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/Institutional Review Board 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, adherence to treatment 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/patient pathway)
- 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 on wounds or intertrigo on clinical and health-economic parameters, product satisfaction, and patient quality of life |
| Leakage problems | Biomarkers of UTI | Gut microbiome | Risk factors related to delayed wound healing or non-healing wounds, and substantiation of proxies / surrogates for predicting wound healing |
| Wear time and consumption of ostomy appliances and what affects it | Bladder dysfunction and management in Multiple Sclerosis and other neurogenic conditions | Bowel dysfunction and management in Multiple Sclerosis and other neurogenic conditions | Methods to detect biofilms 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.
Complete and qualified submissions will be reviewed by the Coloplast Study & Publication Board in accordance with this guidance to determine alignment with Coloplast areas of interest, budget, and compliance with applicable laws/regulations and Coloplast policies, e.g., Legal, Compliance, Regulatory and Medical Affairs.