8 April 2024

Patient representatives were engaged in the planning of the NoDoubt trial. The researchers collected their input on the study design, the endpoints and the recruitment strategy. This collaboration was a rewarding experience for both sides.

A joint process

The NoDoubt trial aims to clarify whether cancer patients with moderate to severe pain benefit from treatment with non-opioids (metamizole and ibuprofen) when administered in addition to opioid therapy. Here, Christopher Böhlke, Senior Physician Palliative Care at the University Hospital Basel, who shares the study leadership with Prof. Jan Gärtner from the Hildegard Palliative Care Center, and patient representative Gernot Mayer report on their mutual experiences in this joint process.

Dialogue at eye level

This approach, known as "Patient and Public Involvement (PPI)", is gaining increasing approval and acceptance in clinical research. PPI relies on dialog between researchers and those who are to benefit from the research. The common goal is to make research relevant and tailored to the needs of the patients concerned.

Support services

The Department of Clinical Research (DKF) supports and accompanies researchers as well as patients, relatives and other interested parties with advice and courses. It is particularly beneficial for researchers planning a submission to the Swiss National Science Foundation's (SNSF) Investigator-initiated Clinical Trials (IICT) funding program to obtain advice on PPI. The SNSF provides separate funding for the initiation of PPI activities. The NoDoubt study was also able to benefit from this funding and finance the initial exchange with PPI representatives.

NoDoubt trial

Image: Co-Principle Investigator Christopher Böhlke and patient representative Gernot Mayer in discussion

NoDoubt trial

Efficacy of non-opioiddrugs in addition to opioid therapy for cancer pain management: a double-blind, randomized, threearm, placebo controlled trial assessing the key non-opioids dipyrone (metamizole) and ibuprofen

Principle Investigators
Prof. Jan Gärtner, DKF Research Group Leader, Chief Physician, Hildegard Palliative Care Center

PD Dr. Christopher Böhlke, Senior Physician, Palliative Care, University Hospital Basel

To compare the efficacy of non-opioids (metamizole and ibuprofen) in addition to opioid therapy in cancer patients with moderate to severe pain

Study design
Double-blind, placebo-controlled, multicenter, randomized clinical trial

Study centres
5 in Switzerland

Number of planned study participants

PPI measures

  • Focus group discussions on the research question, study endpoints and recruitment strategy
  • Implementation of an international PPI Advisory Board as an advisory body during and after the conduct of the study
  • Review of the lay summary by PPI representatives
  • Involvement of three relevant patient organizations

DKF Scientific Services
Methodological consulting, statistics, data management, PPI consulting