My Clinical Trials Diary

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 b...

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 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 a...

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 occurrin...

Can an Ethics Committee member e.g. layman/chairman or anyone in the committee participate in the trial as a subject? Vidya If an Ethics Committee member becomes a trial subject on a trial that he/she was involved in approving then there has been a major conflict of interest. The following situations need to be considered: ● IEC member reviews study without any prior knowledge of the study, votes, and then afterwards is approached by clinical research team to participate. Possibly this is OK but the member should no longer be part of the IEC that reviews that study. This will be difficult in practice, so therefore it is not advisable. ● IEC member already knows about the study and is voting in order to be able to participate. This is clearly not acceptable and made worse if there is additional financial incentive for the study (e.g. volunteer study). ICH GCP requires Ethics Committee members to be independent of the investigator and the sponsor to avoid confl...

Is it necessary to obtain DCGI/EC approval for clinical trial of nutraceutical and register the trial in CTRI? Is it essential to carry out toxicity studies? Binu Kuruvilla DCGI approval is not required unless the indication claim is as per definition of a new drug as per Drugs & Cosmetics Rules.   The definition of drug is as follows: All medicines for internal or external use of human beings and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings. In addition, you should consider new drug definition as per Rule 122E. A drug is considered a new drug if 1) it is a new chemical, biological or recombinant bio-technological or such devices or delivery systems 2) a drug already approved for certain claims is now being considered for modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration 3) f...

Please clarify re: patient reported outcome (PRO) instruments: 1) Post translations whose responsibility is it to validate the translated version of the questionnaire? 2) Could the translated version be submitted to the regulatory authority without validation? 3) Whose responsibility is it to submit the translated questionnaire post validation? 4) If any modification is done in the validated translated version then is there a requirement to validate the modified version and then submit the same to the regulatory authority? 5) What if a translated questionnaire is used without validation considering a situation where only English document has been submitted to the regulatory authorities and the translated version have only been submitted to the respective Ethics Committees? Garima Singh For 1) & 3) - FDA has released a guidance on PRO in Dec 2009. It is addressed to sponsors. Hence, they are responsible for validation of the PRO instrument - both English as well as t...