| Dr Kiran Marthak |
I still recollect early 2000 when Mckinsey Report was out indicating that clinical research would be a boom and would touch the market size of a billion dollar by year 2010-12. In India !!!! How unpredictable the market could be as we all know what is the market size at present. Hence the picture in a crystal ball will always be hazy. But there could be some improvements as I am always optimistic.
I would crystal gaze not on the finance part but on the processes and on expected improvement which would automatically lead to better business.
I will divide it into regulatory authorities, Ethics Committees/ IRB/ IEC, CROs/ SMOs, institutes and investigators and miscellaneous
Regulatory authorities
The whole industry at at present suffering from recession due to erratic approval timelines. I do wish that they would realise the importance of it and would place various timelines on the website and would adhere to it.
I strongly recommend to have a separate director for clinical research activities, separate director for marketing authorisation, and separate director for manufacturing activities in Drugs Controller General of India (DCGI) office. Each director will be master in their own field. This will resolve many issues including timelines.
There should be a decentralisation of certain activities e.g. T-License, inspection of the CRO sites as well as institutes, NOC for BE studies – Local/ export etc. should be managed by Regional Deputy DCGIs. This will reduce a lot of general work load in Delhi office.
Revamp the New Drug Advisory Committee (NDAC) – Give them a target number of protocols to be reviewed within a stipulated time period, make them accountable and also if they do not attend regularly, even replace them. Only certain discreet protocols only should be referred to the NDAC. The fees for the experts should be attractive.
Reconstitute IND committee in a fashion similar to NDAC.
Knowledgeable practical staff right from technical officers upwards. The knowledge should not only be on clinical research but also on time management, finance and International Regulatory Guidelines.
Allow Phase-I studies – F.I.M. even if the molecule is discovered out of India.
Severe penalty clauses in the Schedule-Y and in constitution for those who violate the laws and those do not conform to ICH- GCP Guidelines recommended by ICMR in India.
Online applications for all different NOCs required from health authorities.
KRAs for various positions in DCGI office should reflect the outcome.
Constant dialogue between DCGI and regulatory authorities of developed countries and under developed countries.
Acceptance of the data between the regulatory bodies would hasten the process of launch of the products in many countries simultaneously.
Ethics Committee (EC)
Ethics Committees plays a major role for the subject’s safety and also for his well being in the study.
The guidelines now have placed more responsibilities on the shoulders of ECs. Each EC should be registered with the government organisation. They should be inspected and accredited. Regular inspection/ audit of ECs will make the members realise that they have to be up to date in their knowledge and record keeping. If found non- compliance EC should be de-listed and for major fraud there should be penalty for the members too.
CROs/ SMOs:
SMOs will flourish as there would be more and more systematic approach for patient’s identification, investigators commitment would be required. This would be done through an excellent database of patients, as well as for the investigators.
Compensation to healthy subjects for BE study will increase as the subjects will be more professionals.
Compensation for serious adverse event in a study will be much more and there would be even lawyers looking out for serious adverse events in a subject and to make some quick money out of it. (I see nothing wrong in it).
More and more CROs would go for Pharmacovigillance, Central Lab particularly for ECGs, radilogy, X-Rays, CT Scan, MRI, colour doppler, data management, medical writing, quality assurance, etc. since it does not require any approvals from regulatory authorities and the profit margins are higher.
More use of end –points related to biomarkers. This will provide independent opinion on efficacy and safety of the trial subjects. More and better software related to CTs would be in the market leading to consistency in analysis and minimal chance of fraudulent cases. More practical and acceptable study design will provide better clues about efficacy and safety of the molecules.
Use of robots in Bioanalytical Lab and Central Lab to speed up the process and will have less errors.Patients Group will play a major role in protocol design, compensation, and enrollment in the study. More clinical trials related to medical devices would take place as there would be great demand for the same for various activities in the life and to improve quality of life. Severe punishment for non- compliance to CROs and SMOs.
Institutions and investigators
Institution charges for conduct of CTs would increase as they are now becoming more and more aware about it. Each institute will have a separate clinical research department under taking CTs. The trained staff will take care of it. It would be the duty of the chief of the institution to see that the CTs are performed as per ICH-GCP guidelines. Each institute will have EC too.
Investigators will be specially trained to conduct CTs. However, the investigator fees would be much higher (more than 100 per cent increase compared to present structure) as they would be in demand. Each investigator will conduct the CTs in their super specialised therapeutic areas.
Frequent audits of the institutes and the conduct of the study by the investigators would be a must. Any fraud by institution or by the investigator should be considered as criminal activity and penalty should be the outcome of it. In such cases both can be debarred from undertaking clinical trials for a certain period.
Miscellaneous
There would be more manufacturing units for the formulations related to CTs, packaging, quality control, quality assurance, etc. will mushroom. Courier services work would reduce as there would be more online services. Mobiles would be used more in getting the patients feedback. It will reduce their visits to the sites. Media would be more educated and hence there will be less unnecessary noise in the media
Conclusion
All these can happen if there is a good awareness about clinical research in every partner. Every individual will have to do their best to achieve it. Regulatory agencies will have to be more sharp and understand the reality of the business and science. Even the pharmaceutical, biotech and medical device industries will have to pitch in. Quality will always remain to the top requirement in every aspect. The CTs will become more expensive and there would be less number of new molecules.