•Clinical trials of an advanced pneumonia vaccine by Wyeth caused the death of an infant in Bangalore. The phase III trial was to assess the safety and tolerability of the pneumonia vaccine. Wyeth is believed to have violated drug testing rules in the country?the baby was suffering from a cardiac abnormality. Since then, drugs controller general of India (DCGI) has suspended all further trials of the drug.
• In Hyderabad, a 25-year-old man died after being administered the second dose of a drug for hypertension called Felodipine 10 mg?extended release. The deceased had enrolled for the clinical trials, approved by the country?s drug regulator. Investigations are presently on to find out the cause of the death.
• DCGI has barred some domestic pharmaceutical companies from producing the generic versions of an anti-obesity drug from Sanofi-Aventis. The ban was enforced in India after recommendations by the European drug regulatory authority, European Medicines Agency, that severe side affects had been observed in the patients.
•The death of 49 infants during clinical trials at the country?s apex medical research institute, All India Institute of Medical Sciences (AIIMS) earlier this year is still fresh in the minds of people.
Indian regulator has suspended several drug trials over adverse reactions or efficacy issues. If sources are to be believed, close to 100 people have died in the country in recent times, owing to clinical trials going wrong.
If the scare stories emerging from India aren?t enough to send a chill down your spine, here?s more: Clinical trials for a drug from Novartis for the treatment of irritable bowel syndrome were suspended in the US, after reports surfaced of an increase in cardiovascular side-effects among the patients. A drug from GlaxoSmithKline too was linked to an increase in heart attacks, thereby coming under the US Food and Drug Administration?s (USFDA) scanner. A painkiller from yet another drug major failed to get regulatory clearance from USFDA after liver problems surfaced among patients undergoing clinical trials.
Clearly, pharmaceutical and clinical research companies?domestic as well as multinational?are in the dock for grave violations in the way clinical trials are conducted. While efforts to regulate clinical research activities by bringing them under the ambit of the Central Drugs Authority (CDA) will take some time to materialise, clinical research organisations, investigators and trial sponsors, that is, the pharmaceutical companies are pushing to bring in quality, transparency and efficiency in the entire clinical trials process. They need to establish that the people who undergo clinical trials of drugs should not be exploited. They should be well informed about the risks. Their safety should be ensured.
Faced with drugs rejected by regulators or pulled from the market at the cost of millions of dollars in wasted development and clinical trials, industry is now forced to react. One of the largest barriers pharmaceutical companies face in bringing new drugs to market is the clinical trials process itself. Often paper-based and always subject to intense regulatory pressure, clinical trials involve managing massive amounts of documentation between multiple parties and systems.
Not surprising, contract research organisations (CROs) are looking towards IT tools to bring in transparency and accountability through end-to-end solutions with an efficient clinical trial management solution, or an e-clinical trial data management.
?There is an emerging trend among CROs to use laboratory information management systems (LIMS). These solutions help in better data management of trials. They also assist in providing the record for data and accountability,? says Anuradha Acharya, managing director, Ocimum Biosolutions.
CROs are trying to expedite and improve the drug development process by concentrating on designing clinical trials, implementing them, and reporting their data from investigative sites around the world. As CROs expand their portfolios to include pre-clinical trials, phase I-IV trials, data management and site management, they are looking for technological solutions which could provide value-adds, primarily by helping in study design, and reducing time and cost of studies, says Pradep Nair, head, global life sciences and healthcare sciences practice, HCL Technologies,
A momentum is building up towards an e-clinical trial data management and the components of this include patient, site, data and document management systems. Interestingly, the USFDA has already shown signals to bring in place an e-clinical system.
While it is not yet made mandatory, CROs are trying to bring in line necessary IT tools as per the customer needs to factor in accountability. As Suven Life Sciences CEO Venkat Jasti puts it, ?It brings in speed, safety as well as security to the entire process. And since it is locked, there can be no security lapse even while transmitting the data, thus preventing any alteration to the data.?
On their part, IT companies such as Tata Consultancy Services (TCS), Cognizant Technology Solutions, Satyam Computer Services and many more are gearing up to bring in facilitating solutions to bring in place the much-needed safety management for clinical trials. IS Gandhi, medical director, Vimta Labs says, ?Integration of electronic data capture systems with clinical trial management systems and IVRS is a prime necessity for this value-added qualitative and efficient time saving option. To what extent will it imbalance the need for cost saving by reducing paper burden load versus new skills requiring human resource development and employment to tackle with data entry and data cleaning at multiple diverse sites, is a question worth examining.?
In this direction, Satyam Computer Services is working with Oracle?s new health sciences global business unit to provide clinical development applications. The solution, which Satyam is offering under the umbrella of ?Clinical xPress? will help pharmaceutical and biotech companies and CROs to address their most pressing business challenges, such as cost containment, safety management and accelerated time to market.
TCS has helped drug major Cadila identify and implement an appropriate solution for its clinical data management within tight deadlines. The IT behemoth has also helped improve the efficiency of managing huge amount of data by totally transitioning Cadila?s clinical trials process from paper to electronic mode. TCS also provides a comprehensive strategy for creating efficiency at every stage for accelerated drug development. This is directed towards reduced clinical trial costs, integrated care delivery networks, re-evaluation of safety standards, safety-based drug withdrawals and compliance with quality standards.
Same is the case with Cognizant Technology Solutions, which recently announced an agreement with
AstraZeneca to support the latter?s drive for bringing in greater efficiencies in clinical data management. Cognizant will provide a broad spectrum of centralised data management services for AstraZeneca?s global clinical development programmes. These include data management planning, clinical study set-up for electronic data capture, medical coding, adverse event reconciliation, clinical data management, and training for the clinical sites and investigators.
Frost & Sullivan analysts feel that pharmaceutical companies are increasingly using electronic data capture (EDC) solutions to help clinical research associates and patients enter trial data, store and analyse it and various evaluation procedures of actual data to make faster decisions. EDC could be defined as a set of processes, aimed at collection, storing, sharing and analysis of patient information electronically in order to manage, analyse and report a trial in an efficient manner.
In recent years, pharmaceutical companies have seen the time of trial processes being reduced by 20% and the cost being reduced by around 25% when using EDC systems.
They have also realised the need to implement efficient clinical trial solutions to streamline their trial process. Frost and Sullivan analysts inform that e-clinical trial solutions could bring in greater efficiency in drug development and reduce the overall cost of clinical trials by 25%.
A full fledged e-clinical technology package comes with integrated processes that include technology for data integration and interactive voice response. The delays in the availability of data can have profound effect on any clinical trial and electronic solutions would help in increasing data availability by about 70%, say analysts.
Clearly, the need of the hour is to position India as a global player in the field by ensuring quality, transparency and efficiency in every aspect of clinical research.
