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Approach to Clinical Trials

OSDD model believes that the governments and public funded institutions in the countries with high burden of disease have a responsibility to contribute to the drug development. OSDD alternative is to conduct publicly funded clinical trials involving public institutions. These trials will have to be conducted with internationally accepted standards. Infrastructural and other capacity may have to be built up for conduct of trials, but there are countries like India where such facility already exists in many diseases. OSDD will carry out its clinical trials with the participation of public funded institutions. The cost of trials can therefore be brought down considerably on the open source platform. CSIR has brought many drugs to the market after clinical trials. The experience of CSIR in conducting clinical trials is a guiding point.

Two important points govern the principles under which clinical trials will be conducted under the CSIR/OSDD umbrella but with the Open Source concept. The main features guiding success:

• Appropriate processes and documentation required for clinical trials and during the conduct of it, are maintained to internationally acceptable standards, in collaboration with CRO’s or industry partners with experience in the field.
• Private pharma will be inducted as a stake holder in the process of conducting clinical trials. The arrangements with the different stakeholders will be with the understanding that the drug will be made available to the generic industry for manufacture which in turn ensures ‘affordable pricing’.

In all cases where clinical trials are conducted by OSDD, the data will be available in the open and high standards will be adhered to. Thus, OSDD has a clear alternative approach for the expensive clinical trials conducted in secrecy and at high cost.

OSDD de risks clinical trials for tropical diseases by investing public funds and involving public institutions in the countries where disease occurs. This will bring down the cost of clinical trials. OSDD ensures that clinical trial data, sans personal details, is made public so that community inputs are available while conducting clinical trials and for later designing of new trials. OSDD will also make the commitment that these trials will be conducted following all national regulations, following the best ethical practices in a transparent manner and will be monitored by an independent group appointed by the OSDD.