Conducting clinical trials on neglected diseases means that research must often be conducted in some of the most remote areas of the world, where there is little infrastructure of any kind, let alone health infrastructure. In some areas, there can also be a risk of political instability. While carrying out clinical research at international standards of quality in such conditions is possible, it requires considerable effort to ensure adequate infrastructure, well trained staff, as well as specialized ethics committees, and well-functioning regulatory authorities are in place.
Since its inception in 2003, DNDi has worked to integrate capacity strengthening into its projects in a sustainable manner, through knowledge sharing and technology transfers. The objective is to increase the chances of registration, uptake, and sustainable access of new treatments for neglected diseases and, ultimately, to support the transfer of ownership to disease-endemic countries.
DNDi helped in setting up and works with four regional disease-specific platforms and networks in Africa and Latin America:
- Leishmaniasis East Africa Platform (LEAP) on leishmaniasis
- HAT Platform on sleeping sickness, or human African trypanosomiasis
- Chagas Clinical Research Platform (CCRP) on Chagas disease
- redeLEISH Network on leishmaniasis
Their mission is to:
- Define patients’ needs, taking into consideration the local settings
- Bring together key regional actors in health field, namely representatives of ministries of health, national control programmes, regulatory authorities, academia, civil society groups, and pharmaceutical companies, as well as clinicians and health professionals
- Utilize, capitalize upon, and reinforce clinical capacities in endemic regions, and address infrastructural requirements where necessary
- Provide on-site training in clinical research in sometimes very remote settings
- Contribute to regulatory processes, uptake, and sustainable access of new treatments.
To support strengthening of capacities and ensure sustainability, DNDi’s activities include:
Maintaining and building R&D regional platforms. As an integral part of DNDi’s model, R&D regional research platforms form part of a broader, positive trend of research networks to maximize worldwide collaborations. The objective is to bring together key regional actors (ministries of health, national control programmes, regulatory authorities, academia, civil society groups, pharmaceutical companies, clinicians and health professionals) to share different experiences, knowledge, and problem-solving techniques.
Building health infrastructure, creating R&D training spaces, and setting up research facilities in clinical trial sites. The physical upgrading of facilities needed for clinical research (such as patient wards and diagnostics laboratories) is undertaken by DNDi at trial sites to ensure they are compliant with Good Clinical Practice (GCP) international standards and remain the property of the local public health provider.
Training to support R&D efforts in disease-endemic countries. Trained staff are needed to carry out GCP compliant trials. Training is important not just at the start of a trial, but is a continuous process which involves upgrading existing skill-sets and training new staff members. From external consultants to experienced trial site staff, the sharing of better practice principles helps to motivate teams working in difficult field conditions. In 2016, 628 people were trained across the LEAP, HAT and CCRP platforms.
Transferring technology to local manufacturers. For DNDi, the transfer of technology consists of transferring the industrial development know-how to partners in disease endemic regions to ensure a wide-spread distribution of treatments. It involves providing the required regulatory files and information needed to maintain competitive prices and reinforce the technological and scientific capacities of disease-endemic countries.