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Patients’ roles and rights in research

BMJ 2018; 362 doi: (Published 25 July 2018) Cite this as: BMJ 2018;362:k3193

Rapid Response:

Re: Patients’ roles and rights in research: Still many roadblocks to be removed on the way to success!

This editorial deals with the highly important and relevant topic of REAL patient involvement in biomedical/clinical research. The importance of this stems from the fact that there is an ever-increasing pressure to enhance both effectiveness and efficiency of the drug and the drug development process. In order to meet these expectations, it is of vital importance that stakeholders/participants are much more aligned and work closely together, that administrative hurdles are reduced and that patients, being the end-users, are consulted and included throughout the different stages of the medicines development chain, from discovery until market introduction of the drug.

It has been claimed that active patient involvement in clinical research programs will increase the (average) success rate of projects and will enhance the level of acceptance of a drug upon introduction in the market. In practice, however, there is still significant resistance among doctors, investigators and project managers to include patient involvement in their new way of working, as they are not (yet) fully convinced about the benefits of this concept or they don’t know how to ‘operationalise’ it. It is of utmost importance that these ‘mental roadblocks’ among professionals are fully removed in order to obtain the projected benefits. To this end, the ‘believers’ of patient involvement will have to invest sufficient time and energy to ‘sell the concept’ to their colleagues, and – although some recently published studies do confirm its potential added value – more evidence will have to be collected in order to build a strong scientific basis for it.

This is not the entire story about patient involvement though. A more in-depth evaluation of the challenges ahead adds further complexity, as it reveals not just the above issue, but also numerous other ‘roadblocks’ that need to be recognised, addressed and removed on the road to a successful implementation. In a recent presentation held by the undersigned I categorised the main current roadblocks into 7 types: mental (this includes what was discussed above), communication, logistic, organisational, legal, financial and administrative.

Most of these roadblocks are quite challenging and complex issues. For example, for patient involvement to be successful, communication between professionals and patients must be optimal to avoid any misunderstandings. Interestingly, recent studies carried out in The Netherlands reveal that doctors often do not communicate in a transparent way towards patients about upcoming trials, options to participate in ongoing research programs etc, and that they often withhold pieces of information from them. They do so because they think that providing patients with all relevant information will put too much burden on the patients (particularly when they have received their diagnosis only recently). This can easily lead to confusion, to sub-optimal use of the knowledge and experience of patient investigators in the projects and, over time, less benefits.

Another example of a roadblock is how and where to find the adequate patients for the project stage and challenges at hand. To tackle this issue, project leaders/researchers should not start ‘random’ searches to find patients that may be suited for the job. Instead, a much better working model would be to have the different national patient associations play a central role in creating a ‘pool’ of patients who have received the necessary training to operate as a ‘patient investigator’. In addition, they should provide a single and clear entry point into the patient organisation for researchers who are looking for resources. This entry point then functions as a kind of ‘liaison officer’ who connects demand with supply and coordinates the distribution of the patient investigators over the ongoing projects. This working model has already been shown to be effective in selected cases and area’s within the Netherlands, but a setback of this approach is that national patient organisations usually rely heavily on volunteers and don’t have the financial means nor the required level of professionality to set it this up. This is an implementation challenge that still needs further discussion and action.

The above-described examples make clear that we are still far from the ideal situation, and full implementation of patient involvement is still a long journey with many roadblocks along the way. They also reveal that it will require effort from multiple stakeholders to solve the issues and get the roadblocks removed. Hence, in order to extract the maximum benefit from patient involvement, all relevant parties in the field have to work together to remove the roadblocks towards implementation. The medical/research communities, the patient community, CRO’s, hospitals, the innovative pharma industry, the government, and more – they all need to commit to the process, otherwise it will not work.

Eric Roos
Dutch Clinical Research Foundation (DCRF)

Competing interests: No competing interests

08 August 2018
Eric C Roos
Executive Board Member DCRF, Chairman Dutch Parkinson's Association
Dutch Clinical Research Foundation (DCRF)
DCRF, Trasmolenlaan 5, 3447 GZ Woerden, The Netherlands. Website: