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Collaborating on raising the standard of care with Investigator Initiated Studies (IIS)


At Coloplast, our mission is to make life easier for people with intimate healthcare needs. We are committed to raising the standard of care – in close collaboration with health care professionals like you. One of the ways we do that, is though our commitment to advancing clinical evidence of our products. We therefore support investigator-sponsored research to generate real-world scientific data within our therapeutic areas of focus.

Here you can read more about our approach, and we hope to collaborate with you.

In accordance with MedTech guidelines, an Investigator Initiated Study is a research grant to support clearly defined third party-initiated clinical or non-clinical studies.

Investigator Initiated Studies provide an opportunity for clinicians and researchers to advance their scientific acumen with study-related financial and/or product support.

We welcome unsolicited research proposals that fall within our areas of interest under each therapeutic area of focus. All requests must be in writing and outline the type, nature and objectives of the research activity. Our areas of interest include:

  • Ostomy Care
  • Continence Care (Bladder Management, Bowel Management)
  • Wound Care 
  • Skin Care

If you have an Investigator Initiated Study idea and would like to apply for financial and/or product support, please complete the study proposal form, and submit it to the Coloplast Study & Publication Board (Study_Publ_Board@coloplast.com)

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Investigator responsibilities and requirements

As a potential investigator it’s important that you familiarize yourself with what is expected of you. The tasks may vary from study to study, and will defined if your project is accepted. Learn more about what is expected of you and what you can expect from us. Learn more

What is the role of the Investigator?

In Investigator Initiated Studies an Investigator takes on the role as both Investigator and Sponsor. The Investigator/Sponsor may be an individual, company, institution or organization that takes responsibility for planning, initiation, management and regulatory compliance for the conduct of a clinical study. There can only be one Sponsor per study.

In an Investigator Initiated Study, an Investigator may wish to perform a clinical study with a company product. Coloplast may be willing to support these studies without taking the role of Sponsor. In this situation the Sponsor would be the Investigator who proposed the investigation and who enters into the agreement with Coloplast and who will be taking both the responsibility of initiating and conducting the clinical study.

What are the responsibilities of the Investigator?

The Investigator will bear all obligations related to responsibility for study conception, design, operational execution, data handling, data analysis/interpretation, subsequent reporting/publication, and ensuring compliance with all local laws and regulations. The list of responsibilities is non-exhaustive and could cover the following tasks:

  • Protocol development
  • Submit application and required documents to authorities
  • Register the trial on Clinicaltrials.gov
  • Select qualified sub-investigators, sites and monitors, if relevant
  • Ensure that all patient-related information has been provided to the patient
  • Ensure IRB/EC approval prior to initiating the investigation
  • Develop Case Report Forms and data collection tools
  • Monitor and ensure study conduct according to protocol and regulation
  • Provide study supplies and/or investigational product
  • Report all serious adverse events to authorities according to guidelines
  • Report serious adverse device-related events to Coloplast
  • Perform data analysis and report findings
  • Final study reportsIndemnification of the investigator or insurance of the patient
  • Deliver according to agreed timelines and provide study updates to Coloplast


What are the responsibilities of Coloplast?
 
Coloplast commits to review the Investigator Initiated Study proposal and provide its feedback and potential requests for further information within 1 month.
If the eventual study is accepted and funding is approved an Investigator Initiated Study Agreement defining roles and obligations will be entered into between the Investigator and Coloplast.
It is Coloplast’s responsibility to supply the support agreed between Coloplast and the Investigator according to the Investigator Initiated Study Agreement (see section below).

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Purpose and possibilities

Purpose and possibilities

Coloplast has an interest in supporting studies with a scientific relevant scope within our main areas of interest. Before submitting your application we recommend that you read about what projects we typically are interested in. Read more

What type of support can be provided?

Coloplast may support an Investigator Initiated Study with product supply, monetary funding, resources, material and/or information after ensuring that it correlates with the company defined areas of interest.

Coloplast may also provide comments to the study to ensure that it is based on sound scientific research principles and protects the safety of participants.

Further support in the form of protocol development, statistical analysis plan or applications for ethics committee/IRB approvals are not possible as you as Investigator/Sponsor must retain full responsibility and control of the study to qualify for an Investigator Initiated Study.

What kind of studies do Coloplast support?

The decision of whether Coloplast wishes to support an Investigator Initiated Study will be based on an evaluation of the scope of the Investigator Initiated Study and could include the following considerations:

  • The validity of the scientific question being addressed, ensuring that any data generated by an Investigator Initiated Study complement the existing body of evidence and not simply be a repetition of a previous study/experiment.
  • The robust nature of the Investigator Initiated Study being conducted in terms of ethical and design elements.
  • A commitment by the Investigator/Sponsor to disseminate the findings in an appropriate, transparent, and timely manner.
  • The Investigator’s previous clinical experience and capability of conducting studies.

According to legal requirements, applications for Investigator Initiated Studies must be unsolicited, but Coloplast may divulge specific areas of interest on which the Investigator Initiated Study can be based. Proposals that are within these areas of interest will be prioritized. Requests may also be based on discussions with Coloplast scientific staff.

Studies with a scientifically interesting scope within our main areas of interest, not repeating previous work and applying sound research principles will be preferred.

What are Coloplast’s main areas of interest?

 Coloplast is specifically interested in supporting Investigator Initiated Studies within the following therapeutic areas and topics:

General areas of interest within ostomy care, wound care, bladder and bowel management:

  • Impact of product/product type/treatment method on patient satisfaction, quality of life, treatment costs, compliance, or cost-effectiveness
  • Impact of product/product type/treatment method on clinical benefits or complications (potentially compared to equivalent product/treatment)
  • Impact of patient care or educational programs on patient behavior, satisfaction or quality of life
  • Epidemiological investigations (prevalence/incidence of treatments/interventions within the specific patient groups)
  • Burden of illness
  • Resource utilization

Specific topics of interest (non-exhaustive):

Ostomy care

Bladder management

Bowel management

Wound care

Skin complications

Complications or risk factors related to treatment methods (e.g. urinary tract infection, strictures, trauma, stones etc.), including long-term treatment outcomes

Long-term treatment outcomes

 

Post-surgical bowel dysfunction

Impact of product/treatment method on Intertrigo complications and recurrence, patient quality of life, patient satisfaction, costs and HCP time

Leakage problems

Biomarkers of UTI

Gut microbiome

 

 

Risk factors related to delayed wound healing or non-healing wounds, and substantiation of proxys/surrogates for predicting wound healing

Wear time and consumption of ostomy appliances and what affects it

Bladder dysfunction in Multiple Sclerosis and other neurogenic conditions

Bowel dysfunction in Multiple Sclerosis and other neurogenic conditions

Methods to detect biofilm in vivo in (non-healing) wounds

 

What are Coloplast’s expectations in order to consider collaboration?

Investigator/Sponsor qualifications and obligations - as support from Coloplast is relying on unsolicited, Investigator Initiated Study requests, where the Investigator is responsible for the protocol design, study conduct, data analysis, study registration, approvals etc., we expect that the Investigator possesses a solid knowledge and experience of conducting clinical research and is able to ensure compliance with general as well as local laws, regulations and guidelines. A curriculum vitae of the Investigator will be expected.

Resources - Coloplast also expects the Investigator to have the right and available resources for the conduct of the study (e.g. personnel, time, and equipment).

Dissemination of results - Since Coloplast encourage robust, scientifically interesting studies a commitment by the Investigator to publish the results is expected.

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