The major area’s which we have covered in this model are Long & Unethical early stages, failure at early stages, Study design related problem like end point & study criterion, General acceptance of report and Reasons for long time line like low recruitment rate, IND complications, multiple effects, low survival rate of patients etc.
V – Onco© model has been developed to identify exact input, process and output parameters, in order to bring an effective mechanism in place. Most important aspect of any mechanism is inputs. One cannot expect perfect results without accurate inputs. According to this model, the inputs have to be provided by CRO and Sponsor. Before looking for a CRO the sponsor should have definite plan to introduce modern models for conducting trial like Phase 0, New Phase I designs for reducing the timeline and getting early indication of investigational products. Considering the complications involved in study the sponsor should ease the inclusion exclusion criterion. While selecting a CRO the sponsor must consider the knowledge base, their patent & investigators database, regulatory environment and ability to absorb the SOP.
Once selected, CRO has to play role of partner and select a site not only with high disease prevalence, experienced investigator & favorable regulatory environment but also with clinical research supportive environment. If they are lacking in some area, they help the CRO as a guide or knowledge partner and help the sponsor in selection of right partners with high patient base and knowledge base with current industry patterns. CRO can provide their best inputs through accurate and innovative research methodologies (like translational research), site selection and site feasibility.
With accurate inputs, process becomes easier with boundaries of well defined SOPs and well trained monitor. It is the responsibility of CRO to empathize with the site personnel and patient volunteers for fulfilling their needs related to clinical study. There should be a system of patient follow-up by creating validating and updating the database. There should also be a system of IP administration if patient is unable to visit. Site effectiveness should be highest in order to conduct qualitative trials with 100% source data verification.
CRO support is most crucial aspect of this process which includes complete site based support and recruitment of ICH – GCP trained physicians.
Creating awareness and marketing of suitable clinical trial is also part of the process. All these process parameters are focused on faster subject recruitment with quality data, favorable regulatory environment & understanding of clinical trials among physicians and patients. This can not be done overnight rather a continuous effort is required to achieve this goal. CRO has to conduct a disease prevalence study to know the extent of disease spread. CRO should also maintain database of Primary health centers & general physicians and create awareness about Clinical research to get their support for Volunteer recruitment, which is very vital for Cancer Studies.
Last stage of this system is a suitable output which is directly dependent on above two steps. As per V – Onco© model, with precise inputs and efficient process, one tends to get desired output in terms of faster regulatory approval, quality data, shorter timelines and better return on investment.
As industry demands quality data in most cost effective manner, we have designed V – Onco© model. Industry trends and patterns have changed due to economic slowdown which suggests cost effective research and CRO can be best partner to achieve the same.Below is model for reducing the timeline of Oncology Clinical Trials:
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