|Year : 2022 | Volume
| Issue : 2 | Page : 57-59
Insurance for clinical trials in ASU drugs: An area that needs attention
Subarna Roy1, Manish Barvaliya2, N Chandan3
1 Director and Scientist G, ICMR-National Institute of Traditional Medicine, Belagavi, Karnataka, India
2 Scientist E, Department of Health Systems Research, ICMR-National Institute of Traditional Medicine, Belagavi, Karnataka, India
3 Scientist B, Department of Health Systems Research, ICMR-National Institute of Traditional Medicine, Belagavi, Karnataka, India
|Date of Submission||01-Nov-2022|
|Date of Acceptance||22-Nov-2022|
|Date of Web Publication||12-Dec-2022|
ICMR.National Institute of Traditional Medicine, Belagavi, Karnataka
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Roy S, Barvaliya M, Chandan N. Insurance for clinical trials in ASU drugs: An area that needs attention. Indian J Ayurveda lntegr Med 2022;3:57-9
|How to cite this URL:|
Roy S, Barvaliya M, Chandan N. Insurance for clinical trials in ASU drugs: An area that needs attention. Indian J Ayurveda lntegr Med [serial online] 2022 [cited 2023 Jun 6];3:57-9. Available from: http://www.ijaim.in/text.asp?2022/3/2/57/363112
There is renewed interest in traditional systems of medicine, particularly in India, where there are concerted efforts to strengthen the reach and utility of AYUSH systems. The National Health Policy, 2017, stresses upon the need to promote plurality in health-care delivery. The government is projecting India as a future health and wellness hub for the world, and therefore, the health sector is destined to grow enormously in the next few years. The proposed “heal in India” initiative will attract many foreign patients to the country, and AYUSH systems will likely be the mainstay for such programs. It is, therefore, obvious that research and enterprise in these areas will increase manifold. Research is the systematic collection, analysis, and interpretation of data to answer a certain question or solve a problem. It is done to establish facts and reach new conclusions. There are various types of research that include basic, applied, and translatory aspects. Clinical trials are among the ultimate in research and development work that is systematically designed experiments on human participants (either healthy volunteers or patients) to evaluate the efficacy and safety of drugs, vaccines, medical devices, and diagnostics for the prevention, treatment, or diagnosis of specific diseases. In India, clinical trials are mainly categorized into two types: academic and regulatory.
An “academic clinical trial” is conducted with an approved drug for a certain claim by any investigator from any academic or research institution for evaluating a new indication/route of administration/dose or dosage form. It is also called an “investigator-initiated trial” where the main intention of performing such a trial is to generate evidence but not for the approval of any regulatory authority. In contrast, a “regulatory clinical trial” is intended to generate data for the regulatory authority's approval to market the products. Academic clinical trials should be conducted following National Ethical Guidelines for Biomedical and Health Research involving human participants 2017, whereas regulatory clinical trials should, in addition, follow the New Drug and Clinical Trial Rules 2019 (NDCT Rules, 2019). Clinical trials in AYUSH does not have such clear-cut demarcation for clinical trials as on date. It is mandated that clinical trials for Ayurveda, Siddha, and Unani (ASU) drugs should be carried out following “Good Clinical Practice Guidelines for clinical trials of ASU Medicine” by the Ministry of AYUSH.
Whether it is a trial with ASU or modern medicine, academic or regulatory, all applicable guidelines stipulate the provisioning of compensations for study-related injury, if that happens, to any participant or their legal dependent. When an injury occurs to any participant during a clinical trial, free medical management to such a participant should be provided by the investigator/sponsor up to the duration required in the opinion of the investigator, or otherwise, the investigator has to prove that the injury is not related to the clinical trial. In case of permanent disability, serious injury, or death of a participant due to the study, compensation should be provided to the participant or legal representative of the participant by the sponsor or its representative. For calculating the quantum of compensation, the Seventh Schedule of the NDCT Rules 2019 has provided certain formulas. For the death of a participant, a quantum of compensation is decided by a formula (B*F*R)/99.37 where B is the base amount of INR 8 lakhs, and F is the age-related factor that decreases with increasing age. R is for risk based on the severity of the disease under investigation, which also decreases with more severity. In case of death due to study-related injury, minimum compensation would be INR 2 lakhs, whereas maximum compensation would be INR 73.59 lakhs. If a permanent disability of 100% occurs to any participant, a quantum of compensation should be 90% of the death-related compensation that would apply to the participant. The formula to calculate the quantum of disability compensation is (C*D*90)/(100 × 100), where C is calculated compensation in case of death of that participant and D is the percentage of disability. The maximum compensation in case of disability can be INR 66.23 lakhs. The compensation in case of congenital anomalies would be a lump sum amount that should bring a monthly interest amount equivalent to half of the minimum wage of the unskilled worker (in Delhi). In such cases of serious injury, compensation shall be half of the base amount (INR 8 lakhs) as per the formula for determining the death compensation. In case of injury that is nonpermanent, a quantum of compensation should be enough to meet the daily wedge loss.
Clinical trial insurance is liability insurance that offers protection against legal liabilities arising from the conduct of a clinical trial. It covers mainly the compensation and medical expense liabilities in case of study-related injuries. In addition, clinical trial insurance may cover defense costs, manslaughter defense costs, bodily injury, and cover for the ethics committee on negotiation with the insurance company. However, the investigator should also keep exclusions from coverage in mind. Most insurance companies do not cover pain/suffering during the trial, issues related to medical malpractice, the inefficacy of clinical test/trial drugs, punitive damages, expected injury, compensation for study participation, etc. Investigators should, therefore, understand the requirement of clinical trial insurance based on the level of risk to the study participants by carefully assessing the risk of the trial drug and the severity of the conditions to be studied. All the details should be provided to the insurance provider clearly, as failure to disclose the required information may create disagreements at the time of claim. Terminologies concerning insurance must be understood by the investigator, and he/she should also understand how the insurance premium fluctuates with each term and its liability amount. [Table 1] explains the important terms to be careful about while purchasing insurance. Before finalizing the insurance, the terms and conditions of clinical trial insurance should be discussed with the study team and a lawyer. Terms and conditions can be finalized with the insurance provider through a series of negotiations. All these procedures may take up to 2–3-month time, and therefore, purchasing insurance should be planned well in advance before starting the recruitment of trial participants. Most insurance providers do not agree for covering study participants who are already enrolled in a trial. Investigator should also keep in mind that the insurance policy is a legal document, and it must be submitted to the institutional ethics committee for review at the time of approval.
Academic trials are mainly carried out with drugs or devices already in the market for some time. The risk involved to such participants is less as compared to regulatory trials. These are mainly reversible injuries where free medical care with loss of wages due to participation in the study should be provided. However, investigators should always keep provisions for compensation for study-related injuries. The institutional ethics committees shall always enquire about the mechanisms adopted by investigators to provide medical care or compensation in case of study-related injury. Many institutes have implemented their own standard operative mechanisms in such instances. Insurance companies also provide blanket insurance for the institutes for academic clinical trials to meet the legal liabilities for a specified period.
In the Clinical Trial Registry of India, there were 3632 AYUSH-related studies registered from 2009 to 2020, of which 86.2% were intervention studies, including randomized controlled trials (49.1%), single-arm studies (33.9%), and nonrandomized trials (3.2%) Good clinical practice guidelines for clinical trials of ASU medicine also favors obtaining insurance before starting of clinical trials. However, it sometimes becomes difficult to convince insurance companies about regulations and guidelines to be followed for such clinical trials. Ayurveda, Siddha, and Unani are the oldest systems of medicine and are relatively safer than the modern system. The calculations for insurance based on risk evaluation may differ for clinical trials of ASU medicines. How terms and conditions for insurance and coverage should be different for ASU medicines than the modern drugs is questionable as there are no phase-wise clinical trials for these medicines, as in the case of modern drugs. Furthermore, there is a lack of regulatory authority above the respective ethics committees of the institutions for monitoring and oversight of clinical trials in ASU drugs. Therefore, an independent review of the decisions of the ethics committees on matters of compensation does not exist. The number of clinical trials carried out on ASU drugs has been extremely low, and therefore, not many insurance providers are also aware of the needs of the sector.
Clinical trial insurance not only helps protect the rights and liabilities of trial participants but also helps protect the investigators and institutions against financial losses and adds professionalism and transparency to research. To achieve the target of making India a global health-care hub with integrated and pluralistic health systems, research in ASU drugs should be promoted with the same professionalism and regulatory mechanisms as seen with modern medicine. For this to happen, researchers across the country should be made aware of the various provisions in the guidelines that regulate research and encourage them to get their clinical trials insured appropriately to ensure ethical, legal, and voluntary enrolment of study participants into clinical trials of ASU drugs.
| References|| |
Shree Devi MS, Sathiyarajeswaran P, Kanakavalli K, Vinod NP, Baskar V. Analysis of AYUSH studies registered in clinical trials registry of India from 2009 to 2020. J Ayurveda Integr Med 2021;12:346-50.