patient challenges.    The purpose of my role is to conduct an interview to capture and understand individual patient experiences.   We are looking for patients in regional or rural areas (we have already found people in the cities).

 

The essentials of the interview are-

 

  • The challenges and dilemmas patients face during their treatment pathway
  • Potential solutions to the dilemmas the patient is facing
  • The relationship between the patient and the other stakeholders
  • The tools patients use to gain information and support and any unmet needs with these tools

 

It would be wonderful if you could help with finding one or even two patients who would qualify and would be interested.

 

At the bottom of this email is the privacy statement.  We send this to the patient and by undertaking the interview this is what they are agreeing too.  By the way the paragraph highlighted in red I always leave this blank unless someone for whatever reason wants it included.

 

My number is 0419 416 737 and they can contact me directly either by email or by phone or you can let me have their details and I will contact them directly.

 

Please let me know if there is any more information you would like.

 

Regards

 

Liz Knox

Senior Consultant

KBX Research

www.KBXResearch.com.au

 

Consent and Release Form: Market Research Interviews 

Thank you for your interest in participating in this market research. Just Worldwide (“Agency”) is conducting market research on solid tumour cancer and Multiple Myeloma for the purpose(s) of understanding the patient journey and defining patient ecosystems (“Market Research”). You should consult with your physician prior to consenting to participate in this Market Research to ensure that your participation and any risks associated with participation and your health are discussed, understood and accepted.  Interviews conducted by the Agency are not intended to be a source of medical advice or treatment.  You should communicate any questions about medications, health care, and/or participation in the program to your health care provider. This Market Research is sponsored by a company interested in the biopharmaceutical industry and may be a company engaged in the business of research, development and commercialization of human therapeutics (“Sponsor”).  

Your participation in this Market Research is voluntary; however, if you do not consent, you will not be able to participate in this Market Research. 

1. Information collected during this Market Research.  During your participation in this Market Research, the Agency will collect information about you which will include your personal information and, if applicable, may include health related information (collectively, “Personal Information”) – for example, your contact details (such as name, address, and phone number), medical condition and treatment information, where you work, or your type of practice. The Agency may also utilize audio and video recordings (including, but not limited to, video recordings of your face).

2.  Disclosure of your Personal Information.  Personal Information collected will be used only for purposes of this Market Research.  The results of this Market Research will be reported to the Sponsor in de-identified form only and will not identify you individually, unless you have consented to additional disclosure or are participating in research where Sponsor representatives are actively viewing and/or listening to the research.  The Sponsor may elect to share the de-identified results of this Market Research publicly.

However, if you disclose information having to do with the safety or quality of Sponsor’s products, Agency may be required to disclose non-identifiable information about you (e.g., gender) to the Sponsor as necessary to fulfill regulatory and legal obligations. See Section 5 (adverse events and product quality issues) for more information.

While representatives of the Sponsor may be present to witness your interview in certain cases, Personal Information disclosed by Agency will be kept to a minimum to avoid unnecessary disclosure to the Sponsor or its representatives consistent with the intent of this Market Research being conducted. 

3. Your privacy will be protected. This Market Research is subject to applicable laws governing the protection of Personal Information and your information will be treated confidentially. Your Personal Information provided may be transferred and processed outside the country in which it is collected. Regardless of the country where your Personal Information is collected or processed, Agency maintains appropriate administrative, technical and physical safeguards to maintain data security and protect your Personal Information.  

You may withdraw from this Market Research at any time. You will have the right to withhold information during this Market Research. Your rights to access, correct, delete, restrict, and object to the processing of any Personal Information may be exercised by contacting Just Worldwide at Info@just-worldwide.com.

4. This Market Research is confidential. Except for the limited disclosures which may be required below (Section 6 – Participant’s Obligations) to satisfy your obligation to obtain permission to participate in this Market Research, you acknowledge and agree that (a) your participation in this Market Research, including any information you receive about this Market Research and any information disclosed by the moderator during the interview is confidential and (b) you will not disclose such information to any third party unless required by applicable law.

5. Adverse events and product quality issues. During the course of this Market Research, you may disclose information having to do with the safety or quality of Sponsor’s therapeutic product(s) or medical device(s). Under certain circumstances, there are regulatory and legal obligations to report certain types of safety or quality information to regulatory agencies (e.g., U.S. Food and Drug Administration, European Medicines Agency). As a result, you should be aware that the Agency may be required by law to report safety and quality information reported by you to the Sponsor and/or Sponsor’s authorized agent, business partners or collaborators. In such cases, the Sponsor and/or Sponsor’s authorized agent may need to contact you for further information necessary to fulfill Sponsor’s regulatory and legal reporting obligations.

□  Please check this box if you authorize and consent to having the Agency share your contact information (e.g., name, e-mail, telephone number) with the Sponsor and/or Sponsor’s authorized agent for purposes of following up with you in regard to the safety reporting or product quality issues you reported during this Market Research.

6. Participant’s obligations.  It is your obligation as a participant in this Market Research to obtain all required third party permissions and to be aware of any limitations imposed on your participation by third parties. This includes private or government employers or other entities with which you are affiliated. Neither the Sponsor, nor the Agency, will obtain such permissions on your behalf. It is your sole responsibility to understand any potential conflicts of interest created by your participation and to satisfy any necessary reporting obligations in connection with your participation. By consenting to this Market Research, you acknowledge and agree to this obligation, which is necessary to qualify for participation.

7. Intellectual property/future inventions.  You understand that a commercial therapeutic, diagnostic, device, and/or combination product(s) may be developed using the information you provide, including your feedback and/or medical information collected during this Market Research. Sponsor, other researchers or research companies may patent or sell discoveries that result from or are related to this information.  You do not have any rights to future inventions.  Neither Sponsor nor the Agency will compensate you for the information you provide in excess of the honorarium you may receive for participating in this Market Research, if any.  By consenting to this Market Research, you acknowledge and agree to this paragraph, which is necessary to qualify for participation.

8. Ethnographic research.  You understand that as part of this Market Research, representatives of the Agency and possibly the Sponsor will come to your home or office to interview you and may observe your interactions with the Sponsor’s products. You should consult with your physician prior to consenting to participate in this Market Research to ensure that your participation and any risks associated with participation and your health are discussed, understood and accepted.  Interviews conducted by the Agency are not intended to be a source of medical advice or treatment.  You should communicate any questions about medications, health care, and/or participation in this program to your health care provider. Some or all of this session may be captured on video, audio, or with photographs. Your face, objects in your home and in your general environment may be photographed and videotaped; and while it is not the intent of these activities to identify you individually, you understand that in some cases other individuals may be able to identify you or your home from the photographs, audio or video taken.  

You understand that while efforts will be taken to avoid capturing any images of other individuals who may be in your home at the time of the interview, some images of others may be captured.  It is your responsibility to make sure that other individuals in your home during the interview are aware of and agree to such recording.   

By typing your name below, you certify that you are eighteen (18) years old or older. You certify that you have read and understand the information above, agree to comply with the requirements included herein and to be a participant in this Market Research.

 

Name of Individual:

_________________________________________

 

 

Date:

_________________________________________

 

 

 


 

 

 

 

 

 

 

 

 

 
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