Clinical Trials - IELTS Reading Sample With Explanation

The IELTS reading section examines a candidate’s comprehending skills within the stipulated amount of time. The IELTS reading section comprises passages followed with different kinds of questions to holistically judge a student’s grasping abilities while reading.

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In this IELTS Reading Answer- Clinical Trials- has explained three answers from each genre of questions to help you understand how to attempt the questions. The questions from this passage are of three types:

• Multiple-choice questions
• Completion of statements
• Completion of flowchart

Section 1

Read the Passage to Answer the Following Questions

Clinical Trials - IELTS Reading Sample

1. The benefits of vitamins to our well-being are now familiar to most; however, when the link between diets lacking in citrus fruits and the development of the affliction ‘scurvy’ in sailors was first discovered by James Lind in 1747, the concept of vitamins was yet to be discovered. Scurvy, which causes softening of the gums, oral bleeding and, in extreme cases, tooth loss, is now known to present as a result of lack of Vitamin C in the diet. Additional symptoms include depression, liver spots on the skin – particularly arms and legs – loss of colour in the face and partial immobility; high incidence of the ailment aboard ships took an enormous toll on the crew’s ability to complete essential tasks while at sea.
2. Suggestions that citrus fruit may lower the incidence or indeed prevent scurvy had been made as early as 1600. It was Lind, however, who would conduct the first clinical trial by studying the effect within scientific experimental parameters. However, while the correlation between consuming citrus fruit and avoidance of scurvy was established, the preventative properties were attributed to the presence of acids in the fruit and not what would later be identified as vitamin content.
3. Lind’s subjects for his trial consisted of twelve sailors already exhibiting symptoms of scurvy. These individuals were split into six groups; each pair common diet. Pair 1 were rationed a daily quart of cider, pair 2 elixirs of vitriol, pair 3 a given quantity of vinegar, pair 4 seawater, pair 5 oranges and a lemon and pair 6 barley water. Despite the trial having to be aborted after day five, when supplies of fruit were depleted, the findings of the interventional study showed that only the control group who were given fruit supplements showed any significant improvement in their condition (one had, in fact, recovered to the extent that he was fit enough to return to work). The immediate impact on sailors’ health and incidence of scurvy on board ship was, however, limited as Lind and other physicians remained convinced that the curative effect was acid-based. Therefore, while the consumption of citrus fruit was recommended, it was often replaced by cheaper acid supplements. The preventative Qualities of citrus fruit against scurvy were not truly recognized until 1800, though throughout the latter part of the 1700s, lemon juice was increasingly administered as a cure for sailors already afflicted.
4. Nowadays, the implementation of findings discovered in clinical trials into mainstream medicine remains an arduous and lengthy process and the clinical trials themselves represent only a small stage of the process of developing a new drug from the research stage to launch in the marketplace. On average, for every thousand drugs conceived, only one of the thousand actually makes it to the stage of the clinical trial, other projects being abandoned for a variety of reasons. Stages that need to be fulfilled prior to a clinical trial – where the treatment is actually tested on human subjects -include discovery, purification, characterization and laboratory testing.
5. A new pharmaceutical for the treatment of a disease such as cancer typically takes a period of 6 years or more before reaching the stage of a clinical trial. Since legislation requires subjects participating in such trials to be monitored for a considerable period of time so that side-effects and benefits can be assessed correctly, a further eight years typically passes between the stage of a drug entering clinical trial and being approved for general use. One of the greatest barriers to clinical trial procedures is the availability of subjects willing to participate, Criteria for selection is rigorous and trials where subjects are required to be suffering from the disease in question, experience tremendous recruitment difficulties as individuals already vulnerable due to the effects of their condition, are often reluctant to potentially put their health at higher levels of risk.
6. Clinical trials are conducted in line with a strict protocol and the stages of a trial are generally defined by five distinct phases. A drug that is deemed safe and effective enough to reach the end of stage three is most often, at that point, approved for use in mainstream medicine. Phase 0 involves a first-in-human trial (usually conducted using a small population often to fifteen subjects) with the purpose of ascertaining that the drug’s effect is, in fact, the same as predicted in preclinical studies. If no concerns are raised, the drug then enters Phase 1 of trial where a modest selection (usually between twenty and eighty subjects) of usually healthy volunteers, is exposed to the drug. However, for HIV and cancer drugs, this stage is conducted using patients suffering from the condition in question. There are two main variations of Phase I testing, these being SAD (single ascending dose) and MAD (multiple ascending doses). The former involves a single administration of a drug at a predetermined level to one group of subjects, and the second involves the administration of a predetermined sequence of dosages.
7. Phases 0 and 1 are geared towards establishing the safety of pharmaceutical and once this has been confirmed, drugs pass into Phase II testing where, while safety continues to be monitored, the drug’s effectiveness is also assessed using a larger group of subjects, ranging from twenty up to three hundred. In some trials, Phase II is regarded as involving two sub-stages, in that Phase 11(a) may be concerned with establishing optimum dosage levels and Phase 11(b) to evaluate effectiveness. Phase III is the most expensive, time-consuming and complex stage of the trial process, often involving as many as 3000 patients. At this stage, a new drug’s effectiveness is rigorously tested and compared to that of the best of the existing alternatives already approved and in common use. Where research indicates that a pharmaceutical has passed all requirements of Phases 0, I, II and III, submissions to relevant regulatory and licensing bodies are then made.
8. The final phase of clinical testing, Phase IV, is conducted over a lengthy period of time post-launch for general usage. This stage is, in essence, a safety net which involves continuous monitoring of the drug, its properties and side-effects through which any long term adverse reactions, which remained undetected in the pre-launch clinical testing time frame can be discovered. Identification of harmful effects at this stage, on occasion, has led to the withdrawal of a drug from the market; for example, as was the case with cerivastatin, a cholesterol-lowering drug, which was later found to have an adverse effect on muscle reaction which, on occasion, had fatal consequences.

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Section 2

Solution and Explanation
Questions 1-4

Complete the sentences below.
Write your answers in the blank spaces next to 1-4 on your answer sheet.
The aspirant should choose NO MORE THAN TWO WORDS from the passage for each answer.

1. In advanced cases of scurvy suffers may experience _______________ along with numerous other symptoms.
2. Fruit ads had mistakenly heralded as having ______________ in incidents of scurvy prior to the identification of vitamins.
3. Lind’s subjects for the first clinical trial were seamen who were at the time of ______________ the condition in question.
4. All groups in Lind’s experiment were given an _____________ along with specific rations which had varied for each control group.

Answer 1: Tooth loss

Supporting Statement: Scurvy, which causes softening of the gums, oral bleeding, and in extreme cases, tooth loss, is now known to present as a result of lack of Vitamin C in the diet. Additional symptoms include depression, liver spots on the skin – particularly arms and legs – loss of color in the face,, and partial immobility; high incidence of the ailment aboard ships took an enormous toll on the crew’s ability to complete essential tasks while at sea.

Keywords: Extreme Cases

Keyword Location: paragraph A, third line

Explanation: Scurvy is a disease characterized by softening of gums, oral bleeding, and in severe cases it may result in tooth loss. It occurs due to deficiency of Vitamin C. Prolonged deficiency can result in several other side effects.

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Answer 2: Preventive properties

Supporting Statement: However, while the correlation between consuming citrus fruit and avoidance of scurvy was established, the preventative properties were attributed to the presence of acids in the fruit and not what would later be identified as vitamin content.

Keywords: fruits, vitamins, trial

Keyword Location: paragraph B, last line

Explanation: Fruits rich in Vitamin C prevent scurvy. However, when the clinical trials were performed by Lind which proved that the acid content has the therapeutic action and not the vitamins.

Answer 3: exhibiting symptoms

Supporting Statement: Lind’s subjects for his trial consisted of twelve sailors already exhibiting symptoms of scurvy. These individuals were split into six groups; each pair had a common diet. Pair 1 was rationed a daily quart of cider, pair 2 elixirs of vitriol, pair 3 a given quantity of vinegar, pair 4 seawater, pair 5 oranges, and a lemon, and pair 6 barley water.

Keywords: sailors, scurvy, trials

Keyword Location: Paragraph C, the first line

Explanation: As Lind decided to do a clinical trial to identify how fruits rich in vitamin C treats scurvy, he decided to do the tests on a set of subjects who were sailors and were already suffering from scurvy. He took 12 sailors who were already suffering from scurvy and carried out his trial on them.

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Questions 5-8

Choose the correct letter A, B, C or D

5. The first clinical trial had conducted for only 5 days because

1. that period of time was the planned protocol.
2. the subjects in the relevant control group had already recovered.
3. resources fundamental to the experiment had used up.
4. Those taking part in the trial were too sick to continue.

6. The impact of findings from the trial had not used to full potential because

1. Lind failed to recommend the consumption of citrus fruit.
2. ineffective substitutes had often been made available.
3. Other physicians were unconvinced by his evidence.
4. The trial was not conducted over a long enough period to be valid.

7. One of the greatest hindrances to clinical testing today is

1. low volunteer rates.
2. the poor success rate.
3. the strict protocol.
4. shortage of laboratory staff.

8. Clinical testing for HIV and cancer drugs differs from usual procedures because

1. The clinical trial phase is much longer.
2. The MAD instead of the SAD approach was used during Phase I.
3. subjects exhibiting no symptoms of the illness are not used.
4. effectiveness is more rigorously tested than safety.

Answer 5: C) resources fundamental to the experiment had used up

Supporting Statement: Despite the trial having to be aborted after day five, when supplies of fruit were depleted, the findings of the interventional study showed that only the control group who were given fruit supplements showed any significant improvement in their condition (one had recovered to the extent that he was fit enough to return to work).

Keywords: five days, aborted, trial, finished

Keyword Location: Paragraph C, fourth line

Explanation: The clinical trial to test the action of citrus fruits on scurvy came to an abrupt and unfortunate ending after 5 days since the entire stock of citrus fruits was finished by the end of 5 days.

Answer 6: B) ineffective substitutes had often been the been made available

Supporting Statement: The immediate impact on sailors’ health and incidence of scurvy on board ship was, however, limited as Lind and other physicians remained convinced that the curative effect was acid-based. Therefore, while the consumption of citrus fruit was recommended, it was often replaced by cheaper acid supplements.

Keywords: Cheap, supplements, etc.

Keyword Location: paragraph C, the second last line.

Explanation: Lind’s test proved that the acid content in citrus fruits treated and reduced scurvy amongst the sailors. However, the credibility of the trial was constantly questioned, since the trial was carried out for a short period of time, i.e. just for 5 days. Moreover, certain industries took the advantage of the result and sold cheap alternatives to the acid component of the citrus fruits.

Answer 7: A) low volunteer rates

Supporting Statement: One of the greatest barriers to clinical trial procedures is the availability of subjects willing to participate, Criteria for selection is rigorous and trials where subjects are required to be suffering from the disease in question, experience tremendous recruitment difficulties as individuals already vulnerable due to the effects of their condition, are often reluctant to potentially put their health at higher levels of risk.

Keywords: greatest barrier, clinical trials, subjects, etc.

Keyword Location: Paragraph E, last three lines

Explanation: Clinical trials are one of the most crucial steps involved in the release and production of a new drug. And it faces several barriers which make it unsuccessful at times. One of the greatest barriers that clinical trials face is the lack of subjects on whom the trail has to be carried out. The human subjects are often reluctant to be a part of clinical trials, since clinical trials include a large number of health risks, which people do not want to face.

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Questions 9-13

Choose ONE WORD ONLY from the passage for each answer.

Phases of Clinical Testing:

9. Phase 0: 10 to 15 subjects were tested to confirm the assumptions in the _____ stages were accurate.
10. Phase 1: Two different approaches may be used. One involving one-off exposure to the drug, other involving a _____.
11. Phase 2: May involve two sub-stages to establish ____ quantities and usefulness.
12. Phase 3: The most ___ protracted and costly of all the stages. Submissions made post-testing at this stage are all agreeable.
13. Phase 4: Precautionary monitoring continues post-launch. A serious issue uncovered can, an occasion, result in ____.

Answer 9: Pre-clinical

Supporting Statement: Phase 0 involves a first-in-human trial (usually conducted using a small population often of fifteen subjects) to ascertain that the drug’s effect is, in fact, the same as predicted in preclinical studies.

Keywords: Phase 0, fifteen, ten, subjects, ascertain, etc.

Keyword Location: Paragraph F, second line.

Explanation: The clinical trials are carried out in five phases initiated by phase 0. Phase 0 involves a small number of subjects at least ten to fifteen. It is mainly carried out to test the safety of the drug which is confirmed in the pre-clinical trials.

Answer 10: Sequence

Supporting Statement: There are two main variations of Phase I testing, these being SAD (single ascending dose) and MAD (multiple ascending doses). The former involves a single administration of a drug at a predetermined level to one group of subjects, and the second involves the administration of a predetermined sequence of dosages.

Keywords: Phase one, two phases

Keyword Location: Paragraph F, last line.

Explanation: Phase one can be performed in two phases, these two phases are, these being SAD (single ascending dose) and MAD (multiple ascending doses). The former involves a single administration of a drug at a predetermined level to one group of subjects, and the second involves the administration of a predetermined sequence of dosages.

Answer 11: Optimum

Supporting Statement: In some trials, Phase II has been regarded as involving two sub-stages, in that Phase II (a) may be concerned with establishing optimum dosage levels and Phase II (b) to evaluate effectiveness.

Keywords: optimum, dosage, phase two, etc.

Keyword Location: Paragraph G, third line

Explanation: Phase two can be performed in two sub-stages, these two phases are termed II a and II b. In Phase II (a) the trial is concerned with and focused on establishing optimum dosage levels and Phase II (b) is done to evaluate the effectiveness of the drug.

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Answer 12: Complex

Supporting Statement: Phase III is the most expensive, time-consuming and complex stage of the trial process,

Keywords: expensive, time-consuming

Keyword Location: Paragraph G, Eight line

Explanation: It is mentioned in the passage that phase III is a very expensive and complex stage and it involves 3000 patients. “Expensive” and “Time-consuming” have already been mentioned in the question, hence the answer must be complex.

Answer 13: withdrawal

Supporting Statement: “Identification of harmful effects at this stage, on occasion, has led to withdrawal of a drug”

Keywords: harmful effects, has led to

Keyword Location: Paragraph H, last third line

Explanation: At the fourth stage, precautions are monitored precisely for the identification of harmful effects. ‘Serious issues uncovered’ is similar to ‘harmful effects’ and ‘ result in’ is same as ‘led to’.