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:
V – Onco© Model:
Business Development Manager
Above V – Onco© is copyrighted and property of Vedic Lifesciences Pvt Ltd. It shall not be used without written consent of Vedic Lifesciences Pvt Ltd.
13 comments:
Dear Dhirendra,
It is very good and informative article. It can definitely bring some changes in Cancer clinical Studies.
Thanks
1. do not make the opening statement as Cancer is the biggest killer make it one of the biggest.people will have evidence that infectious diseases like malaria and also hunger are the biggest killers.
2.There is a good link missing between clinical Trails and Cancer.Include a paragraph about clinical trials after the first paragraph.
3. explain your model a little more and compare it to the traditional model to generate more interest
Hope this will be helpful
Suhasini
Dear Dhiru,
Its been a indepth analysis of indian cancer related dignostic problems,which are there in India and we can expect it more widen with event of time....so more scope for companies like yous to fill the gap! As Indian Govt. has been a mere spectator in this field of highly resource demanding field in Clinical Diagnostics.
Do more research by covering some villages,and see the number of patients be ignorant about their disease.!
Best of Luck !
Gourav Baru
Dear Sir,
Your Article is mind blowing and its really helpful to those people who are doing deep study and research on Cancer.
Thanks
Mr.Dhirendra,
Thanks for your article.
It is very useful and informative article for freshers like me who are interested in clinical research and like to participate for conducting clinical trials on cancer in India.
Hello Dhirendra,
I think this is the new area which should be explored in clinical trails at least for life threatening diseases.
I think subtitle you gave - uncontrolled growth....cells, I am not able to understand. As per defination, Cancer is the disease caused by uncontrolled growth of cells. So in your subtitle, i will suggest to keep cancer or carcinogenic cell, not both.
Hi Dhirendra,
Thanks for your article.It is informative and gives a brief idea about cancar. would be good if you can add some recent developments in cancer.
Dear Dhirendra,
Cancer is a critical disease of universal. Always there is a query in my mind; does cancer kill the recipient or the medicine used for the treatment? By doing more clinical trials on this subject some where we may be able to identify the figure for better.
Hi Dhirendra,
I do appreciate your concern and efforts for writing this article.
Malignant Neoplasm – Curable for Rich and life Arrester of the poor
Cancer can be cured but is actually a life taking disease for the poorer section of society due to high cost of treatment. Major reason behind the same is longer Research timeline as rightly mentioned in your article.
You have hit the nail right by developing the model to reduce the time line and there by reducing the cost.
Hope to see that your study proves as a boon to the needy section. Do keep on sharing your knowledge on the same.
Dear Lovely,
You said it right "Malignant Neoplasm – Curable for Rich and life Arrester of the poor". As the treatment expenses are too high, it becomes difficult for the patients to bear the expenses.
Participation in Clinical Research gives an option for treatment to the ones who are unable to afford medical expenses, with extensive care.
Thanks for raising this point.
Kind Regards,
Dhirendra
Hi Dhirendra,
this is truly one of the most comprehensive & precise article on Cancer Clinical Trials.
Also, You have successfully drafted out a very complex process of trials in a simplified manner through your 'Model'.
This MODEL will definitely prove to be a vital tool to curtail the time and therby the cost of many of the undergoing trials.
Congratulations.
Keep up the good work.
Dhirendra,
I read your manuscript/proposal on Oncology Clinical trials with great interest. I agree with your rationale for the suggestions you have made which are based on the assumption that the Oncology Clinical Trials are performed without proper transnational research. Tumor is a complex collection of distinct mutations. The presence of the drug target in the tumor does not mean that the tumor is dependent on it for survival. Drugs make it to the clinical phase of development on the basis of preclinical data, but these preclinical models do not recapitulate the complexity of human tumor and therefore are not predictive of clinical response.
I think it is an excellent model to follow as it considers all of the variables a research has to consider. I hope you try to have this published in other scientific journals as it is clear and concise information.
Congratulations on a wonderful article!
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