Indian trial compensation guidelines open to comment

India is seeking comments on draft guidelines that detail sponsors’ clinical trial injury compensation responsibilities.


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Indian trial compensation guidelines open to comment

Registration of BA/BE studies with CTRI to become mandatory soon

After more than two years since the registration of clinical trials was made mandatory in the country, the Union health ministry will soon make the registration of bioavailability and bioequivalance (BA/BE) studies mandatory with the Clinical Trial Registry of India (CTRI).

According to sources, the Union health ministry has already taken the decision in-principle to make the registration of BA/BE studies mandatory, on the same lines of the other clinical trials in the country. The drugs controller general of India (DCGI) Dr Surinder Singh has already directed the senior officials in the CTRI to make the necessary changes in its web network to incorporate the BA/BE features, sources said.

According to sources, just like the clinical trials, the DCGI wanted to streamline the BA/BE studies in the country. So far, registration of BA/BE studies with the CTRI was optional. Once the DCGI makes it mandatory, all the BA/BE studies have to be registered with the CRTI without which the DCGI will not give permission to conduct BA/BE studies which are conducted on healthy volunteers.

ROLE OF ETHICS COMMITTEES

The most costly part of new drug discovery is the three phase clinical research lasting for three to four years involving thousands of human volunteers and investigators in multi locations. Any of these potential drug candidates can be abandoned during the trial period if their adverse drug events are beyond the acceptable limits. 

It is certainly a high risk activity involving millions of dollars and pharmaceutical companies usually make sure that trial reports reaching the regulatory authorities are favourable. No new drug can be approved for marketing without submission of trial reports and their scrutiny by the regulatory authorities. Because of these reasons, the whole operation  of clinical research is highly secretive. 

Apart from top MNCs like Pfizer, GSK, Novartis and Novo Nordisk, there are a large number of contract research organizations engaged in clinical trials in India for the last ten years.

Compensation package for clinical trial victims in the offing

NEW DELHI: India will soon quantify the amount of compensation to be paid by pharmaceutical companies, if a volunteer dies or gets injured during a clinical trial.

On October 10, the Drug Technical Advisory Board (DTAB) gave its nod to the Central Drugs Standard Control Organization (CDSCO) to prepare a "compensation chart" or extensive guidelines that will specify the amount to be paid.

Ethical committees of the company will have to decide the quantum of compensation on the basis of these guidelines.

The compensation has to be paid by the trial's sponsor or its representative within 90 days of the death or injury to the victim or the next of h/his kin. In the first 30 days, the firm will have to prove to the ethics panel that the death or injury wasn't due to the drug, else it has to pay.

In India, pharma companies pay compensation "according to their will" that varies between Rs 1 lakh and Rs 10 lakhs since "no set parameters have been laid down".

CTRI Confirms Leading Indian CRO Supports Majority of Hemophilia Trials in India

Max Neeman International is the only CRO in India to manage hemophilia trials according to the Clinical Trials Registry-India (CTRI). Of the total hemophilia trials currently being conducted in India, Max Neeman can boast supporting 80% of these with the remaining conducted by pharma companies. 

Max Neeman International has established a team of experts specialized in carrying out hemophilia trials in response to sponsor demand. The team has the required expertise via involvement of academia with industry, hemophilia trial experience and extensive database of best Investigators for indication to develop innovative approaches to optimize complex study design. Often strict inclusion/exclusion criteria and data analysis for such studies create the greatest challenge for Biotech and Pharma that the company's expertise can address.

BE guidelines regarding investigator

BE guidelines recommend investigator should possess appropriate medical qualification, experience for conducting pharmacokinetic studies

Can chairperson of EC directly write to sponsor to clarify some of the queries of clinical trial raised in EC meeting?
Dr. Sreevatsa

Please see an extract from FDA's comment on IRB-sponsor relationship.

The interrelationship and interaction between the research sponsor (e.g., drug, biologic and device manufacturers), the clinical investigator and the Institutional Review Board (IRB) may be very complex. The regulations do not prohibit direct sponsor-IRB contacts, although, the sponsor-IRB interaction customarily occurs through the investigator who conducts the clinical study.

The clinical investigator generally provides the communication link between the IRB and the sponsor. Such linkage is agreed to by the sponsors and investigators when they sign forms FDA-1571 and FDA-1572, respectively, for drug and biologic studies or an investigator agreement for device studies. There are occasions when direct communication between the IRB and the sponsor may facilitate resolution of concerns about study procedures or specific wording in an informed consent document. The clinical investigator should be kept apprised of the discussion.

In India, there is no separate guidance on pregnancy reporting

How will we conclude that the subject is illiterate?
Dr Prakash Atlam
The guidelines don’t use the term illiterate. Their focus is subject’s ability to read and/or write.

Schedule Y treats anyone who is unable to read or write in the same way. See the excerpt below.

If the subject or his/her legally acceptable representative is unable to read/write - an impartial witness should be present during the entire informed consent process who must append his/her signatures to the consent form.

While designing a protocol we found that there are high likely chances of worsening of some of the symptoms. Do we have to wait for these to happen and report it as SAE or in case we define them in the protocol upfront then can we prevent from expediting reporting it as SAE?
Om
Please see suggested guidance from ICH. Exemption from reporting such events would require prior agreement with regulatory authorities.

ICH E3 12.2.2 Display of Adverse Events: All adverse events occurring after initiation of study treatments (including events likely to be related to the underlying disease or likely to represent concomitant illness, unless there is a prior agreement with the regulatory authority to consider specified events as disease related) should be displayed in summary tables (section 14.3.1). The tables should include changes in vital signs and any laboratory changes that were considered serious adverse events or other significant adverse events. In most cases, it will also be useful to identify in such tables "treatment emergent signs and symptoms" (TESS; those not seen at baseline and those that worsened even if present at baseline).